Doxazosin Mesylate
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
44bfe5d7-a56a-46f1-8ef3-ad386ab35f0f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 23, 2024
Manufacturers
FDA
Unichem Pharmaceuticals (USA), Inc.
DUNS: 181620514
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Doxazosin Mesylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code29300-352
Application NumberANDA212329
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxazosin Mesylate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 23, 2024
FDA Product Classification
INGREDIENTS (7)
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
DOXAZOSIN MESYLATEActive
Quantity: 2 mg in 1 1
Code: 86P6PQK0MU
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
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
Doxazosin Mesylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code29300-354
Application NumberANDA212329
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxazosin Mesylate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 23, 2024
FDA Product Classification
INGREDIENTS (6)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
DOXAZOSIN MESYLATEActive
Quantity: 8 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
Doxazosin Mesylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code29300-351
Application NumberANDA212329
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxazosin Mesylate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 23, 2024
FDA Product Classification
INGREDIENTS (7)
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
DOXAZOSIN MESYLATEActive
Quantity: 1 mg in 1 1
Code: 86P6PQK0MU
Classification: ACTIM
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
Doxazosin Mesylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code29300-353
Application NumberANDA212329
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxazosin Mesylate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 23, 2024
FDA Product Classification
INGREDIENTS (8)
DOXAZOSIN MESYLATEActive
Quantity: 4 mg in 1 1
Code: 86P6PQK0MU
Classification: ACTIM
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
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