Medicine
Metformin 1000 mg extended-release tablet
Metformin 1000 mg extended-release tablet is a generic prescription medicine for oral use, made by 22 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
- 1000 mg
- Dosage form
- Extended-release tablet
- Route
- Oral
- Packs
- 60 tablets, 90 tablets, 500 tablets and 46 more
- Manufacturers
- Micro LabsIndiaGlenmark PharmaceuticalsIndiaGranules IndiaIndiaAjanta PharmaIndiaLupinIndiaAurobindo PharmaIndiaMacleods PharmaceuticalsIndiaRemedyrepackScieGen PharmaceuticalsIngenus Pharmaceuticals22 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). Keep tightly closed (protect from moisture). Protect from light. Protect from light.
- 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
- 17 June 2008
- Identifiers
- RxCUI 1807894, 1807917, 1807888 +2DailyMed set ID 96c8a89d-99db-24b1-e053-2a95a90ac2b8, 356b02d0-d239-4441-bb33-c4c54166fcd7, 1cb2b2be-595c-4e72-8d2c-c1edc7f85682 +27NDC 11788-038, 42806-406, 51407-059 +27Application ANDA209993, ANDA203832, ANDA091664 +15
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 22 labelers. The register lists 49 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 60 tablet, extended release in 1 bottle | 27241-189-60 | Ajanta PharmaIndia | 9 April 2020 |
| 90 tablet, extended release in 1 bottle | 27241-241-90 | Ajanta PharmaIndia | 9 March 2021 |
| 500 tablet, extended release in 1 bottle | 62207-497-47 | Granules IndiaIndia | 1 February 2021 |
| 30 tablet, extended release in 1 bottle | 62207-497-54 | Granules IndiaIndia | 1 February 2021 |
| 90 tablet, extended release in 1 bottle | 70010-497-09 | Granules IndiaIndia | 22 January 2021 |
| 60 tablet, extended release in 1 bottle | 68180-337-07 | LupinIndia | 30 September 2011 |
| 90 tablet, extended release in 1 bottle | 68180-339-09 | LupinIndia | 1 February 2016 |
| 60 tablet, extended release in 1 bottle | 59651-043-60 | Aurobindo PharmaIndia | 18 October 2024 |
| 100 tablet, film coated, extended release in 1 bottle | 68462-521-01 | Glenmark PharmaceuticalsIndia | 25 November 2019 |
| 500 tablet, film coated, extended release in 1 bottle | 68462-521-05 | Glenmark PharmaceuticalsIndia | 25 November 2019 |
| 90 tablet, film coated, extended release in 1 bottle | 68462-521-90 | Glenmark PharmaceuticalsIndia | 25 November 2019 |
| 90 tablet, extended release in 1 bottle | 33342-378-10 | Macleods PharmaceuticalsIndia | 13 March 2024 |
| 100 tablet, film coated, extended release in 1 bottle | 42571-334-01 | Micro LabsIndia | 1 March 2023 |
| 500 tablet, film coated, extended release in 1 bottle | 42571-334-05 | Micro LabsIndia | 1 March 2023 |
| 60 tablet, film coated, extended release in 1 bottle | 42571-334-60 | Micro LabsIndia | 1 March 2023 |
| 90 tablet, film coated, extended release in 1 bottle | 42571-334-90 | Micro LabsIndia | 1 March 2023 |
| 500 tablet, film coated, extended release in 1 bottle, plastic | 50228-446-05 | ScieGen Pharmaceuticals | 16 April 2021 |
| 30 tablet, film coated, extended release in 1 bottle, plastic | 50228-446-30 | ScieGen Pharmaceuticals | 16 April 2021 |
| 90 tablet, film coated, extended release in 1 bottle, plastic | 50228-446-90 | ScieGen Pharmaceuticals | 16 April 2021 |
| 500 tablet, film coated, extended release in 1 bottle, plastic | 50228-504-05 | ScieGen Pharmaceuticals | 22 February 2022 |
| 30 tablet, film coated, extended release in 1 bottle, plastic | 50228-504-30 | ScieGen Pharmaceuticals | 22 February 2022 |
| 60 tablet, film coated, extended release in 1 bottle, plastic | 50228-504-60 | ScieGen Pharmaceuticals | 22 February 2022 |
| 60 tablet, film coated, extended release in 1 bottle, plastic | 11788-038-60 | AiPing Pharmaceutical | 15 December 2025 |
| 60 tablet, film coated, extended release in 1 bottle | 42806-406-60 | Epic Pharma | 4 January 2019 |
| 1000 tablet, extended release in 1 bottle | 50742-634-10 | Ingenus Pharmaceuticals | 10 December 2018 |
| 30 tablet, extended release in 1 bottle | 50742-634-30 | Ingenus Pharmaceuticals | 10 December 2018 |
| 60 tablet, extended release in 1 bottle | 50742-634-60 | Ingenus Pharmaceuticals | 10 December 2018 |
| 60 tablet, film coated, extended release in 1 bottle, plastic | 0378-6001-91 | Mylan Pharmaceuticals | 23 August 2016 |
| 90 tablet, film coated, extended release in 1 bottle | 68682-018-90 | Oceanside Pharmaceuticals | 17 June 2008 |
| 60 tablet, film coated, extended release in 1 bottle, plastic | 70247-018-60 | Qingdao BAHEAL Pharmaceutical | 27 December 2018 |
| 90 tablet, extended release in 1 bottle | 43547-504-09 | Solco Healthcare | 31 May 2022 |
| 500 tablet, extended release in 1 bottle | 43547-504-50 | Solco Healthcare | 31 May 2022 |
| 90 tablet, extended release in 1 bottle, plastic | 72664-228-90 | VGYAAN Pharmaceuticals | 30 November 2021 |
| 30 pouch in 1 box / 1 tablet, extended release in 1 pouch | 70518-4369-0 | Remedyrepack | 24 June 2025 |
| 50 pouch in 1 box / 1 tablet, extended release in 1 pouch | 70518-4369-2 | Remedyrepack | 10 July 2026 |
| 30 pouch in 1 box / 1 tablet, extended release in 1 pouch | 70518-4651-0 | Remedyrepack | 30 April 2026 |
| 30 pouch in 1 box / 1 tablet, extended release in 1 pouch | 70518-4652-0 | Remedyrepack | 4 May 2026 |
| 90 tablet, extended release in 1 bottle, plastic | 70518-4677-0 | Remedyrepack | 15 June 2026 |
| 30 pouch in 1 box / 1 tablet, extended release in 1 pouch | 70518-4677-1 | Remedyrepack | 16 June 2026 |
| 50 pouch in 1 box / 1 tablet, extended release in 1 pouch | 70518-4677-3 | Remedyrepack | 16 October 2026 |
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 1000 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 1000 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.