"69452-478-55" National Drug Code (NDC)

Brompheniramine Maleate, Pseudoephedrine Hydrochloride, And Dextromethorphan Hydrobromide 118 mL in 1 BOTTLE (69452-478-55)
(BIONPHARMA INC.)

NDC Code69452-478-55
Package Description118 mL in 1 BOTTLE (69452-478-55)
Product NDC69452-478
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameBrompheniramine Maleate, Pseudoephedrine Hydrochloride, And Dextromethorphan Hydrobromide
Non-Proprietary NameBrompheniramine Maleate, Pseudoephedrine Hydrochloride, And Dextromethorphan Hydrobromide
Dosage FormSYRUP
UsageORAL
Start Marketing Date20251001
Marketing Category NameANDA
Application NumberANDA203997
ManufacturerBIONPHARMA INC.
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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