Alprazolam
Approved
Approval ID
86d1eec6-fb4d-42da-86f4-16ecd9f6a0df
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 25, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 4
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 Code54868-4663
Application NumberANDA074046
Product Classification
M
Marketing Category
C73584
G
Generic Name
Alprazolam
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 25, 2012
FDA Product Classification
INGREDIENTS (10)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
ALPRAZOLAMActive
Quantity: 2 mg in 1 1
Code: YU55MQ3IZY
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
Alprazolam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-2930
Application NumberANDA074046
Product Classification
M
Marketing Category
C73584
G
Generic Name
Alprazolam
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 25, 2012
FDA Product Classification
INGREDIENTS (12)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
ALPRAZOLAMActive
Quantity: 0.5 mg in 1 1
Code: YU55MQ3IZY
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
Alprazolam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-2929
Application NumberANDA074046
Product Classification
M
Marketing Category
C73584
G
Generic Name
Alprazolam
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 25, 2012
FDA Product Classification
INGREDIENTS (11)
ALPRAZOLAMActive
Quantity: 0.25 mg in 1 1
Code: YU55MQ3IZY
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
Alprazolam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-3005
Application NumberANDA074046
Product Classification
M
Marketing Category
C73584
G
Generic Name
Alprazolam
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 25, 2012
FDA Product Classification
INGREDIENTS (10)
ALPRAZOLAMActive
Quantity: 1 mg in 1 1
Code: YU55MQ3IZY
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
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