NDC 67544-236

isosorbide mononitrate

Isosorbide Mononitrate

isosorbide mononitrate is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Isosorbide Mononitrate.

Product ID67544-236_74bda58d-0659-4d1d-b968-a2d3fbf6e50d
NDC67544-236
Product TypeHuman Prescription Drug
Proprietary Nameisosorbide mononitrate
Generic NameIsosorbide Mononitrate
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date1998-10-30
Marketing CategoryANDA / ANDA
Application NumberANDA075155
Labeler NameAphena Pharma Solutions - Tennessee, LLC
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 67544-236-09

9000 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (67544-236-09)
Marketing Start Date2014-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67544-236-60 [67544023660]

isosorbide mononitrate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA075155
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-02-03

NDC 67544-236-56 [67544023656]

isosorbide mononitrate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA075155
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-02-06

NDC 67544-236-30 [67544023630]

isosorbide mononitrate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA075155
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-05-24

NDC 67544-236-99 [67544023699]

isosorbide mononitrate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA075155
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-03-01

NDC 67544-236-09 [67544023609]

isosorbide mononitrate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA075155
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-03-01

Drug Details

Active Ingredients

IngredientStrength
ISOSORBIDE MONONITRATE30 mg/1

OpenFDA Data

SPL SET ID:06faac0a-d719-4b54-85df-fdf3a5c6599f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 317110

    • 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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