What this pack is
Glucophage is the brand name in this record; metformin is the generic name. Read both together with the dosage form (oral tablet).
PACK CHECK · MARKET FIRST
GlucophageGeneric namemetformin
Mainland China pack-name cue格华止®Historical or public source cue · verify the current target-market record · Open reference ↗
How this medicine works
The FDA public GLUCOPHAGE / GLUCOPHAGE XR label describes metformin as decreasing hepatic glucose production and intestinal glucose absorption, and improving insulin sensitivity by increasing peripheral glucose uptake and use. These are an overview of pharmacologic pathways, not an individual dose, combination, switch or stopping plan.
Read source: United States ↗Historical public record · reviewed 2026-08-20More about its action and precautions →Check the market, names, dosage form and route together
A medicine may use different brand names across markets. Keep the market, brand, generic name, dosage form and route together; one matching field does not prove that two packs are the same or interchangeable.
Open the complete product-identity record
Use these fields when the pack, market name or package image needs closer checking. They are evidence boundaries, not substitution instructions.
- Mainland China pack-name cue
- 格华止®
- International brand name
- Glucophage
- Generic name
- metformin
- Dosage-form class
- Metformin hydrochloride immediate-release and extended-release oral tablets; verify the brand, dosage form, milligrams per tablet and market together
- Route
- Oral
- Package-image status
- A source-linked public label image is available below
Mainland China trade-name search cue:格华止®. This is a historical/public cue for reading pack text. It does not establish current approval, holder, supply or sale eligibility. Open reference ↗
FOR EVERYDAY QUESTIONS
After the leaflet, continue with the question you still need to check
What this page can show
This is a source-traceable public record. It helps you read the product identity and its listed source documents; each market still needs its own current record check.
What to bring to the next conversation
Bring the actual pack, the label or prescription, and a complete medicine list when you speak with a pharmacist or clinician.
NEXT SAFE STEP
Choose the next safe check
A question about changing, combining or splitting?Put the exact packs on one list before a pharmacist or prescriber checks the full context.Open the family medicine list →A question about cost, reimbursement or availability?First lock the market, exact presentation and date. Use local official reimbursement, hospital or pharmacy channels for a current answer rather than a web estimate.Open regulator and market-record entry points →Unsure about a pack or a cross-border product?Photo reading can return possible record matches only. Check the actual product against the current regulator record for its market.Identify pack text locally →Saw a recall, approval or procurement headline?Open the original publisher, then match its product, market and date. Do not make a stop or switch decision from a headline.Read primary-source news →
PRODUCT PRESENTATION IDENTITY
Strength, pack and device identity
Package strength is not an individual dose. These fields help identify the exact labelled product; they do not calculate how much, how often, a missed-use action, splitting, switching or conversion.
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 · DailyMed public historical archive (Bristol-Myers Squibb; representative package panel, not a current-label or availability conclusion)
500 mg per tablet; 100-tablet bottle; immediate-release historical package panel
- Product code
- NDC 0087-6060-05
- Form and route
- GLUCOPHAGE metformin hydrochloride oral film-coated tablet (archived package) · oral
- Container
- 100-tablet bottle (historical archive)
- Listing review
- Cited product evidence reviewed 2026-08-21; actual marketing, stock and availability are not established.
- metformin hydrochloride
- 500 mgamount stated per tablet in the historical label; not an individual's tablet count, immediate-/extended-release conversion, splitting or adjustment rule
- Package
- 100 tablets per bottle
- Labelled appearance
- white to off-white · round film-coated tablet · imprint BMS 6060 / 500Unscored in this labelled presentation
United States label · DailyMed public historical archive (Bristol-Myers Squibb; representative package panel, not a current-label or availability conclusion)
850 mg per tablet; 100-tablet bottle; immediate-release historical package panel
- Product code
- NDC 0087-6070-05
- Form and route
- GLUCOPHAGE metformin hydrochloride oral film-coated tablet (archived package) · oral
- Container
- 100-tablet bottle (historical archive)
- Listing review
- Cited product evidence reviewed 2026-08-21; actual marketing, stock and availability are not established.
- metformin hydrochloride
- 850 mgamount stated per tablet in the historical label; not an individual's tablet count, immediate-/extended-release conversion, splitting or adjustment rule
- Package
- 100 tablets per bottle
- Labelled appearance
- white to off-white · round film-coated tablet · imprint BMS 6070 / 850Unscored in this labelled presentation
United States label · DailyMed public historical archive (Bristol-Myers Squibb; representative package panel, not a current-label or availability conclusion)
1000 mg per tablet; 100-tablet bottle; immediate-release historical package panel
- Product code
- NDC 0087-6071-11
- Form and route
- GLUCOPHAGE metformin hydrochloride oral film-coated tablet (archived package) · oral
- Container
- 100-tablet bottle (historical archive)
- Listing review
- Cited product evidence reviewed 2026-08-21; actual marketing, stock and availability are not established.
- metformin hydrochloride
- 1000 mgamount stated per tablet in the historical label; not an individual's tablet count, immediate-/extended-release conversion, splitting or adjustment rule
- Package
- 100 tablets per bottle
- Labelled appearance
- white · oval biconvex film-coated tablet · imprint BMS 6071 / 1000Unscored in this labelled presentation
United States label · DailyMed public historical archive (Bristol-Myers Squibb; representative package panel, not a current-label or availability conclusion)
500 mg per tablet; 100-tablet bottle; extended-release historical package panel
- Product code
- NDC 0087-6063-13
- Form and route
- GLUCOPHAGE XR metformin hydrochloride extended-release tablet (archived package) · oral
- Container
- 100-tablet bottle (historical archive)
- Listing review
- Cited product evidence reviewed 2026-08-21; actual marketing, stock and availability are not established.
- metformin hydrochloride
- 500 mgamount stated per tablet in the historical label; not an individual's tablet count, immediate-/extended-release conversion, splitting or adjustment rule
- Package
- 100 tablets per bottle
- Labelled appearance
- white to off-white · capsule-shaped biconvex extended-release tablet · imprint BMS 6063 / 500Unscored in this labelled presentation
United States label · DailyMed public historical archive (Bristol-Myers Squibb; representative package panel, not a current-label or availability conclusion)
750 mg per tablet; 100-tablet bottle; extended-release historical package panel
- Product code
- NDC 0087-6064-13
- Form and route
- GLUCOPHAGE XR metformin hydrochloride extended-release tablet (archived package) · oral
- Container
- 100-tablet bottle (historical archive)
- Listing review
- Cited product evidence reviewed 2026-08-21; actual marketing, stock and availability are not established.
- metformin hydrochloride
- 750 mgamount stated per tablet in the historical label; not an individual's tablet count, immediate-/extended-release conversion, splitting or adjustment rule
- Package
- 100 tablets per bottle
- Labelled appearance
- pale red, possibly mottled · capsule-shaped biconvex extended-release tablet · imprint BMS 6064 / 750Unscored in this labelled presentation
PUBLIC LABEL IMAGE
Appearance and package-text clues
This dated or historical public-label image is for checking the brand, generic-name, strength and dosage-form clues only. It does not authenticate a product or establish originator status, a current label, current packaging, target-market approval or sale eligibility.
Open the public label source ↗LABEL READING · NOT A PRESCRIPTION
GLUCOPHAGE XR label reading: an extended-release tablet is not an ordinary tablet to split
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 uses the May 2018 U.S. FDA historical label as a reading entry point, explaining the immediate-release/extended-release distinction and the “swallow whole” requirement for GLUCOPHAGE and GLUCOPHAGE XR; it does not create an individual glucose-lowering plan.
- This historical label separately lists GLUCOPHAGE 500, 850 and 1000 mg tablets and GLUCOPHAGE XR 500 and 750 mg extended-release tablets. A shared generic name does not make those different forms, strengths and dosing schedules self-convertible or interchangeable.
- The FDA label explicitly says to swallow GLUCOPHAGE XR whole and never crush, cut or chew it. Therefore, “half a tablet equals half a dose” cannot be applied to this extended-release tablet; swallowing difficulty, a desired reduction or a form change should first be reviewed by the prescribing team or pharmacist.
- The label identifies kidney function, iodinated contrast procedures, alcohol and some co-medications as situations requiring professional assessment. Especially with older age or multiple conditions, do not self-stop, change between extended-release and ordinary tablets, or temporarily increase use from a generic name, glucose reading or package strength alone.
- With long-term use, vitamin B12 and haematologic measures are label-listed review cues. Do not replace testing with self-selected supplements or stop from one result. Recent tests, diet or absorption concerns and the complete medicine list need professional review together.
- Diarrhoea or nausea does not by itself mean lactic acidosis, and a webpage cannot diagnose the cause. Rapidly worsening extreme weakness, breathing difficulty, marked drowsiness or altered consciousness, persistent severe abdominal pain or circulatory instability requires local emergency care with the exact pack and complete medicine list.
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 checkFDA · United States · Regulatory product record or label archive · 2026-08-20
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.
This record’s label or product-record routePrimary-source record (open linked document) ↗Historical public record · reviewed 2026-08-20
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.
- U.S. National Library of Medicine DailyMed · United States · Public medicine label · 2026-08-20DailyMed (NLM) archive: historical U.S. GLUCOPHAGE / GLUCOPHAGE XR public label (Bristol-Myers Squibb) ↗Historical public record · reviewed 2026-08-20
- FDA · United States · Regulatory product record or label archive · 2026-08-20FDA: GLUCOPHAGE / GLUCOPHAGE XR 2017 U.S. historical label (NDA 020357 / 021202) ↗Historical public record · reviewed 2026-08-20
Reviewed official safety records
A dated record is not automatically a current alert. Read the named product, form, batch, market, date and source type before treating it as relevant.
- FDA Drug Safety Communication: labelling update for metformin-containing medicines in reduced kidney function2016-04-08 · On 2016-04-08, FDA issued a U.S. labelling update for all metformin-containing medicines. After its review, FDA changed the kidney-function measure used in labelling to eGFR and expanded labelled use for some people with mild or moderate renal impairment. This is a U.S. ingredient-level regulatory labelling change. It does not determine whether GLUCOPHAGE, an extended-release form, a product in another market, or any individual is suitable or unsuitable, and it does not support self-starting, stopping, reducing, increasing, or exchanging immediate-release and extended-release products. Kidney function, dosage form and co-medication questions require the exact product, current target-market label and review by the prescribing team or pharmacist.U.S. National Library of Medicine Bookshelf: historical FDA metformin safety-announcement archive, including the 8 Apr 2016 kidney-function labelling update ↗reviewed 2026-08-22
Global official safety gateways
- NMPA Centre for Drug Reevaluation · Mainland ChinaPrimary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item.Drug-vigilance bulletins and safety notices ↗reviewed 2026-08-22
- FDA · United StatesPrimary FDA pages for important new safety issues, labelling changes and risk communications.Drug Safety Communications ↗reviewed 2026-08-22
- FDA MedWatch · United StatesU.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality.Safety information and serious-problem reporting ↗reviewed 2026-08-22
- EMA · European Union / European Economic AreaOfficial EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment.Pharmacovigilance overview and EudraVigilance ↗reviewed 2026-08-22
- MHRA · United KingdomPrimary UK MHRA medicine-safety updates for professionals and the public.Drug Safety Update ↗reviewed 2026-08-22
- PMDA · JapanPMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents.Medicine safety information ↗reviewed 2026-08-22
- MFDS · Republic of KoreaMFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case.Medicine safety letters ↗reviewed 2026-08-22
- HSA · SingaporeHSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information.Adverse-event reporting and medicine-safety information ↗reviewed 2026-08-22
- Health Canada · CanadaHealth Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item.MedEffect Canada: advisories, warnings and recalls ↗reviewed 2026-08-22
- TGA · AustraliaPrimary Australian TGA safety alerts, advisories and monitoring information for therapeutic products.Medicine safety alerts ↗reviewed 2026-08-22
- Swissmedic · SwitzerlandOfficial Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality.Pharmacovigilance and suspected adverse-reaction reporting ↗reviewed 2026-08-22
- Medsafe · New ZealandNew Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information.Medicine safety communications ↗reviewed 2026-08-22
- SAHPRA · South AfricaSAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information.Medicine safety information, alerts and pharmacovigilance ↗reviewed 2026-08-22
- WHO · GlobalWHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market.Medicine and vaccine safety-alert archive ↗reviewed 2026-08-22
- Anvisa · BrazilAnvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item.Pharmacovigilance, alerts and VigiMed ↗reviewed 2026-08-22
This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline.
For severe or rapidly worsening symptoms, suspected overdose, a severe allergic reaction, loss of consciousness or another emergency, use local emergency services. Do not wait for an online alert search or change a medicine from this page.
PRIVATE FAMILY LIST
Bring this record into a local medicine list
Only the brand, generic name, dosage form and route are added, and they stay in this browser. Copy strength, label directions, start/stop history and any concern from the actual pack; this tool does not calculate a dose or decide combination, switching or stopping.
Add to the family medicine list →PACK · LABEL · MEDICINE LIST
Six checks for this medicine pack
Use this card to organise questions about Glucophage (metformin). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
Glucophage is the brand in this record and metformin is the active-ingredient name. Check both with the dosage form (Metformin hydrochloride immediate-release and extended-release oral tablets; verify the brand, dosage form, milligrams per tablet and market together) 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.
- Primary-source record (open linked document) ↗Historical public record · reviewed 2026-08-20
- DailyMed (NLM) archive: historical U.S. GLUCOPHAGE / GLUCOPHAGE XR public label (Bristol-Myers Squibb) ↗Historical public record · reviewed 2026-08-20
- FDA: GLUCOPHAGE / GLUCOPHAGE XR 2017 U.S. historical label (NDA 020357 / 021202) ↗Historical public record · reviewed 2026-08-20
HOW IT WORKS · NOT A TREATMENT PLAN
How metformin works: it involves the liver, intestine and the body's response to insulin
- Do not simplify this into “it works on only one organ” or “a high glucose result means it can be self-added.” A mechanism helps read label language, but cannot replace the combined assessment of diagnosis, recent tests, actual product identity and an individual prescription.
- Ordinary tablets and GLUCOPHAGE XR extended-release tablets can share the active ingredient, but “the same mechanism” does not make their form, strength, swallow-whole requirement or schedule self-convertible. Any thought of changing between immediate- and extended-release forms, splitting, or changing frequency needs the exact label and pharmacist or prescribing-team review first.
- When other glucose-lowering medicines, insulin, diuretics or products that may affect kidney function are also used, the mechanism only signals that the complete medicine list and actual packages need joint review; it cannot answer whether a person should add, substitute, temporarily stop or manage a missed use.
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) archive: historical U.S. GLUCOPHAGE / GLUCOPHAGE XR public label (Bristol-Myers Squibb) ↗Historical public record · reviewed 2026-08-20
- FDA: GLUCOPHAGE / GLUCOPHAGE XR 2017 U.S. historical label (NDA 020357 / 021202) ↗Historical public record · reviewed 2026-08-20
- FDA: U.S. regulatory history for metformin / metformin XR in a 2025 clinical review ↗reviewed 2026-08-20
- DailyMed (NLM): current generic metformin hydrochloride immediate-release tablet label (current dosage-form and safety-reading context only) ↗Current regulatory record · reviewed 2026-08-20
- DailyMed (NLM): current generic metformin hydrochloride extended-release tablet label (current dosage-form and safety-reading context only) ↗Current regulatory record · reviewed 2026-08-20
- EMA: referral for metformin and metformin-containing medicines, with national-authorisation context ↗Current regulatory record · reviewed 2026-08-20
- FDA Drugs@FDA official search entry ↗Official lookup entry · reviewed 2026-08-20
SOURCE-TRACEABLE ARCHIVE
Glucophagemetformin
This page links to public primary-source material for Glucophage. 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 GLUCOPHAGE
The regulatory-history table in a 2025 FDA clinical review links NDA 020357, this date and Glucophage; it is a U.S. historical approval node, not evidence of current supply.
FDA: U.S. metformin regulatory-history table in a 2025 clinical review ↗FDA approved GLUCOPHAGE XR
The same FDA regulatory-history table links NDA 021202 to Glucophage XR; immediate-release and extended-release products must be read as distinct complete identities.
FDA: U.S. metformin XR regulatory-history table in a 2025 clinical review ↗U.S. historical brand-label update node
This label lists GLUCOPHAGE 500/850/1000 mg and GLUCOPHAGE XR 500/750 mg and explicitly warns that it may not be the latest FDA-approved label.
FDA: GLUCOPHAGE / GLUCOPHAGE XR 2017 U.S. historical label (Reference ID 4079189) ↗
MARKET SCOPE
Market-record boundary
U.S. historical brand archive
Five historical brand packages are itemised; current brand supply is not claimedThe page preserves NDC, per-tablet milligrams, immediate/extended-release form, tablet imprint and historical-label source. Current generic labels may add safety-reading context but must not be presented as current GLUCOPHAGE brand labels.
EU and member states
Metformin products are nationally authorised; brand and current leaflet require country-by-country checkingThe EMA referral page notes products including the name Glucophage, but this does not establish current pack, supply, originator status or interchangeability in any country.
Mainland China, Japan and other markets
Current market record not yet establishedNo local trade name, approval, pack, supply or switching relationship is inferred from the U.S. historical brand or generic name.
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.
Mainland China trade-name search cue: 格华止®
This cue helps read packaging and search official records. It does not establish current approval, holder, strength, originator relationship, supply or sale eligibility. Open historical reference ↗
RECORD FAQ
Record questions
Does 500 mg mean there are 500 tablets in the pack?
No. Here, 500 mg is the labelled metformin hydrochloride amount per tablet; pack count is a separate field. Tablets per use and uses per day require the exact prescription and cannot be inferred from mg alone.
Can GLUCOPHAGE XR be split in half?
The historical brand label requires GLUCOPHAGE XR to be swallowed whole and not crushed or chewed; current generic extended-release labels further say not to cut it. Do not split it yourself; take the exact pack to a pharmacist or prescriber if swallowing is difficult or a change is needed.
Must it be stopped before contrast CT or angiography?
Do not stop it yourself merely because contrast imaging is planned. The label considers contrast type and route, kidney function, liver disease, heart failure and alcohol history together. Give the imaging notice and recent kidney results to the prescriber and imaging service in advance and follow their specific instructions.
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.