NDC 50991-782

ALA-HIST PE

Phenylephrine Hydrochloride, Dexbrompheniramine Maleate

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

Product ID50991-782_66285656-e152-2f9d-e053-2a91aa0ab514
NDC50991-782
Product TypeHuman Otc Drug
Proprietary NameALA-HIST PE
Generic NamePhenylephrine Hydrochloride, Dexbrompheniramine Maleate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2011-09-15
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NamePoly Pharmaceuticals, Inc.
Substance NamePHENYLEPHRINE HYDROCHLORIDE; DEXBROMPHENIRAMINE MALEATE
Active Ingredient Strength10 mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 50991-782-02

12 BLISTER PACK in 1 CARTON (50991-782-02) > 1 TABLET in 1 BLISTER PACK
Marketing Start Date2011-09-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50991-782-02 [50991078202]

ALA-HIST PE TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-09-15

NDC 50991-782-90 [50991078290]

ALA-HIST PE TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2019-06-01

NDC 50991-782-60 [50991078260]

ALA-HIST PE TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2011-09-15
Marketing End Date2019-06-06

Drug Details

Active Ingredients

IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:3a98ffbd-f864-4550-a2ba-568feb8bd272
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1041508
  • 968670
  • UPC Code
  • 0350991782608
  • Medicade Reported Pricing

    50991078260 ALA-HIST PE TABLET

    Pricing Unit: EA | Drug Type:

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