NDC 45737-227

BioTPres Pediatric

Dextromethorphan, Guaifenesin, Phenylephrine

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

Product ID45737-227_4cc0e86e-b079-400c-958d-4644a620069e
NDC45737-227
Product TypeHuman Otc Drug
Proprietary NameBioTPres Pediatric
Generic NameDextromethorphan, Guaifenesin, Phenylephrine
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2009-10-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameAdvanced Generic Corporation
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength5 mg/5mL; mg/5mL; mg/5mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 45737-227-16

473 mL in 1 BOTTLE (45737-227-16)
Marketing Start Date2009-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 45737-227-16 [45737022716]

BioTPres Pediatric LIQUID
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2009-10-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE5 mg/5mL

OpenFDA Data

SPL SET ID:d6b2d191-e2fb-4da4-92e0-35b81e07e673
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1119541

    • NDC Crossover Matching brand name "BioTPres Pediatric" or generic name "Dextromethorphan, Guaifenesin, Phenylephrine"

    NDCBrand NameGeneric Name
    45737-246BiobronDextromethorphan, Guaifenesin, Phenylephrine
    45737-221BiodespDextromethorphan, Guaifenesin, Phenylephrine
    45737-205BioGtussDextromethorphan, Guaifenesin, Phenylephrine
    45737-242BioGtussDextromethorphan, Guaifenesin, Phenylephrine
    45737-225BioTPresDextromethorphan, Guaifenesin, Phenylephrine
    45737-227BioTPresDextromethorphan, Guaifenesin, Phenylephrine
    11856-0031Goyescas 7 Syrups Alcohol and Sugar FreeDextromethorphan, Guaifenesin, Phenylephrine
    11856-0001Goyescas 7 Syrups OriginalDextromethorphan, Guaifenesin, Phenylephrine
    11856-0016Goyescas Broncovac 1Dextromethorphan, Guaifenesin, Phenylephrine
    11856-0025Goyescas Broncovac 3Dextromethorphan, Guaifenesin, Phenylephrine
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