NDC 58605-150

BroveX PSB

Pseudoephedrine Hydrochloride And Brompheniramine Maleate

BroveX PSB 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.

Product ID58605-150_79c81ee6-bae5-45b4-93c8-7b896a0975e3
NDC58605-150
Product TypeHuman Otc Drug
Proprietary NameBroveX PSB
Generic NamePseudoephedrine Hydrochloride And Brompheniramine Maleate
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
Active Ingredient Strength20 mg/5mL; mg/5mL
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 58605-150-01

473 mL in 1 BOTTLE, PLASTIC (58605-150-01)
Marketing Start Date2007-11-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58605-150-02 [58605015002]

BroveX PSB LIQUID
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2007-11-30
Marketing End Date2014-04-30
Inactivation Date2019-10-29
Reactivation Date2020-05-20

NDC 58605-150-01 [58605015001]

BroveX PSB LIQUID
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2007-11-30
Marketing End Date2014-04-30
Inactivation Date2019-10-29
Reactivation Date2020-05-20

Drug Details

Active Ingredients

IngredientStrength
PSEUDOEPHEDRINE HYDROCHLORIDE20 mg/5mL

OpenFDA Data

SPL SET ID:4c5708e8-7814-4766-b0f5-4885a9560a45
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1243500
  • 1094330
  • UPC Code
  • 0358605150010

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