What this pack is
CEFTIN is the brand name in this record; cefuroxime axetil is the generic name. Read both together with the dosage form (multiple oral forms (tablets and oral liquid)).
PACK CHECK · MARKET FIRST
CEFTINGeneric namecefuroxime axetil
How this medicine works
After oral administration, cefuroxime axetil is converted to cefuroxime, which acts through bacterial penicillin-binding proteins and inhibition of cell-wall synthesis. The mechanism explains the class but cannot establish the organism, susceptibility, need for an antibacterial or course from symptoms alone.
Read source: Canada ↗Current regulatory record · reviewed 2026-08-29More 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
- CEFTIN
- Source-scoped market brand names
- CEFTIN · United StatesHistorical regulator record ↗Historical FDA Orange Book RLD; tablets and suspension are currently listed as discontinued.
- CEFTIN · CanadaCurrent regulator record ↗Current Health Canada DIN 02212307: 125 mg/5 mL granules for suspension, Sandoz Canada.
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
- cefuroxime axetil
- Dosage-form class
- Cefuroxime axetil oral tablets and reconstituted oral suspension; mg per tablet and mg/5 mL use different measurement bases and cannot be directly exchanged from the numbers alone
- 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 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.
6 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 product identity in the current FDA Orange Book dataset (checked 29 Aug 2026)
Equivalent to cefuroxime 125 per tablet; historical U.S. RLD currently listed as discontinued
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
- NDA 050605 / Product 001
- Form and route
- CEFTIN cefuroxime axetil oral tablet (historical U.S. RLD) · oral (historical regulatory product-identity field)
- Listing review
- Cited product evidence reviewed 2026-08-29; actual marketing, stock and availability are not established.
- cefuroxime (supplied as cefuroxime axetil)
- 125 mghistorical regulatory amount per tablet; not an individual's tablet count, frequency or course
United States label · Historical product identity in the current FDA Orange Book dataset (checked 29 Aug 2026)
Equivalent to cefuroxime 250 per tablet; historical U.S. RLD currently listed as discontinued
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
- NDA 050605 / Product 002
- Form and route
- CEFTIN cefuroxime axetil oral tablet (historical U.S. RLD) · oral (historical regulatory product-identity field)
- Listing review
- Cited product evidence reviewed 2026-08-29; actual marketing, stock and availability are not established.
- cefuroxime (supplied as cefuroxime axetil)
- 250 mghistorical regulatory amount per tablet; not an individual's tablet count, frequency or course
United States label · Historical product identity in the current FDA Orange Book dataset (checked 29 Aug 2026)
Equivalent to cefuroxime 500 per tablet; historical U.S. RLD currently listed as discontinued
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
- NDA 050605 / Product 003
- Form and route
- CEFTIN cefuroxime axetil oral tablet (historical U.S. RLD) · oral (historical regulatory product-identity field)
- Listing review
- Cited product evidence reviewed 2026-08-29; actual marketing, stock and availability are not established.
- cefuroxime (supplied as cefuroxime axetil)
- 500 mghistorical regulatory amount per tablet; not an individual's tablet count, frequency or course
United States label · Historical product identity in the current FDA Orange Book dataset (checked 29 Aug 2026)
Equivalent to cefuroxime 125 per 5 mL after reconstitution; historical U.S. RLD currently listed as discontinued
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
- NDA 050672 / Product 001
- Form and route
- CEFTIN cefuroxime axetil powder for oral suspension (historical U.S. RLD) · oral (historical regulatory product-identity field)
- Labelled concentration
- 125 mg/5 mL after reconstitutionProduct identity, not an individual dose
- Listing review
- Cited product evidence reviewed 2026-08-29; actual marketing, stock and availability are not established.
- cefuroxime (supplied as cefuroxime axetil)
- 125 mghistorical regulatory concentration per 5 mL after reconstitution; not an individual's millilitres, frequency or course
United States label · Historical product identity in the current FDA Orange Book dataset (checked 29 Aug 2026)
Equivalent to cefuroxime 250 per 5 mL after reconstitution; historical U.S. RLD currently listed as discontinued
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
- NDA 050672 / Product 002
- Form and route
- CEFTIN cefuroxime axetil powder for oral suspension (historical U.S. RLD) · oral (historical regulatory product-identity field)
- Labelled concentration
- 250 mg/5 mL after reconstitutionProduct identity, not an individual dose
- Listing review
- Cited product evidence reviewed 2026-08-29; actual marketing, stock and availability are not established.
