NDC Code | 42192-607-40 |
Package Description | 40 CUP, UNIT-DOSE in 1 CASE (42192-607-40) / 5 mL in 1 CUP, UNIT-DOSE (42192-607-05) |
Product NDC | 42192-607 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide |
Non-Proprietary Name | Brompheniramine Maleate, Pseudoephedrine Hydrochloride, And Dextromethorphan Hydrobromide |
Dosage Form | SYRUP |
Usage | ORAL |
Start Marketing Date | 20160921 |
Marketing Category Name | ANDA |
Application Number | ANDA203375 |
Manufacturer | Acella Pharmaceuticals, LLC |
Substance Name | BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE |
Strength | 2; 10; 30 |
Strength Unit | mg/5mL; mg/5mL; mg/5mL |
Pharmacy Classes | Adrenergic 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] |