| NDC Code | 27808-057-01 |
|---|
| Package Description | 473 mL in 1 BOTTLE, PLASTIC (27808-057-01) |
|---|
| Product NDC | 27808-057 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Promethazine Hydrochloride And Dextromethorphan Hydrobromide |
|---|
| Non-Proprietary Name | Promethazine Hydrochloride And Dextromethorphan Hydrobromide |
|---|
| Dosage Form | SOLUTION |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20140131 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA091687 |
|---|
| Manufacturer | Tris Pharma 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] |
|---|