NDC 0228-2631

Isosorbide Mononitrate

Isosorbide Mononitrate

Isosorbide Mononitrate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is Isosorbide Mononitrate.

Product ID0228-2631_77d5bbc0-cd62-459c-99cd-fc57c9369357
NDC0228-2631
Product TypeHuman Prescription Drug
Proprietary NameIsosorbide Mononitrate
Generic NameIsosorbide Mononitrate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1998-10-30
Marketing CategoryANDA / ANDA
Application NumberANDA075037
Labeler NameActavis Pharma, Inc.
Substance NameISOSORBIDE MONONITRATE
Active Ingredient Strength10 mg/1
Pharm ClassesNitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
NDC Exclude FlagN
Listing Certified Through2024-12-31

Packaging

NDC 0228-2631-11

100 TABLET in 1 BOTTLE (0228-2631-11)
Marketing Start Date1998-10-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0228-2631-11 [00228263111]

Isosorbide Mononitrate TABLET
Marketing CategoryANDA
Application NumberANDA075037
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1998-10-30

Drug Details

Active Ingredients

IngredientStrength
ISOSORBIDE MONONITRATE10 mg/1

OpenFDA Data

SPL SET ID:ae8f74f0-e600-4452-8557-958b603e2709
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311192
  • 311197
  • UPC Code
  • 0302282620113
  • 0302282631119
  • Pharmacological Class

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

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