NDC 54838-125

Brotapp

Brompheniramine Maleate And Pseudoephedrine Hydrochloride

Brotapp is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Lannett Company, Inc.. The primary component is Brompheniramine Maleate; Pseudoephedrine Hydrochloride.

• Product ID: 54838-125_359f98a1-f1bc-42c0-89c1-a5e7e4d64999
• NDC: 54838-125
• Product Type: Human Otc Drug
• Proprietary Name: Brotapp
• Generic Name: Brompheniramine Maleate And Pseudoephedrine Hydrochloride
• Dosage Form: Liquid
• Route of Administration: ORAL
• Marketing Start Date: 2001-04-05
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Lannett Company, Inc.
• Substance Name: BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE
• Active Ingredient Strength: 1 mg/5mL; mg/5mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 54838-125-40

118 mL in 1 BOTTLE, PLASTIC (54838-125-40)

• Marketing Start Date: 2001-04-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 54838-125-70 [54838012570]

Brotapp LIQUID

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2001-04-05

NDC 54838-125-80 [54838012580]

Brotapp LIQUID

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2001-04-05

NDC 54838-125-40 [54838012540]

Brotapp LIQUID

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2001-04-05

Drug Details

Active Ingredients

Ingredient	Strength
BROMPHENIRAMINE MALEATE	1 mg/5mL

OpenFDA Data

• SPL SET ID: 5a6dbbda-a393-4cbe-b876-1314865a913e
• Manufacturer:
  • Lannett Company, Inc.
• UNII:
  • 6V9V2RYJ8N
  • IXA7C9ZN03
• RxNorm Concept Unique ID - RxCUI:
  • 1098498

Medicade Reported Pricing

54838012580 BROTAPP LIQUID

Pricing Unit: ML | Drug Type:

54838012570 BROTAPP LIQUID

Pricing Unit: ML | Drug Type:

54838012540 BROTAPP LIQUID

Pricing Unit: ML | Drug Type:

NDC Crossover Matching brand name "Brotapp" or generic name "Brompheniramine Maleate And Pseudoephedrine Hydrochloride"

NDC	Brand Name	Generic Name
54838-125	Brotapp	Brompheniramine maleate and Pseudoephedrine hydrochloride
0095-0860	Lodrane D	brompheniramine maleate and pseudoephedrine hydrochloride
68788-9184	Q-Tapp	Brompheniramine maleate and Pseudoephedrine hydrochloride
0485-0202	RYNEX PE	BROMPHENIRAMINE MALEATE and PSEUDOEPHEDRINE HYDROCHLORIDE
0485-0206	RYNEX PSE	BROMPHENIRAMINE MALEATE and PSEUDOEPHEDRINE HYDROCHLORIDE