Alprazolam
These highlights do not include all the information needed to use ALPRAZOLAM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM EXTENDED-RELEASE TABLETS. ALPRAZOLAM extended-release tablets, for oral use, CIV Initial U.S. Approval: 1981
aaab422d-c763-4352-8ffc-5aafdf91e8dd
HUMAN PRESCRIPTION DRUG LABEL
Aug 20, 2025
Bryant Ranch Prepack
DUNS: 171714327
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Alprazolam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (7)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Alprazolam ER 1mg (CIV) Tablet
RECENT MAJOR CHANGES SECTION
RECENT MAJOR CHANGES
Boxed Warning 2/2021
Dosage and Administration (2.3) 2/2021
Warnings and Precautions (5.2, 5.3) 2/2021
DESCRIPTION SECTION
11 DESCRIPTION
Alprazolam extended-release tablets USP contain alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds.
The chemical name of alprazolam is 8-chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The molecular formula is C17H13ClN4 which corresponds to a molecular weight of 308.76.
The structural formula is represented below:
Alprazolam USP is a white to off-white, crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH.
Each alprazolam extended-release tablet USP, for oral administration, contains 0.5 mg, 1 mg, 2 mg, or 3 mg of alprazolam USP. The inactive ingredients are colloidal silicon dioxide, hypromellose, lactose monohydrate, and magnesium stearate. In addition, the 1 mg and 3 mg tablets contain D&C Yellow No. 10 aluminum lake and the 2 mg and 3 mg tablets contain FD&C Blue No. 2 lake.
Meets USP Dissolution Test 4.
HOW SUPPLIED SECTION
16 HOW SUPPLIED/STORAGE AND HANDLING
Alprazolam Extended-Release Tablets USP, 1 mg are yellow colored, round, biconvex tablets with beveled edge debossed with ‘X’ on one
side and ‘73’ on the other side.
NDC: 71335-1839-1: 30 Tablets in a BOTTLE
NDC: 71335-1839-2: 60 Tablets in a BOTTLE
NDC: 71335-1839-3: 90 Tablets in a BOTTLE
NDC: 71335-1839-4: 28 Tablets in a BOTTLE
NDC: 71335-1839-5: 120 Tablets in a BOTTLE
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504