NDC 13668-106

ISOSORBIDE MONONITRATE

Isosorbide Mononitrate

ISOSORBIDE MONONITRATE is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Torrent Pharmaceuticals Limited. The primary component is Isosorbide Mononitrate.

Product ID13668-106_91901717-443c-4ee4-9bae-76c6fdb67bdf
NDC13668-106
Product TypeHuman Prescription Drug
Proprietary NameISOSORBIDE MONONITRATE
Generic NameIsosorbide Mononitrate
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2011-06-03
Marketing CategoryANDA / ANDA
Application NumberANDA200495
Labeler NameTorrent Pharmaceuticals Limited
Substance NameISOSORBIDE MONONITRATE
Active Ingredient Strength120 mg/1
Pharm ClassesNitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 13668-106-01

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-106-01)
Marketing Start Date2011-06-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 13668-106-10 [13668010610]

ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA200495
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-06-03

NDC 13668-106-74 [13668010674]

ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA200495
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-06-03

NDC 13668-106-59 [13668010659]

ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA200495
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-06-03

NDC 13668-106-01 [13668010601]

ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA200495
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-06-03

NDC 13668-106-05 [13668010605]

ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA200495
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-06-03

Drug Details

Active Ingredients

IngredientStrength
ISOSORBIDE MONONITRATE120 mg/1

OpenFDA Data

SPL SET ID:0a1e317a-7b05-4d30-9bbc-1d4ccd56ba3c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 317110
  • 311196
  • 353538
  • UPC Code
  • 0313668104011
  • 0313668106053
  • Pharmacological Class

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

    Medicade Reported Pricing

    13668010601 ISOSORBIDE MONONIT ER 120 MG

    Pricing Unit: EA | Drug Type:

    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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