NDC 0485-0202

RYNEX PE

Brompheniramine Maleate And Pseudoephedrine Hydrochloride

RYNEX PE is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Edwards Pharmaceuticals, Inc.. The primary component is Brompheniramine Maleate; Pseudoephedrine Hydrochloride.

Product ID0485-0202_02e9a349-1fc1-4121-a8ea-4b0f8ef8dc78
NDC0485-0202
Product TypeHuman Otc Drug
Proprietary NameRYNEX PE
Generic NameBrompheniramine Maleate And Pseudoephedrine Hydrochloride
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2011-03-07
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameEDWARDS PHARMACEUTICALS, INC.
Substance NameBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active Ingredient Strength1 mg/5mL; mg/5mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0485-0202-16

473 mL in 1 BOTTLE, PLASTIC (0485-0202-16)
Marketing Start Date2011-03-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0485-0202-16 [00485020216]

RYNEX PE LIQUID
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2011-03-07

Drug Details

Active Ingredients

IngredientStrength
BROMPHENIRAMINE MALEATE1 mg/5mL

OpenFDA Data

SPL SET ID:77ae1cf6-b8e5-4f3c-b7bc-e2609a8991ef
Manufacturer
UNII
UPC Code
  • 0304850202165

    • NDC Crossover Matching brand name "RYNEX PE" or generic name "Brompheniramine Maleate And Pseudoephedrine Hydrochloride"

    NDCBrand NameGeneric Name
    0485-0202RYNEX PEBROMPHENIRAMINE MALEATE and PSEUDOEPHEDRINE HYDROCHLORIDE
    54838-125BrotappBrompheniramine maleate and Pseudoephedrine hydrochloride
    0095-0860Lodrane Dbrompheniramine maleate and pseudoephedrine hydrochloride
    68788-9184Q-TappBrompheniramine maleate and Pseudoephedrine hydrochloride
    0485-0206RYNEX PSEBROMPHENIRAMINE MALEATE and PSEUDOEPHEDRINE HYDROCHLORIDE

    Trademark Results [RYNEX PE]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    RYNEX PE
    RYNEX PE
    86287467 4698724 Live/Registered
    Edwards Pharmaceuticals, Inc.
    2014-05-21
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