Active substance
Alprazolam
- SFDA 8
- US FDA 40
- Health Canada 13
- US price lines 19
- Safety 3
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| XANAX 0.25 MG TABLET | 0.25 mg | Tablet · Oral use | 50 Blister | SAR 12.20 | Generic · Prescription | Viatris Healthcare | Valid |
| XANAX 0.5 MG TABLET | 0.5 mg | Tablet · Oral use | 50 Blister | SAR 20.20 | Generic · Prescription | Viatris Healthcare | Valid |
| XANAX 1 MG TABLET | 1 mg | Tablet · Oral use | 30 Blister | SAR 13.70 | Generic · Prescription | Viatris Healthcare | Valid |
| XANAX 1MG TAB | 1 mg | Tablet · Oral use | 30 Blister | SAR 29.35 | NCE · Prescription | PHARMACIA UPJOHN | Withdrawn by regulatory authority · Not Marketed |
| XANAX TAB 0.25MG | 0.25 mg | Tablet · Oral use | 20 Blister | SAR 9.15 | NCE · Prescription | PHARMACIA UPJOHN | Withdrawn by MAH · Not Marketed |
| XANAX TAB 0.25MG | 0.25 mg | Tablet · Oral use | 50 Blister | SAR 20.65 | NCE · Prescription | PHARMACIA UPJOHN | Withdrawn by regulatory authority · Not Marketed |
| XANAX TAB 0.5MG | 0.5 mg | Tablet · Oral use | 20 Blister | SAR 15.00 | NCE · Prescription | PHARMACIA UPJOHN | Withdrawn by MAH · Not Marketed |
| XANAX TAB 0.5MG | 0.5 mg | Tablet · Oral use | 50 Blister | SAR 28.40 | NCE · Prescription | PHARMACIA UPJOHN | Withdrawn by regulatory authority · Not Marketed |
Indications — CHI Daman Drug Formulary
ACUTE MANIA; ANXIETY DISORDERS; INSOMNIA; JET LAG - INSOMNIA; SCHIZOPHRENIA; VERTIGO - BENIGN PAROXYSMAL POSITIONAL VERTIGO AND ACUTE VESTIBULAR NEURONITIS OR LABYRINTHITIS OR MENIERE'S DISEASE; VERTIGO - MOTION SICKNESS
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| XANAX | 0.25MG; 0.5MG; 1MG; 2MG | tablet · oral | UPJOHN | Prescription | 16 Oct 1981 |
| ALPRAZOLAM | 0.25MG; 0.5MG; 1MG; 2MG | tablet · oral | NOVITIUM PHARMA | Prescription | 19 Oct 1993 |
| ALPRAZOLAM | 1MG/ML | concentrate · oral | HIKMA PHARMS | Prescription | 31 Oct 1993 |
| ALPRAZOLAM | 0.25MG; 0.5MG; 1MG; 2MG | tablet · oral | ACTAVIS ELIZABETH | Prescription | 31 Oct 1993 |
| ALPRAZOLAM | 0.25MG; 0.5MG; 1MG | tablet · oral | SANDOZ | Prescription | 29 Dec 1995 |
| ALPRAZOLAM | 2MG | tablet · oral | SANDOZ | Prescription | 25 Mar 1998 |
| XANAX XR | 0.5MG; 1MG; 2MG; 3MG | tablet, extended release · oral | UPJOHN | Prescription | 17 Jan 2003 |
| ALPRAZOLAM | 0.5MG; 1MG; 2MG; 3MG | tablet, extended release · oral | AMNEAL PHARMS NY | Prescription | 30 May 2008 |
| ALPRAZOLAM | 0.25MG; 0.5MG; 1MG; 2MG | tablet, orally disintegrating · oral | PH HEALTH | Prescription | 9 Jan 2009 |
| ALPRAZOLAM | 0.25MG; 0.5MG; 1MG; 2MG | tablet, orally disintegrating · oral | ACTAVIS ELIZABETH | Prescription | 16 Mar 2010 |
| ALPRAZOLAM | 0.5MG; 1MG; 2MG; 3MG | tablet, extended release · oral | AUROBINDO PHARMA | Prescription | 7 Jun 2011 |
| ALPRAZOLAM | 0.25MG; 0.5MG; 1MG; 2MG | tablet · oral | NATCO | Prescription | 15 Apr 2015 |
| ALPRAZOLAM | 0.25MG; 0.5MG; 1MG; 2MG | tablet · oral | AUROBINDO PHARMA | Prescription | 31 Jul 2015 |
| ALPRAZOLAM | 0.25MG; 0.5MG; 1MG; 2MG | tablet · oral | UNICHEM | Prescription | 13 Jul 2026 |
| ALPRAZOLAM | 0.25MG; 0.5MG; 1MG; 2MG | tablet · oral | PHARMOBEDIENT | Discontinued | 19 Oct 1993 |
| ALPRAZOLAM | 0.5MG/5ML | solution · oral | ROXANE | Discontinued | 31 Oct 1993 |
| ALPRAZOLAM | 0.25MG; 0.5MG; 1MG; 2MG | tablet · oral | MYLAN | Discontinued | 27 Jan 1994 |
| ALPRAZOLAM | 0.25MG; 0.5MG; 1MG; 2MG | tablet · oral | ANI PHARMS | Discontinued | 16 Feb 1994 |
| ALPRAZOLAM | 0.25MG; 0.5MG; 1MG; 2MG | tablet · oral | IVAX SUB TEVA PHARMS | Discontinued | 29 Jul 1994 |
| ALPRAZOLAM | 0.25MG; 0.5MG; 1MG | tablet · oral | WATSON LABS | Discontinued | 31 Aug 1995 |
| ALPRAZOLAM | 0.25MG; 0.5MG; 1MG | tablet · oral | WATSON LABS | Discontinued | 21 Jan 1997 |
| NIRAVAM | 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet, orally disintegrating · oral | UCB INC | Discontinued | 19 Jan 2005 |
| ALPRAZOLAM | 3MG; 0.5MG; 1MG; 2MG | tablet, extended release · oral | PHARMOBEDIENT | Discontinued | 26 Jan 2006 |
| ALPRAZOLAM | 0.5MG; 1MG; 2MG; 3MG | tablet, extended release · oral | SANDOZ INC | Discontinued | 30 Jun 2006 |
| ALPRAZOLAM | 0.5MG; 1MG; 3MG; 2MG | tablet, extended release · oral | ANI PHARMS | Discontinued | 31 Jul 2006 |
15 more — full table
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| APO-ALPRAZ | 00865397 | 0.25 MG | TABLET · ORAL | APOTEX INC |
| APO-ALPRAZ | 00865400 | 0.5 MG | TABLET · ORAL | APOTEX INC |
| APO-ALPRAZ | 02243611 | 1 MG | TABLET · ORAL | APOTEX INC |
| APO-ALPRAZ TS | 02243612 | 2 MG | TABLET · ORAL | APOTEX INC |
| PRO-ALPRAZOLAM | 01908170 | 0.5 MG | TABLET · ORAL | PRO DOC LIMITEE |
| PRO-ALPRAZOLAM | 01908189 | 0.25 MG | TABLET · ORAL | PRO DOC LIMITEE |
| PRO-ALPRAZOLAM | 02248706 | 1 MG | TABLET · ORAL | PRO DOC LIMITEE |
| TEVA-ALPRAZOLAM | 01913484 | 0.25 MG | TABLET · ORAL | TEVA CANADA LIMITED |
| TEVA-ALPRAZOLAM | 01913492 | 0.5 MG | TABLET · ORAL | TEVA CANADA LIMITED |
| XANAX | 00548359 | 0.25 MG | TABLET · ORAL | BGP PHARMA ULC |
| XANAX | 00548367 | 0.5 MG | TABLET · ORAL | BGP PHARMA ULC |
| XANAX | 00723770 | 1 MG | TABLET · ORAL | BGP PHARMA ULC |
| XANAX TS | 00813958 | 2 MG | TABLET · ORAL | BGP PHARMA ULC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | ALPRAZOLAM 0.25 MG TABLET | $0.02356 | per EA | 23 Sep 2026 |
| US NADAC | ALPRAZOLAM 0.5 MG TABLET | $0.02245 | per EA | 23 Sep 2026 |
| US NADAC | ALPRAZOLAM 1 MG TABLET | $0.02433 | per EA | 23 Sep 2026 |
| US NADAC | ALPRAZOLAM 2 MG TABLET | $0.04877 | per EA | 23 Sep 2026 |
| US NADAC | ALPRAZOLAM ER 0.5 MG TABLET | $0.15333 | per EA | 23 Sep 2026 |
| US NADAC | ALPRAZOLAM ER 1 MG TABLET | $0.15598 | per EA | 23 Sep 2026 |
| US NADAC | ALPRAZOLAM ER 2 MG TABLET | $0.20607 | per EA | 23 Sep 2026 |
| US NADAC | ALPRAZOLAM ER 3 MG TABLET | $0.26176 | per EA | 23 Sep 2026 |
| US NADAC | ALPRAZOLAM ODT 0.25 MG TAB | $0.96967 | per EA | 23 Sep 2026 |
| US NADAC | ALPRAZOLAM ODT 0.5 MG TAB | $1.23092 | per EA | 23 Sep 2026 |
| US NADAC | ALPRAZOLAM ODT 1 MG TAB | $1.77 | per EA | 23 Sep 2026 |
| US NADAC | ALPRAZOLAM XR 0.5 MG TABLET | $0.15333 | per EA | 23 Sep 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- EMA PRAC 7 May 2026 PRAC signal: Miscarriage associated with in utero exposure to benzodiazepines (including fixed-dose combinations)
Action for MAH: update of the product information: No - US FDA 13 Jan 2023 XANAX — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 13 Jan 2023 XANAX XR — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.