NDC 68788-6453

Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide

Brompheniramine Maleate, Pseudoephedrine Hydrochloride And Dextromethorphan Hydrobromide

Brompheniramine Maleate, Pseudoephedrine Hydrochloride and 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: 68788-6453_2bd2cde7-d621-49de-a456-dc21551a1ae3
• NDC: 68788-6453
• Product Type: Human Prescription Drug
• Proprietary Name: Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide
• Generic Name: Brompheniramine Maleate, Pseudoephedrine Hydrochloride And Dextromethorphan Hydrobromide
• Dosage Form: Syrup
• Route of Administration: ORAL
• Marketing Start Date: 2016-08-05
• Marketing Category: ANDA / ANDA
• Application Number: ANDA205292
• 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: Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 68788-6453-1

118 mL in 1 BOTTLE, PLASTIC (68788-6453-1)

• Marketing Start Date: 2016-08-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68788-6453-1 [68788645301]

Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide SYRUP

• Marketing Category: ANDA
• Application Number: ANDA205292
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-08-05
• Marketing End Date: 2020-04-07

Drug Details

Active Ingredients

Ingredient	Strength
BROMPHENIRAMINE MALEATE	2 mg/5mL

OpenFDA Data

• SPL SET ID: 59f6c57a-c7c6-458e-b0da-aba548bbbfd9
• 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 and Dextromethorphan Hydrobromide" or generic name "Brompheniramine Maleate, Pseudoephedrine Hydrochloride And Dextromethorphan Hydrobromide"

NDC	Brand Name	Generic Name
0121-0933	Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide
0574-1104	Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide	Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide
50090-5625	Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide	Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide
51862-535	brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide	brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide
63187-664	Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide	Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide
63629-8615	Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide	Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide
63629-8616	Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide	Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide
68788-6453	Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide	Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide
68788-7610	brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide	brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide
71205-346	brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide	brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide
60432-837	Bromfed DM	brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide
68025-002	Bromfed DM	Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide
0527-5302	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide
63629-2085	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide
63629-2086	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide