Isosorbide Dinitrate
Isosorbide Dinitrate Tablets
Approved
Approval ID
723d9f78-9d77-4575-af27-1aa117e6b8d7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 2, 2020
Manufacturers
FDA
Oceanside Pharmaceuticals
DUNS: 832011691
Products 2
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 Code68682-193
Application NumberNDA012093
Product Classification
M
Marketing Category
C73594
G
Generic Name
isosorbide dinitrate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 2, 2020
FDA Product Classification
INGREDIENTS (5)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
ISOSORBIDE DINITRATEActive
Quantity: 5 mg in 1 1
Code: IA7306519N
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
isosorbide dinitrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68682-192
Application NumberNDA012093
Product Classification
M
Marketing Category
C73594
G
Generic Name
isosorbide dinitrate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 2, 2020
FDA Product Classification
INGREDIENTS (6)
POWDERED CELLULOSEInactive
Code: SMD1X3XO9M
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
ISOSORBIDE DINITRATEActive
Quantity: 40 mg in 1 1
Code: IA7306519N
Classification: ACTIB
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT