Alprazolam
These highlights do not include all the information needed to use ALPRAZOLAM safely and effectively. See full prescribing information for ALPRAZOLAM. ALPRAZOLAM (alprazolam) tablets, for oral use, CIV Initial U.S. Approval: 1981
Approved
Approval ID
4579facb-b225-4108-a5ef-dada926ef7cf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 1, 2022
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
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 Code71205-652
Application NumberNDA018276
Product Classification
M
Marketing Category
C73605
G
Generic Name
alprazolam
Product Specifications
Route of AdministrationORAL
Effective DateApril 1, 2022
FDA Product Classification
INGREDIENTS (9)
ALPRAZOLAMActive
Quantity: 0.5 mg in 1 1
Code: YU55MQ3IZY
Classification: ACTIB
POWDERED CELLULOSEInactive
Code: SMD1X3XO9M
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT