Medicine
Zolpidem 10 mg tablet
Zolpidem 10 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 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Zolpidem
- Brand
- Sold under the generic name
- Strength
- 10 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 10 blister pack and 168 more
- Manufacturers
- Torrent PharmaceuticalsIndiaAurobindo PharmaIndiaBryant Ranch PrepackSandozThe ACME LaboratoriesACI HealthcareCalvin ScottChartwell RX24 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).
- 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
- 23 April 2007
- Identifiers
- RxCUI 854873, 854876DailyMed set ID af87df4e-2c97-e23e-e053-2a95a90ab354, e68a1b3b-b3d1-495e-be46-466113e7dbd6, 25f1176d-5195-1a99-e054-00144ff8d46c +37NDC 80425-0061, 50090-5804, 61919-663 +37Application ANDA078413, ANDA077903, ANDA077322 +3
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 171 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet, film coated in 1 bottle | 65862-160-01 | Aurobindo PharmaIndia | 4 May 2007 |
| 500 tablet, film coated in 1 bottle | 65862-160-05 | Aurobindo PharmaIndia | 4 May 2007 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 65862-160-10 | Aurobindo PharmaIndia | 4 May 2007 |
| 1000 tablet, film coated in 1 bottle | 65862-160-99 | Aurobindo PharmaIndia | 4 May 2007 |
| 100 tablet in 1 bottle | 13668-008-01 | Torrent PharmaceuticalsIndia | 5 September 2007 |
| 500 tablet in 1 bottle | 13668-008-05 | Torrent PharmaceuticalsIndia | 5 September 2007 |
| 1000 tablet in 1 bottle | 13668-008-10 | Torrent PharmaceuticalsIndia | 5 September 2007 |
| 1500 tablet in 1 bottle | 13668-008-15 | Torrent PharmaceuticalsIndia | 5 September 2007 |
| 30 tablet in 1 bottle | 13668-008-30 | Torrent PharmaceuticalsIndia | 5 September 2007 |
| 90 tablet in 1 bottle | 13668-008-90 | Torrent PharmaceuticalsIndia | 5 September 2007 |
| 100 tablet in 1 bottle | 71093-156-04 | ACI Healthcare | 24 September 2020 |
| 1000 tablet in 1 bottle | 71093-156-06 | ACI Healthcare | 24 September 2020 |
| 30 tablet, film coated in 1 bottle | 72722-104-01 | The ACME Laboratories | 30 November 2024 |
| 100 tablet, film coated in 1 bottle | 72722-104-05 | The ACME Laboratories | 30 November 2024 |
| 1000 tablet, film coated in 1 bottle | 72722-104-07 | The ACME Laboratories | 30 November 2024 |
| 30 tablet in 1 bottle | 17224-970-30 | Calvin Scott | 5 September 2007 |
| 90 tablet in 1 bottle | 62135-779-90 | Chartwell RX | 27 August 2024 |
| 100 tablet, coated in 1 bottle | 0781-5318-01 | Sandoz | 23 April 2007 |
| 500 tablet, coated in 1 bottle | 0781-5318-05 | Sandoz | 23 April 2007 |
| 1000 tablet, coated in 1 bottle | 0781-5318-10 | Sandoz | 23 April 2007 |
| 30 tablet, coated in 1 bottle | 0781-5318-31 | Sandoz | 23 April 2007 |
| 30 tablet in 1 bottle | 63629-8999-1 | Bryant Ranch Prepack | 4 April 2024 |
| 60 tablet in 1 bottle | 63629-8999-2 | Bryant Ranch Prepack | 4 April 2024 |
| 90 tablet in 1 bottle | 63629-8999-3 | Bryant Ranch Prepack | 4 April 2024 |
| 1000 tablet in 1 bottle | 63629-9614-1 | Bryant Ranch Prepack | 3 February 2023 |
| 5 tablet in 1 bottle | 71335-0154-0 | Bryant Ranch Prepack | 29 May 2024 |
| 30 tablet in 1 bottle | 71335-0154-1 | Bryant Ranch Prepack | 4 April 2018 |
| 60 tablet in 1 bottle | 71335-0154-2 | Bryant Ranch Prepack | 22 February 2018 |
| 100 tablet in 1 bottle | 71335-0154-3 | Bryant Ranch Prepack | 31 August 2023 |
| 50 tablet in 1 bottle | 71335-0154-4 | Bryant Ranch Prepack | 29 May 2024 |
| 90 tablet in 1 bottle | 71335-0154-5 | Bryant Ranch Prepack | 14 February 2018 |
| 10 tablet in 1 bottle | 71335-0154-6 | Bryant Ranch Prepack | 11 May 2018 |
| 15 tablet in 1 bottle | 71335-0154-7 | Bryant Ranch Prepack | 27 February 2018 |
| 28 tablet in 1 bottle | 71335-0154-8 | Bryant Ranch Prepack | 11 July 2018 |
| 120 tablet in 1 bottle | 71335-0154-9 | Bryant Ranch Prepack | 3 October 2018 |
| 1000 tablet in 1 bottle | 71335-2303-1 | Bryant Ranch Prepack | 1 December 2023 |
| 5 tablet in 1 bottle | 71335-9684-0 | Bryant Ranch Prepack | 3 April 2024 |
| 30 tablet in 1 bottle | 71335-9684-1 | Bryant Ranch Prepack | 30 May 2023 |
| 60 tablet in 1 bottle | 71335-9684-2 | Bryant Ranch Prepack | 3 April 2024 |
| 100 tablet in 1 bottle | 71335-9684-3 | Bryant Ranch Prepack | 3 April 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 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
Alternatives
Other makers and brands of Zolpidem 10 mg tablet.
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 10 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.