NDC 50742-176

Isosorbide Mononitrate

Isosorbide Mononitrate

Isosorbide Mononitrate is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Ingenus Pharmaceuticals, Llc. The primary component is Isosorbide Mononitrate.

Product ID50742-176_1672236d-6141-41be-b457-0fe597cf0171
NDC50742-176
Product TypeHuman Prescription Drug
Proprietary NameIsosorbide Mononitrate
Generic NameIsosorbide Mononitrate
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2018-11-13
Marketing CategoryANDA / ANDA
Application NumberANDA210918
Labeler NameIngenus Pharmaceuticals, LLC
Substance NameISOSORBIDE MONONITRATE
Active Ingredient Strength60 mg/1
Pharm ClassesNitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 50742-176-01

100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50742-176-01)
Marketing Start Date2018-11-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50742-176-05 [50742017605]

Isosorbide Mononitrate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA210918
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-11-13

NDC 50742-176-01 [50742017601]

Isosorbide Mononitrate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA210918
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-11-13

NDC 50742-176-10 [50742017610]

Isosorbide Mononitrate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA210918
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-11-13
Marketing End Date2018-11-26

Drug Details

Active Ingredients

IngredientStrength
ISOSORBIDE MONONITRATE60 mg/1

OpenFDA Data

SPL SET ID:c950760f-0e32-483f-96f2-eecaf057c0ec
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 317110
  • 311196
  • 353538
    • UPC Code
  • 0350742176014
  • 0350742175017
  • 0350742177011

    • Pharmacological Class

    • Nitrate Vasodilator [EPC]
    • Nitrates [CS]
    • Vasodilation [PE]

    NDC Crossover Matching brand name "Isosorbide Mononitrate" or generic name "Isosorbide Mononitrate"

    NDCBrand NameGeneric Name
    0143-1333Isosorbide MononitrateIsosorbide Mononitrate
    0228-2620Isosorbide MononitrateIsosorbide Mononitrate
    0228-2631Isosorbide MononitrateIsosorbide Mononitrate
    0603-4110Isosorbide MononitrateIsosorbide Mononitrate
    0603-4111Isosorbide MononitrateIsosorbide Mononitrate
    0603-4112Isosorbide MononitrateIsosorbide Mononitrate
    0615-4544Isosorbide MononitrateIsosorbide mononitrate
    0615-4546Isosorbide MononitrateIsosorbide mononitrate
    0615-5549Isosorbide MononitrateIsosorbide Mononitrate
    0615-5550Isosorbide MononitrateIsosorbide Mononitrate
    0615-7756Isosorbide MononitrateIsosorbide Mononitrate
    0615-7757Isosorbide MononitrateIsosorbide Mononitrate
    0615-7767ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATE
    0615-7768ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATE
    0615-8043ISOSORBIDE MONONITRATEisosorbide mononitrate
    0615-8044ISOSORBIDE MONONITRATEisosorbide mononitrate
    0904-6449ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATE
    0904-6450ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATE
    0904-6451ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATE
    10544-243ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATE
    13668-104ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATE
    13668-105ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATE
    68071-1953Isosorbide MononitrateIsosorbide Mononitrate
    68071-1926isosorbide mononitrateisosorbide mononitrate
    68071-3015ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATE
    68071-3081Isosorbide MononitrateIsosorbide Mononitrate
    68071-3296Isosorbide MononitrateIsosorbide Mononitrate
    68071-3266isosorbide mononitrateisosorbide mononitrate
    68071-4290Isosorbide MononitrateIsosorbide Mononitrate
    68084-591isosorbide mononitrateisosorbide mononitrate
    68084-592isosorbide mononitrateisosorbide mononitrate
    68151-1420isosorbide mononitrateisosorbide mononitrate
    68151-0314isosorbide mononitrateisosorbide mononitrate
    68382-651ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATE
    68382-650ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATE
    68382-652ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATE
    68788-6863isosorbide mononitrateisosorbide mononitrate
    70518-0009isosorbide mononitrateisosorbide mononitrate
    70518-0214ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATE
    70518-1080ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATE
    70518-1485Isosorbide MononitrateIsosorbide Mononitrate
    70934-183Isosorbide MononitrateIsosorbide Mononitrate
    71335-0037Isosorbide MononitrateIsosorbide Mononitrate
    71335-0431Isosorbide MononitrateIsosorbide Mononitrate
    13668-106ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATE
    21695-575isosorbide mononitrateisosorbide mononitrate
    21695-777isosorbide mononitrateisosorbide mononitrate
    21695-837isosorbide mononitrateisosorbide mononitrate
    23155-628Isosorbide MononitrateIsosorbide Mononitrate
    23155-178Isosorbide MononitrateIsosorbide Mononitrate
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.