NDC 23155-519

Isosorbide Mononitrate

Isosorbide Mononitrate

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

Product ID23155-519_4773f833-4d9d-4e7e-80be-2bb01c7a4d46
NDC23155-519
Product TypeHuman Prescription Drug
Proprietary NameIsosorbide Mononitrate
Generic NameIsosorbide Mononitrate
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2017-01-05
Marketing CategoryANDA / ANDA
Application NumberANDA075522
Labeler NameHeritage Pharmaceuticals Inc.
Substance NameISOSORBIDE MONONITRATE
Active Ingredient Strength30 mg/1
Pharm ClassesNitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 23155-519-01

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (23155-519-01)
Marketing Start Date2017-01-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 23155-519-05 [23155051905]

Isosorbide Mononitrate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA075522
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-01-05

NDC 23155-519-01 [23155051901]

Isosorbide Mononitrate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA075522
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-01-05

NDC 23155-519-03 [23155051903]

Isosorbide Mononitrate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA075522
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-01-05

Drug Details

Active Ingredients

IngredientStrength
ISOSORBIDE MONONITRATE30 mg/1

OpenFDA Data

SPL SET ID:ef08d90f-ba26-4b68-8e3a-d0320e4b0f8e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 317110
  • 353538
  • UPC Code
  • 0323155519013
  • 0323155178012
  • Pharmacological Class

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

    Medicade Reported Pricing

    23155051905 ISOSORBIDE MONONIT ER 30 MG TB

    Pricing Unit: EA | Drug Type:

    23155051901 ISOSORBIDE MONONIT ER 30 MG TB

    Pricing Unit: EA | Drug Type:

    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.