Medicine
Metformin 500 mg tablet
Metformin 500 mg tablet is a generic prescription medicine for oral use, made by 41 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20°to 25°C (68°to 77°F), excursions permitted to 15° to 30°C (59° to…
Key facts
- Active ingredient (INN)
- Metformin
- Brand
- Sold under the generic name
- Strength
- 500 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 1000 tablets and 372 more
- Manufacturers
- Granules IndiaIndiaAurobindo PharmaIndiaAscend LaboratoriesIndia41 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20°to 25°C (68°to 77°F), excursions permitted to 15° to 30°C (59° to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A10BA02 Metformin
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 24 January 2002
- Identifiers
- RxCUI 861007, 861004, 861010 +4DailyMed set ID 32d6c5f4-0116-4e38-b179-e1967ae63e66, 6a9ab61a-a5d0-41ef-b528-59eac6b4cfe6, fb296500-55cb-45ce-be0c-59aa2e3d4624 +37NDC 71335-1834, 71335-2466, 71335-3132 +37Application ANDA203769, ANDA213320, ANDA077095 +12
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
A sample of 40 packs from 41 labelers. The register lists 375 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet, film coated in 1 bottle | 67877-217-01 | Ascend LaboratoriesIndia | 31 January 2011 |
| 500 tablet, film coated in 1 bottle | 67877-217-05 | Ascend LaboratoriesIndia | 31 January 2011 |
| 1000 tablet, film coated in 1 bottle | 67877-217-10 | Ascend LaboratoriesIndia | 31 January 2011 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 67877-217-38 | Ascend LaboratoriesIndia | 31 January 2011 |
| 100 tablet in 1 bottle | 67877-561-01 | Ascend LaboratoriesIndia | 6 February 2017 |
| 500 tablet in 1 bottle | 67877-561-05 | Ascend LaboratoriesIndia | 6 February 2017 |
| 1000 tablet in 1 bottle | 67877-561-10 | Ascend LaboratoriesIndia | 6 February 2017 |
| 100 tablet, film coated in 1 bottle | 67877-930-01 | Ascend LaboratoriesIndia | 25 August 2025 |
| 500 tablet, film coated in 1 bottle | 67877-930-05 | Ascend LaboratoriesIndia | 25 August 2025 |
| 1000 tablet, film coated in 1 bottle | 67877-930-10 | Ascend LaboratoriesIndia | 25 August 2025 |
| 100 tablet in 1 bottle | 62207-440-43 | Granules IndiaIndia | 4 July 2019 |
| 500 tablet in 1 bottle | 62207-440-47 | Granules IndiaIndia | 4 July 2019 |
| 1000 tablet in 1 bottle | 62207-440-49 | Granules IndiaIndia | 4 July 2019 |
| 60 tablet in 1 bottle | 62207-440-50 | Granules IndiaIndia | 4 July 2019 |
| 90 tablet in 1 bottle | 62207-440-57 | Granules IndiaIndia | 4 July 2019 |
| 55833 tablet in 1 drum | 62207-440-96 | Granules IndiaIndia | 4 July 2019 |
| 5000 tablet in 1 pouch | 62207-491-31 | Granules IndiaIndia | 28 June 2018 |
| 25000 tablet in 1 carton | 62207-491-35 | Granules IndiaIndia | 28 June 2018 |
| 100 tablet in 1 bottle | 62207-491-43 | Granules IndiaIndia | 25 July 2019 |
| 500 tablet in 1 bottle | 62207-491-47 | Granules IndiaIndia | 25 July 2019 |
| 1000 tablet in 1 bottle | 62207-491-49 | Granules IndiaIndia | 25 July 2019 |
| 30 tablet in 1 bottle | 62207-491-54 | Granules IndiaIndia | 25 July 2019 |
| 100 tablet in 1 bottle | 70010-063-01 | Granules IndiaIndia | 26 June 2019 |
| 500 tablet in 1 bottle | 70010-063-05 | Granules IndiaIndia | 26 June 2019 |
| 60 tablet in 1 bottle | 70010-063-06 | Granules IndiaIndia | 26 June 2019 |
| 90 tablet in 1 bottle | 70010-063-09 | Granules IndiaIndia | 26 June 2019 |
| 1000 tablet in 1 bottle | 70010-063-10 | Granules IndiaIndia | 26 June 2019 |
| 100 tablet, film coated in 1 bottle | 59651-854-01 | Aurobindo PharmaIndia | 29 March 2024 |
| 500 tablet, film coated in 1 bottle | 59651-854-05 | Aurobindo PharmaIndia | 29 March 2024 |
| 4500 tablet, film coated in 1 bottle | 59651-854-45 | Aurobindo PharmaIndia | 29 March 2024 |
| 50 tablet, film coated in 1 bottle | 59651-854-50 | Aurobindo PharmaIndia | 29 March 2024 |
| 60 tablet, film coated in 1 bottle | 59651-854-60 | Aurobindo PharmaIndia | 29 March 2024 |
| 300 tablet, film coated in 1 bottle | 59651-854-79 | Aurobindo PharmaIndia | 29 March 2024 |
| 90 tablet, film coated in 1 bottle | 59651-854-90 | Aurobindo PharmaIndia | 29 March 2024 |
| 1000 tablet, film coated in 1 bottle | 59651-854-99 | Aurobindo PharmaIndia | 29 March 2024 |
| 100 tablet, film coated in 1 bottle | 65862-008-01 | Aurobindo PharmaIndia | 14 January 2005 |
| 500 tablet, film coated in 1 bottle | 65862-008-05 | Aurobindo PharmaIndia | 14 January 2005 |
| 300 tablet, film coated in 1 bottle | 65862-008-33 | Aurobindo PharmaIndia | 14 January 2005 |
| 4500 tablet, film coated in 1 bottle | 65862-008-45 | Aurobindo PharmaIndia | 14 January 2005 |
| 50 tablet, film coated in 1 bottle | 65862-008-50 | Aurobindo PharmaIndia | 14 January 2005 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 3 March 1995 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Metformin
Clinical summary
Metformin is a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It is available as tablets, extended-release tablets and oral solution. MedsAcross supplies Metformin for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about MetforminFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Glumetza prescribing information (Santarus) · U.S. National Library of Medicine, DailyMed
Need Metformin 500 mg tablet for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.