NDC Code | 68788-8100-1 |
Package Description | 118 mL in 1 BOTTLE (68788-8100-1) |
Product NDC | 68788-8100 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Promethazine Hydrochloride And Dextromethorphan Hydrobromide Oral Solution |
Non-Proprietary Name | Promethazine Hydrochloride And Dextromethorphan Hydrobromide Oral Solution |
Dosage Form | SOLUTION |
Usage | ORAL |
Start Marketing Date | 20211008 |
Marketing Category Name | ANDA |
Application Number | ANDA040649 |
Manufacturer | Preferred Pharmaceuticals Inc. |
Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE |
Strength | 15; 6.25 |
Strength Unit | mg/5mL; mg/5mL |
Pharmacy Classes | Phenothiazine [EPC], Phenothiazines [CS], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA] |