NDC 58605-152

BroveX PEB

Brompheniramine Maleate And Phenylephrine Hydrochloride

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

• Product ID: 58605-152_004dd25b-e97b-4264-b664-b3fee1ec4022
• NDC: 58605-152
• Product Type: Human Otc Drug
• Proprietary Name: BroveX PEB
• Generic Name: Brompheniramine Maleate And Phenylephrine Hydrochloride
• Dosage Form: Liquid
• Route of Administration: ORAL
• Marketing Start Date: 2007-11-30
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: MCR American Pharmaceuticals, Inc.
• Substance Name: BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 4 mg/5mL; mg/5mL
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 58605-152-02

20 mL in 1 BOTTLE, PLASTIC (58605-152-02)

• Marketing Start Date: 2007-11-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58605-152-01 [58605015201]

BroveX PEB LIQUID

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2007-11-30
• Marketing End Date: 2014-11-30
• Inactivation Date: 2019-10-29
• Reactivation Date: 2020-05-21

NDC 58605-152-02 [58605015202]

BroveX PEB LIQUID

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2007-11-30
• Marketing End Date: 2014-11-30
• Inactivation Date: 2019-10-29
• Reactivation Date: 2020-05-21

Drug Details

Active Ingredients

Ingredient	Strength
BROMPHENIRAMINE MALEATE	4 mg/5mL

OpenFDA Data

• SPL SET ID: ceb99dea-44ca-40c8-b479-da97707c513f
• Manufacturer:
  • MCR American Pharmaceuticals, Inc.
• UNII:
  • 04JA59TNSJ
  • IXA7C9ZN03
• RxNorm Concept Unique ID - RxCUI:
  • 1356841
  • 1356843
• UPC Code:
  • 0358605152014

NDC Crossover Matching brand name "BroveX PEB" or generic name "Brompheniramine Maleate And Phenylephrine Hydrochloride"

NDC	Brand Name	Generic Name
58605-152	BroveX PEB	Brompheniramine Maleate and Phenylephrine Hydrochloride
28595-300	Brohist D	Brompheniramine Maleate and Phenylephrine Hydrochloride
80070-300	Dimetapp	BROMPHENIRAMINE MALEATE and PHENYLEPHRINE HYDROCHLORIDE
58605-306	Maxi-Tuss PE	BROMPHENIRAMINE MALEATE and PHENYLEPHRINE HYDROCHLORIDE
28595-900	Ru-Hist D	Brompheniramine Maleate and Phenylephrine Hydrochloride
66992-490	VAZOBID-PD	Brompheniramine maleate and Phenylephrine hydrochloride