ALPRAZOLAM
Alprazolam Tablets, USP
Approved
Approval ID
263d7c02-ca81-4035-9b3e-5104e8aff086
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 10, 2011
Manufacturers
FDA
STAT Rx USA LLC
DUNS: 786036330
Products 2
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 Code16590-005
Application NumberANDA074112
Product Classification
M
Marketing Category
C73584
G
Generic Name
ALPRAZOLAM
Product Specifications
Route of AdministrationORAL
Effective DateNovember 10, 2011
FDA Product Classification
INGREDIENTS (8)
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
ALPRAZOLAMActive
Quantity: 0.5 mg in 1 1
Code: YU55MQ3IZY
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ALPRAZOLAM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-006
Application NumberANDA074112
Product Classification
M
Marketing Category
C73584
G
Generic Name
ALPRAZOLAM
Product Specifications
Route of AdministrationORAL
Effective DateNovember 10, 2011
FDA Product Classification
INGREDIENTS (8)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ALPRAZOLAMActive
Quantity: 1 mg in 1 1
Code: YU55MQ3IZY
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT