Medicine
Glyburide and Metformin 5 mg/500 mg tablet
Glyburide and Metformin 5 mg/500 mg tablet is a generic prescription medicine for oral use, made by 9 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 (68º to 77°F), excursions permitted to 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Glyburide and Metformin
- Brand
- Sold under the generic name
- Strength
- 5 mg/500 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 30 tablets and 64 more
- Manufacturers
- Zydus LifesciencesIndiaAurobindo PharmaIndiaAvet PharmaceuticalsIndiaBryant Ranch PrepackRising Pharma Holdings9 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68º 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
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 14 November 2007
- Identifiers
- RxCUI 861743, 861748, 861753DailyMed set ID 372af566-d6ec-446f-88db-0b4cc83b577f, 2239742b-74e1-4bc2-b5a8-15c4758d6f7b, a58ff524-e975-4d51-a896-e869f8ea6624 +13NDC 57237-025, 68382-655, 68788-8634 +13Application ANDA077870, ANDA206748, ANDA079009
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 9 labelers. The register lists 67 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet in 1 bottle | 65841-826-01 | Zydus LifesciencesIndia | 7 April 2016 |
| 500 tablet in 1 bottle | 65841-826-05 | Zydus LifesciencesIndia | 7 April 2016 |
| 30 tablet in 1 bottle | 65841-826-06 | Zydus LifesciencesIndia | 7 April 2016 |
| 1000 tablet in 1 bottle | 65841-826-10 | Zydus LifesciencesIndia | 7 April 2016 |
| 90 tablet in 1 bottle | 65841-826-16 | Zydus LifesciencesIndia | 7 April 2016 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 65841-826-77 | Zydus LifesciencesIndia | 7 April 2016 |
| 100 tablet in 1 bottle | 68382-655-01 | Zydus LifesciencesIndia | 7 April 2016 |
| 500 tablet in 1 bottle | 68382-655-05 | Zydus LifesciencesIndia | 7 April 2016 |
| 30 tablet in 1 bottle | 68382-655-06 | Zydus LifesciencesIndia | 7 April 2016 |
| 1000 tablet in 1 bottle | 68382-655-10 | Zydus LifesciencesIndia | 7 April 2016 |
| 90 tablet in 1 bottle | 68382-655-16 | Zydus LifesciencesIndia | 7 April 2016 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 68382-655-77 | Zydus LifesciencesIndia | 7 April 2016 |
| 100 tablet, film coated in 1 bottle | 65862-082-01 | Aurobindo PharmaIndia | 14 November 2007 |
| 500 tablet, film coated in 1 bottle | 65862-082-05 | Aurobindo PharmaIndia | 14 November 2007 |
| 30 tablet, film coated in 1 bottle | 65862-082-30 | Aurobindo PharmaIndia | 14 November 2007 |
| 100 tablet in 1 bottle | 23155-235-01 | Avet PharmaceuticalsIndia | 1 May 2024 |
| 500 tablet in 1 bottle | 23155-235-05 | Avet PharmaceuticalsIndia | 1 May 2024 |
| 1000 tablet in 1 bottle | 23155-235-10 | Avet PharmaceuticalsIndia | 1 May 2024 |
| 100 tablet, film coated in 1 bottle | 57237-025-01 | Rising Pharma Holdings | 14 November 2007 |
| 500 tablet, film coated in 1 bottle | 57237-025-05 | Rising Pharma Holdings | 14 November 2007 |
| 30 tablet, film coated in 1 bottle | 71335-0360-1 | Bryant Ranch Prepack | 8 June 2018 |
| 60 tablet, film coated in 1 bottle | 71335-0360-3 | Bryant Ranch Prepack | 16 March 2018 |
| 90 tablet, film coated in 1 bottle | 71335-0360-4 | Bryant Ranch Prepack | 29 October 2018 |
| 120 tablet, film coated in 1 bottle | 71335-0360-5 | Bryant Ranch Prepack | 18 August 2026 |
| 100 tablet, film coated in 1 bottle | 71335-0360-6 | Bryant Ranch Prepack | 26 February 2018 |
| 180 tablet, film coated in 1 bottle | 71335-0360-7 | Bryant Ranch Prepack | 18 August 2026 |
| 25 tablet, film coated in 1 bottle | 71335-0360-8 | Bryant Ranch Prepack | 30 March 2018 |
| 30 tablet, film coated in 1 bottle | 71335-0967-1 | Bryant Ranch Prepack | 15 October 2018 |
| 60 tablet, film coated in 1 bottle | 71335-0967-3 | Bryant Ranch Prepack | 15 October 2018 |
| 90 tablet, film coated in 1 bottle | 71335-0967-4 | Bryant Ranch Prepack | 30 May 2024 |
| 120 tablet, film coated in 1 bottle | 71335-0967-5 | Bryant Ranch Prepack | 30 May 2024 |
| 100 tablet, film coated in 1 bottle | 71335-0967-6 | Bryant Ranch Prepack | 11 October 2018 |
| 180 tablet, film coated in 1 bottle | 71335-0967-7 | Bryant Ranch Prepack | 30 May 2024 |
| 25 tablet, film coated in 1 bottle | 71335-0967-8 | Bryant Ranch Prepack | 30 May 2024 |
| 30 tablet in 1 bottle | 71335-2508-1 | Bryant Ranch Prepack | 21 October 2024 |
| 60 tablet in 1 bottle | 71335-2508-3 | Bryant Ranch Prepack | 21 October 2024 |
| 90 tablet in 1 bottle | 71335-2508-4 | Bryant Ranch Prepack | 21 October 2024 |
| 120 tablet in 1 bottle | 71335-2508-5 | Bryant Ranch Prepack | 21 October 2024 |
| 100 tablet in 1 bottle | 71335-2508-6 | Bryant Ranch Prepack | 21 October 2024 |
| 180 tablet in 1 bottle | 71335-2508-7 | Bryant Ranch Prepack | 21 October 2024 |
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 31 July 2000 | 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 Glyburide and Metformin
Clinical summary
Glyburide and Metformin is a fixed-dose combination of a biguanide and a sulfonylurea indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. MedsAcross supplies Glyburide and 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 Glyburide and 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
- glyburide-metformin hydrochloride prescribing information (Avet Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Glyburide and Metformin 5 mg/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.