NDC 45737-205

BioGtuss

Dextromethorphan, Guaifenesin, Phenylephrine

BioGtuss 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 ID45737-205_1e82e992-c581-48a8-b332-b42c2efaf29f
NDC45737-205
Product TypeHuman Otc Drug
Proprietary NameBioGtuss
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 Strength15 mg/5mL; mg/5mL; mg/5mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 45737-205-16

473 mL in 1 BOTTLE (45737-205-16)
Marketing Start Date2009-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 45737-205-16 [45737020516]

BioGtuss 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 HYDROBROMIDE15 mg/5mL

OpenFDA Data

SPL SET ID:28c143f4-1575-44fe-871c-8e281322994e
Manufacturer
UNII

NDC Crossover Matching brand name "BioGtuss" or generic name "Dextromethorphan, Guaifenesin, Phenylephrine"

NDCBrand NameGeneric Name
45737-205BioGtussDextromethorphan, Guaifenesin, Phenylephrine
45737-242BioGtussDextromethorphan, Guaifenesin, Phenylephrine
45737-605BiogtussGuaifenesin, Phenylephrine HCl, Dextromethorphan HBr
45737-246BiobronDextromethorphan, Guaifenesin, Phenylephrine
45737-221BiodespDextromethorphan, 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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