Isosorbide dinitrate
Isosorbide Dinitrate Tablets, USP RX Only
Approved
Approval ID
bee4b215-e79f-44a4-97d4-2c7b8b9a2764
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 11, 2024
Manufacturers
FDA
REMEDYREPACK INC.
DUNS: 829572556
Products 1
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 Code70518-3444
Application NumberANDA213057
Product Classification
M
Marketing Category
C73584
G
Generic Name
Isosorbide dinitrate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 11, 2024
FDA Product Classification
INGREDIENTS (6)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
ISOSORBIDE DINITRATEActive
Quantity: 10 mg in 1 1
Code: IA7306519N
Classification: ACTIB