NDC 54859-801

Tusnel

Dextromethorphan Hbr, Guaifenesin, Pseudoephedrine Hcl

Tusnel is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Llorens Pharmaceuticals International Division. The primary component is Dextromethorphan Hydrobromide; Guaifenesin; Pseudoephedrine Hydrochloride.

Product ID54859-801_732630f4-d829-4cab-8834-74ce18a6f145
NDC54859-801
Product TypeHuman Otc Drug
Proprietary NameTusnel
Generic NameDextromethorphan Hbr, Guaifenesin, Pseudoephedrine Hcl
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2007-07-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameLLORENS PHARMACEUTICALS INTERNATIONAL DIVISION
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active Ingredient Strength30 mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 54859-801-60

60 TABLET in 1 BOTTLE (54859-801-60)
Marketing Start Date2007-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54859-801-60 [54859080160]

Tusnel TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2007-07-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE30 mg/1

OpenFDA Data

SPL SET ID:a8784c65-47a5-4b72-a85b-fb51cfd22c6c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1251296
  • NDC Crossover Matching brand name "Tusnel" or generic name "Dextromethorphan Hbr, Guaifenesin, Pseudoephedrine Hcl"

    NDCBrand NameGeneric Name
    54859-502TusnelDextromethorphan, Guiafenesin, Pseudoephedrine HCl
    54859-506TusnelDextromethorphan HBr, Guaifenesin
    54859-507TusnelGuaifenesin
    54859-517TusnelDextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    54859-520TusnelCodeine Phosphate, Guiafenesin, Pseudoephedrine HCl
    54859-544TusnelDextromethorphan, Guiafenesin, Pseudoephedrine HCl
    54859-801TusnelDextromethorphan HBr, Guaifenesin, Pseudoephedrine HCl

    Trademark Results [Tusnel]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    TUSNEL
    TUSNEL
    87532022 5527955 Live/Registered
    LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION
    2017-07-18
    TUSNEL
    TUSNEL
    86162169 not registered Dead/Abandoned
    Llorens Pharmaceutical International Division, Inc.
    2014-01-10
    TUSNEL
    TUSNEL
    85690038 not registered Dead/Abandoned
    Pharmaceutical Generic Developers Inc. USA
    2012-07-30
    TUSNEL
    TUSNEL
    77666900 not registered Dead/Abandoned
    Llorens Pharmaceutical International Divison, Inc
    2009-02-10

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