Isosorbide Dinitrate
ISOSORBIDE DINITRATE TABLETS, USP (Oral)
Approved
Approval ID
9e806b87-e67f-4f01-9c22-3b53f9622b34
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 30, 2011
Manufacturers
FDA
Carilion Materials Management
DUNS: 079239644
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 Code68151-2475
Application NumberANDA086067
Product Classification
M
Marketing Category
C73584
G
Generic Name
Isosorbide Dinitrate
Product Specifications
Route of AdministrationORAL
Effective DateApril 12, 2012
FDA Product Classification
INGREDIENTS (6)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
ISOSORBIDE DINITRATEActive
Quantity: 5 mg in 1 1
Code: IA7306519N
Classification: ACTIB
AMMONIUM PHOSPHATE, DIBASICInactive
Code: 10LGE70FSU
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT