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
NDC Product Code71335-1669
Application NumberANDA090871
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateApril 30, 2021
Generic NameAlprazolam
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