Isosorbide Mononitrate
Isosorbide Mononitrate Extended-Release Tablets, USP
Approved
Approval ID
9ea70e22-9687-40eb-9388-744768a2b33a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 20, 2019
Manufacturers
FDA
Aphena Pharma Solutions - Tennessee, LLC
DUNS: 128385585
Products 3
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 Code71610-338
Application NumberANDA210918
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 20, 2019
Generic NameIsosorbide Mononitrate
INGREDIENTS (7)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYDROXYPROPYL CELLULOSE (TYPE M)Inactive
Code: U3JF91U133
Classification: IACT
HYPROMELLOSE 2208 (100000 MPA.S)Inactive
Code: VM7F0B23ZI
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ISOSORBIDE MONONITRATEActive
Quantity: 30 mg in 1 1
Code: LX1OH63030
Classification: ACTIB
Isosorbide Mononitrate
PRODUCT DETAILS
NDC Product Code71610-321
Application NumberANDA210918
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 20, 2019
Generic NameIsosorbide Mononitrate
INGREDIENTS (7)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE 2208 (100000 MPA.S)Inactive
Code: VM7F0B23ZI
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYDROXYPROPYL CELLULOSE (TYPE M)Inactive
Code: U3JF91U133
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ISOSORBIDE MONONITRATEActive
Quantity: 120 mg in 1 1
Code: LX1OH63030
Classification: ACTIB
Isosorbide Mononitrate
PRODUCT DETAILS
NDC Product Code71610-337
Application NumberANDA210918
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 20, 2019
Generic NameIsosorbide Mononitrate
INGREDIENTS (7)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYDROXYPROPYL CELLULOSE (TYPE M)Inactive
Code: U3JF91U133
Classification: IACT
HYPROMELLOSE 2208 (100000 MPA.S)Inactive
Code: VM7F0B23ZI
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ISOSORBIDE MONONITRATEActive
Quantity: 60 mg in 1 1
Code: LX1OH63030
Classification: ACTIB