NDC 63187-930

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 Proficient Rx Lp. The primary component is Brompheniramine Maleate; Pseudoephedrine Hydrochloride; Dextromethorphan Hydrobromide.

Product ID63187-930_1b79a7d8-a8f4-4525-8b94-3e317fc5a717
NDC63187-930
Product TypeHuman Prescription Drug
Proprietary NameBrompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide
Generic NameBrompheniramine Maleate, Pseudoephedrine Hydrochloride, And Dextromethorphan Hydrobromide
Dosage FormSyrup
Route of AdministrationORAL
Marketing Start Date2016-09-21
Marketing CategoryANDA / ANDA
Application NumberANDA203375
Labeler NameProficient Rx LP
Substance NameBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
Active Ingredient Strength2 mg/5mL; mg/5mL; mg/5mL
Pharm ClassesAdrenergic 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 FlagN
Listing Certified Through2019-12-31

Packaging

NDC 63187-930-04

118 mL in 1 BOTTLE, PLASTIC (63187-930-04)
Marketing Start Date2017-11-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63187-930-04 [63187093004]

Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide SYRUP
Marketing CategoryANDA
Application NumberANDA203375
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-11-01

NDC 63187-930-16 [63187093016]

Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide SYRUP
Marketing CategoryANDA
Application NumberANDA203375
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-11-01

Drug Details

Active Ingredients

IngredientStrength
BROMPHENIRAMINE MALEATE2 mg/5mL

OpenFDA Data

SPL SET ID:1b79a7d8-a8f4-4525-8b94-3e317fc5a717
Manufacturer
UNII
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"

    NDCBrand NameGeneric Name
    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
    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
    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
    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
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