Isosorbide Dinitrate
Rx only
Approved
Approval ID
3d6164d7-3083-41c5-a6a6-7e144fe29f7d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 21, 2021
Manufacturers
FDA
Par Pharmaceutical, Inc.
DUNS: 092733690
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 Code49884-556
Application NumberANDA211290
Product Classification
M
Marketing Category
C73584
G
Generic Name
Isosorbide Dinitrate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 21, 2021
FDA Product Classification
INGREDIENTS (7)
ISOSORBIDE DINITRATEActive
Quantity: 40 mg in 1 1
Code: IA7306519N
Classification: ACTIB
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT