Isosorbide Mononitrate
Isosorbide Mononitrate Extended-Release Tablets, USP
Approved
Approval ID
441ddd35-6cb8-44d0-8009-1635390ede83
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 24, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Isosorbide Mononitrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71335-2194
Application NumberANDA210918
Product Classification
M
Marketing Category
C73584
G
Generic Name
Isosorbide Mononitrate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 22, 2021
FDA Product Classification
INGREDIENTS (7)
ISOSORBIDE MONONITRATEActive
Quantity: 30 mg in 1 1
Code: LX1OH63030
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYDROXYPROPYL CELLULOSE (1200000 WAMW)Inactive
Code: U3JF91U133
Classification: IACT
HYPROMELLOSE 2208 (100000 MPA.S)Inactive
Code: VM7F0B23ZI
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT