NDC 42858-320

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 Rhodes Pharmaceuticals L.p.. The primary component is Brompheniramine Maleate; Dextromethorphan Hydrobromide; Pseudoephedrine Hydrochloride.

Product ID42858-320_e5ff67d3-df79-4fb3-99e9-0e86068756f9
NDC42858-320
Product TypeHuman Prescription Drug
Proprietary NameBrompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide
Generic NameBrompheniramine Maleate, Pseudoephedrine Hydrochloride, And Dextromethorphan Hydrobromide
Dosage FormSyrup
Route of AdministrationORAL
Marketing Start Date2022-10-12
Marketing CategoryANDA /
Application NumberANDA202955
Labeler NameRhodes Pharmaceuticals L.P.
Substance NameBROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active Ingredient Strength2 mg/5mL; mg/5mL; mg/5mL
Pharm ClassesAdrenergic alpha-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 42858-320-12

118 mL in 1 BOTTLE, PLASTIC (42858-320-12)
Marketing Start Date2022-10-12
NDC Exclude FlagN
Sample Package?N

Drug Details

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

NDCBrand NameGeneric Name
0527-5302Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromidebrompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide
42858-320Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan HydrobromideBrompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide
51672-4165Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan HydrobromideBrompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide
51991-847Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan HydrobromideBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, and DEXTROMETHORPHAN HYDROBROMIDE
60432-275Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan HydrobromideBrompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide
63629-2058Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan HydrobromideBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, and DEXTROMETHORPHAN HYDROBROMIDE
63629-2059Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan HydrobromideBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, and DEXTROMETHORPHAN HYDROBROMIDE
63629-2085Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromidebrompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide
63629-2086Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromidebrompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide
64376-657BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDEBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE
68788-7554Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan HydrobromideBrompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide
68788-7861Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan HydrobromideBrompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide
0121-0933Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan HydrobromideBrompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide
63187-400Brompheniramine Maleate, Pseudoephedrine Hydrochloride and DextromethorphanHydrobromideBrompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide
42192-607Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan HydrobromideBrompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide
63187-930Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan HydrobromideBrompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide
68788-7123Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan HydrobromideBrompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide
68788-7975Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan HydrobromideBrompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide
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