PACK CHECK · MARKET FIRST

BIAXINGeneric nameclarithromycin

Reading size

How this medicine works

Clarithromycin is a macrolide antibacterial that binds to the bacterial 50S ribosomal subunit and inhibits protein synthesis. It also involves CYP3A and transporter interactions, so a shared antibacterial class or the same 500 mg number cannot justify self-substitution.

Read source: United States ↗Current regulatory record · reviewed 2026-09-02More 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.

International brand name
BIAXIN
Generic name
clarithromycin
Dosage-form class
Historical oral clarithromycin product dossier: BIAXIN 250/500 mg immediate-release tablets, BIAXIN XL 500 mg extended-release tablets, and BIAXIN suspension containing 125/250 mg per 5 mL after constitution. A shared ingredient does not make immediate-release tablets, extended-release tablets and liquid self-interchangeable by milligrams.
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 →

No source-verifiable mainland-China trade-name cue has been established for this record. This does not establish whether the medicine exists, is approved or is available in mainland China. Check pack text and current CDE/NMPA records item by item.

FOR EVERYDAY QUESTIONS

After the leaflet, continue with the question you still need to check

What this pack is

BIAXIN is the brand name in this record; clarithromycin is the generic name. Read both together with the dosage form (multiple oral forms (tablets and oral liquid)).

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.

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.

How to read a score line: ‘scored’ or ‘unscored’ first identifies this labelled presentation. A score line by itself does not permit self-splitting, reducing or changing the product. Only an explicit statement in the current label for this exact presentation, checked with a pharmacist against the prescription, can support any further handling.

5 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.

United States label · Historical DailyMed repackaged public label (updated 22 Feb 2012); current FDA Orange Book status checked separately

Clarithromycin 250 mg per tablet; 20 tablets in a bottle

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 54868-3820-0
Form and route
BIAXIN clarithromycin immediate-release film-coated tablet · oral (historical exact-product identity field)
Container
a bottle
Listing review
Cited product evidence reviewed 2026-08-29; actual marketing, stock and availability are not established.
clarithromycin
250 mglabelled amount per tablet; not an individual's tablet count, frequency, course or conversion from another form
Package
20 tablets per pack
Labelled appearance
yellow · oval, approximately 15 mm, unscored · imprint KTUnscored in this labelled presentation
Open the presentation source ↗Historical public record · reviewed 2026-08-29

United States label · Historical DailyMed repackaged public label (updated 22 Feb 2012); current FDA Orange Book status checked separately

Clarithromycin 500 mg per tablet; 14 tablets in a bottle

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 54868-2338-2
Form and route
BIAXIN clarithromycin immediate-release film-coated tablet · oral (historical exact-product identity field)
Container
a bottle
Listing review
Cited product evidence reviewed 2026-08-29; actual marketing, stock and availability are not established.
clarithromycin
500 mglabelled amount per tablet; not an individual's tablet count, frequency, course or conversion from another form
Package
14 tablets per pack
Labelled appearance
yellow · oval, approximately 18 mm, unscored · imprint KLUnscored in this labelled presentation
Open the presentation source ↗Historical public record · reviewed 2026-08-29

United States label · Historical DailyMed repackaged public label (updated 22 Feb 2012); current FDA Orange Book status checked separately

Clarithromycin 500 mg per tablet; 20 tablets in a bottle

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 54868-4191-0
Form and route
BIAXIN XL clarithromycin extended-release film-coated tablet · oral (historical exact-product identity field)
Container
a bottle
Listing review
Cited product evidence reviewed 2026-08-29; actual marketing, stock and availability are not established.
clarithromycin
500 mglabelled amount per tablet; not an individual's tablet count, frequency, course or conversion from another form
Package
20 tablets per pack
Labelled appearance
yellow · oval, approximately 19 mm, unscored · imprint KJUnscored in this labelled presentation
Open the presentation source ↗Historical public record · reviewed 2026-08-29

United States label · Historical DailyMed repackaged public label (updated 22 Feb 2012); current FDA Orange Book status checked separately

Clarithromycin 125 mg per 5 mL after constitution; 100 mL bottle

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 54868-4919-0
Form and route
BIAXIN clarithromycin granules for oral suspension (after constitution) · oral (historical exact-product identity field)
Container
100 mL bottle
Listing review
Cited product evidence reviewed 2026-08-29; actual marketing, stock and availability are not established.
clarithromycin
125 mglabelled amount per 5 mL after constitution; not the bottle total, an individual's millilitres or a household-measure conversion
Package
100 mL per bottle after constitution
Open the presentation source ↗Historical public record · reviewed 2026-08-29

United States label · Historical DailyMed repackaged public label (updated 22 Feb 2012); current FDA Orange Book status checked separately

Clarithromycin 250 mg per 5 mL after constitution; 100 mL bottle

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 54868-3384-0
Form and route
BIAXIN clarithromycin granules for oral suspension (after constitution) · oral (historical exact-product identity field)
Container
100 mL bottle
Listing review
Cited product evidence reviewed 2026-08-29; actual marketing, stock and availability are not established.
clarithromycin
250 mglabelled amount per 5 mL after constitution; not the bottle total, an individual's millilitres or a household-measure conversion
Package
100 mL per bottle after constitution
Open the presentation source ↗Historical public record · reviewed 2026-08-29

PACKAGE-VISUAL STATUS

No current official image was found that maps one-to-one to a single original-brand strength and pack

The searchable DailyMed page is explicitly a historical Physicians Total Care repackaged label. To avoid presenting a repackaged, generic or different-form image as original-brand BIAXIN appearance, the dossier shows five reviewed text identity cards and no package image.

