NDC 0904-6450

ISOSORBIDE MONONITRATE

Isosorbide Mononitrate

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

Product ID0904-6450_476da661-b1f6-4f61-876e-b829cfbc50fc
NDC0904-6450
Product TypeHuman Prescription Drug
Proprietary NameISOSORBIDE MONONITRATE
Generic NameIsosorbide Mononitrate
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2015-01-05
Marketing CategoryANDA / ANDA
Application NumberANDA200495
Labeler NameMajor Pharmaceuticals
Substance NameISOSORBIDE MONONITRATE
Active Ingredient Strength60 mg/1
Pharm ClassesNitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0904-6450-61

100 BLISTER PACK in 1 CARTON (0904-6450-61) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date2015-01-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0904-6450-61 [00904645061]

ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA200495
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-01-05

NDC 0904-6450-74 [00904645074]

ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA200495
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-01-05
Marketing End Date2015-01-23

NDC 0904-6450-01 [00904645001]

ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA200495
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-01-05
Marketing End Date2015-01-23

NDC 0904-6450-10 [00904645010]

ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA200495
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-01-05
Marketing End Date2015-01-23

NDC 0904-6450-20 [00904645020]

ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA200495
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-01-05
Marketing End Date2015-01-23

NDC 0904-6450-05 [00904645005]

ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA200495
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-01-05
Marketing End Date2015-01-23

Drug Details

Active Ingredients

IngredientStrength
ISOSORBIDE MONONITRATE60 mg/1

OpenFDA Data

SPL SET ID:8cbb364a-bafe-454b-a53f-bd7cd69a5593
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 317110
  • 311196
  • 353538
    • UPC Code
  • 0309046449614

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