- cefuroxime (supplied as cefuroxime axetil)
- 250 mghistorical regulatory concentration per 5 mL after reconstitution; not an individual's millilitres, frequency or course
CA · Current Health Canada product monograph (3 Oct 2025)
Equivalent to cefuroxime 125 mg per 5 mL after reconstitution; the public record does not establish an individual's millilitres
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
- DIN 02212307
- Form and route
- CEFTIN cefuroxime axetil granules for oral suspension · oral (current Canadian market record)
- Labelled concentration
- 125 mg/5 mL after reconstitutionProduct identity, not an individual dose
- Listing review
- Cited public label display reviewed 2026-08-29; actual marketing, stock and availability are not established.
- cefuroxime (supplied as cefuroxime axetil)
- 125 mglabelled concentration per 5 mL after reconstitution; not an individual's millilitres, frequency or course
PACKAGE-VISUAL STATUS
Six official text product identities are established; no generic, retail or historical image is presented as an originator-brand pack
FDA data verify dosage form, strength, NDA, product number, RLD and discontinued status for five historical U.S. products; Health Canada verifies the current Canadian DIN, form and concentration. The reviewed official sources do not provide an originator-brand principal display panel safely matched one-to-one to all six identities, so the page shows traceable text cards and an enlarged label while explicitly disclosing the image gap.
LABEL READING · NOT A PRESCRIPTION
CEFTIN label reading: separate mg per tablet, mg/5 mL after reconstitution and an individual's millilitres
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 current Canadian monograph identifies CEFTIN as an oral suspension containing 125 mg/5 mL after reconstitution. 125 mg/5 mL is a concentration, not an instruction to take 5 mL and not anyone's dose. Actual millilitres, frequency and course must return to the exact prescription, age/weight, infection context, kidney function and dosing device.
- Tablet 125, 250 and 500 mg values are per tablet; suspension 125 or 250 mg/5 mL values are concentrations per 5 mL after reconstitution. Matching numbers do not permit self-substitution between tablets and suspension, and FDA label material states that the forms are not bioequivalent and are not directly substitutable milligram for milligram.
- Use the pharmacy label and an oral dosing device for the reconstituted Canadian suspension; an ordinary kitchen spoon is not an accurate dosing device. The monograph requires refrigeration at 2–8°C and disposal of the remaining reconstituted suspension after 10 days. The site does not convert the concentration into individual millilitres.
- The Canadian monograph recommends use with food for optimal absorption, but this page does not decide personal timing or extend that statement to historical U.S. tablets, another brand or another market. Check the exact pack and current local label first.
- Before use, disclose cephalosporin, penicillin or other drug allergies, kidney problems and the complete medicine list. Breathing difficulty, swelling of the face/lips/tongue/throat, fainting, a severe skin reaction or chest discomfort with allergic features requires immediate local emergency care. Severe, persistent or bloody diarrhoea needs prompt medical assessment.
- Acid-reducing medicines, aminoglycosides, diuretics and all other prescription, OTC and supplement products belong on the complete medicine list for pharmacist or prescriber review. The site does not decide co-use, separation or adjustment from two medicine names alone.
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 checkHealth Canada · Canada · Regulatory product record or current product monograph · 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
- Canada · 1
- United States · 1
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 routeHealth Canada: current CEFTIN cefuroxime axetil suspension product monograph and patient medication information (3 Oct 2025) ↗Current regulatory record · reviewed 2026-08-29
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.
- FDA · United States · Regulatory product record or label archive · 2026-08-29FDA Orange Book: historical RLD records for CEFTIN (cefuroxime axetil) NDA 050605 tablets and NDA 050672 suspension ↗reviewed 2026-08-29
This is not a conclusion that the medicine has no risk, warning, recall or newer notice in another market. Start with the checked product-level label above, then use the official market gateways below for the product in hand.
See the reviewed safety-record directory →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 CEFTIN (cefuroxime axetil). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
CEFTIN is the brand in this record and cefuroxime axetil is the active-ingredient name. Check both with the dosage form (Cefuroxime axetil oral tablets and reconstituted oral suspension; mg per tablet and mg/5 mL use different measurement bases and cannot be directly exchanged from the numbers alone) 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.
