NDC 68788-7123

Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide

Brompheniramine Maleate, Pseudoephedrine Hydrochloride, And Dextromethorphan Hydrobromide

Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide is a Oral Syrup in the Human Prescription Drug category. It is labeled and distributed by Preferred Pharmaceuticals Inc.. The primary component is Brompheniramine Maleate; Pseudoephedrine Hydrochloride; Dextromethorphan Hydrobromide.

• Product ID: 68788-7123_41964eed-b8d4-4fd7-be43-0417f66a0fe5
• NDC: 68788-7123
• Product Type: Human Prescription Drug
• Proprietary Name: Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide
• Generic Name: Brompheniramine Maleate, Pseudoephedrine Hydrochloride, And Dextromethorphan Hydrobromide
• Dosage Form: Syrup
• Route of Administration: ORAL
• Marketing Start Date: 2018-03-22
• Marketing Category: ANDA / ANDA
• Application Number: ANDA203375
• Labeler Name: Preferred Pharmaceuticals Inc.
• Substance Name: BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
• Active Ingredient Strength: 2 mg/5mL; mg/5mL; mg/5mL
• Pharm Classes: Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC],Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 68788-7123-1

118 mL in 1 BOTTLE, PLASTIC (68788-7123-1)

• Marketing Start Date: 2018-03-22
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68788-7123-1 [68788712301]

Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide SYRUP

• Marketing Category: ANDA
• Application Number: ANDA203375
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-03-22

Drug Details

Active Ingredients

Ingredient	Strength
BROMPHENIRAMINE MALEATE	2 mg/5mL

OpenFDA Data

• SPL SET ID: 6cb9db9b-b96c-4ac6-acf7-2e307081824c
• Manufacturer:
  • Preferred Pharmaceuticals Inc.
• UNII:
  • 6V9V2RYJ8N
  • 9D2RTI9KYH
  • IXA7C9ZN03
• RxNorm Concept Unique ID - RxCUI:
  • 1357010

Pharmacological Class

• Adrenergic alpha-Agonists [MoA]
• alpha-Adrenergic Agonist [EPC]
• Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]
• Sigma-1 Agonist [EPC]
• Uncompetitive NMDA Receptor Antagonists [MoA]
• Sigma-1 Receptor Agonists [MoA]

NDC Crossover Matching brand name "Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide" or generic name "Brompheniramine Maleate, Pseudoephedrine Hydrochloride, And Dextromethorphan Hydrobromide"

NDC	Brand Name	Generic Name
42192-607	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide
63187-930	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide
68788-7123	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide
68788-7975	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide
0121-0933	Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide
63187-400	Brompheniramine Maleate, Pseudoephedrine Hydrochloride and DextromethorphanHydrobromide	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide
42858-320	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide
51672-4165	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide
51991-847	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, and DEXTROMETHORPHAN HYDROBROMIDE
60432-275	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide
63629-2058	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, and DEXTROMETHORPHAN HYDROBROMIDE
63629-2059	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, and DEXTROMETHORPHAN HYDROBROMIDE
64376-657	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE
68788-7554	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide
68788-7861	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide