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
Approved
Approval ID
0dce8232-0b0e-4f81-af95-36e6febdb550
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 7, 2023
Manufacturers
FDA
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
NDC Product Code71335-1669
Application NumberANDA090871
Product Classification
M
Marketing Category
C73584
G
Generic Name
Alprazolam
Product Specifications
Route of AdministrationORAL
Effective DateApril 30, 2021
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ALPRAZOLAMActive
Quantity: 0.5 mg in 1 1
Code: YU55MQ3IZY
Classification: ACTIB
HYPROMELLOSE 2208 (4000 MPA.S)Inactive
Code: 39J80LT57T
Classification: IACT
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712K
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT