promethazine hydrochloride, phenylephrine hydrochloride and codeine phosphate is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Akorn. The primary component is Codeine Phosphate; Phenylephrine Hydrochloride; Promethazine Hydrochloride.
| Product ID | 50383-805_185dc6d3-db04-4fcd-94d2-d530a53f0197 |
| NDC | 50383-805 |
| Product Type | Human Prescription Drug |
| Proprietary Name | promethazine hydrochloride, phenylephrine hydrochloride and codeine phosphate |
| Generic Name | Promethazine Hydrochloride, Phenylephrine Hydrochloride And Codeine Phosphate |
| Dosage Form | Solution |
| Route of Administration | ORAL |
| Marketing Start Date | 2015-06-16 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA040674 |
| Labeler Name | Akorn |
| Substance Name | CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE |
| Active Ingredient Strength | 10 mg/5mL; mg/5mL; mg/5mL |
| Pharm Classes | Adrenergic alpha1-Agonists [MoA], Full Opioid Agonists [MoA], Opioid Agonist [EPC], Phenothiazine [EPC], Phenothiazines [CS], alpha-1 Adrenergic Agonist [EPC] |
| DEA Schedule | CV |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |