NDC 52083-637

Presgen B

Dextromethorphan Hydrobromide, Brompheniramine Maleate, Phenylephrine Hydrochloride

Presgen B is a Oral Syrup in the Human Otc Drug category. It is labeled and distributed by Kramer Novis. The primary component is Dextromethorphan Hydrobromide; Brompheniramine Maleate; Phenylephrine Hydrochloride.

Product ID52083-637_1aa66658-5a79-4048-95bf-18c939f62c3d
NDC52083-637
Product TypeHuman Otc Drug
Proprietary NamePresgen B
Generic NameDextromethorphan Hydrobromide, Brompheniramine Maleate, Phenylephrine Hydrochloride
Dosage FormSyrup
Route of AdministrationORAL
Marketing Start Date2011-03-29
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameKRAMER NOVIS
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength20 mg/5mL; mg/5mL; mg/5mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 52083-637-16

480 mL in 1 BOTTLE (52083-637-16)
Marketing Start Date2011-03-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52083-637-16 [52083063716]

Presgen B SYRUP
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2011-03-29

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/5mL

OpenFDA Data

SPL SET ID:5befa829-32bd-4978-8a0e-1d6513ff37a4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1148155
  • UPC Code
  • 0352083637162
  • NDC Crossover Matching brand name "Presgen B" or generic name "Dextromethorphan Hydrobromide, Brompheniramine Maleate, Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    52083-637Presgen Bdextromethorphan hydrobromide, brompheniramine maleate, phenylephrine hydrochloride
    52083-237Tussi Pres Bdextromethorphan hydrobromide, brompheniramine maleate, phenylephrine hydrochloride

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