Isosorbide
ISOSORBIDE DINITRATE TABLETS, USP (Oral)
Approved
Approval ID
1b6503dc-0852-4a4c-9fc3-ac9c5ffd447a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 3, 2010
Manufacturers
FDA
State of Florida DOH Central Pharmacy
DUNS: 829348114
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 Code53808-0275
Application NumberANDA086066
Product Classification
M
Marketing Category
C73584
G
Generic Name
ISOSORBIDE DINITRATE
Product Specifications
Route of AdministrationORAL
Effective DateJune 3, 2010
FDA Product Classification
INGREDIENTS (9)
ISOSORBIDE DINITRATEActive
Quantity: 20 mg in 1 1
Code: IA7306519N
Classification: ACTIB
AMMONIUM PHOSPHATE, DIBASICInactive
Code: 10LGE70FSU
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
ISOSORBIDE DINITRATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0274
Application NumberANDA086066
Product Classification
M
Marketing Category
C73584
G
Generic Name
ISOSORBIDE DINITRATE
Product Specifications
Route of AdministrationORAL
Effective DateJune 3, 2010
FDA Product Classification
INGREDIENTS (6)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
ISOSORBIDE DINITRATEActive
Quantity: 10 mg in 1 1
Code: IA7306519N
Classification: ACTIB
AMMONIUM PHOSPHATE, DIBASICInactive
Code: 10LGE70FSU
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT