Isosorbide Dinitrate
Approved
Approval ID
ad51e5ef-31e6-470b-9332-dab8d1533483
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 6, 2017
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 Code68151-2476
Application NumberANDA087946
Product Classification
M
Marketing Category
C73584
G
Generic Name
isosorbide dinitrate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 30, 2017
FDA Product Classification
INGREDIENTS (2)
ISOSORBIDE DINITRATEActive
Quantity: 30 mg in 1 1
Code: IA7306519N
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT