NDC 69140-620

Klernaz

Guaifenesin, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide

Klernaz is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Pharma Associate Consultants, Inc. The primary component is Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.

Product ID69140-620_1cba7bae-bc4c-2fc5-e054-00144ff88e88
NDC69140-620
Product TypeHuman Otc Drug
Proprietary NameKlernaz
Generic NameGuaifenesin, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2015-08-07
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NamePharma Associate Consultants, Inc
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength15 mg/1; mg/1; mg/1
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 69140-620-03

30 TABLET in 1 BOTTLE (69140-620-03)
Marketing Start Date2015-08-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69140-620-03 [69140062003]

Klernaz TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-08-07
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE15 mg/1

OpenFDA Data

SPL SET ID:1cba7bae-bc4b-2fc5-e054-00144ff88e88
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1552200
  • NDC Crossover Matching brand name "Klernaz" or generic name "Guaifenesin, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide"

    NDCBrand NameGeneric Name
    69140-620KlernazGuaifenesin, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide
    52083-632Presgenguaifenesin, phenylephrine hydrochloride, dextromethorphan hydrobromide
    52083-231Tussi Presguaifenesin, phenylephrine hydrochloride, dextromethorphan hydrobromide
    52083-233Tussi Presguaifenesin, phenylephrine hydrochloride, dextromethorphan hydrobromide

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