Alprazolam
Alprazolam Tablets, USP
Approved
Approval ID
366500a0-6e91-4aaf-802a-8966b1c5a3e5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 25, 2011
Manufacturers
FDA
Contract Pharmacy Services-PA
DUNS: 945429777
Products 3
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 Code67046-962
Application NumberANDA074112
Product Classification
M
Marketing Category
C73584
G
Generic Name
Alprazolam
Product Specifications
Route of AdministrationORAL
Effective DateJune 1, 2009
FDA Product Classification
INGREDIENTS (8)
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
AlprazolamActive
Quantity: 1 mg in 1 1
Code: YU55MQ3IZY
Classification: ACTIM
docusate sodiumInactive
Code: F05Q2T2JA0
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
sodium benzoateInactive
Code: OJ245FE5EU
Classification: IACT
FD&C Blue No. 2Inactive
Code: L06K8R7DQK
Classification: IACT
Alprazolam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67046-960
Application NumberANDA074112
Product Classification
M
Marketing Category
C73584
G
Generic Name
Alprazolam
Product Specifications
Route of AdministrationORAL
Effective DateJune 1, 2009
FDA Product Classification
INGREDIENTS (7)
docusate sodiumInactive
Code: F05Q2T2JA0
Classification: IACT
AlprazolamActive
Quantity: 0.25 mg in 1 1
Code: YU55MQ3IZY
Classification: ACTIM
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
sodium benzoateInactive
Code: OJ245FE5EU
Classification: IACT
Alprazolam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67046-961
Application NumberANDA074112
Product Classification
M
Marketing Category
C73584
G
Generic Name
Alprazolam
Product Specifications
Route of AdministrationORAL
Effective DateJune 1, 2009
FDA Product Classification
INGREDIENTS (8)
AlprazolamActive
Quantity: 0.5 mg in 1 1
Code: YU55MQ3IZY
Classification: ACTIM
docusate sodiumInactive
Code: F05Q2T2JA0
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
sodium benzoateInactive
Code: OJ245FE5EU
Classification: IACT
FD&C Yellow No. 6Inactive
Code: H77VEI93A8
Classification: IACT