"42192-607-40" National Drug Code (NDC)

Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide 40 CUP, UNIT-DOSE in 1 CASE (42192-607-40) / 5 mL in 1 CUP, UNIT-DOSE (42192-607-05)
(Acella Pharmaceuticals, LLC)

NDC Code42192-607-40
Package Description40 CUP, UNIT-DOSE in 1 CASE (42192-607-40) / 5 mL in 1 CUP, UNIT-DOSE (42192-607-05)
Product NDC42192-607
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameBrompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide
Non-Proprietary NameBrompheniramine Maleate, Pseudoephedrine Hydrochloride, And Dextromethorphan Hydrobromide
Dosage FormSYRUP
UsageORAL
Start Marketing Date20160921
Marketing Category NameANDA
Application NumberANDA203375
ManufacturerAcella Pharmaceuticals, LLC
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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