NDC 50991-783

ALA-HIST IR

Dexbrompheniramine Maleate

ALA-HIST IR is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Poly Pharmaceuticals, Inc.. The primary component is Dexbrompheniramine Maleate.

Product ID50991-783_6628186f-7c3d-2825-e053-2a91aa0a723c
NDC50991-783
Product TypeHuman Otc Drug
Proprietary NameALA-HIST IR
Generic NameDexbrompheniramine Maleate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2011-08-22
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NamePoly Pharmaceuticals, Inc.
Substance NameDEXBROMPHENIRAMINE MALEATE
Active Ingredient Strength2 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 50991-783-02

12 BLISTER PACK in 1 CARTON (50991-783-02) > 1 TABLET in 1 BLISTER PACK
Marketing Start Date2011-08-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50991-783-02 [50991078302]

ALA-HIST IR TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-08-22

NDC 50991-783-60 [50991078360]

ALA-HIST IR TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2011-08-22

Drug Details

Active Ingredients

IngredientStrength
DEXBROMPHENIRAMINE MALEATE2 mg/1

OpenFDA Data

SPL SET ID:0d203b5c-8b10-428b-8703-17be6b4ce6eb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1041512
  • 240826
    • UPC Code
  • 0350991783605

    • Medicade Reported Pricing

    50991078360 ALA-HIST IR 2 MG TABLET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "ALA-HIST IR" or generic name "Dexbrompheniramine Maleate"

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