NDC 45737-605

Biogtuss TR

Guaifenesin, Phenylephrine Hcl, Dextromethorphan Hbr

Biogtuss TR is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Advanced Generic Corporation. The primary component is Guaifenesin; Phenylephrine Hydrochloride; Dextromethorphan Hydrobromide.

Product ID45737-605_678a8e9a-7480-4fbe-ad80-4907383b59c8
NDC45737-605
Product TypeHuman Otc Drug
Proprietary NameBiogtuss TR
Generic NameGuaifenesin, Phenylephrine Hcl, Dextromethorphan Hbr
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2014-04-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameAdvanced Generic Corporation
Substance NameGUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
Active Ingredient Strength388 mg/1; mg/1; mg/1
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 45737-605-10

100 TABLET in 1 BOTTLE (45737-605-10)
Marketing Start Date2014-04-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 45737-605-10 [45737060510]

Biogtuss TR TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-04-01
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN388 mg/1

OpenFDA Data

SPL SET ID:bdc5b26f-bb43-4a5e-ac00-5bae1414c3e5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 899263
  • UPC Code
  • 0345737605105

  • © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.