Alprazolam
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ALPRAZOLAM TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM TABLETS. ALPRAZOLAM tablets, for oral use, CIV Initial U.S. Approval: 1981
Approved
Approval ID
b3c55877-2538-4892-bdb1-d618c643d29c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 7, 2023
Manufacturers
FDA
Natco Pharma USA LLC
DUNS: 079590418
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Alprazolam
PRODUCT DETAILS
NDC Product Code69339-200
Application NumberANDA200739
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 7, 2023
Generic NameAlprazolam
INGREDIENTS (7)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ALPRAZOLAMActive
Quantity: 0.5 mg in 1 1
Code: YU55MQ3IZY
Classification: ACTIB
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
Alprazolam
PRODUCT DETAILS
NDC Product Code69339-202
Application NumberANDA200739
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 7, 2023
Generic NameAlprazolam
INGREDIENTS (6)
ALPRAZOLAMActive
Quantity: 2 mg in 1 1
Code: YU55MQ3IZY
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
Alprazolam
PRODUCT DETAILS
NDC Product Code69339-201
Application NumberANDA200739
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 7, 2023
Generic NameAlprazolam
INGREDIENTS (7)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ALPRAZOLAMActive
Quantity: 1 mg in 1 1
Code: YU55MQ3IZY
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
Alprazolam
PRODUCT DETAILS
NDC Product Code69339-199
Application NumberANDA200739
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 7, 2023
Generic NameAlprazolam
INGREDIENTS (6)
ALPRAZOLAMActive
Quantity: 0.25 mg in 1 1
Code: YU55MQ3IZY
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT