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
NDC Product Code70771-1502
Application NumberANDA213057
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateNovember 7, 2023
Generic NameIsosorbide dinitrate
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
NDC Product Code70771-1501
Application NumberANDA213057
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateNovember 7, 2023
Generic NameIsosorbide dinitrate
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
NDC Product Code70771-1504
Application NumberANDA213057
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateNovember 7, 2023
Generic NameIsosorbide dinitrate
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
NDC Product Code70771-1505
Application NumberANDA213057
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateNovember 7, 2023
Generic NameIsosorbide dinitrate
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
NDC Product Code70771-1503
Application NumberANDA213057
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateNovember 7, 2023
Generic NameIsosorbide dinitrate
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