Medicine
Alprazolam 3 mg extended-release tablet
Alprazolam 3 mg extended-release tablet is a generic prescription medicine for oral use, made by 4 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 o to 25 • C (68 o to 77 • F), excursions permitted between 15 o to…
Key facts
- Active ingredient (INN)
- Alprazolam
- Brand
- Sold under the generic name
- Strength
- 3 mg
- Dosage form
- Extended-release tablet
- Route
- Oral
- Packs
- 60 tablets, 7000 tablets, 1000 tablets and 7 more
- Manufacturers
- Aurobindo PharmaIndiaAmneal PharmaceuticalsAsclemedMylan Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20 o to 25 • C (68 o to 77 • F), excursions permitted between 15 o to 30 • C (59 o to 86 • F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Schedule CIV
- ATC code
- N05BA12 Alprazolam
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 17 January 2003
- Identifiers
- RxCUI 433798, 433799, 433800 +1DailyMed set ID 259387c1-e374-4bc2-9510-5f7f2c60d1a5, 5d839a8b-0f45-42bf-acc1-2bd28f948e53, 1338d1c9-7c75-42ed-95f3-9eb1b6fc51d3 +1NDC 65162-813, 76420-654, 59762-0068 +1Application ANDA078387, ANDA090871, NDA021434
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 |
|---|---|---|---|
| 60 tablet, extended release in 1 bottle | 65862-457-60 | Aurobindo PharmaIndia | 7 June 2011 |
| 7000 tablet, extended release in 1 bottle | 65862-457-71 | Aurobindo PharmaIndia | 7 June 2011 |
| 1000 tablet, extended release in 1 bottle | 65862-457-99 | Aurobindo PharmaIndia | 7 June 2011 |
| 30 tablet, extended release in 1 bottle | 65162-813-03 | Amneal Pharmaceuticals | 3 December 2009 |
| 60 tablet, extended release in 1 bottle | 65162-813-06 | Amneal Pharmaceuticals | 3 December 2009 |
| 500 tablet, extended release in 1 bottle | 65162-813-50 | Amneal Pharmaceuticals | 3 December 2009 |
| 60 tablet, extended release in 1 bottle | 59762-0068-1 | Mylan Pharmaceuticals | 17 January 2003 |
| 30 tablet, extended release in 1 bottle | 76420-654-30 | Asclemed | 5 January 2024 |
| 60 tablet, extended release in 1 bottle | 76420-654-60 | Asclemed | 5 January 2024 |
| 90 tablet, extended release in 1 bottle | 76420-654-90 | Asclemed | 5 January 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 October 1981 | 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 Alprazolam 3 mg extended-release tablet.
Other strengths and forms of Alprazolam
Clinical summary
Alprazolam is a benzodiazepine indicated for the acute treatment of generalized anxiety disorder (GAD) in adults, among other approved uses. It is available as tablets, extended-release tablets and orally disintegrating tablets. MedsAcross supplies Alprazolam 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 AlprazolamFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Alprazolam prescribing information (Mylan Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Alprazolam 3 mg extended-release 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.