Isosorbide Dinitrate

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 829572556

Effective Date

January 3, 2024

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

70518-0063

Application Number

ANDA086223

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 3, 2024

Ingredients

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

Code: IA7306519NClass: ACTIBQuantity: 10 mg in 1 1