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 ID: 58605-150_79c81ee6-bae5-45b4-93c8-7b896a0975e3
• NDC: 58605-150
• Product Type: Human Otc Drug
• Proprietary Name: BroveX PSB
• Generic Name: Pseudoephedrine Hydrochloride And Brompheniramine Maleate
• 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: PSEUDOEPHEDRINE HYDROCHLORIDE; BROMPHENIRAMINE MALEATE
• Active Ingredient Strength: 20 mg/5mL; mg/5mL
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 58605-150-01

473 mL in 1 BOTTLE, PLASTIC (58605-150-01)

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

NDC SPL Data Element Entries

NDC 58605-150-02 [58605015002]

BroveX PSB LIQUID

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2007-11-30
• Marketing End Date: 2014-04-30
• Inactivation Date: 2019-10-29
• Reactivation Date: 2020-05-20

NDC 58605-150-01 [58605015001]

BroveX PSB 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: 2014-04-30
• Inactivation Date: 2019-10-29
• Reactivation Date: 2020-05-20

Drug Details

Active Ingredients

Ingredient	Strength
PSEUDOEPHEDRINE HYDROCHLORIDE	20 mg/5mL

OpenFDA Data

• SPL SET ID: 4c5708e8-7814-4766-b0f5-4885a9560a45
• Manufacturer:
  • MCR American Pharmaceuticals, Inc.
• UNII:
  • 6V9V2RYJ8N
  • IXA7C9ZN03
• RxNorm Concept Unique ID - RxCUI:
  • 1243500
  • 1094330
• UPC Code:
  • 0358605150010