NDC 62175-361

Monoket

Isosorbide Mononitrate

Monoket is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Kremers Urban Pharmaceuticals Inc.. The primary component is Isosorbide Mononitrate.

Product ID62175-361_051c2183-7e60-4bf3-b342-09d940d7bd91
NDC62175-361
Product TypeHuman Prescription Drug
Proprietary NameMonoket
Generic NameIsosorbide Mononitrate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1993-06-30
Marketing CategoryNDA / NDA
Application NumberNDA020215
Labeler NameKremers Urban Pharmaceuticals Inc.
Substance NameISOSORBIDE MONONITRATE
Active Ingredient Strength10 mg/1
Pharm ClassesNitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 62175-361-01

100 TABLET in 1 BOTTLE (62175-361-01)
Marketing Start Date1993-06-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 62175-361-01 [62175036101]

Monoket TABLET
Marketing CategoryNDA
Application NumberNDA020215
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1993-06-30

Drug Details

Active Ingredients

IngredientStrength
ISOSORBIDE MONONITRATE10 mg/1

OpenFDA Data

SPL SET ID:d8f4202c-5103-40dc-9309-dcf72da02d0d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 206854
  • 206856
  • 311197
  • 311192
    • UPC Code
  • 0362175361011

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Monoket" or generic name "Isosorbide Mononitrate"

    NDCBrand NameGeneric Name
    62175-361MonoketMonoket
    62175-362MonoketMonoket
    0143-2230IsosorbideIsosorbide mononitrate
    0143-2260IsosorbideIsosorbide mononitrate
    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

    Trademark Results [Monoket]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    MONOKET
    MONOKET
    73642900 1453886 Live/Registered
    SCHWARZ GMBH
    1987-02-04
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