| NDC Code | 50383-805-04 |
|---|
| Package Description | 118 mL in 1 BOTTLE (50383-805-04) |
|---|
| Product NDC | 50383-805 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Promethazine Hydrochloride, Phenylephrine Hydrochloride And Codeine Phosphate |
|---|
| Non-Proprietary Name | Promethazine Hydrochloride, Phenylephrine Hydrochloride And Codeine Phosphate |
|---|
| Dosage Form | SOLUTION |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20150616 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA040674 |
|---|
| Manufacturer | Akorn |
|---|
| 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 |
|---|