NDC 51862-535

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 Mayne Pharma. The primary component is Brompheniramine Maleate; Pseudoephedrine Hydrochloride; Dextromethorphan Hydrobromide.

Product ID51862-535_a704c065-a1ea-0dc0-e053-2a95a90af016
NDC51862-535
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 Date2019-02-06
Marketing CategoryANDA / ANDA
Application NumberANDA207676
Labeler NameMayne Pharma
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 Through2021-12-31

Packaging

NDC 51862-535-04

118 mL in 1 BOTTLE, PLASTIC (51862-535-04)
Marketing Start Date2019-02-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51862-535-16 [51862053516]

brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide SYRUP
Marketing CategoryANDA
Application NumberANDA207676
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-02-06

NDC 51862-535-04 [51862053504]

brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide SYRUP
Marketing CategoryANDA
Application NumberANDA207676
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-02-06

Drug Details

Active Ingredients

IngredientStrength
BROMPHENIRAMINE MALEATE2 mg/5mL

OpenFDA Data

SPL SET ID:1adfc024-0e18-4f27-9277-ebdc46fb9fd8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1357010
    • UPC Code
  • 0351862535163

    • 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]
    • 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"

    NDCBrand NameGeneric Name
    0121-0933Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan HydrobromideBrompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide
    0574-1104Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan HydrobromideBrompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide
    50090-5625Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan HydrobromideBrompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide
    51862-535brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromidebrompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide
    63187-664Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan HydrobromideBrompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide
    63629-8615Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan HydrobromideBrompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide
    63629-8616Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan HydrobromideBrompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide
    68788-6453Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan HydrobromideBrompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide
    68788-7610brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromidebrompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide
    71205-346brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromidebrompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide
    60432-837Bromfed DMbrompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide
    68025-002Bromfed DMBrompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide
    0527-5302Brompheniramine 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
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