Quick answers
- What is Alprazolam used for?
- The FDA-approved label (Xanax, Pharmacia & Upjohn Company LLC, January 18, 2023) says: “XANAX is indicated for the: • acute treatment of generalized anxiety disorder (GAD) in adults. • treatment of panic disorder (PD), with or without agoraphobia in adults. XANAX is a benzodiazepine indicated for the: • Acute treatment of generalized anxiety disorder in adults. • Treatment of panic disorder with or without agoraphobia in adults.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Alprazolam have a boxed warning?
- Yes. The FDA label for Xanax has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Alprazolam?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Alprazolam been recalled?
- FDA enforcement reports list 7 recalls of products of this medicine; the newest started March 17, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Alprazolam?
- 31 companies list prescription products of Alprazolam in the FDA NDC Directory, including Asclemed USA, Inc., Proficient Rx LP and Bryant Ranch Prepack.
What Alprazolam is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
XANAX is indicated for the: • acute treatment of generalized anxiety disorder (GAD) in adults. • treatment of panic disorder (PD), with or without agoraphobia in adults. XANAX is a benzodiazepine indicated for the: • Acute treatment of generalized anxiety disorder in adults. • Treatment of panic disorder with or without agoraphobia in adults.
— FDA label: Xanax, Pharmacia & Upjohn Company LLC, effective January 18, 2023. Read the full label on DailyMed →
The FDA has 77 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
73 of 77 FDA labels for this medicine have a boxed warning.
Forms and how it is given
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| alprazolam 0.25 mg tablet | Generic | $0.0230 per tablet |
| alprazolam 0.25 mg tablet | Brand: Xanax | $5.63 per tablet |
| alprazolam 0.25 mg tablet, orally disintegrating | Generic | $0.9652 per tablet |
| alprazolam 0.5 mg tablet | Generic | $0.0228 per tablet |
| alprazolam 0.5 mg tablet | Brand: Xanax | $7.03 per tablet |
| alprazolam 0.5 mg tablet, extended release | Generic | $0.1497 per tablet |
| alprazolam 0.5 mg tablet, orally disintegrating | Generic | $1.24 per tablet |
| alprazolam 1 mg tablet | Generic | $0.0246 per tablet |
| alprazolam 1 mg tablet | Brand: Xanax | $9.35 per tablet |
| alprazolam 1 mg tablet, extended release | Generic | $0.1530 per tablet |
| alprazolam 1 mg tablet, orally disintegrating | Generic | $1.77 per tablet |
| alprazolam 2 mg tablet | Generic | $0.0478 per tablet |
| alprazolam 2 mg tablet | Brand: Xanax | $15.91 per tablet |
| alprazolam 2 mg tablet, extended release | Generic | $0.2126 per tablet |
| alprazolam 3 mg tablet, extended release | Generic | $0.2472 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Asclemed USA, Inc.12 products
- Proficient Rx LP12 products
- Bryant Ranch Prepack11 products
- Mylan Pharmaceuticals Inc.8 products
- Actavis Pharma, Inc.8 products
- Aurobindo Pharma Limited8 products
- Aphena Pharma Solutions - Tennessee, LLC7 products
- NuCare Pharmaceuticals, Inc.7 products
- Viatris Specialty LLC6 products
- PD-Rx Pharmaceuticals, Inc.5 products
- Direct_Rx4 products
- Sandoz Inc4 products
- Par Health USA, LLC4 products
- Natco Pharma USA LLC4 products
- ANI Pharmaceuticals, Inc.4 products
- A-S Medication Solutions4 products
- Amneal Pharmaceuticals LLC4 products
- Clinical Solutions Wholesale, LLC4 products
- Advanced Rx of Tennessee, LLC4 products
- AvPAK3 products
- Pharmacia & Upjohn Company LLC3 products
- American Health Packaging2 products
- Coupler LLC2 products
- Preferred Pharmaceuticals Inc.2 products
- Northwind Health Company, LLC1 product
- St. Mary's Medical Park Pharmacy1 product
- Advanced Rx Pharmacy of Tennessee, LLC1 product
- Remedyrepack Inc.1 product
- Medsource Pharmaceuticals1 product
- PreferredPharmaceuticals Inc.1 product
- Hikma Pharmaceuticals USA Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA018276 XANAX | Upjohn | October 16, 1981 | 39, latest January 13, 2023 2023: Labeling · 2021: Labeling · 2021: Labeling |
| NDA021434 XANAX XR | Upjohn | January 17, 2003 | 9, latest January 13, 2023 2023: Labeling · 2021: Labeling · 2021: Labeling |
Generic approvals (12)
- ANDA074174Novitium Pharma · October 19, 1993
- ANDA074312Hikma · October 31, 1993
- ANDA074342Actavis Elizabeth · October 31, 1993
- ANDA074112Sandoz · December 29, 1995
- ANDA074909Sandoz · March 25, 1998
- ANDA078056Actavis Elizabeth · February 13, 2007
- ANDA078387Amneal Pharms Ny · May 30, 2008
- ANDA078088Ph Health · January 9, 2009
- ANDA078561Actavis Elizabeth · March 16, 2010
- ANDA090871Aurobindo Pharma · June 7, 2011
- ANDA200739Natco · April 15, 2015
- ANDA203346Aurobindo Pharma · July 31, 2015
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
March 17, 2026 · Class II · Ongoing · D-0444-2026
Failed Dissolution Specifications
Xanax XR, alprazolam, extended-release tablets, 3 mg, 60 Tablets bottles, Rx only, Distributed by: Viatris Specialty LLC, Morgantown, WV 06506, U.S.A, Made in Ireland, NDC 58151-506-91 — Viatris, Inc.
-
April 28, 2022 · Class II · Terminated · D-0844-2022
Failed Dissolution Specifications: low out-of-specification dissolution test results observed.
alprazolam XR extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC 59762-0068-1. — Viatris Inc
-
September 24, 2015 · Class II · Terminated · D-0161-2016
Subpotent Drug
Xanax (alprazolam) tablets, 0.25 mg, 100-count bottle, Rx only, Distributed by Pharmacia & Upjohn Co. Division of Pfizer Inc, NY, NY 10017, NDC 0009-0029-01 — Pfizer Inc.
-
December 17, 2014 · Class II · Terminated · D-0326-2015
Subpotent Drug
Alprazolam tablets, USP, CIV, 0.25 mg, Rx Only, a) 500 count bottle, b) 1000 count bottle, Distributed by: Greenstone LLC, Peapack, NJ, 07977, a) NDC 59762-3719-3, b) NDC 59762-3719-4. — Neolpharma, Inc.
-
July 25, 2014 · Class II · Terminated · D-1509-2014
Presence of Foreign Substance; tablets may contain stainless steel metal particulates
Alprazolam Tablets, USP, 0.25mg, Rx only, 1000 tablets, Sandoz Inc., Princeton, NJ --- NDC 0781-1061-10 — Sandoz Incorporated
-
February 10, 2014 · Class II · Terminated · D-1153-2014
Failed Tablet/Capsule Specifications: Complaints were received for significant tablet erosion for Alprazolam 1 mg.
Alprazolam 1 mg Tablets, USP, 500 count Bottle, Rx Only , C IV, Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue Elizabeth, NJ 07207 USA, NDC 0228-2031-50 — Actavis Elizabeth LLC
-
October 9, 2013 · Class II · Terminated · D-018-2014
Failed Tablet/Capsule Specifications; partial tablet erosion resulting in tablet weights below specification in some tablets
Alprazolam Orally Disintegrating Tablets, USP 2 mg, 100 count bottles, Rx Only, MFG. BY ACTAVIS ELIZABETH LLC., Elizabeth, NJ, NDC 0228-4025-11 — Actavis Elizabeth LLC
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Xanax, Pharmacia & Upjohn Company LLC, effective January 18, 2023; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →