NDC 71205-346

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

Product ID71205-346_2daad986-907a-4b6c-baae-e465c1bb38f7
NDC71205-346
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 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 Through2020-12-31

Packaging

NDC 71205-346-04

118 mL in 1 BOTTLE, PLASTIC (71205-346-04)
Marketing Start Date2019-11-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71205-346-04 [71205034604]

brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide SYRUP
Marketing CategoryANDA
Application NumberANDA207676
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-11-01

Drug Details

Active Ingredients

IngredientStrength
BROMPHENIRAMINE MALEATE2 mg/5mL

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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