NDC 0143-2260

Isosorbide

Isosorbide Mononitrate

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

Product ID0143-2260_168b47c9-04ee-4589-a4d9-fa7f4e446ab7
NDC0143-2260
Product TypeHuman Prescription Drug
Proprietary NameIsosorbide
Generic NameIsosorbide Mononitrate
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2006-03-30
Marketing End Date2020-09-30
Marketing CategoryANDA / ANDA
Application NumberANDA076813
Labeler NameHikma Pharmaceuticals USA Inc.
Substance NameISOSORBIDE MONONITRATE
Active Ingredient Strength60 mg/1
Pharm ClassesNitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]
NDC Exclude FlagN

Packaging

NDC 0143-2260-10

1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0143-2260-10)
Marketing Start Date2006-03-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0143-2260-10 [00143226010]

Isosorbide TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA076813
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2006-03-30
Marketing End Date2020-12-31

NDC 0143-2260-09 [00143226009]

Isosorbide TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA076813
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-03-30
Marketing End Date2012-04-10

NDC 0143-2260-01 [00143226001]

Isosorbide TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA076813
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2006-03-30
Marketing End Date2020-12-31

NDC 0143-2260-30 [00143226030]

Isosorbide TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA076813
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-03-30
Marketing End Date2012-04-10

NDC 0143-2260-05 [00143226005]

Isosorbide TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA076813
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-03-30
Marketing End Date2020-12-31

Drug Details

Active Ingredients

IngredientStrength
ISOSORBIDE MONONITRATE60 mg/1

OpenFDA Data

SPL SET ID:0c7f9a96-12b8-4149-9f32-78639e98dfd0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 317110
  • 353538

    • Pharmacological Class

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

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

    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
    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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.