Alprazolam
Alprazolam Tablets, USP CIV
Approved
Approval ID
8895a5a9-ea0a-406a-8c92-e03bbc3d0bd8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 13, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code42254-033
Application NumberANDA090082
Product Classification
M
Marketing Category
C73584
G
Generic Name
Alprazolam
Product Specifications
Route of AdministrationORAL
Effective DateJune 18, 2010
FDA Product Classification
INGREDIENTS (9)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ALPRAZOLAMActive
Quantity: 0.25 mg in 1 1
Code: YU55MQ3IZY
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Alprazolam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42254-048
Application NumberANDA090082
Product Classification
M
Marketing Category
C73584
G
Generic Name
Alprazolam
Product Specifications
Route of AdministrationORAL
Effective DateJune 18, 2010
FDA Product Classification
INGREDIENTS (10)
ALPRAZOLAMActive
Quantity: 0.25 mg in 1 1
Code: YU55MQ3IZY
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT