Cardura
These highlights do not include all the information needed to use CARDURA safely and effectively. See full prescribing information for CARDURA. CARDURA (doxazosin) tablets, for oral use Initial U.S. Approval: 1990
Approved
Approval ID
eefc47bc-c10f-49bb-8ef7-5999f798ab39
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 20, 2022
Manufacturers
FDA
ROERIG
DUNS: 829076996
Products 8
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 Code0049-2512
Application NumberNDA019668
Product Classification
M
Marketing Category
C73594
G
Generic Name
doxazosin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 20, 2022
FDA Product Classification
INGREDIENTS (6)
DOXAZOSIN MESYLATEActive
Quantity: 2 mg in 1 1
Code: 86P6PQK0MU
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
doxazosin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0049-2410
Application NumberNDA019668
Product Classification
M
Marketing Category
C73594
G
Generic Name
doxazosin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 20, 2022
FDA Product Classification
INGREDIENTS (6)
DOXAZOSIN MESYLATEActive
Quantity: 1 mg in 1 1
Code: 86P6PQK0MU
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
doxazosin mesylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0049-2750
Application NumberNDA019668
Product Classification
M
Marketing Category
C73594
G
Generic Name
doxazosin mesylate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 20, 2022
FDA Product Classification
INGREDIENTS (6)
DOXAZOSIN MESYLATEActive
Quantity: 1 mg in 1 1
Code: 86P6PQK0MU
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
doxazosin mesylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0049-2780
Application NumberNDA019668
Product Classification
M
Marketing Category
C73594
G
Generic Name
doxazosin mesylate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 20, 2022
FDA Product Classification
INGREDIENTS (8)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
DOXAZOSIN MESYLATEActive
Quantity: 8 mg in 1 1
Code: 86P6PQK0MU
Classification: ACTIM
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
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 Code0049-2716
Application NumberNDA019668
Product Classification
M
Marketing Category
C73594
G
Generic Name
doxazosin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 20, 2022
FDA Product Classification
INGREDIENTS (6)
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
DOXAZOSIN MESYLATEActive
Quantity: 8 mg in 1 1
Code: 86P6PQK0MU
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
doxazosin mesylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0049-2760
Application NumberNDA019668
Product Classification
M
Marketing Category
C73594
G
Generic Name
doxazosin mesylate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 20, 2022
FDA Product Classification
INGREDIENTS (8)
DOXAZOSIN MESYLATEActive
Quantity: 2 mg in 1 1
Code: 86P6PQK0MU
Classification: ACTIM
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
doxazosin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0049-2614
Application NumberNDA019668
Product Classification
M
Marketing Category
C73594
G
Generic Name
doxazosin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 20, 2022
FDA Product Classification
INGREDIENTS (6)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
DOXAZOSIN MESYLATEActive
Quantity: 4 mg in 1 1
Code: 86P6PQK0MU
Classification: ACTIM
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
doxazosin mesylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0049-2770
Application NumberNDA019668
Product Classification
M
Marketing Category
C73594
G
Generic Name
doxazosin mesylate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 20, 2022
FDA Product Classification
INGREDIENTS (7)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
DOXAZOSIN MESYLATEActive
Quantity: 4 mg in 1 1
Code: 86P6PQK0MU
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT