NDC 0187-0192

Isordil Titradose

Isosorbide Dinitrate

Isordil Titradose is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Valeant Pharmaceuticals North America Llc. The primary component is Isosorbide Dinitrate.

Product ID0187-0192_019c0456-2c8a-4658-8cec-039614dda0a4
NDC0187-0192
Product TypeHuman Prescription Drug
Proprietary NameIsordil Titradose
Generic NameIsosorbide Dinitrate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2013-04-01
Marketing CategoryNDA / NDA
Application NumberNDA012093
Labeler NameValeant Pharmaceuticals North America LLC
Substance NameISOSORBIDE DINITRATE
Active Ingredient Strength40 mg/1
Pharm ClassesNitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0187-0192-01

100 TABLET in 1 BOTTLE (0187-0192-01)
Marketing Start Date2013-04-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0187-0192-01 [00187019201]

Isordil Titradose TABLET
Marketing CategoryNDA
Application NumberNDA012093
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-04-01

Drug Details

Active Ingredients

IngredientStrength
ISOSORBIDE DINITRATE40 mg/1

OpenFDA Data

SPL SET ID:8ddd2577-311a-4967-bb67-ad72e2b76f83
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 314055
  • 197840
  • 793872
  • 793873

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Isordil Titradose" or generic name "Isosorbide Dinitrate"

    NDCBrand NameGeneric Name
    0187-0152Isordilisosorbide dinitrate
    0187-0192Isordilisosorbide dinitrate
    0143-1765Isosorbide DinitrateIsosorbide Dinitrate
    0143-1767Isosorbide DinitrateIsosorbide Dinitrate
    0143-1769Isosorbide DinitrateIsosorbide Dinitrate
    0143-1771Isosorbide DinitrateIsosorbide Dinitrate
    0143-1772Isosorbide DinitrateIsosorbide Dinitrate
    0615-1560Isosorbide DinitrateIsosorbide Dinitrate
    0615-1575Isosorbide DinitrateIsosorbide Dinitrate
    0615-7584Isosorbide Dinitrateisosorbide dinitrate
    0615-7902Isosorbide DinitrateIsosorbide Dinitrate
    0615-7903Isosorbide DinitrateIsosorbide Dinitrate
    0615-8157Isosorbide Dinitrateisosorbide dinitrate
    0615-8193Isosorbide Dinitrateisosorbide dinitrate
    0615-8294Isosorbide Dinitrateisosorbide dinitrate
    0781-1556Isosorbide DinitrateIsosorbide Dinitrate
    0781-1635Isosorbide DinitrateIsosorbide Dinitrate
    0781-1695Isosorbide DinitrateIsosorbide Dinitrate
    0904-6619Isosorbide DinitrateIsosorbide Dinitrate

    Trademark Results [Isordil]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ISORDIL
    ISORDIL
    72081865 0697014 Live/Registered
    AMERICAN HOME PRODUCTS CORPORATION
    1959-09-23
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