What this pack is
Amaryl is the brand name in this record; glimepiride is the generic name. Read both together with the dosage form (oral tablet).
PACK CHECK · MARKET FIRST
AmarylGeneric nameglimepiride
How this medicine works
This historical label describes glimepiride as primarily lowering blood glucose by stimulating insulin release from pancreatic beta cells; sulfonylureas bind the beta-cell sulfonylurea receptor and then affect the ATP-sensitive potassium channel. This explains a pathway, not an individual's glucose target, tablet count, suitability, co-use or switching plan.
Read source: United States ↗Historical public record · reviewed 2026-08-23More 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
- Amaryl
- Generic name
- glimepiride
- 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 →
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.
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.
3 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 · U.S. DailyMed historical public label (Sanofi-Aventis; revised Dec 2018; label records U.S. marketing ended 31 Aug 2023)
Glimepiride 1 mg per tablet; 100-tablet bottle (historical U.S. 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 0039-0221-10
- Form and route
- AMARYL glimepiride oral tablet (historical U.S. label) · oral (historical-label product-identity field)
- Container
- bottle
- Listing review
- Cited product evidence reviewed 2026-08-23; actual marketing, stock and availability are not established.
- glimepiride
- 1 mg1 mg is a labelled amount per tablet; not an individual's tablet count, frequency or conversion instruction
- Package
- 100 tablets per bottle
- Labelled appearance
- pink · flat oval tablet with two score marks (an appearance clue, not a splitting instruction) · imprint AMA RYLTwo score marks are visible; this is not permission to split it yourself
United States label · U.S. DailyMed historical public label (Sanofi-Aventis; revised Dec 2018; label records U.S. marketing ended 31 Aug 2023)
Glimepiride 2 mg per tablet; 100-tablet bottle (historical U.S. 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 0039-0222-10
- Form and route
- AMARYL glimepiride oral tablet (historical U.S. label) · oral (historical-label product-identity field)
- Container
- bottle
- Listing review
- Cited product evidence reviewed 2026-08-23; actual marketing, stock and availability are not established.
- glimepiride
- 2 mg2 mg is a labelled amount per tablet; not an individual's tablet count, frequency or conversion instruction
- Package
- 100 tablets per bottle
- Labelled appearance
- green · flat oval tablet with two score marks (an appearance clue, not a splitting instruction) · imprint AMA RYLTwo score marks are visible; this is not permission to split it yourself
United States label · U.S. DailyMed historical public label (Sanofi-Aventis; revised Dec 2018; label records U.S. marketing ended 31 Aug 2023)
Glimepiride 4 mg per tablet; 100-tablet bottle (historical U.S. 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 0039-0223-10
- Form and route
- AMARYL glimepiride oral tablet (historical U.S. label) · oral (historical-label product-identity field)
- Container
- bottle
- Listing review
- Cited product evidence reviewed 2026-08-23; actual marketing, stock and availability are not established.
- glimepiride
- 4 mg4 mg is a labelled amount per tablet; not an individual's tablet count, frequency or conversion instruction
- Package
- 100 tablets per bottle
- Labelled appearance
- blue · flat oval tablet with two score marks (an appearance clue, not a splitting instruction) · imprint AMA RYLTwo score marks are visible; this is not permission to split it yourself
PACKAGE-VISUAL STATUS
Historical U.S. label text was reviewed, but no one-to-one official package image was retained, so no package visual is shown
This dossier retains AMARYL, glimepiride, 1 mg/2 mg/4 mg, three NDCs, 100-tablet bottles, color and score-mark wording from a DailyMed historical public label, which records U.S. marketing end for all three products on 31 Aug 2023. The PDF includes bottle display text, but this review did not retain a separately verified image safe to present as an exact historical pack; to avoid reading a historical image as current marketing, another-market packaging or a means of authentication, the page shows no package image and retains the primary label for enlarged reading.
LABEL READING · NOT A PRESCRIPTION
AMARYL historical-label reading: identify 1/2/4 mg and the historical market record first
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 reads only Sanofi-Aventis' U.S. historical label: AMARYL, glimepiride, 1/2/4 mg per tablet, three NDCs, 100-tablet bottles and the U.S. marketing-end record of 31 Aug 2023. It does not provide individual glucose management, tablet count, missed-use, splitting, meals, add-on therapy, stopping, co-use with another glucose-lowering medicine or switching plans.
- Check AMARYL, glimepiride, 1/2/4 mg, NDC, the 100-tablet bottle and market together. mg is a labelled amount per tablet in this historical label, not a web rule for tablets per day, adding strengths or replacing another glucose-lowering medicine.
- This historical label describes two score marks on all three tablets. Score marks and color are pack/tablet checking clues, not instructions to self-split, change use, combine products or substitute another strength; the historical label also cannot be extended to a generic tablet, another market or a current product.
- The label warns about hypoglycemia, serious hypersensitivity, hemolytic anemia related to G6PD deficiency and multiple interactions; older people, people with renal impairment or people using another glucose-lowering medicine especially need review by a professional who knows the complete history and medicine list. This page does not decide continuation, pausing, make-up use or a treatment change for anyone.
- For suspected hypoglycemia, altered consciousness, seizure, serious allergic features or another acute serious concern, use local urgent and medical pathways; do not self-treat with sugar, make up medicine, stop or adjust based on this page.
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 checkU.S. National Library of Medicine DailyMed · United States · Public medicine label · 2026-08-23
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 · 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 routeDailyMed (NLM): AMARYL glimepiride U.S. historical public label (Sanofi-Aventis; revised Dec 2018) ↗Historical public record · reviewed 2026-08-23
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 Amaryl (glimepiride). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
Amaryl is the brand in this record and glimepiride 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.
HOW IT WORKS · NOT A TREATMENT PLAN
How glimepiride works: it stimulates insulin release from pancreatic beta cells
- ‘Stimulating insulin release’ explains why hypoglycemia risk needs serious attention, but does not let a webpage decide how much anyone should use, how to combine it with insulin/metformin/another glucose-lowering medicine or when to stop.
- Being glucose-lowering medicines, having similar names, a changing glucose reading or mg on both packages does not establish that products can be self-combined, alternated, made up or replaced. Bring all prescription medicines, OTC products, supplements and actual packs for item-by-item pharmacist or prescriber review.
- This historical U.S. label's mechanism material does not establish product status in another market and cannot replace a current label, glucose-monitoring plan, diet/activity advice or individualised care.
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.
- DailyMed (NLM): AMARYL glimepiride U.S. historical public label (Sanofi-Aventis; revised Dec 2018) ↗Historical public record · reviewed 2026-08-23
- FDA Drugs@FDA official search entry (NDA 020496) ↗Official lookup entry · reviewed 2026-08-20
SOURCE-TRACEABLE ARCHIVE
Amarylglimepiride
This page links to public primary-source material for Amaryl. 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
Initial U.S. approval year listed in the historical label
The AMARYL U.S. historical DailyMed label lists Initial U.S. Approval: 1995. This locates only the cited U.S. historical archive and does not establish approval, supply, sale eligibility, originator/generic relationship or individual suitability in Mainland China, the EU, Japan or another market.
DailyMed (NLM): AMARYL glimepiride U.S. historical public label (Sanofi-Aventis; revised Dec 2018) ↗Historical public-label revision
The cited AMARYL label is marked revised Dec 2018. The date identifies only the document version and does not represent current labelling, current safety conclusions, stock, purchase eligibility or another-market status.
DailyMed (NLM): AMARYL glimepiride U.S. historical public label (Sanofi-Aventis; revised Dec 2018) ↗U.S. marketing-end date listed in historical product data
All three NDC product records in the same historical public label list 31 Aug 2023 as a U.S. marketing-end date. This page therefore does not describe AMARYL as currently marketed, purchasable, interchangeable or still supplied in the United States; current-product questions require current target-market official material and a professional.
DailyMed (NLM): AMARYL glimepiride U.S. historical public label (NDC 0039-0221/0222/0223; marketing-end records) ↗
MARKET SCOPE
Market-record boundary
United States
Historical product records list marketing ended for three NDCs on 31 Aug 2023This page retains only the historical-label identity and primary-document entry point for AMARYL glimepiride 1 mg, 2 mg and 4 mg, the three NDCs and 100-tablet bottles; it does not establish current marketing, stock, purchase, switching or supply.
Mainland China, EU, Japan and other markets
Current market record not establishedNo local trade name, approval, packaging, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from this U.S. historical label; each market needs separate checking against current local regulatory 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.
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
Can AMARYL's historical 1, 2 and 4 mg strengths, 100-tablet bottles and score marks decide how to use it today, split it or change to another glucose-lowering medicine?
No. These details identify only the exact tablets and bottles in the cited U.S. historical label, whose three NDCs are recorded as marketing-ended in the United States. A shared generic name, similar mg number, color, score marks or package wording does not establish self-initiation, increase, repetition, splitting, stopping, co-use, alternation or substitution; have a pharmacist or prescribing team review the current pack, prescription and complete medicine list.
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.