NDC 50991-535

Duraflu

Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Pseudoephedrine Hcl

Duraflu is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Poly Pharmaceuticals, Inc.. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Guaifenesin; Pseudoephedrine Hydrochloride.

Product ID50991-535_3f767a59-37fc-4646-ab6b-d571b1f0962c
NDC50991-535
Product TypeHuman Otc Drug
Proprietary NameDuraflu
Generic NameAcetaminophen, Dextromethorphan Hbr, Guaifenesin, Pseudoephedrine Hcl
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2015-10-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NamePoly Pharmaceuticals, Inc.
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active Ingredient Strength325 mg/1; mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 50991-535-01

100 TABLET in 1 BOTTLE (50991-535-01)
Marketing Start Date2015-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50991-535-01 [50991053501]

Duraflu TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2015-10-01

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/1

OpenFDA Data

SPL SET ID:55fffc1d-8449-4c28-a391-c6f60dd85622
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1673869

    • Medicade Reported Pricing

    50991053501 DURAFLU 325-20-200-60 MG TAB

    Pricing Unit: EA | Drug Type:

    Trademark Results [Duraflu]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    DURAFLU
    DURAFLU
    76297856 2712009 Live/Registered
    POLY PHARMACEUTICALS, INC.
    2001-08-10
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