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Medicine

Alprazolam 0.5 mg tablet

Alprazolam · Oral
Available on requestPrescription onlyUS FDAControlled, schedule CIVGeneric name

Alprazolam 0.5 mg tablet is a generic prescription medicine for oral use, made by 22 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

Available on request

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° to 25°C (68° to 77°F).

Key facts

Active ingredient (INN)
Alprazolam
Brand
Sold under the generic name
Strength
0.5 mg
Dosage form
Tablet
Route
Oral
Packs
100 tablets, 500 tablets, 1000 tablets and 97 more
Manufacturers
Aurobindo PharmaIndiaNatco PharmaIndiaUnichem LaboratoriesIndiaProficient RxAphena Pharma Solutions - TennesseeActavis PharmaAdvanced Rx of TennesseeANI PharmaceuticalsMylan PharmaceuticalsSandoz22 labelers on the register
Origin register
US FDA, United States
Storage
Store at controlled room temperature 20° to 25°C (68° to 77°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
16 October 1981
Identifiers
RxCUI 308048, 197321, 197322 +1DailyMed set ID b39e2bc8-b68f-0f4e-e053-2995a90a00fd, d2fd0b3e-9b78-44d0-82a6-96d6c6238750, 38428a1b-718c-49cc-94ae-2e3644ba6256 +26NDC 80425-0099, 65862-677, 70954-509 +26Application ANDA074342, ANDA203346, ANDA074174 +4

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 22 labelers. The register lists 100 packs for this generic presentation, and we confirm the exact pack on the quote.

PackCodeLabelerMarketed since
100 tablet in 1 bottle65862-677-01Aurobindo PharmaIndia31 July 2015
500 tablet in 1 bottle65862-677-05Aurobindo PharmaIndia31 July 2015
1000 tablet in 1 bottle65862-677-99Aurobindo PharmaIndia31 July 2015
100 tablet in 1 bottle69339-200-01Natco PharmaIndia28 July 2023
500 tablet in 1 bottle69339-200-05Natco PharmaIndia28 July 2023
1000 tablet in 1 bottle69339-200-10Natco PharmaIndia28 July 2023
100 tablet in 1 bottle29300-361-01Unichem LaboratoriesIndia2 November 2026
500 tablet in 1 bottle29300-361-05Unichem LaboratoriesIndia2 November 2026
1000 tablet in 1 bottle29300-361-10Unichem LaboratoriesIndia2 November 2026
100 tablet in 1 bottle0228-2029-10Actavis Pharma1 October 1993
500 tablet in 1 bottle0228-2029-50Actavis Pharma1 October 1993
1000 tablet in 1 bottle0228-2029-96Actavis Pharma1 October 1993
100 tablet in 1 bottle70954-509-10ANI Pharmaceuticals11 May 2021
500 tablet in 1 bottle70954-509-20ANI Pharmaceuticals11 May 2021
1000 tablet in 1 bottle70954-509-30ANI Pharmaceuticals11 May 2021
100 tablet in 1 bottle59762-3720-1Mylan Pharmaceuticals16 October 1981
500 tablet in 1 bottle59762-3720-3Mylan Pharmaceuticals16 October 1981
1000 tablet in 1 bottle59762-3720-4Mylan Pharmaceuticals16 October 1981
100 tablet in 1 bottle0781-1077-01Sandoz29 December 1995
500 tablet in 1 bottle0781-1077-05Sandoz29 December 1995
1000 tablet in 1 bottle0781-1077-10Sandoz29 December 1995
30 tablet in 1 bottle63187-225-30Proficient Rx3 March 2014
60 tablet in 1 bottle63187-225-60Proficient Rx3 March 2014
90 tablet in 1 bottle63187-225-90Proficient Rx3 March 2014
30 tablet in 1 bottle71205-652-30Proficient Rx12 April 2022
60 tablet in 1 bottle71205-652-60Proficient Rx12 April 2022
90 tablet in 1 bottle71205-652-90Proficient Rx12 April 2022
30 tablet in 1 bottle82804-035-30Proficient Rx26 October 2023
60 tablet in 1 bottle82804-035-60Proficient Rx26 October 2023
90 tablet in 1 bottle82804-035-90Proficient Rx26 October 2023
60 tablet in 1 bottle80425-0099-2Advanced Rx of Tennessee1 October 1993
30 tablet in 1 bottle80425-0284-1Advanced Rx of Tennessee8 March 2023
60 tablet in 1 bottle80425-0284-2Advanced Rx of Tennessee8 March 2023
15 tablet in 1 bottle67544-415-15Aphena Pharma Solutions - Tennessee10 May 2006
20 tablet in 1 bottle67544-415-20Aphena Pharma Solutions - Tennessee26 April 2010
30 tablet in 1 bottle67544-415-30Aphena Pharma Solutions - Tennessee23 June 2005
45 tablet in 1 bottle67544-415-45Aphena Pharma Solutions - Tennessee25 May 2006
60 tablet in 1 bottle67544-415-53Aphena Pharma Solutions - Tennessee23 June 2005
75 tablet in 1 bottle67544-415-55Aphena Pharma Solutions - Tennessee26 April 2010
90 tablet in 1 bottle67544-415-60Aphena Pharma Solutions - Tennessee23 June 2005

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.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 16 October 1981Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS 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 0.5 mg tablet.

Compare 1

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 Alprazolam

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Alprazolam 0.5 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.