NDC 52083-231

Tussi Pres

Guaifenesin, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide

Tussi Pres is a Oral Syrup in the Human Otc Drug category. It is labeled and distributed by Kramer Novis. The primary component is Guaifenesin; Phenylephrine Hydrochloride; Dextromethorphan Hydrobromide.

Product ID52083-231_38d65dfe-47df-434e-9680-d62a63d48da4
NDC52083-231
Product TypeHuman Otc Drug
Proprietary NameTussi Pres
Generic NameGuaifenesin, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide
Dosage FormSyrup
Route of AdministrationORAL
Marketing Start Date2011-03-28
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameKramer Novis
Substance NameGUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
Active Ingredient Strength200 mg/5mL; mg/5mL; mg/5mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 52083-231-10

10 mL in 1 PACKET (52083-231-10)
Marketing Start Date2011-03-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52083-231-16 [52083023116]

Tussi Pres SYRUP
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2011-03-28

NDC 52083-231-04 [52083023104]

Tussi Pres SYRUP
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2011-03-28
Marketing End Date2017-07-12

NDC 52083-231-10 [52083023110]

Tussi Pres SYRUP
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2011-03-28

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN200 mg/5mL

OpenFDA Data

SPL SET ID:0d4ee530-2a5c-41a0-88bf-ac92d538661b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1098647
  • UPC Code
  • 0352083231100
  • 0352083231162
  • NDC Crossover Matching brand name "Tussi Pres" or generic name "Guaifenesin, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide"

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

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