Medicine
Ambien 5 mg tablet
Ambien 5 mg tablet is a prescription medicine containing Zolpidem for oral use, marketed by Cosette Pharmaceuticals, 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
- Ambien
- Strength
- 5 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets
- Marketing authorisation holder
- Cosette Pharmaceuticals
- Manufacturer
- Cosette Pharmaceuticals
- 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
- 7 February 2025
- Identifiers
- RxCUI 854873, 854875, 854876 +1DailyMed set ID 747949c5-2c91-4909-8a07-71b6826f8e97NDC 0713-5401Application NDA019908
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet, film coated in 1 bottle | 0713-5401-01 | Cosette Pharmaceuticals | 7 February 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
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 Ambien 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.