Medicine
Glimepiride 4 mg tablet
Glimepiride 4 mg tablet is a generic prescription medicine for oral use, made by 24 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 25ºC (77ºF), excursions permitted to 20ºC to 25ºC (68º to 77ºF).
Key facts
- Active ingredient (INN)
- Glimepiride
- Brand
- Sold under the generic name
- Strength
- 4 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 250 tablets and 89 more
- Manufacturers
- Aurobindo PharmaIndiaDr. Reddy's LaboratoriesIndiaAccord HealthcareIndiaMicro LabsIndiaA-S Medication SolutionsCarlsbad TechnologyFlorida Pharmaceutical ProductsRising Pharma HoldingsSolco HealthcarePD-Rx Pharmaceuticals24 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 25ºC (77ºF), excursions permitted to 20ºC to 25ºC (68º to 77ºF).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A10BB12 Glimepiride
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 6 October 2005
- Identifiers
- RxCUI 199247, 199245, 199246 +3DailyMed set ID f4ffb19e-6d65-49fd-83ce-514d38d9d97c, 669a67c2-2f97-4b7e-8bba-83a015e0fa94, def20e38-01f7-4ead-beb6-3dc11062a342 +35NDC 72789-048, 0615-8334, 50090-1006 +35Application ANDA077911, ANDA091220, ANDA077091 +4
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 24 labelers. The register lists 92 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet in 1 bottle | 16729-003-01 | Accord HealthcareIndia | 23 August 2007 |
| 500 tablet in 1 bottle | 16729-003-16 | Accord HealthcareIndia | 25 August 2016 |
| 100 tablet in 1 bottle | 65862-581-01 | Aurobindo PharmaIndia | 29 June 2012 |
| 500 tablet in 1 bottle | 65862-581-05 | Aurobindo PharmaIndia | 29 June 2012 |
| 250 tablet in 1 bottle | 65862-581-25 | Aurobindo PharmaIndia | 29 June 2012 |
| 1000 tablet in 1 bottle | 65862-581-99 | Aurobindo PharmaIndia | 29 June 2012 |
| 100 tablet in 1 bottle | 55111-322-01 | Dr. Reddy's LaboratoriesIndia | 6 October 2005 |
| 500 tablet in 1 bottle | 55111-322-05 | Dr. Reddy's LaboratoriesIndia | 6 October 2005 |
| 30 tablet in 1 bottle | 55111-322-30 | Dr. Reddy's LaboratoriesIndia | 6 October 2005 |
| 100 blister pack in 1 carton / 1 tablet in 1 blister pack | 55111-322-78 | Dr. Reddy's LaboratoriesIndia | 6 October 2005 |
| 100 tablet in 1 bottle | 42571-103-01 | Micro LabsIndia | 13 June 2013 |
| 500 tablet in 1 bottle | 42571-103-05 | Micro LabsIndia | 13 June 2013 |
| 100 tablet in 1 bottle | 61442-117-01 | Carlsbad Technology | 1 January 2012 |
| 500 tablet in 1 bottle | 61442-117-05 | Carlsbad Technology | 1 January 2012 |
| 1000 tablet in 1 bottle | 61442-117-10 | Carlsbad Technology | 1 January 2012 |
| 100 tablet in 1 bottle | 71921-216-01 | Florida Pharmaceutical Products | 31 July 2023 |
| 500 tablet in 1 bottle | 71921-216-50 | Florida Pharmaceutical Products | 31 July 2023 |
| 100 tablet in 1 bottle | 16571-775-01 | Rising Pharma Holdings | 29 June 2012 |
| 500 tablet in 1 bottle | 16571-775-50 | Rising Pharma Holdings | 29 June 2012 |
| 100 tablet in 1 bottle, plastic | 43547-396-10 | Solco Healthcare | 30 January 2017 |
| 500 tablet in 1 bottle, plastic | 43547-396-50 | Solco Healthcare | 30 January 2017 |
| 30 tablet in 1 bottle | 50090-1006-0 | A-S Medication Solutions | 28 November 2014 |
| 100 tablet in 1 bottle | 50090-1006-1 | A-S Medication Solutions | 28 November 2014 |
| 60 tablet in 1 bottle | 50090-1006-2 | A-S Medication Solutions | 28 November 2014 |
| 90 tablet in 1 bottle | 50090-1006-3 | A-S Medication Solutions | 28 November 2014 |
| 180 tablet in 1 bottle | 50090-1006-4 | A-S Medication Solutions | 29 March 2023 |
| 30 tablet in 1 bottle | 50090-6322-0 | A-S Medication Solutions | 10 January 2023 |
| 100 tablet in 1 bottle | 50090-6322-1 | A-S Medication Solutions | 10 January 2023 |
| 60 tablet in 1 bottle | 50090-6322-2 | A-S Medication Solutions | 10 January 2023 |
| 90 tablet in 1 bottle | 50090-6322-3 | A-S Medication Solutions | 10 January 2023 |
| 180 tablet in 1 bottle | 50090-6322-4 | A-S Medication Solutions | 10 January 2023 |
| 90 tablet in 1 bottle | 50090-6852-0 | A-S Medication Solutions | 29 November 2023 |
| 30 tablet in 1 bottle | 50090-7406-0 | A-S Medication Solutions | 24 October 2024 |
| 100 tablet in 1 bottle | 50090-7406-1 | A-S Medication Solutions | 24 October 2024 |
| 60 tablet in 1 bottle | 50090-7406-2 | A-S Medication Solutions | 24 October 2024 |
| 90 tablet in 1 bottle | 50090-7406-3 | A-S Medication Solutions | 24 October 2024 |
| 180 tablet in 1 bottle | 50090-7406-4 | A-S Medication Solutions | 24 October 2024 |
| 90 tablet in 1 bottle | 50090-7407-0 | A-S Medication Solutions | 24 October 2024 |
| 90 tablet in 1 bottle | 50090-7823-0 | A-S Medication Solutions | 15 December 2025 |
| 30 tablet in 1 bottle, plastic | 43063-122-30 | PD-Rx Pharmaceuticals | 19 December 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 30 November 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 Glimepiride
Clinical summary
Glimepiride is a sulfonylurea indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It is available as tablets for oral use. MedsAcross supplies Glimepiride 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 GlimepirideFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Glimepiride prescribing information (Aurobindo Pharma) · U.S. National Library of Medicine, DailyMed
Need Glimepiride 4 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.