Isosorbide Mononitrate
Isosorbide Mononitrate Extended-Release Tablets, USP
Approved
Approval ID
df5fd5e2-3a7b-5a5b-e053-2995a90a0dd3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 18, 2023
Manufacturers
FDA
Northwind Pharmaceuticals, LLC
DUNS: 036986393
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
NDC Product Code51655-922
Application NumberANDA210918
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 18, 2023
Generic NameIsosorbide Mononitrate
INGREDIENTS (7)
CELLULOSE, MICROCRYSTALLINEInactive
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
ISOSORBIDE MONONITRATEActive
Quantity: 30 mg in 1 1
Code: LX1OH63030
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT