Medicine
Metformin 500 mg extended-release tablet
Metformin 500 mg extended-release tablet is a generic prescription medicine for oral use, made by 48 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 from 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Metformin
- Brand
- Sold under the generic name
- Strength
- 500 mg
- Dosage form
- Extended-release tablet
- Route
- Oral
- Packs
- 500 tablets, 30 tablets, 100 tablets and 345 more
- Manufacturers
- Granules IndiaIndiaAscend LaboratoriesIndiaUnichem LaboratoriesIndiaLaurus LabsIndiaAurobindo PharmaIndiaGlenmark PharmaceuticalsIndiaAjanta PharmaIndiaLupinIndia48 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted from 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
- 28 September 2005
- Identifiers
- RxCUI 860975, 860981, 861004 +6DailyMed set ID c1bfc7b5-c7e0-4353-b772-05d463c12886, 6b8824c0-ece0-4b15-ba71-e893d6d2bfdf, c047cf64-467a-40f3-be46-a1926b3b8d56 +37NDC 71335-3166, 71610-652, 72162-2424 +37Application ANDA078321, ANDA078596, ANDA209313 +30
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 48 labelers. The register lists 348 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 500 tablet, extended release in 1 bottle | 62207-496-47 | Granules IndiaIndia | 1 February 2021 |
| 30 tablet, extended release in 1 bottle | 62207-496-54 | Granules IndiaIndia | 1 February 2021 |
| 100 tablet, extended release in 1 bottle | 70010-491-01 | Granules IndiaIndia | 31 July 2018 |
| 500 tablet, extended release in 1 bottle | 70010-491-05 | Granules IndiaIndia | 31 July 2018 |
| 90 tablet, extended release in 1 bottle | 70010-491-09 | Granules IndiaIndia | 16 April 2020 |
| 1000 tablet, extended release in 1 bottle | 70010-491-10 | Granules IndiaIndia | 31 July 2018 |
| 5000 tablet, extended release in 1 pouch | 70010-491-18 | Granules IndiaIndia | 14 June 2019 |
| 25000 tablet, extended release in 1 carton | 70010-491-19 | Granules IndiaIndia | 14 June 2019 |
| 100 tablet, extended release in 1 bottle | 70010-496-01 | Granules IndiaIndia | 22 January 2021 |
| 60 tablet, extended release in 1 bottle | 27241-188-60 | Ajanta PharmaIndia | 9 April 2020 |
| 100 tablet, extended release in 1 bottle | 27241-240-01 | Ajanta PharmaIndia | 9 March 2021 |
| 100 tablet, extended release in 1 bottle | 67877-159-01 | Ascend LaboratoriesIndia | 25 November 2016 |
| 500 tablet, extended release in 1 bottle | 67877-159-05 | Ascend LaboratoriesIndia | 25 November 2016 |
| 1000 tablet, extended release in 1 bottle | 67877-159-10 | Ascend LaboratoriesIndia | 25 November 2016 |
| 100 tablet, extended release in 1 bottle | 67877-413-01 | Ascend LaboratoriesIndia | 27 October 2018 |
| 500 tablet, extended release in 1 bottle | 67877-413-05 | Ascend LaboratoriesIndia | 27 October 2018 |
| 1000 tablet, extended release in 1 bottle | 67877-413-10 | Ascend LaboratoriesIndia | 27 October 2018 |
| 10 blister pack in 1 carton / 10 tablet, extended release in 1 blister pack | 67877-413-33 | Ascend LaboratoriesIndia | 27 October 2018 |
| 90 tablet, extended release in 1 bottle | 67877-413-90 | Ascend LaboratoriesIndia | 27 December 2019 |
| 60 tablet, extended release in 1 bottle | 59651-042-60 | Aurobindo PharmaIndia | 18 October 2024 |
| 100 tablet, extended release in 1 bottle | 59651-548-01 | Aurobindo PharmaIndia | 15 April 2024 |
| 500 tablet, extended release in 1 bottle | 59651-548-05 | Aurobindo PharmaIndia | 15 April 2024 |
| 1000 tablet, extended release in 1 bottle | 59651-548-99 | Aurobindo PharmaIndia | 15 April 2024 |
| 60 tablet, extended release in 1 bottle | 68180-336-07 | LupinIndia | 30 September 2011 |
| 100 tablet, extended release in 1 bottle | 68180-338-01 | LupinIndia | 1 February 2016 |
| 100 tablet, extended release in 1 bottle | 29300-389-01 | Unichem LaboratoriesIndia | 11 August 2021 |
| 500 tablet, extended release in 1 bottle | 29300-389-05 | Unichem LaboratoriesIndia | 11 August 2021 |
| 1000 tablet, extended release in 1 bottle | 29300-389-10 | Unichem LaboratoriesIndia | 11 August 2021 |
| 90 tablet, extended release in 1 bottle | 29300-389-19 | Unichem LaboratoriesIndia | 11 August 2021 |
| 100 tablet, extended release in 1 bottle | 76385-128-01 | Unichem LaboratoriesIndia | 17 July 2018 |
| 1000 tablet, extended release in 1 bottle | 76385-128-10 | Unichem LaboratoriesIndia | 17 July 2018 |
| 500 tablet, extended release in 1 bottle | 76385-128-50 | Unichem LaboratoriesIndia | 25 July 2019 |
| 100 tablet, film coated, extended release in 1 bottle | 68462-520-01 | Glenmark PharmaceuticalsIndia | 25 November 2019 |
| 500 tablet, film coated, extended release in 1 bottle | 68462-520-05 | Glenmark PharmaceuticalsIndia | 25 November 2019 |
| 1000 tablet, film coated, extended release in 1 bottle | 68462-520-10 | Glenmark PharmaceuticalsIndia | 25 November 2019 |
| 100 tablet, extended release in 1 bottle | 42385-977-01 | Laurus LabsIndia | 6 October 2023 |
| 500 tablet, extended release in 1 bottle | 42385-977-05 | Laurus LabsIndia | 6 October 2023 |
| 1000 tablet, extended release in 1 bottle | 42385-977-11 | Laurus LabsIndia | 6 October 2023 |
| 180 tablet, extended release in 1 bottle | 42385-977-18 | Laurus LabsIndia | 6 October 2023 |
| 30 tablet, extended release in 1 bottle | 42385-977-30 | Laurus LabsIndia | 6 October 2023 |
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
Alternatives
Other makers and brands of Metformin 500 mg extended-release tablet.
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 extended-release 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.