NDC 52083-289

Tusicof

Guaifenesin, Phenylephrine Hcl, Dextromethorphan

Tusicof is a Oral Tablet, Coated in the Human Otc Drug category. It is labeled and distributed by Kramer Novis.. The primary component is Guaifenesin; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride.

Product ID52083-289_9f336526-25df-419b-9cc9-b08d7ab5f0f0
NDC52083-289
Product TypeHuman Otc Drug
Proprietary NameTusicof
Generic NameGuaifenesin, Phenylephrine Hcl, Dextromethorphan
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2012-07-18
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameKramer Novis.
Substance NameGUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength400 mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 52083-289-02

2 TABLET, COATED in 1 PACKET (52083-289-02)
Marketing Start Date2012-07-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52083-289-02 [52083028902]

Tusicof TABLET, COATED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-07-18

NDC 52083-289-60 [52083028960]

Tusicof TABLET, COATED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2012-07-18

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN400 mg/1

OpenFDA Data

SPL SET ID:e6391d61-36ea-4926-878c-6758f65caa7e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1305214
  • UPC Code
  • 0352083289606
  • NDC Crossover Matching brand name "Tusicof" or generic name "Guaifenesin, Phenylephrine Hcl, Dextromethorphan"

    NDCBrand NameGeneric Name
    52083-239TUSICOFdextromethorphan, guaifenesin, and phenylephrine
    52083-289TusicofGuaifenesin, phenylephrine HCL, Dextromethorphan

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