Isordil
Isordil® Titradose® (isosorbide dinitrate) Tablets
Approved
Approval ID
8ddd2577-311a-4967-bb67-ad72e2b76f83
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 8, 2019
Manufacturers
FDA
Bausch Health US LLC
DUNS: 831922468
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 Code0187-0192
Application NumberNDA012093
Product Classification
M
Marketing Category
C73594
G
Generic Name
isosorbide dinitrate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 8, 2019
FDA Product Classification
INGREDIENTS (6)
POWDERED CELLULOSEInactive
Code: SMD1X3XO9M
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
ISOSORBIDE DINITRATEActive
Quantity: 40 mg in 1 1
Code: IA7306519N
Classification: ACTIB
isosorbide dinitrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0187-0152
Application NumberNDA012093
Product Classification
M
Marketing Category
C73594
G
Generic Name
isosorbide dinitrate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 8, 2019
FDA Product Classification
INGREDIENTS (4)
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ISOSORBIDE DINITRATEActive
Quantity: 5 mg in 1 1
Code: IA7306519N
Classification: ACTIB
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT