What this pack is
Levaquin is the brand name in this record; levofloxacin is the generic name. Read both together with the dosage form (oral tablet).
PACK CHECK · MARKET FIRST
LevaquinGeneric namelevofloxacin
Mainland China pack-name cue可乐必妥®Historical or public source cue · verify the current target-market record · Open reference ↗
How this medicine works
The 2019 FDA public label describes levofloxacin as inhibiting bacterial DNA gyrase and topoisomerase IV. These type II topoisomerases are involved in bacterial DNA replication, transcription, repair and recombination. This mechanism cannot determine whether symptoms are a bacterial infection or choose an antibacterial medicine, route or course.
Read source: United States ↗Historical public record · reviewed 2026-09-13More about its action and precautions →Check the market, names, dosage form and route together
A medicine may use different brand names across markets. Keep the market, brand, generic name, dosage form and route together; one matching field does not prove that two packs are the same or interchangeable.
Open the complete product-identity record
Use these fields when the pack, market name or package image needs closer checking. They are evidence boundaries, not substitution instructions.
- Mainland China pack-name cue
- 可乐必妥®
- International brand name
- Levaquin
- Source-scoped market brand names
- CRAVIT · JapanCurrent regulator record ↗The current PMDA product page lists CRAVIT (クラビット) 250 mg and 500 mg tablets and 10% fine granules, with Daiichi Sankyo as marketing authorisation holder.
- 可乐必妥 · Mainland ChinaSource-scoped evidence ↗Brand name in Daiichi Sankyo China's 2021 historical full leaflet; retained only as dated brand, strength and approval-number evidence, not current approval, pack, supply or sale eligibility.
- LEVAQUIN · United StatesHistorical regulator record ↗U.S. brand name in the 2019 FDA historical oral-tablet label archive.
- TAVANIC · EuropeFirst-party brand history ↗European brand name stated in a 2009 Daiichi Sankyo first-party release; it does not replace a current country-specific approval record.
The evidence status and note below apply only to the stated market and source. They do not prove that packs in different markets can be substituted.
- Generic name
- levofloxacin
- Dosage-form class
- Dosage form and presentation as documented in the linked primary label
- Route
- Oral
- Package-image status
- No exact original-brand package image is shown This is deliberate: do not use a retailer, repackager or another-market image to identify the pack in hand. See why and what to check instead →
Mainland China trade-name search cue:可乐必妥®. This is a historical/public cue for reading pack text. It does not establish current approval, holder, supply or sale eligibility. Open reference ↗
FOR EVERYDAY QUESTIONS
After the leaflet, continue with the question you still need to check
What this page can show
This is a source-traceable public record. It helps you read the product identity and its listed source documents; each market still needs its own current record check.
What to bring to the next conversation
Bring the actual pack, the label or prescription, and a complete medicine list when you speak with a pharmacist or clinician.
NEXT SAFE STEP
Choose the next safe check
A question about changing, combining or splitting?Put the exact packs on one list before a pharmacist or prescriber checks the full context.Open the family medicine list →A question about cost, reimbursement or availability?First lock the market, exact presentation and date. Use local official reimbursement, hospital or pharmacy channels for a current answer rather than a web estimate.Open regulator and market-record entry points →Unsure about a pack or a cross-border product?Photo reading can return possible record matches only. Check the actual product against the current regulator record for its market.Identify pack text locally →Saw a recall, approval or procurement headline?Open the original publisher, then match its product, market and date. Do not make a stop or switch decision from a headline.Read primary-source news →
PRODUCT PRESENTATION IDENTITY
Strength, pack and device identity
Package strength is not an individual dose. These fields help identify the exact labelled product; they do not calculate how much, how often, a missed-use action, splitting, switching or conversion.
These are historical U.S. LEVAQUIN tablet-label identities. CRAVIT in Japan has a separate current PMDA record. Neither record establishes the current package, availability or interchangeability of a product in another market.
15 source-backed strength, pack or device records — open the full list
First match the market, dosage form and labelled amount on the pack in hand. The number of tablets, sachets or devices in a pack is not a personal dose or schedule.
JP · Current PMDA Japan electronic label (20 May 2025; version 2)
250 mg levofloxacin per tablet; 100-tablet loose-fill plastic bottle (current Japan label)
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- 6241013F2020
- Form and route
- CRAVIT levofloxacin hydrate 250 mg oral tablet · oral (current Japan product-identity field)
- levofloxacin (as levofloxacin hydrate)
- 250 mgcurrent Japan labelled amount per tablet; not an individual tablet count, frequency or course
- Package
- 100 tablets per pack
JP · Current PMDA Japan electronic label (20 May 2025; version 2)
250 mg levofloxacin per tablet; 100-tablet PTP pack (10 × 10) (current Japan label)
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- 6241013F2020
- Form and route
- CRAVIT levofloxacin hydrate 250 mg oral tablet · oral (current Japan product-identity field)
- levofloxacin (as levofloxacin hydrate)
- 250 mgcurrent Japan labelled amount per tablet; not an individual tablet count, frequency or course
- Package
- 100 tablets per pack
JP · Current PMDA Japan electronic label (20 May 2025; version 2)
250 mg levofloxacin per tablet; 500-tablet PTP pack (10 × 50) (current Japan label)
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- 6241013F2020
- Form and route
- CRAVIT levofloxacin hydrate 250 mg oral tablet · oral (current Japan product-identity field)
- levofloxacin (as levofloxacin hydrate)
- 250 mgcurrent Japan labelled amount per tablet; not an individual tablet count, frequency or course
- Package
- 500 tablets per pack
JP · Current PMDA Japan electronic label (20 May 2025; version 2)
500 mg levofloxacin per tablet; 100-tablet loose-fill plastic bottle (current Japan label)
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- 6241013F3027
- Form and route
- CRAVIT levofloxacin hydrate 500 mg oral tablet · oral (current Japan product-identity field)
- levofloxacin (as levofloxacin hydrate)
- 500 mgcurrent Japan labelled amount per tablet; not an individual tablet count, frequency or course
- Package
- 100 tablets per pack
JP · Current PMDA Japan electronic label (20 May 2025; version 2)
500 mg levofloxacin per tablet; 50-tablet PTP pack (5 × 10) (current Japan label)
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- 6241013F3027
- Form and route
- CRAVIT levofloxacin hydrate 500 mg oral tablet · oral (current Japan product-identity field)
- levofloxacin (as levofloxacin hydrate)
- 500 mgcurrent Japan labelled amount per tablet; not an individual tablet count, frequency or course
- Package
- 50 tablets per pack
JP · Current PMDA Japan electronic label (20 May 2025; version 2)
500 mg levofloxacin per tablet; 100-tablet PTP pack (5 × 20) (current Japan label)
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- 6241013F3027
- Form and route
- CRAVIT levofloxacin hydrate 500 mg oral tablet · oral (current Japan product-identity field)
- levofloxacin (as levofloxacin hydrate)
- 500 mgcurrent Japan labelled amount per tablet; not an individual tablet count, frequency or course
- Package
- 100 tablets per pack
JP · Current PMDA Japan electronic label (20 May 2025; version 2)
500 mg levofloxacin per tablet; 500-tablet PTP pack (5 × 100) (current Japan label)
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- 6241013F3027
- Form and route
- CRAVIT levofloxacin hydrate 500 mg oral tablet · oral (current Japan product-identity field)
- levofloxacin (as levofloxacin hydrate)
- 500 mgcurrent Japan labelled amount per tablet; not an individual tablet count, frequency or course
- Package
- 500 tablets per pack
JP · Current PMDA Japan electronic label (20 May 2025; version 2)
100 mg levofloxacin per 1 g of fine granules (10%); 100 g plastic bottle (current Japan label)
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- 6241013C2024
- Form and route
- CRAVIT levofloxacin hydrate 10% fine granules · oral (current Japan product-identity field)
- levofloxacin (as levofloxacin hydrate)
- 100 mgcurrent Japan labelled amount per 1 g of granules; not an individual gram amount, sachet count, frequency or course
- Package
- 100 g per bottle
JP · Current PMDA Japan electronic label (20 May 2025; version 2)
100 mg levofloxacin per 1 g of fine granules (10%); 100 sachets of 2.5 g (current Japan label)
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- 6241013C2024
- Form and route
- CRAVIT levofloxacin hydrate 10% fine granules · oral (current Japan product-identity field)
- levofloxacin (as levofloxacin hydrate)
- 100 mgcurrent Japan labelled amount per 1 g of granules; not an individual gram amount, sachet count, frequency or course
- Package
- 100 sachets per box
United States label · FDA U.S. historical oral-tablet label (May 2019; not a current-package or availability finding)
250 mg per tablet; 50-tablet bottle (U.S. historical label)
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDC 50458-920-50
- Form and route
- levofloxacin capsule-shaped coated oral tablet · oral
- levofloxacin
- 250 mghistorical labelled amount per tablet
- Package
- 50 tablets per bottle
- Labelled appearance
- terra cotta pink · capsule-shaped coated tablet · imprint LEVAQUIN / 250
United States label · FDA U.S. historical oral-tablet label (May 2019; not a current-package or availability finding)
500 mg per tablet; 50-tablet bottle (U.S. historical label)
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDC 50458-925-50
- Form and route
- levofloxacin capsule-shaped coated oral tablet · oral
- levofloxacin
- 500 mghistorical labelled amount per tablet
- Package
- 50 tablets per bottle
- Labelled appearance
- peach · capsule-shaped coated tablet · imprint LEVAQUIN / 500
United States label · FDA U.S. historical oral-tablet label (May 2019; not a current-package or availability finding)
750 mg per tablet; 20-tablet bottle (U.S. historical label)
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDC 50458-930-20
- Form and route
- levofloxacin capsule-shaped coated oral tablet · oral
- levofloxacin
- 750 mghistorical labelled amount per tablet
- Package
- 20 tablets per bottle
- Labelled appearance
- white · capsule-shaped coated tablet · imprint LEVAQUIN / 750
CN · Daiichi Sankyo China historical public full leaflet (revised May 2021; not a current approval, supply or pack finding)
CRAVIT® levofloxacin tablets: 0.1 g (100 mg) per tablet, 10-tablet blister/box (China historical leaflet)
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- H20000655
- Form and route
- levofloxacin tablet · oral (historical-leaflet product-identity field)
- levofloxacin
- 100 mghistorical leaflet amount per tablet; not an individual tablet count or conversion
- Package
- 10 tablets per blister/box
CN · Daiichi Sankyo China historical public full leaflet (revised May 2021; not a current approval, supply or pack finding)
CRAVIT® levofloxacin tablets: 0.1 g (100 mg) per tablet, 6-tablet blister/box (China historical leaflet)
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- H20000655
- Form and route
- levofloxacin tablet · oral (historical-leaflet product-identity field)
- levofloxacin
- 100 mghistorical leaflet amount per tablet; not an individual tablet count or conversion
- Package
- 6 tablets per blister/box
CN · Daiichi Sankyo China historical public full leaflet (revised Apr 2021; not a current approval, supply or pack finding)
CRAVIT® levofloxacin tablets: 0.5 g (500 mg) per tablet, 4-tablet blister/box (China historical leaflet)
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- H20040091
- Form and route
- levofloxacin tablet · oral (historical-leaflet product-identity field)
- levofloxacin
- 500 mghistorical leaflet amount per tablet; not an individual tablet count or conversion
- Package
- 4 tablets per blister/box
LOOK CLOSER · CHECK THE SOURCE
Official product-appearance references
- Check the name and strengthMatch the full medicine name, mg, form and country on your pack to the image title.
- Enlarge to read the markingsFor tablets, read the imprint; for sachets, check the name and strength. Similar colour or shape alone is not enough.
- Compare with the official guideOpen the source below the image. If details differ or are unclear, show the actual pack to a pharmacist.
Scope: dated Japanese PMDA patient-guide images—not an exact outer package, not a China or U.S. pack. Appearance cannot establish authenticity, availability, interchangeability or how much to take.
Japan · PMDA patient guide
CRAVIT 250 mg tablet: official Japan dosage-form appearance
Not an exact outer-package image and not a China or U.S. pack; appearance alone cannot authenticate the product or determine use.
Open the official PMDA patient guide ↗Japan · PMDA patient guide
CRAVIT 500 mg tablet: official Japan dosage-form appearance
Not an exact outer-package image and not a China or U.S. pack; the 250 mg and 500 mg appearances must not be confused.
Open the official PMDA patient guide ↗Japan · PMDA patient guide
CRAVIT 10% fine granules: official Japan sachet appearance
The sachet's 250 mg per packet and 2.5 g are product-identity fields, not an individual amount or course instruction.
Open the official PMDA patient guide ↗PACKAGE-VISUAL STATUS
The repackaged historical label is not an original-brand outer package; official Japan dosage-form appearances are shown separately
The searchable DailyMed LEVAQUIN label is identified by RedPharm Drug Inc. as repackaged and cannot serve as an original-brand outer-package image. Exact LEVAQUIN, CRAVIT or 可乐必妥 outer packages therefore remain withheld. A separate module shows Japan-only CRAVIT 250 mg tablet, 500 mg tablet and 10% fine-granule dosage-form appearances from the PMDA patient guide dated 26 June 2025; they are not China or U.S. packs, authentication evidence or individual-use instructions.
LABEL READING · NOT A PRESCRIPTION
CRAVIT / LEVAQUIN label reading: first confirm market, dosage form and strength
Reading level: drug-specific label reading. This record has been expanded around its dosage form or a higher-risk reading question; the current target-market label and professional review still apply.
This module first links the PMDA Japan CRAVIT patient medication guide, updated in June 2025. Its first page separately identifies 250 mg and 500 mg tablets and 10% fine granules as levofloxacin hydrate; the 2019 U.S. LEVAQUIN oral-tablet archive remains a reading document for a different market. Neither document decides whether an infection needs an antibacterial medicine or converts package numbers into a personal tablet count, course or switching plan.
- First check the complete pack brand: CRAVIT in Japan, 可乐必妥® in the historical China material, LEVAQUIN in the U.S. historical label and TAVANIC as a European brand-history cue; then check levofloxacin, dosage form, stated strength per unit and target market. A brand family does not make products from different markets self-interchangeable.
- The May 2025 PMDA electronic label separately lists 250 mg tablets in a 100-tablet bottle and 100/500-tablet PTP packs; 500 mg tablets in a 100-tablet bottle and 50/100/500-tablet PTP packs; and 10% fine granules in a 100 g bottle or 100 sachets of 2.5 g. Total pack amount, per-tablet strength and amount per 1 g of granules are different fields and do not derive an individual's tablet, gram or sachet count or course.
- 250, 500 and 750 mg first identify the labelled strength per tablet; they are not an answer to “how many tablets today.” Tablet count, leftovers, symptom severity or someone else’s prescription do not permit self-combining strengths, halving, substituting or extending a course.
- The current PMDA electronic label and historical FDA label both contain serious adverse-reaction warnings. With sudden or persistent abdominal, chest or back pain, tendon pain or swelling, numbness or tingling, marked mood or mental-status change, severe low-glucose-like symptoms, breathing trouble or a similar concern, use local urgent medical support immediately; do not wait for a website decision, continue, or self-switch to another antibacterial medicine.
- The current PMDA electronic label notes that older adults are more prone to tendon disorders and often have reduced renal function; oral or injected corticosteroids may further increase tendon risk. A website cannot calculate any person's tablet count, interval or course from this. Have the prescriber or pharmacist review age, renal information, corticosteroid use and the complete medicine list.
- Whether an antibacterial medicine is appropriate, which route is used and how long it is used must be determined from the specific infection, testing, individual circumstances and the current target-market label. With glucose medicines, anticoagulants, antiarrhythmics, mineral supplements or multiple prescription/OTC products, bring the full medicine list and actual pack for clinician or pharmacist review; a webpage cannot decide individual combination, switching or adjustment.
- Daiichi Sankyo's official public patient-information directory exposes separate entries for CRAVIT 250 mg tablets, 500 mg tablets and 10% fine granules. This record retains that official directory together with the PMDA patient guide for enlarged reading. The three products do not replace one another or convert tablet strength, amount per gram of granules or package count into an individual amount to use.
PHARMACOVIGILANCE · OFFICIAL ROUTES
Check safety information in the right market
Start with the public label or product record linked to this dossier, then use the official safety routes below for the market that applies to the medicine in hand.
Match five details before using a safety record
- Brand and generic nameBoth must match the medicine named by the record.
- Dosage form and strengthTablet, capsule, injection, inhaler, patch and eye drop are not interchangeable.
- Market and notice dateA record applies only to the country or region and date it names.
- Lot, pack and manufacturerRecord these only when the official notice specifically names them.
- Current product informationA historical record may have been superseded by the current label.
This checklist only helps organise the right question. It does not create a personal conclusion about stopping, switching, dose, combination or suitability.
This dossier’s product-level source checkPMDA · Japan · Regulatory product record · 2026-08-24
This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk.
Markets actually represented by the reviewed product documents
- Japan · 4
- United States · 1
- Mainland China · 2
This is a document-coverage summary, not a claim that the medicine is authorised, supplied, interchangeable or actively monitored in every listed market today.
This record’s label or product-record routePMDA: CRAVIT 250 mg / 500 mg tablets and 10% fine granules patient medication guide (Japan public record; updated Jun 2025) ↗reviewed 2026-08-24
Other official market or version documents for this record
These are separately reviewed product documents for the same dossier. Their market, date, dosage form and document status must stay attached to each link; they do not establish interchangeability between products, strengths, packs, indications or countries.
- PMDA · Japan · Regulatory product record · 2026-08-20PMDA: current CRAVIT 250 mg / 500 mg tablets and 10% fine granules product page ↗Current regulatory record · reviewed 2026-08-20
- PMDA · Japan · Regulatory product record · 2026-08-30PMDA: current CRAVIT 250 mg / 500 mg tablets and 10% fine granules electronic label (20 May 2025; package section) ↗Current regulatory record · reviewed 2026-08-30
- PMDA · Japan · Regulatory product record · 2026-08-20PMDA: public-facing current CRAVIT 250 mg / 500 mg tablets and 10% fine granules page ↗Current regulatory record · reviewed 2026-08-20
- FDA · United States · Regulatory product record or label archive · 2026-09-13FDA: LEVAQUIN 2019 U.S.oral tabletsprescribing information (NDA 020634) ↗Historical public record · reviewed 2026-09-13
- Daiichi Sankyo China · Mainland China · Manufacturer public leaflet · 2026-08-20Daiichi Sankyo China: levofloxacin 0.1 g tablet leaflet (2021, historical public material) ↗Historical public record · reviewed 2026-08-20
- Daiichi Sankyo China · Mainland China · Manufacturer public leaflet · 2026-08-20Daiichi Sankyo China: levofloxacin 0.5 g full leaflet (2021, historical public material) ↗Historical public record · reviewed 2026-08-20
Reviewed official safety records
A dated record is not automatically a current alert. Read the named product, form, batch, market, date and source type before treating it as relevant.
- WHO historical quality alert: specific LEVAQUIN injection batches and unauthorised-channel risk2006-11-28 · This notice concerns only two named 2006 batches of LEVAQUIN (levofloxacin) injection 25 mg/mL in 20 mL vials and their unauthorised distribution/storage risk. It does not apply to this dossier’s oral tablets, Japanese CRAVIT, or any current product-status conclusion.WHO：2006-11-28 Levaquin injection quality and safety notice ↗Historical public record · reviewed 2026-08-22
- FDA Drug Safety Communication: peripheral-neuropathy label updates for systemic fluoroquinolones2013-08-15 · On 2013-08-15, FDA issued a Drug Safety Communication requiring clearer peripheral-neuropathy information in labels and Medication Guides for systemic (oral or injectable) fluoroquinolones. The notice explicitly lists Levaquin, Cipro and Avelox, and says this risk may occur soon after treatment starts and may persist. This is a dated U.S. class communication; it does not turn class membership into an individual stop, switch, dosage-form conversion or symptom-attribution conclusion. With acute or concerning pain, burning, tingling, numbness, weakness or altered sensation, use local medical support and have a professional check the actual product and complete medicine list.Primary-source record (open linked document) ↗reviewed 2026-08-22
Global official safety gateways
- NMPA Centre for Drug Reevaluation · Mainland ChinaPrimary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item.Drug-vigilance bulletins and safety notices ↗reviewed 2026-08-22
- FDA · United StatesPrimary FDA pages for important new safety issues, labelling changes and risk communications.Drug Safety Communications ↗reviewed 2026-08-22
- FDA MedWatch · United StatesU.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality.Safety information and serious-problem reporting ↗reviewed 2026-08-22
- EMA · European Union / European Economic AreaOfficial EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment.Pharmacovigilance overview and EudraVigilance ↗reviewed 2026-08-22
- MHRA · United KingdomPrimary UK MHRA medicine-safety updates for professionals and the public.Drug Safety Update ↗reviewed 2026-08-22
- PMDA · JapanPMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents.Medicine safety information ↗reviewed 2026-08-22
- MFDS · Republic of KoreaMFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case.Medicine safety letters ↗reviewed 2026-08-22
- HSA · SingaporeHSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information.Adverse-event reporting and medicine-safety information ↗reviewed 2026-08-22
- Health Canada · CanadaHealth Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item.MedEffect Canada: advisories, warnings and recalls ↗reviewed 2026-08-22
- TGA · AustraliaPrimary Australian TGA safety alerts, advisories and monitoring information for therapeutic products.Medicine safety alerts ↗reviewed 2026-08-22
- Swissmedic · SwitzerlandOfficial Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality.Pharmacovigilance and suspected adverse-reaction reporting ↗reviewed 2026-08-22
- Medsafe · New ZealandNew Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information.Medicine safety communications ↗reviewed 2026-08-22
- SAHPRA · South AfricaSAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information.Medicine safety information, alerts and pharmacovigilance ↗reviewed 2026-08-22
- WHO · GlobalWHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market.Medicine and vaccine safety-alert archive ↗reviewed 2026-08-22
- Anvisa · BrazilAnvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item.Pharmacovigilance, alerts and VigiMed ↗reviewed 2026-08-22
This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline.
For severe or rapidly worsening symptoms, suspected overdose, a severe allergic reaction, loss of consciousness or another emergency, use local emergency services. Do not wait for an online alert search or change a medicine from this page.
PRIVATE FAMILY LIST
Bring this record into a local medicine list
Only the brand, generic name, dosage form and route are added, and they stay in this browser. Copy strength, label directions, start/stop history and any concern from the actual pack; this tool does not calculate a dose or decide combination, switching or stopping.
Add to the family medicine list →PACK · LABEL · MEDICINE LIST
Six checks for this medicine pack
Use this card to organise questions about Levaquin (levofloxacin). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
Levaquin is the brand in this record and levofloxacin is the active-ingredient name. Check both with the dosage form (Dosage form and presentation as documented in the linked primary label) and the market on the actual pack.
Read the labelled strength in context
mg, mcg, mg/mL or a percentage describes the labelled amount in one tablet, capsule, measured volume, spray or other unit. It is not an answer to how many units a person should take.
Check before splitting or opening
Before splitting, crushing, chewing or opening anything, find an explicit instruction for this exact product in its current label and ask a pharmacist. A score line or a previous pack is not enough by itself.
Put every product on one list
Include prescriptions, over-the-counter products, eye drops, creams, vitamins, minerals, herbs and supplements. A pharmacist or prescriber needs the whole list before any combination, alternation, switch or stop is considered.
Ask a specific pharmacogenetics question
Ask which medicine, which gene and what clinical decision a result could change. A gene–drug association does not mean broad genetic testing is needed for everyone and must not be used to change treatment without professional review.
Know when to seek urgent help
For a suspected overdose, a severe allergic reaction, fainting or difficulty breathing, use the local emergency or poison-information service now. Do not wait for a website reply or alter several medicines to test what caused it.
This card does not calculate a dose, decide whether medicines can be combined, or replace a clinician or pharmacist. Market-specific current labels and the person's full context still need review.
MARKET DOCUMENTS · READ SEPARATELY
Enlarged market leaflets and regulator documents
Each link retains its own market, date, dosage form and document status. These documents support larger-print reading and item-by-item checking; they do not make products, strengths, packs, indications or use between countries or regions interchangeable.
- PMDA: CRAVIT 250 mg / 500 mg tablets and 10% fine granules patient medication guide (Japan public record; updated Jun 2025) ↗reviewed 2026-08-24
- PMDA: current CRAVIT 250 mg / 500 mg tablets and 10% fine granules product page ↗Current regulatory record · reviewed 2026-08-20
- PMDA: current CRAVIT 250 mg / 500 mg tablets and 10% fine granules electronic label (20 May 2025; package section) ↗Current regulatory record · reviewed 2026-08-30
- PMDA: public-facing current CRAVIT 250 mg / 500 mg tablets and 10% fine granules page ↗Current regulatory record · reviewed 2026-08-20
- FDA: LEVAQUIN 2019 U.S.oral tabletsprescribing information (NDA 020634) ↗Historical public record · reviewed 2026-09-13
- Daiichi Sankyo China: levofloxacin 0.1 g tablet leaflet (2021, historical public material) ↗Historical public record · reviewed 2026-08-20
- Daiichi Sankyo China: levofloxacin 0.5 g full leaflet (2021, historical public material) ↗Historical public record · reviewed 2026-08-20
CO-MEDICATION REVIEW · NOT A TREATMENT DECISION
When COUMADIN / warfarin is on the same list: review INR and bleeding-monitoring records first
The FDA's 2019 historical U.S. oral-tablet label for LEVAQUIN lists warfarin as a medicine requiring review and describes postmarketing reports of enhanced warfarin effect, increased prothrombin time or INR, and bleeding episodes. The document also states that it may not be FDA's latest approved label. This card is therefore only a dated, U.S., ingredient-level priority-review cue: promptly take both actual packs, current target-market labels, recent monitoring records, and every prescription, OTC product and supplement to the prescribing team, pharmacist or anticoagulation service. It does not decide individual co-use, provide an INR target, tablet count, timing interval or stop/switch plan, or advise self-stopping, time-separation, replacement or adjustment of either medicine.
Open the Coumadin / warfarin record →
Add both records to this device's family medicine list →
Open the primary source for this co-medication review cue ↗Historical public record · reviewed 2026-09-13HOW IT WORKS · NOT A TREATMENT PLAN
How levofloxacin works: it interferes with two enzymes needed for bacterial DNA replication
- “Affecting bacterial DNA” is not a diagnosis of infection or a medicine-selection conclusion. Whether an antibacterial medicine is needed still depends on the specific infection, testing, individual circumstances and the current target-market label.
- A shared mechanism does not make 250, 500 or 750 mg oral tablets self-convertible, combinable or substitutable, and does not derive oral solution or intravenous products from this page. Product identity, route, strength and current prescription must each be checked separately.
- A mechanism page also cannot decide combination, switching, stopping or course length. With multiple medicines, symptoms or a contemplated change, take the actual pack and complete medicine list to a clinician or pharmacist for review.
SOURCE EVIDENCE REGISTER
Source evidence map
Every public link is labelled with its market, document status and document type. A historical public record is not a current label, and an official lookup entry is not a product-specific record.
- Daiichi Sankyo: levofloxacin discovered by the company and launched as CRAVIT in Japan in 1993 (2011 release) ↗Historical public record · reviewed 2026-08-20
- Daiichi Sankyo: levofloxacin discovery and global brand-name account (2009) ↗Historical public record · reviewed 2026-08-20
- PMDA: current CRAVIT 250 mg / 500 mg tablets and 10% fine granules product page ↗Current regulatory record · reviewed 2026-08-20
- PMDA: current CRAVIT 250 mg / 500 mg tablets and 10% fine granules electronic label (20 May 2025; package section) ↗Current regulatory record · reviewed 2026-08-30
- Japan MHLW: current NHI reimbursement-listing codes for CRAVIT 250 mg / 500 mg tablets (2026 directory) ↗Current regulatory record · reviewed 2026-08-30
- PMDA: public-facing current CRAVIT 250 mg / 500 mg tablets and 10% fine granules page ↗Current regulatory record · reviewed 2026-08-20
- PMDA: CRAVIT 250 mg / 500 mg tablets and 10% fine granules patient medication guide (Japan public record; updated Jun 2025) ↗reviewed 2026-08-24
- Daiichi Sankyo Japan: official patient-information directory for CRAVIT 250 mg / 500 mg tablets and 10% fine granules ↗reviewed 2026-08-31
- FDA: LEVAQUIN 2019 U.S.oral tabletsprescribing information (NDA 020634) ↗Historical public record · reviewed 2026-09-13
- Daiichi Sankyo China: levofloxacin 0.1 g tablet leaflet (2021, historical public material) ↗Historical public record · reviewed 2026-08-20
- Daiichi Sankyo China: levofloxacin 0.5 g full leaflet (2021, historical public material) ↗Historical public record · reviewed 2026-08-20
- FDA Drugs@FDA official search entry ↗Official lookup entry · reviewed 2026-08-20
SOURCE-TRACEABLE ARCHIVE
Levaquinlevofloxacin
This page links to public primary-source material for Levaquin. The archive is historical or documentary evidence only; it does not by itself establish originator status, product quality, current labelling, availability or sale eligibility.
DOCUMENT TIMELINE
Document timeline
CRAVIT launched in Japan
Daiichi Sankyo states that levofloxacin was originally discovered by the company and first launched in Japan in 1993 under the CRAVIT® brand. This is research and brand-history evidence, not a substitute for any current market approval record.
Daiichi Sankyo: levofloxacin discovered by the company and launched as CRAVIT in Japan in 1993 (2011 release) ↗Initial U.S. approval year listed in the FDA label
The FDA label archive linked here lists Initial U.S. Approval: 1996. This historical locator is not a conclusion about current approval, availability, holder or another market.
FDA: LEVAQUIN oral-tablet label archive ↗First-party account of global brand names
A Daiichi Sankyo release identifies LEVAQUIN as the U.S. brand and TAVANIC as the European brand and again states that levofloxacin originated at Daiichi Sankyo. The name relationship supports cross-market retrieval; it does not mean dosage forms, strengths, labels or supply are the same.
Daiichi Sankyo: levofloxacin discovery and global brand-name account (2009) ↗FDA label archive version
This page links the 2019 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document.
FDA: LEVAQUIN oral-tablet label archive ↗Daiichi Sankyo China historical full 0.5 g leaflet
A full Daiichi Sankyo China public leaflet from 2021 identifies 可乐必妥® as a trade name for levofloxacin tablets and lists a 0.5 g tablet. It is a traceable historical document, not a conclusion about current Mainland China approval, holder, labeling, supply, originator status or sale eligibility.
Primary-source record (open linked document) ↗Daiichi Sankyo China historical public leaflet
A Daiichi Sankyo China public leaflet from 2021 identifies 可乐必妥® as a trade name for levofloxacin tablets and lists a 0.1 g tablet. It is a traceable historical document, not a conclusion about current Mainland China approval, holder, labeling, supply, originator status or sale eligibility.
Primary-source record (open linked document) ↗Current Japan PMDA product page
The PMDA product page lists CRAVIT 250 mg and 500 mg tablets and 10% fine granules, with levofloxacin hydrate as the non-proprietary name and Daiichi Sankyo as marketing authorisation holder. It confirms only the products listed for Japan and cannot be extrapolated to China, the United States or Europe.
PMDA: current CRAVIT 250 mg / 500 mg tablets and 10% fine granules product page ↗
MARKET SCOPE
Market-record boundary
Japan
Current PMDA product page linkedThe current PMDA page lists CRAVIT 250 mg and 500 mg tablets and 10% fine granules, with Daiichi Sankyo as marketing authorisation holder; this applies only to the products listed for Japan.
United States
FDA historical oral-tablet label linkedOnly the 2019 FDA oral-tablet document listed on this page is linked.
Mainland China
First-party historical full leaflets linked; current official record unverifiedDaiichi Sankyo China full historical 0.5 g and 0.1 g leaflets from 2021 provide traceable reading cues for 可乐必妥® tablets; they do not establish current approval, holder, strength, supply or sale eligibility.
Europe
TAVANIC brand-history cue established; current country records unverifiedA 2009 Daiichi Sankyo release states the European brand name TAVANIC; it is not used to infer current approval, holder, strength, supply or sale eligibility in any European country.
Other markets
Market record not establishedNo other-market status is inferred from Japanese, U.S., China or European material.
How to read this record
Read each document in its stated market, date and dosage-form context. A historical record is not a current label and does not support individual medical, substitution or purchasing conclusions.
RECORD FAQ
Record questions
Why does one record show CRAVIT, 可乐必妥, LEVAQUIN and TAVANIC?
They are market-specific brand-name cues for levofloxacin: Daiichi Sankyo material records CRAVIT in Japan, the historical China material uses 可乐必妥®, the U.S. brand is LEVAQUIN and the European brand-history cue is TAVANIC. The relationship supports retrieval; it does not mean current approvals, strengths, labels, packages, supply or sale eligibility are the same across markets.
READ NEXT
Related reading
Evidence status
The listed links are public sources selected for traceability. They must be rechecked against the current target-market record before any use beyond reading and research.