Open the visual-withholding verification source ↗

Open this record's official electronic leaflet ↗

LABEL READING · NOT A PRESCRIPTION

BIAXIN label reading: first separate immediate-release tablets, extended-release tablets and suspension per 5 mL

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.

The same clarithromycin name historically covered immediate-release tablets, BIAXIN XL extended-release tablets and suspension after constitution. A 500 mg immediate-release tablet and a 500 mg extended-release tablet are not self-interchangeable from the number alone. This page separates mg per tablet, mg per 5 mL after constitution, extended-release design, historical status and higher-risk interactions; it calculates no individual's tablet count, millilitres, frequency or course.

  • BIAXIN 500 mg immediate-release tablets and BIAXIN XL 500 mg extended-release tablets have the same number per tablet but are not the same release product. The historical label says BIAXIN XL is taken with food and swallowed whole, not chewed, broken or crushed. A shared 500 mg number does not permit self-switching, combining or alternating.
  • Suspension 125 mg/5 mL or 250 mg/5 mL is the concentration per 5 mL after constitution, not the bottle total or an individual amount to estimate with a household spoon. The historical label also says to shake well before each use, not refrigerate and use within 14 days after mixing; the actual product and current local instructions still require separate review.
  • The current U.S. generic clarithromycin tablet label and historical BIAXIN label both describe important interaction boundaries involving medicines such as simvastatin or lovastatin, colchicine, warfarin, certain rhythm medicines, calcium-channel blockers, carbamazepine and other CYP3A-related products. The site does not decide co-use from names alone; give a pharmacist every prescription, OTC product, supplement and actual pack.
  • FDA's 2018 Drug Safety Communication advises caution and benefit-risk review before prescribing clarithromycin to patients with heart disease. It does not mean every person will have a problem and does not support self-stopping an antibacterial or heart medicine. Chest pain, marked breathing difficulty, one-sided weakness or slurred speech requires immediate local emergency care.
  • Clarithromycin is an antibacterial and does not treat an ordinary viral cold. Do not use leftovers, share with family, switch to azithromycin, amoxicillin or another antibacterial because symptoms look similar, or assemble a course yourself.
  • Severe or bloody diarrhoea, marked abdominal pain with fever or dehydration, jaundice or dark urine, palpitations or fainting, severe rash or breathing difficulty needs prompt medical assessment. Trouble breathing, fainting, severe allergy or another emergency requires immediate local emergency care.
Open this record's official electronic leaflet ↗

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

  1. Brand and generic nameBoth must match the medicine named by the record.
  2. Dosage form and strengthTablet, capsule, injection, inhaler, patch and eye drop are not interchangeable.
  3. Market and notice dateA record applies only to the country or region and date it names.
  4. Lot, pack and manufacturerRecord these only when the official notice specifically names them.
  5. 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 checkU.S. National Library of Medicine DailyMed · United States · Public medicine label · 2026-08-29

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
  • United States · 3

This is a document-coverage summary, not a claim that the medicine is authorised, supplied, interchangeable or actively monitored in every listed market today.

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.

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.

  • FDA Drug Safety Communication: potential long-term risk with clarithromycin (BIAXIN) in patients with heart disease2018-02-22 · On 22 Feb 2018, FDA issued a Drug Safety Communication advising careful benefit-risk review before prescribing clarithromycin (BIAXIN) to patients with heart disease because long-term follow-up data suggested a potential increase in heart problems or death years after treatment. This is a dated U.S. regulatory communication for a named population context. It does not mean every user will have a problem and does not support self-stopping an antibacterial or heart medicine or switching to another antibacterial. Chest pain, marked breathing difficulty, one-sided weakness or slurred speech requires immediate local emergency care; non-emergency co-use or substitution questions require the actual pack and complete medicine list to be reviewed by the prescribing team or pharmacist.DailyMed (NLM): current U.S. clarithromycin label warning on long-term all-cause mortality risk in patients with coronary artery disease (current label evidence for the FDA communication issued 22 Feb 2018) ↗Current regulatory record · reviewed 2026-09-02

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 BIAXIN (clarithromycin). Keep the exact pack, its current label and the full medicine list together.

  1. Identify the exact product

    BIAXIN is the brand in this record and clarithromycin is the active-ingredient name. Check both with the dosage form (Historical oral clarithromycin product dossier: BIAXIN 250/500 mg immediate-release tablets, BIAXIN XL 500 mg extended-release tablets, and BIAXIN suspension containing 125/250 mg per 5 mL after constitution. A shared ingredient does not make immediate-release tablets, extended-release tablets and liquid self-interchangeable by milligrams.) and the market on the actual pack.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

HOW IT WORKS · NOT A TREATMENT PLAN

How clarithromycin works: inhibiting bacterial protein synthesis does not replace organism or interaction review

  • Acting on bacterial protein synthesis does not allow cough, fever, sore throat or sputum colour alone to identify the cause, susceptibility or need for an antibacterial.
  • Immediate- and extended-release tablets have different release profiles. The mg number describes labelled amount per tablet, not the absorption curve, individual frequency or interchangeability.
  • CYP3A/P-gp interactions can change exposure to some co-medications. Age, kidney and liver function, rhythm risk and the complete medicine list can change professional judgement, so the site does not generate a universal co-use list.
Open the primary pharmacology source ↗

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.

SOURCE-TRACEABLE ARCHIVE

BIAXINclarithromycin

This page links to public primary-source material for BIAXIN. 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

  1. BIAXIN 250/500 mg immediate-release tablets approved

    FDA Orange Book lists the NDA 050662 250 mg and 500 mg product rows as historical RLD products; current Product Type is Discontinued and RS is No.

    Current FDA Orange Book data: all five historical BIAXIN / BIAXIN XL RLD product rows are listed as Discontinued ↗
  2. BIAXIN 125/250 mg per 5 mL suspension products approved

    FDA Orange Book lists the NDA 050698 125 mg/5 mL and 250 mg/5 mL rows as historical RLD products. This dossier does not include the non-RLD historical 187 mg/5 mL row.

    Current FDA Orange Book data: all five historical BIAXIN / BIAXIN XL RLD product rows are listed as Discontinued ↗
  3. BIAXIN XL 500 mg extended-release tablet approved

    FDA Orange Book lists the NDA 050775 500 mg extended-release tablet as a historical RLD; current Product Type is Discontinued and RS is No.

    Current FDA Orange Book data: all five historical BIAXIN / BIAXIN XL RLD product rows are listed as Discontinued ↗
  4. FDA issued long-term-risk safety communication for patients with heart disease

    FDA advised careful benefit-risk review before prescribing clarithromycin to patients with heart disease; the communication does not support self-stopping or switching.

    DailyMed (NLM): current U.S. clarithromycin label warning on long-term all-cause mortality risk in patients with coronary artery disease (current label evidence for the FDA communication issued 22 Feb 2018) ↗
  5. Current U.S. generic clarithromycin immediate-release tablet label published

    This label supports current ingredient-level warning and interaction review; it does not transfer a generic product pack or availability status to historical BIAXIN.

    DailyMed (NLM): current U.S. clarithromycin 500 mg immediate-release film-coated tablet label (published 5 Mar 2026; not a BIAXIN brand identity) ↗

MARKET SCOPE

Market-record boundary

United States

All five historical RLD product rows are currently Discontinued; RS is No for each

The historical label supports reading boundaries among immediate-release tablets, extended-release tablets and suspension, but does not establish current BIAXIN stock, purchasing availability or self-substitution with a generic product.

Mainland China, EU, Japan and other markets

Current brand and product records not yet established

No local trade name, approval, strength, pack, supply, originator/generic relationship or interchangeability is inferred from the U.S. BIAXIN brand, NDA, shared generic name or historical repackaged label.

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.

Keep international and mainland China records separate

This page has a U.S. public history/regulatory archive but no mainland China record for this specific product. That does not establish whether the medicine exists, is approved or is available in mainland China. Verify product identity, dosage form, strength, holder and the current label item by item.

CDE listed-drug directory ↗ NMPA public query ↗

RECORD FAQ

Record questions

Are BIAXIN 500 mg and BIAXIN XL 500 mg the same?

No. One is immediate release and one is extended release. The same 500 mg per tablet does not make release, administration or interchangeability the same. The historical label also says XL is swallowed whole and not broken or crushed.

Does 125 mg/5 mL mean 5 mL each time?

No. It only states concentration per 5 mL after constitution, not an individual's millilitres per use. An exact prescription and professional review of age, weight, infection, kidney and liver function, dosage form and full medicine list are required.

Can clarithromycin be self-added while taking a statin or colchicine?

No. Clarithromycin has important interaction and contraindication boundaries with some statins, colchicine and many other medicines. Give the exact packs, all medicine names, forms, strengths and organ-function information to a pharmacist or prescribing team.

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.

EDITORIAL RECORD

Who prepared and checked this page

Byline
OriginDrug Content Editorial
Review role
Public primary-source verification
Last reviewed
2026-08-29
Source record
6 clickable primary-source entry points are listed with this dossier.

The review role checks source traceability, stated market, document version and product-identity fields. It is not a claim of clinical licensure, prescribing authority or individual pharmacy service. Read the editorial policy.

Search records
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