Medicine
Zaleplon 5 mg capsule
Zaleplon 5 mg capsule is a generic prescription medicine for oral use, made by 7 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 to 25°C (68°F to 77°F).
Key facts
- Active ingredient (INN)
- Zaleplon
- Brand
- Sold under the generic name
- Strength
- 5 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 100 capsules, 500 capsules, 30 capsules and 11 more
- Manufacturers
- Unichem LaboratoriesIndiaAurobindo PharmaIndiaBryant Ranch PrepackBionpharmaHikma PharmaceuticalsPD-Rx PharmaceuticalsRising Pharma Holdings
- Origin register
- US FDA, United States
- Storage
- Store at controlled room temperature, 20°C to 25°C (68°F to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Schedule CIV
- ATC code
- N05CF03 Zaleplon
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 6 June 2008
- Identifiers
- RxCUI 313762, 313761DailyMed set ID d8c88122-ce04-4caf-bd4d-0a4368ea89ad, 57a1a11d-7767-4caf-b98a-75d7561d9165, cadd9d75-2139-4fab-94ce-2992e6a55780 +4NDC 71335-0236, 29300-131, 0054-0084 +4Application ANDA078989, ANDA077237, ANDA078829 +1
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 |
|---|---|---|---|
| 100 capsule in 1 bottle | 65862-214-01 | Aurobindo PharmaIndia | 6 June 2008 |
| 500 capsule in 1 bottle | 65862-214-05 | Aurobindo PharmaIndia | 6 June 2008 |
| 100 capsule in 1 bottle, plastic | 29300-131-01 | Unichem LaboratoriesIndia | 5 May 2009 |
| 500 capsule in 1 bottle, plastic | 29300-131-05 | Unichem LaboratoriesIndia | 5 May 2009 |
| 30 capsule in 1 bottle, plastic | 29300-131-13 | Unichem LaboratoriesIndia | 5 May 2009 |
| 100 capsule in 1 bottle | 69452-364-20 | Bionpharma | 17 February 2024 |
| 100 capsule in 1 bottle | 0054-0084-25 | Hikma Pharmaceuticals | 6 June 2008 |
| 100 capsule in 1 bottle | 57237-239-01 | Rising Pharma Holdings | 6 June 2008 |
| 30 capsule in 1 bottle | 71335-0236-1 | Bryant Ranch Prepack | 8 May 2019 |
| 60 capsule in 1 bottle | 71335-0236-2 | Bryant Ranch Prepack | 23 March 2018 |
| 90 capsule in 1 bottle | 71335-0236-3 | Bryant Ranch Prepack | 27 December 2021 |
| 20 capsule in 1 bottle | 71335-0236-4 | Bryant Ranch Prepack | 27 December 2021 |
| 28 capsule in 1 bottle | 71335-0236-5 | Bryant Ranch Prepack | 27 December 2021 |
| 30 capsule in 1 bottle, plastic | 43063-505-30 | PD-Rx Pharmaceuticals | 17 May 2013 |
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.
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 Zaleplon
Clinical summary
Zaleplon is a gamma-aminobutyric acid A receptor agonist indicated for the short-term treatment of insomnia. It is available as capsules for oral use. MedsAcross supplies Zaleplon 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 ZaleplonFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- ZALEPLON prescribing information (Aurobindo Pharma) · U.S. National Library of Medicine, DailyMed
Need Zaleplon 5 mg capsule 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.