| NDC Code | 65162-694-90 |
| Package Description | 473 mL in 1 BOTTLE (65162-694-90) |
| Product NDC | 65162-694 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Promethazine Hcl, Phenylephrine Hcl, Codeine Phosphate |
| Non-Proprietary Name | Promethazine, Phenylephrine, Codeine |
| Dosage Form | SYRUP |
| Usage | ORAL |
| Start Marketing Date | 20131101 |
| Marketing Category Name | ANDA |
| Application Number | ANDA200963 |
| Manufacturer | Amneal Pharmaceuticals LLC |
| Substance Name | CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE |
| Strength | 10; 5; 6.25 |
| Strength Unit | mg/5mL; mg/5mL; mg/5mL |
| Pharmacy Classes | Adrenergic alpha1-Agonists [MoA], Full Opioid Agonists [MoA], Opioid Agonist [EPC], Phenothiazine [EPC], Phenothiazines [CS], alpha-1 Adrenergic Agonist [EPC] |
| DEA Schedule | CV |