NDC 52244-920

Dilatrate SR

Isosorbide Dinitrate

Dilatrate SR is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Endo Pharmaceuticals, Inc.. The primary component is Isosorbide Dinitrate.

Product ID52244-920_68d2bf45-ac0b-4cae-9a0c-d67a4da95b44
NDC52244-920
Product TypeHuman Prescription Drug
Proprietary NameDilatrate SR
Generic NameIsosorbide Dinitrate
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2012-02-15
Marketing CategoryNDA / NDA
Application NumberNDA019790
Labeler NameEndo Pharmaceuticals, Inc.
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 52244-920-10

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (52244-920-10)
Marketing Start Date2012-02-15
Marketing End Date2021-08-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52244-920-10 [52244092010]

Dilatrate SR CAPSULE, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA019790
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-02-15

Drug Details

Active Ingredients

IngredientStrength
ISOSORBIDE DINITRATE40 mg/1

OpenFDA Data

SPL SET ID:7ec5ba03-6164-4199-a333-7cd8d7c75e17
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 891870
  • 314040

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Dilatrate SR" or generic name "Isosorbide Dinitrate"

    NDCBrand NameGeneric Name
    52244-920Dilatrate SRDilatrate SR
    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 [Dilatrate]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    DILATRATE
    DILATRATE
    73225986 1151441 Live/Registered
    Block Drug Company, Inc.
    1979-08-03
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