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)).
PACK CHECK · MARKET FIRST
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 →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.
Use these fields when the pack, market name or package image needs closer checking. They are evidence boundaries, not substitution instructions.
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
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)).
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.
Bring the actual pack, the label or prescription, and a complete medicine list when you speak with a pharmacist or clinician.
NEXT SAFE STEP
PRODUCT PRESENTATION 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.
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
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.
United States label · Historical DailyMed repackaged public label (updated 22 Feb 2012); current FDA Orange Book status checked separately
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.
United States label · Historical DailyMed repackaged public label (updated 22 Feb 2012); current FDA Orange Book status checked separately
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.
United States label · Historical DailyMed repackaged public label (updated 22 Feb 2012); current FDA Orange Book status checked separately
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.
United States label · Historical DailyMed repackaged public label (updated 22 Feb 2012); current FDA Orange Book status checked separately
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.
PACKAGE-VISUAL STATUS
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.
LABEL READING · NOT A PRESCRIPTION
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.
PHARMACOVIGILANCE · OFFICIAL ROUTES
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.
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 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.
This is a document-coverage summary, not a claim that the medicine is authorised, supplied, interchangeable or actively monitored in every listed market today.
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.
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.
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
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
Use this card to organise questions about BIAXIN (clarithromycin). Keep the exact pack, its current label and the full medicine list together.
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.
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.
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.
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 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.
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
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
SOURCE EVIDENCE REGISTER
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
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
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 ↗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 ↗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 ↗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) ↗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
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.
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.
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.
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
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.
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.
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
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.