NDC 45737-206

Bionel

Dextromethorphan, Guaifenesin, Pseudoephedrine Hydrochloride

Bionel 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; Pseudoephedrine Hydrochloride.

Product ID45737-206_432ffab3-9f96-4d68-8935-a2288e92bc65
NDC45737-206
Product TypeHuman Otc Drug
Proprietary NameBionel
Generic NameDextromethorphan, Guaifenesin, Pseudoephedrine Hydrochloride
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; PSEUDOEPHEDRINE HYDROCHLORIDE
Active Ingredient Strength15 mg/5mL; mg/5mL; mg/5mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 45737-206-16

473 mL in 1 BOTTLE (45737-206-16)
Marketing Start Date2009-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 45737-206-16 [45737020616]

Bionel 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:8c46a467-fb6b-4e16-ba99-e880a3f04974
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1098227
  • NDC Crossover Matching brand name "Bionel" or generic name "Dextromethorphan, Guaifenesin, Pseudoephedrine Hydrochloride"

    NDCBrand NameGeneric Name
    45737-206BionelDextromethorphan, Guaifenesin, Pseudoephedrine Hydrochloride
    45737-207BionelDextromethorphan, Guaifenesin, Pseudoephedrine Hydrochloride

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