NDC 0527-5302

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 Lannett Company, Inc.. The primary component is Brompheniramine Maleate; Pseudoephedrine Hydrochloride; Dextromethorphan Hydrobromide.

Product ID0527-5302_4f43980b-610b-4533-90dc-97ddb012bbe7
NDC0527-5302
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 Date2020-04-17
Marketing CategoryANDA / ANDA
Application NumberANDA213125
Labeler NameLannett Company, Inc.
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 0527-5302-64

118 mL in 1 BOTTLE, PLASTIC (0527-5302-64)
Marketing Start Date2020-04-17
Marketing End Date2023-12-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0527-5302-70 [00527530270]

Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide SYRUP
Marketing CategoryANDA
Application NumberANDA213125
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-04-17

NDC 0527-5302-64 [00527530264]

Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide SYRUP
Marketing CategoryANDA
Application NumberANDA213125
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-04-17

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]

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
60432-837Bromfed DMbrompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide
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
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
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