"0121-0933-16" National Drug Code (NDC)

Brompheniramine Maleate, Pseudoephedrine Hydrochloride And Dextromethorphan Hydrobromide 473 mL in 1 BOTTLE (0121-0933-16)
(PAI Holdings, LLC dba PAI Pharma)

NDC Code0121-0933-16
Package Description473 mL in 1 BOTTLE (0121-0933-16)
Product NDC0121-0933
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameBrompheniramine Maleate, Pseudoephedrine Hydrochloride And Dextromethorphan Hydrobromide
Non-Proprietary NameBrompheniramine Maleate, Pseudoephedrine Hydrochloride, And Dextromethorphan Hydrobromide
Dosage FormSOLUTION
UsageORAL
Start Marketing Date20220303
Marketing Category NameANDA
Application NumberANDA202940
ManufacturerPAI Holdings, LLC dba PAI Pharma
Substance NameBROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Strength2; 10; 30
Strength Unitmg/5mL; mg/5mL; mg/5mL
Pharmacy ClassesAdrenergic alpha-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-Adrenergic Agonist [EPC]

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