Alprazolam
Alprazolam Tablets, USP CIV
Approved
Approval ID
c4520457-0b0e-493f-805c-c04a788268ee
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 5, 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 Code67046-965
Application NumberNDA018276
Product Classification
M
Marketing Category
C73605
G
Generic Name
alprazolam
Product Specifications
Route of AdministrationORAL
Effective DateApril 26, 2010
FDA Product Classification
INGREDIENTS (9)
alprazolamActive
Quantity: 1 mg in 1 1
Code: YU55MQ3IZY
Classification: ACTIB
Powdered CelluloseInactive
Code: SMD1X3XO9M
Classification: IACT
docusate sodiumInactive
Code: F05Q2T2JA0
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
lactoseInactive
Code: J2B2A4N98G
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
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 Code67046-963
Application NumberNDA018276
Product Classification
M
Marketing Category
C73605
G
Generic Name
alprazolam
Product Specifications
Route of AdministrationORAL
Effective DateApril 26, 2010
FDA Product Classification
INGREDIENTS (8)
alprazolamActive
Quantity: 0.25 mg in 1 1
Code: YU55MQ3IZY
Classification: ACTIB
Powdered CelluloseInactive
Code: SMD1X3XO9M
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
docusate sodiumInactive
Code: F05Q2T2JA0
Classification: IACT
lactoseInactive
Code: J2B2A4N98G
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
sodium benzoateInactive
Code: OJ245FE5EU
Classification: IACT
alprazolam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67046-964
Application NumberNDA018276
Product Classification
M
Marketing Category
C73605
G
Generic Name
alprazolam
Product Specifications
Route of AdministrationORAL
Effective DateApril 26, 2010
FDA Product Classification
INGREDIENTS (9)
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
docusate sodiumInactive
Code: F05Q2T2JA0
Classification: IACT
lactoseInactive
Code: J2B2A4N98G
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
alprazolamActive
Quantity: 0.5 mg in 1 1
Code: YU55MQ3IZY
Classification: ACTIB
Powdered CelluloseInactive
Code: SMD1X3XO9M
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
sodium benzoateInactive
Code: OJ245FE5EU
Classification: IACT
FD&C Yellow No. 6Inactive
Code: H77VEI93A8
Classification: IACT