| NDC Code | 65162-694-86 |
|---|
| Package Description | 118 mL in 1 BOTTLE (65162-694-86) |
|---|
| 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 |
|---|