| NDC Code | 65162-695-90 |
| Package Description | 473 mL in 1 BOTTLE (65162-695-90) |
| Product NDC | 65162-695 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Promethazine Hydrochloride And Codeine Phosphate |
| Non-Proprietary Name | Promethazine And Codeine |
| Dosage Form | SOLUTION |
| Usage | ORAL |
| Start Marketing Date | 20130315 |
| Marketing Category Name | ANDA |
| Application Number | ANDA200894 |
| Manufacturer | Amneal Pharmaceuticals LLC |
| Substance Name | PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE |
| Strength | 6.25; 10 |
| Strength Unit | mg/5mL; mg/5mL |
| Pharmacy Classes | Phenothiazine [EPC],Phenothiazines [CS],Full Opioid Agonists [MoA],Opioid Agonist [EPC] |
| DEA Schedule | CV |