NDC Code | 17856-0155-1 |
Package Description | 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0155-1) / 5 mL in 1 CUP, UNIT-DOSE (17856-0155-2) |
Product NDC | 17856-0155 |
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 | 20201005 |
Marketing Category Name | ANDA |
Application Number | ANDA040649 |
Manufacturer | ATLANTIC BIOLOGICALS CORP. |
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] |