NDC 0615-8043

ISOSORBIDE MONONITRATE

Isosorbide Mononitrate

ISOSORBIDE MONONITRATE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Ncs Healthcare Of Ky, Llc Dba Vangard Labs. The primary component is Isosorbide Mononitrate.

Product ID0615-8043_32d9d4bb-e603-411e-a2e7-995a46c0bf40
NDC0615-8043
Product TypeHuman Prescription Drug
Proprietary NameISOSORBIDE MONONITRATE
Generic NameIsosorbide Mononitrate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2013-12-19
Marketing End Date2023-10-31
Marketing CategoryANDA / ANDA
Application NumberANDA075395
Labeler NameNCS HealthCare of KY, LLC dba Vangard Labs
Substance NameISOSORBIDE MONONITRATE
Active Ingredient Strength30 mg/1
Pharm ClassesNitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
NDC Exclude FlagN

Packaging

NDC 0615-8043-05

15 TABLET in 1 BLISTER PACK (0615-8043-05)
Marketing Start Date2016-05-13
Marketing End Date2023-10-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0615-8043-05 [00615804305]

ISOSORBIDE MONONITRATE TABLET
Marketing CategoryANDA
Application NumberANDA075395
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-05-13

NDC 0615-8043-30 [00615804330]

ISOSORBIDE MONONITRATE TABLET
Marketing CategoryANDA
Application NumberANDA075395
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-05-19

NDC 0615-8043-39 [00615804339]

ISOSORBIDE MONONITRATE TABLET
Marketing CategoryANDA
Application NumberANDA075395
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-05-13

Drug Details

Active Ingredients

IngredientStrength
ISOSORBIDE MONONITRATE30 mg/1

OpenFDA Data

SPL SET ID:8ac09a48-01e4-42d6-8e99-9866b2f27f4f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 317110
  • 353538

    • 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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