Medicine
Zolpidem 3.5 mg sublingual tablet
Zolpidem 3.5 mg sublingual tablet is a generic prescription medicine for sublingual use, made by 2 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 between 20° to 25°C (68° to 77°F). Excursions permitted between 15° to…
Key facts
- Active ingredient (INN)
- Zolpidem
- Brand
- Sold under the generic name
- Strength
- 3.5 mg
- Dosage form
- Sublingual tablet
- Route
- Sublingual
- Packs
- 30 pouches
- Manufacturers
- LupinIndiaPar Health
- Origin register
- US FDA, United States
- Storage
- Store between 20° to 25°C (68° to 77°F). Excursions permitted between 15° to 30°C (59° to 86°F). Protect from moisture.
- 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
- 22 March 2016
- Identifiers
- RxCUI 1232194, 1232202DailyMed set ID 44b34e58-114b-4774-9fab-4b188dfe0228, 6db679f6-b1f8-4fbf-9e87-9cef4650c45aNDC 49884-899, 43386-761Application ANDA204229, ANDA204299
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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 30 pouch in 1 carton / 1 blister pack in 1 pouch / 1 tablet in 1 blister pack | 43386-761-30 | LupinIndia | 22 March 2016 |
| 30 pouch in 1 carton / 1 tablet in 1 pouch | 49884-899-11 | Par Health | 11 September 2017 |
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 3.5 mg sublingual 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.