- Health Canada: current CEFTIN cefuroxime axetil suspension product monograph and patient medication information (3 Oct 2025) ↗Current regulatory record · reviewed 2026-08-29
- FDA Orange Book: historical RLD records for CEFTIN (cefuroxime axetil) NDA 050605 tablets and NDA 050672 suspension ↗reviewed 2026-08-29
HOW IT WORKS · NOT A TREATMENT PLAN
How cefuroxime works: inhibiting bacterial cell-wall synthesis does not mean it treats every fever or cough
- Antibacterials do not treat an ordinary viral cold. Do not use leftovers, share, self-start because symptoms seem similar or shorten a prescribed course because you feel better.
- CEFTIN, KEFLEX, amoxicillin, AUGMENTIN, ZITHROMAX and LEVAQUIN are not one medicine that can be self-switched, alternated or combined from milligram numbers. Class, organism and susceptibility, infection site, allergy history, kidney function and the complete medicine list all affect professional judgement.
- The site explains the exact product and official label. It does not select an antibacterial, calculate tablets or millilitres, or decide whether culture, susceptibility testing or follow-up is needed for an individual.
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.
- FDA Orange Book: historical RLD records for CEFTIN (cefuroxime axetil) NDA 050605 tablets and NDA 050672 suspension ↗reviewed 2026-08-29
- FDA: CEFTIN NDA 050605/S-051 and NDA 050672/S-037 supplemental approval letter (25 Apr 2019) ↗reviewed 2026-08-29
- Health Canada: current Drug Product Database (DPD) access page; search CEFTIN 125 mg/5 mL / DIN 02212307 in the database ↗Official lookup entry · reviewed 2026-09-13
- Health Canada: current CEFTIN cefuroxime axetil suspension product monograph and patient medication information (3 Oct 2025) ↗Current regulatory record · reviewed 2026-08-29
SOURCE-TRACEABLE ARCHIVE
CEFTINcefuroxime axetil
This page links to public primary-source material for CEFTIN. 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
FDA approved CEFTIN oral tablets
The current Orange Book dataset links 125, 250 and 500 mg tablets to NDA 050605, RLD identity and current discontinued status.
FDA Orange Book: historical RLD records for CEFTIN (cefuroxime axetil) NDA 050605 tablets and NDA 050672 suspension ↗FDA approved the 125 mg/5 mL suspension
This product belongs to NDA 050672; the 250 mg/5 mL product was later approved on 29 Apr 1997. Both are currently listed as discontinued.
FDA Orange Book: historical RLD records for CEFTIN (cefuroxime axetil) NDA 050605 tablets and NDA 050672 suspension ↗FDA approved CEFTIN labelling supplements
The approval letter links the tablet and suspension NDAs as a dated regulatory node; it is not a finding of current stock or relaunch.
FDA: CEFTIN NDA 050605/S-051 and NDA 050672/S-037 supplemental approval letter (25 Apr 2019) ↗Current Health Canada monograph date
DIN 02212307 is currently listed as marketed: granules for suspension, 125 mg/5 mL, held by Sandoz Canada Inc.
Health Canada: current Drug Product Database (DPD) access page; search CEFTIN 125 mg/5 mL / DIN 02212307 in the database ↗
MARKET SCOPE
Market-record boundary
United States
Five historical RLD products are currently listed as discontinuedThe FDA identities are retained for historical traceability and do not establish stock, purchasing availability, individual suitability or direct interchangeability with a current generic.
Canada
DIN 02212307 125 mg/5 mL granules for suspension are currently listed as marketed‘Marketed’ is a regulatory-database status, not proof of stock at a particular pharmacy or an individual purchasing or use recommendation.
Mainland China, EU, Japan and other markets
Current market record not establishedNo local trade name, approval, holder, pack, supply, originator/generic relationship or interchangeability is inferred from U.S. or Canadian brand records.
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.
RECORD FAQ
Record questions
Does 125 mg/5 mL mean taking 5 mL every time?
No. It is the concentration: 125 mg in each 5 mL after reconstitution. Individual millilitres, frequency and course must come from the exact prescription and pharmacy label and be measured with an appropriate oral dosing device.
Can a 250 mg tablet and 250 mg/5 mL suspension be directly exchanged?
Do not self-exchange them from the number alone. One is an amount per tablet and the other is a concentration after reconstitution. Their forms, absorption and preparation differ, and FDA material states that the forms are not bioequivalent or directly substitutable milligram for milligram. Ask the pharmacist or prescriber to check the exact product and prescription.
Does discontinued U.S. CEFTIN mean it was unsafe?
That inference is not justified. The FDA Orange Book records a Federal Register determination that the NDA 050605 tablets were not discontinued or withdrawn for safety or effectiveness reasons. The site still does not infer a particular commercial reason, current stock or another market's status.
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.