NDC 0574-1104

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 Paddock Laboratories, Llc. The primary component is Brompheniramine Maleate; Pseudoephedrine Hydrochloride; Dextromethorphan Hydrobromide.

Product ID0574-1104_46673dd3-3560-4ef9-a3f4-102be76fc941
NDC0574-1104
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 Date2015-02-06
Marketing CategoryANDA / ANDA
Application NumberANDA205292
Labeler NamePaddock Laboratories, LLC
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 Through2020-12-31

Packaging

NDC 0574-1104-04

118 mL in 1 BOTTLE, PLASTIC (0574-1104-04)
Marketing Start Date2015-02-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0574-1104-04 [00574110404]

Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide SYRUP
Marketing CategoryANDA
Application NumberANDA205292
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-02-06

NDC 0574-1104-16 [00574110416]

Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide SYRUP
Marketing CategoryANDA
Application NumberANDA205292
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-02-06

Drug Details

Active Ingredients

IngredientStrength
BROMPHENIRAMINE MALEATE2 mg/5mL

OpenFDA Data

SPL SET ID:06db369d-09fe-4ca2-b98c-705356b7c403
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1357010
    • UPC Code
  • 0305741104049

    • 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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