NDC 0603-4112

Isosorbide Mononitrate

Isosorbide Mononitrate

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

Product ID0603-4112_4a86d677-edfd-4901-b857-d0b6a92c170e
NDC0603-4112
Product TypeHuman Prescription Drug
Proprietary NameIsosorbide Mononitrate
Generic NameIsosorbide Mononitrate
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2010-08-11
Marketing End Date2019-10-31
Marketing CategoryANDA / ANDA
Application NumberANDA090598
Labeler NamePar Pharmaceutical
Substance NameISOSORBIDE MONONITRATE
Active Ingredient Strength120 mg/1
Pharm ClassesNitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]
NDC Exclude FlagN

Packaging

NDC 0603-4112-32

1000 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0603-4112-32)
Marketing Start Date2010-08-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0603-4112-10 [00603411210]

Isosorbide Mononitrate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA090598
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-08-11
Marketing End Date2018-12-04

NDC 0603-4112-25 [00603411225]

Isosorbide Mononitrate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA090598
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-08-11
Marketing End Date2017-11-30

NDC 0603-4112-21 [00603411221]

Isosorbide Mononitrate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA090598
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-08-11
Marketing End Date2019-10-31

NDC 0603-4112-32 [00603411232]

Isosorbide Mononitrate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA090598
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-08-11
Marketing End Date2019-10-31

Drug Details

Active Ingredients

IngredientStrength
ISOSORBIDE MONONITRATE120 mg/1

OpenFDA Data

SPL SET ID:c53983a9-8736-4f7f-9ef2-274c0d9a85bc
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 317110
  • 311196
  • 353538
    • UPC Code
  • 0306034110211
  • 0306034111218
  • 0306034112215

    • 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
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