Dextromethorphan Hydrobromide and Promethazine Hydrochloride is a Oral Syrup in the Human Prescription Drug category. It is labeled and distributed by Proficient Rx Lp. The primary component is Dextromethorphan Hydrobromide; Promethazine Hydrochloride.
| Product ID | 63187-355_237dfeed-9ff8-4ae1-81fd-1322cf252599 |
| NDC | 63187-355 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Dextromethorphan Hydrobromide and Promethazine Hydrochloride |
| Generic Name | Dextromethorphan Hydrobromide And Promethazine Hydrochloride |
| Dosage Form | Syrup |
| Route of Administration | ORAL |
| Marketing Start Date | 1985-01-04 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA088864 |
| Labeler Name | Proficient Rx LP |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE |
| Active Ingredient Strength | 15 mg/5mL; mg/5mL |
| Pharm Classes | Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA],Phenothiazine [EPC],Phenothiazines [CS] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2016-09-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA088864 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2016-09-01 |
| Marketing Category | ANDA |
| Application Number | ANDA088864 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2017-12-01 |
| Ingredient | Strength |
|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 15 mg/5mL |
| SPL SET ID: | c155b478-c04d-47e5-891b-408d09a5acf3 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 17856-0604 | Dextromethorphan Hydrobromide and Promethazine Hydrochloride | Dextromethorphan Hydrobromide and Promethazine Hydrochloride |
| 63187-355 | Dextromethorphan Hydrobromide and Promethazine Hydrochloride | Dextromethorphan Hydrobromide and Promethazine Hydrochloride |
| 0603-1586 | PROMETHAZINE DM | Dextromethorphan Hydrobromide and Promethazine Hydrochloride |
| 17856-1586 | PROMETHAZINE DM | Dextromethorphan Hydrobromide and Promethazine Hydrochloride |
| 33261-732 | PROMETHAZINE DM | Dextromethorphan Hydrobromide and Promethazine Hydrochloride |
| 50090-0225 | PROMETHAZINE DM | Dextromethorphan Hydrobromide and Promethazine Hydrochloride |
| 50090-4125 | PROMETHAZINE DM | Dextromethorphan Hydrobromide and Promethazine Hydrochloride |
| 50436-1867 | PROMETHAZINE DM | Dextromethorphan Hydrobromide and Promethazine Hydrochloride |
| 53002-4260 | PROMETHAZINE DM | Dextromethorphan Hydrobromide and Promethazine Hydrochloride |
| 63187-272 | PROMETHAZINE DM | Dextromethorphan Hydrobromide and Promethazine Hydrochloride |
| 68071-1643 | PROMETHAZINE DM | Dextromethorphan Hydrobromide and Promethazine Hydrochloride |
| 68788-9097 | PROMETHAZINE DM | Dextromethorphan Hydrobromide and Promethazine Hydrochloride |
| 70518-0418 | PROMETHAZINE DM | Dextromethorphan Hydrobromide and Promethazine Hydrochloride |