NDC 68001-373

Isosorbide

Isosorbide Dinitrate

Isosorbide is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Bluepoint Laboratories. The primary component is Isosorbide Dinitrate.

Product ID68001-373_9498fa14-1614-4a8e-b872-41c11745b01e
NDC68001-373
Product TypeHuman Prescription Drug
Proprietary NameIsosorbide
Generic NameIsosorbide Dinitrate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-11-30
Marketing CategoryANDA / ANDA
Application NumberANDA086067
Labeler NameBluePoint Laboratories
Substance NameISOSORBIDE DINITRATE
Active Ingredient Strength5 mg/1
Pharm ClassesNitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68001-373-00

100 TABLET in 1 BOTTLE, PLASTIC (68001-373-00)
Marketing Start Date2018-11-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68001-373-00 [68001037300]

Isosorbide TABLET
Marketing CategoryANDA
Application NumberANDA086067
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-11-30

Drug Details

Active Ingredients

IngredientStrength
ISOSORBIDE DINITRATE5 mg/1

OpenFDA Data

SPL SET ID:9498fa14-1614-4a8e-b872-41c11745b01e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 314055
  • 206842
  • 381056
  • UPC Code
  • 0368001374002
  • 0368001373005
  • 0368001375009
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0143-2230IsosorbideIsosorbide mononitrate
    0143-2260IsosorbideIsosorbide mononitrate
    68001-373IsosorbideIsosorbide
    68001-375IsosorbideIsosorbide
    68001-374IsosorbideIsosorbide
    68071-4390IsosorbideIsosorbide
    68071-4689IsosorbideIsosorbide
    68151-1418IsosorbideIsosorbide
    71335-0739IsosorbideIsosorbide
    53808-0275IsosorbideIsosorbide
    53808-0274IsosorbideIsosorbide
    59115-129IsosorbideIsosorbide
    59115-143IsosorbideIsosorbide
    59115-130IsosorbideIsosorbide
    0187-0152Isordilisosorbide dinitrate
    0187-0192Isordilisosorbide dinitrate
    0143-1765Isosorbide DinitrateIsosorbide Dinitrate
    0143-1767Isosorbide DinitrateIsosorbide Dinitrate
    0143-1769Isosorbide DinitrateIsosorbide Dinitrate
    0143-1771Isosorbide DinitrateIsosorbide Dinitrate
    0143-1772Isosorbide DinitrateIsosorbide Dinitrate
    0615-1560Isosorbide DinitrateIsosorbide Dinitrate
    0615-1575Isosorbide DinitrateIsosorbide Dinitrate
    0615-7584Isosorbide Dinitrateisosorbide dinitrate
    0615-7902Isosorbide DinitrateIsosorbide Dinitrate
    0615-7903Isosorbide DinitrateIsosorbide Dinitrate
    0615-8157Isosorbide Dinitrateisosorbide dinitrate
    0615-8193Isosorbide Dinitrateisosorbide dinitrate
    0615-8294Isosorbide Dinitrateisosorbide dinitrate
    0781-1556Isosorbide DinitrateIsosorbide Dinitrate
    0781-1635Isosorbide DinitrateIsosorbide Dinitrate
    0781-1695Isosorbide DinitrateIsosorbide Dinitrate

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