Doxazosin
These highlights do not include all the information needed to use DOXAZOSIN TABLETS safely and effectively. See full prescribing information for DOXAZOSIN TABLETS.DOXAZOSIN tablets, for oral useInitial U.S. Approval: 1990
Approved
Approval ID
7991373e-8a62-47f9-b4fb-90573485af4e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 4, 2022
Manufacturers
FDA
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
DUNS: 780779901
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Doxazosin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code23155-095
Application NumberANDA205210
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxazosin
Product Specifications
Route of AdministrationORAL
Effective DateApril 4, 2022
FDA Product Classification
INGREDIENTS (8)
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
DOXAZOSIN MESYLATEActive
Quantity: 8 mg in 1 1
Code: 86P6PQK0MU
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
Doxazosin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code23155-093
Application NumberANDA205210
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxazosin
Product Specifications
Route of AdministrationORAL
Effective DateApril 4, 2022
FDA Product Classification
INGREDIENTS (8)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
DOXAZOSIN MESYLATEActive
Quantity: 2 mg in 1 1
Code: 86P6PQK0MU
Classification: ACTIM
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
Doxazosin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code23155-092
Application NumberANDA205210
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxazosin
Product Specifications
Route of AdministrationORAL
Effective DateApril 4, 2022
FDA Product Classification
INGREDIENTS (6)
DOXAZOSIN MESYLATEActive
Quantity: 1 mg in 1 1
Code: 86P6PQK0MU
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
Doxazosin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code23155-094
Application NumberANDA205210
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxazosin
Product Specifications
Route of AdministrationORAL
Effective DateApril 4, 2022
FDA Product Classification
INGREDIENTS (7)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
DOXAZOSIN MESYLATEActive
Quantity: 4 mg in 1 1
Code: 86P6PQK0MU
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT