Medicine
Zolpidem 12.5 mg extended-release tablet
Zolpidem 12.5 mg extended-release tablet is a generic prescription medicine for oral use, made by 12 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 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F).
Key facts
- Active ingredient (INN)
- Zolpidem
- Brand
- Sold under the generic name
- Strength
- 12.5 mg
- Dosage form
- Extended-release tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 30 tablets and 55 more
- Manufacturers
- Sun Pharmaceutical IndustriesIndiaLupinIndiaBryant Ranch PrepackProficient RxAphena Pharma Solutions - TennesseeSandozAsclemedBreckenridge Pharmaceutical12 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (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
- Schedule CIV
- ATC code
- N05CF02 Zolpidem
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 6 December 2010
- Identifiers
- RxCUI 854880, 854894DailyMed set ID c3f23bc3-595b-28e5-e053-2a95a90a9c2c, 25e71199-c55d-4cc6-8388-b309d654d2b0, 08411424-e8a8-4964-bd04-5b0b5aa5baaf +17NDC 72189-230, 63187-114, 71610-730 +17Application ANDA078970, ANDA090107, ANDA213592 +2
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 12 labelers. The register lists 58 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet, extended release in 1 bottle | 68180-780-04 | LupinIndia | 21 May 2024 |
| 500 tablet, film coated, extended release in 1 bottle | 47335-308-13 | Sun Pharmaceutical IndustriesIndia | 15 May 2017 |
| 100 tablet, film coated, extended release in 1 bottle | 47335-308-88 | Sun Pharmaceutical IndustriesIndia | 15 May 2017 |
| 100 tablet, extended release in 1 bottle | 51991-982-01 | Breckenridge Pharmaceutical | 18 May 2026 |
| 100 tablet, extended release in 1 bottle | 0781-5316-01 | Sandoz | 31 October 2011 |
| 500 tablet, extended release in 1 bottle | 0781-5316-05 | Sandoz | 31 October 2011 |
| 30 tablet, extended release in 1 bottle | 0781-5316-31 | Sandoz | 31 October 2011 |
| 30 tablet, extended release in 1 bottle | 63629-4597-1 | Bryant Ranch Prepack | 29 August 2012 |
| 60 tablet, extended release in 1 bottle | 63629-4597-2 | Bryant Ranch Prepack | 16 November 2015 |
| 28 tablet, extended release in 1 bottle | 63629-4597-3 | Bryant Ranch Prepack | 5 September 2024 |
| 8 tablet, extended release in 1 bottle | 63629-4597-4 | Bryant Ranch Prepack | 5 September 2024 |
| 18 tablet, extended release in 1 bottle | 63629-4597-5 | Bryant Ranch Prepack | 5 September 2024 |
| 90 tablet, extended release in 1 bottle | 63629-4597-6 | Bryant Ranch Prepack | 5 September 2024 |
| 30 tablet, extended release in 1 bottle | 71335-1180-1 | Bryant Ranch Prepack | 4 April 2019 |
| 60 tablet, extended release in 1 bottle | 71335-1180-2 | Bryant Ranch Prepack | 9 July 2024 |
| 28 tablet, extended release in 1 bottle | 71335-1180-3 | Bryant Ranch Prepack | 9 July 2024 |
| 8 tablet, extended release in 1 bottle | 71335-1180-4 | Bryant Ranch Prepack | 9 July 2024 |
| 18 tablet, extended release in 1 bottle | 71335-1180-5 | Bryant Ranch Prepack | 9 July 2024 |
| 90 tablet, extended release in 1 bottle | 71335-1180-6 | Bryant Ranch Prepack | 9 July 2024 |
| 30 tablet, film coated, extended release in 1 bottle | 71335-1468-1 | Bryant Ranch Prepack | 9 January 2020 |
| 60 tablet, film coated, extended release in 1 bottle | 71335-1468-2 | Bryant Ranch Prepack | 12 May 2022 |
| 28 tablet, film coated, extended release in 1 bottle | 71335-1468-3 | Bryant Ranch Prepack | 12 May 2022 |
| 8 tablet, film coated, extended release in 1 bottle | 71335-1468-4 | Bryant Ranch Prepack | 12 May 2022 |
| 18 tablet, film coated, extended release in 1 bottle | 71335-1468-5 | Bryant Ranch Prepack | 12 May 2022 |
| 90 tablet, film coated, extended release in 1 bottle | 71335-1468-6 | Bryant Ranch Prepack | 12 October 2020 |
| 120 tablet, film coated, extended release in 1 bottle | 71335-1468-7 | Bryant Ranch Prepack | 12 October 2020 |
| 100 tablet, film coated, extended release in 1 bottle | 72162-2441-1 | Bryant Ranch Prepack | 15 January 2025 |
| 30 tablet, film coated, extended release in 1 bottle | 72162-2441-3 | Bryant Ranch Prepack | 15 January 2025 |
| 30 tablet, extended release in 1 bottle | 63187-114-30 | Proficient Rx | 1 January 2019 |
| 15 tablet, film coated, extended release in 1 bottle | 63187-862-15 | Proficient Rx | 1 June 2017 |
| 30 tablet, film coated, extended release in 1 bottle | 63187-862-30 | Proficient Rx | 1 June 2017 |
| 60 tablet, film coated, extended release in 1 bottle | 63187-862-60 | Proficient Rx | 1 June 2017 |
| 90 tablet, film coated, extended release in 1 bottle | 63187-862-90 | Proficient Rx | 1 June 2017 |
| 30 tablet, extended release in 1 bottle | 71205-286-30 | Proficient Rx | 21 June 2019 |
| 60 tablet, extended release in 1 bottle | 71205-286-60 | Proficient Rx | 21 June 2019 |
| 90 tablet, extended release in 1 bottle | 71205-286-90 | Proficient Rx | 21 June 2019 |
| 30 tablet, film coated, extended release in 1 bottle | 71610-254-30 | Aphena Pharma Solutions - Tennessee | 22 March 2019 |
| 28 tablet, extended release in 1 bottle | 71610-730-28 | Aphena Pharma Solutions - Tennessee | 12 April 2024 |
| 30 tablet, extended release in 1 bottle | 71610-730-30 | Aphena Pharma Solutions - Tennessee | 30 August 2023 |
| 100 tablet, extended release in 1 bottle | 76420-319-01 | Asclemed | 11 April 2025 |
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 16 December 1992 | 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 Zolpidem
Clinical summary
Zolpidem is a gamma-aminobutyric acid A receptor positive modulator indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. It is available as tablets, extended-release tablets and sublingual tablets for oral use. MedsAcross supplies Zolpidem 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 ZolpidemFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Ambien prescribing information (Cosette Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Zolpidem 12.5 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.