Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Rpk Pharmaceuticals, Inc.. The primary component is Dextromethorphan Hydrobromide; Promethazine Hydrochloride.
| Product ID | 53002-4262_4b99239e-0abb-4e42-b144-abd0a36192b0 |
| NDC | 53002-4262 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral |
| Generic Name | Promethazine Hydrochloride And Dextromethorphan Hydrobromide Oral |
| Dosage Form | Solution |
| Route of Administration | ORAL |
| Marketing Start Date | 2020-10-05 |
| Marketing Category | ANDA / |
| Application Number | ANDA040649 |
| Labeler Name | RPK Pharmaceuticals, Inc. |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE |
| Active Ingredient Strength | 15 mg/5mL; mg/5mL |
| Pharm Classes | Phenothiazine [EPC], Phenothiazines [CS], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |