Medicine
Zolpidem 5 mg tablet
Zolpidem 5 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 controlled room temperature 20°C-25°C (68°F-77°F).
Key facts
- Active ingredient (INN)
- Zolpidem
- Brand
- Sold under the generic name
- Strength
- 5 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 10 blister pack and 153 more
- Manufacturers
- Torrent PharmaceuticalsIndiaAurobindo PharmaIndiaBryant Ranch PrepackSandozThe ACME LaboratoriesACI HealthcareChartwell RX24 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at controlled room temperature 20°C-25°C (68°F-77°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 854876, 854873DailyMed set ID f9c108d1-5e2f-41c7-a845-2aed48c30905, df130798-1458-455b-a4e1-c33c4ecee43b, 38c838a4-9943-445a-8e80-e823d56eeaa5 +37NDC 71335-9629, 72162-1982, 72789-390 +37Application ANDA077322, ANDA077214, ANDA078413 +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 156 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 | 65862-159-01 | Aurobindo PharmaIndia | 4 May 2007 |
| 500 tablet, film coated in 1 bottle | 65862-159-05 | Aurobindo PharmaIndia | 4 May 2007 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 65862-159-10 | Aurobindo PharmaIndia | 4 May 2007 |
| 1000 tablet, film coated in 1 bottle | 65862-159-99 | Aurobindo PharmaIndia | 4 May 2007 |
| 100 tablet in 1 bottle | 13668-007-01 | Torrent PharmaceuticalsIndia | 5 September 2007 |
| 500 tablet in 1 bottle | 13668-007-05 | Torrent PharmaceuticalsIndia | 5 September 2007 |
| 1000 tablet in 1 bottle | 13668-007-10 | Torrent PharmaceuticalsIndia | 5 September 2007 |
| 1500 tablet in 1 bottle | 13668-007-15 | Torrent PharmaceuticalsIndia | 5 September 2007 |
| 30 tablet in 1 bottle | 13668-007-30 | Torrent PharmaceuticalsIndia | 5 September 2007 |
| 90 tablet in 1 bottle | 13668-007-90 | Torrent PharmaceuticalsIndia | 5 September 2007 |
| 100 tablet in 1 bottle | 71093-155-04 | ACI Healthcare | 24 September 2020 |
| 1000 tablet in 1 bottle | 71093-155-06 | ACI Healthcare | 24 September 2020 |
| 30 tablet, film coated in 1 bottle | 72722-103-01 | The ACME Laboratories | 30 November 2024 |
| 100 tablet, film coated in 1 bottle | 72722-103-05 | The ACME Laboratories | 30 November 2024 |
| 1000 tablet, film coated in 1 bottle | 72722-103-07 | The ACME Laboratories | 30 November 2024 |
| 90 tablet in 1 bottle | 62135-778-90 | Chartwell RX | 27 August 2024 |
| 100 tablet, coated in 1 bottle | 0781-5317-01 | Sandoz | 23 April 2007 |
| 500 tablet, coated in 1 bottle | 0781-5317-05 | Sandoz | 23 April 2007 |
| 1000 tablet, coated in 1 bottle | 0781-5317-10 | Sandoz | 23 April 2007 |
| 30 tablet, coated in 1 bottle | 0781-5317-31 | Sandoz | 23 April 2007 |
| 100 tablet in 1 bottle | 63629-1170-1 | Bryant Ranch Prepack | 24 September 2020 |
| 25 tablet in 1 bottle | 63629-3549-0 | Bryant Ranch Prepack | 26 April 2013 |
| 30 tablet in 1 bottle | 63629-3549-1 | Bryant Ranch Prepack | 6 August 2026 |
| 60 tablet in 1 bottle | 63629-3549-2 | Bryant Ranch Prepack | 12 August 2008 |
| 10 tablet in 1 bottle | 63629-3549-3 | Bryant Ranch Prepack | 7 January 2009 |
| 100 tablet in 1 bottle | 63629-3549-4 | Bryant Ranch Prepack | 6 February 2009 |
| 20 tablet in 1 bottle | 63629-3549-5 | Bryant Ranch Prepack | 1 October 2009 |
| 90 tablet in 1 bottle | 63629-3549-6 | Bryant Ranch Prepack | 29 March 2010 |
| 56 tablet in 1 bottle | 63629-3549-7 | Bryant Ranch Prepack | 2 March 2010 |
| 28 tablet in 1 bottle | 63629-3549-8 | Bryant Ranch Prepack | 20 July 2010 |
| 120 tablet in 1 bottle | 63629-3549-9 | Bryant Ranch Prepack | 3 October 2014 |
| 30 tablet in 1 bottle | 63629-8998-1 | Bryant Ranch Prepack | 4 April 2024 |
| 60 tablet in 1 bottle | 63629-8998-2 | Bryant Ranch Prepack | 4 April 2024 |
| 90 tablet in 1 bottle | 63629-8998-3 | Bryant Ranch Prepack | 4 April 2024 |
| 1000 tablet in 1 bottle | 63629-9613-1 | Bryant Ranch Prepack | 3 February 2023 |
| 25 tablet, coated in 1 bottle | 71335-9629-0 | Bryant Ranch Prepack | 23 January 2023 |
| 30 tablet, coated in 1 bottle | 71335-9629-1 | Bryant Ranch Prepack | 23 January 2023 |
| 60 tablet, coated in 1 bottle | 71335-9629-2 | Bryant Ranch Prepack | 23 January 2023 |
| 10 tablet, coated in 1 bottle | 71335-9629-3 | Bryant Ranch Prepack | 23 January 2023 |
| 100 tablet, coated in 1 bottle | 71335-9629-4 | Bryant Ranch Prepack | 23 January 2023 |
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 5 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 5 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.