NDC 58605-151

BroveX PSB DM

Pseudoephedrine Hydrochloride, Brompheniramine Maleate, And Dextromethorphan Hydrobromide

BroveX PSB DM is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Mcr American Pharmaceuticals, Inc.. The primary component is Pseudoephedrine Hydrochloride; Brompheniramine Maleate; Dextromethorphan Hydrobromide.

Product ID58605-151_b652e5a8-f339-4e39-b410-9e0857ffba3a
NDC58605-151
Product TypeHuman Otc Drug
Proprietary NameBroveX PSB DM
Generic NamePseudoephedrine Hydrochloride, Brompheniramine Maleate, And Dextromethorphan Hydrobromide
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2007-11-30
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameMCR American Pharmaceuticals, Inc.
Substance NamePSEUDOEPHEDRINE HYDROCHLORIDE; BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
Active Ingredient Strength20 mg/5mL; mg/5mL; mg/5mL
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 58605-151-02

20 mL in 1 BOTTLE, PLASTIC (58605-151-02)
Marketing Start Date2007-11-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58605-151-01 [58605015101]

BroveX PSB DM LIQUID
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2007-11-30
Marketing End Date2013-10-31
Inactivation Date2019-10-29
Reactivation Date2020-05-21

NDC 58605-151-02 [58605015102]

BroveX PSB DM LIQUID
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2007-11-30
Marketing End Date2013-10-31
Inactivation Date2019-10-29
Reactivation Date2020-05-21

Drug Details

Active Ingredients

IngredientStrength
PSEUDOEPHEDRINE HYDROCHLORIDE20 mg/5mL

OpenFDA Data

SPL SET ID:5a6f21f8-651f-4559-98d8-bb2646a216ca
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1356838
  • UPC Code
  • 0358605151017

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