NDC 15370-112

PediaVent

Dexbrompheniramine Maleate

PediaVent is a Oral Tablet, Chewable in the Human Otc Drug category. It is labeled and distributed by Carwin Pharmaceutical Associates, Llc. The primary component is Dexbrompheniramine Maleate.

Product ID15370-112_ba4c3759-8540-4ccf-a18c-043eae719702
NDC15370-112
Product TypeHuman Otc Drug
Proprietary NamePediaVent
Generic NameDexbrompheniramine Maleate
Dosage FormTablet, Chewable
Route of AdministrationORAL
Marketing Start Date2014-08-05
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameCarWin Pharmaceutical Associates, LLC
Substance NameDEXBROMPHENIRAMINE MALEATE
Active Ingredient Strength1 mg/1
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 15370-112-60

60 TABLET, CHEWABLE in 1 BOTTLE (15370-112-60)
Marketing Start Date2014-08-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 15370-112-60 [15370011260]

PediaVent TABLET, CHEWABLE
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2014-08-05
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DEXBROMPHENIRAMINE MALEATE1 mg/1

OpenFDA Data

SPL SET ID:f0b90cc2-901c-4498-b892-d8883182b6fd
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1545306
  • NDC Crossover Matching brand name "PediaVent" or generic name "Dexbrompheniramine Maleate"

    NDCBrand NameGeneric Name
    15370-110PediaVentDEXBROMPHENIRAMINE MALEATE
    15370-112PediaVentDEXBROMPHENIRAMINE MALEATE
    50991-783ALA-HIST IRDexbrompheniramine Maleate

    Trademark Results [PediaVent]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PEDIAVENT
    PEDIAVENT
    78237845 not registered Dead/Abandoned
    Ascent Pediatrics, Inc.
    2003-04-15
    PEDIAVENT
    PEDIAVENT
    74686956 2070450 Dead/Cancelled
    ASCENT PEDIATRICS, INC.
    1995-06-12

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