Isosorbide dinitrate
Isosorbide Dinitrate Tablets, USP RX Only
Approved
Approval ID
5b0db8af-bcf9-458f-b752-420130cba428
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 7, 2023
Manufacturers
FDA
Zydus Lifesciences Limited
DUNS: 918596198
Products 5
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Isosorbide dinitrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1502
Application NumberANDA213057
Product Classification
M
Marketing Category
C73584
G
Generic Name
Isosorbide dinitrate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 7, 2023
FDA Product Classification
INGREDIENTS (6)
ISOSORBIDE DINITRATEActive
Quantity: 10 mg in 1 1
Code: IA7306519N
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
Isosorbide dinitrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1501
Application NumberANDA213057
Product Classification
M
Marketing Category
C73584
G
Generic Name
Isosorbide dinitrate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 7, 2023
FDA Product Classification
INGREDIENTS (7)
ISOSORBIDE DINITRATEActive
Quantity: 5 mg in 1 1
Code: IA7306519N
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
Isosorbide dinitrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1504
Application NumberANDA213057
Product Classification
M
Marketing Category
C73584
G
Generic Name
Isosorbide dinitrate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 7, 2023
FDA Product Classification
INGREDIENTS (7)
ISOSORBIDE DINITRATEActive
Quantity: 30 mg in 1 1
Code: IA7306519N
Classification: ACTIB
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
Isosorbide dinitrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1505
Application NumberANDA213057
Product Classification
M
Marketing Category
C73584
G
Generic Name
Isosorbide dinitrate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 7, 2023
FDA Product Classification
INGREDIENTS (8)
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
ISOSORBIDE DINITRATEActive
Quantity: 40 mg in 1 1
Code: IA7306519N
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
Isosorbide dinitrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1503
Application NumberANDA213057
Product Classification
M
Marketing Category
C73584
G
Generic Name
Isosorbide dinitrate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 7, 2023
FDA Product Classification
INGREDIENTS (8)
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ISOSORBIDE DINITRATEActive
Quantity: 20 mg in 1 1
Code: IA7306519N
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT