| Product NDC: | 52125-647 |
| Proprietary Name: | PROMETHAZINE DM |
| Non Proprietary Name: | Dextromethorphan Hydrobromide and Promethazine Hydrochloride |
| Active Ingredient(s): | 15; 6.25 mg/5mL; mg/5mL & nbsp; Dextromethorphan Hydrobromide and Promethazine Hydrochloride |
| Administration Route(s): | ORAL |
| Dosage Form(s): | SYRUP |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 52125-647 |
| Labeler Name: | REMEDYREPACK INC. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA040649 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20130617 |
| Package NDC: | 52125-647-01 |
| Package Description: | 118 mL in 1 BOTTLE (52125-647-01) |
| NDC Code | 52125-647-01 |
| Proprietary Name | PROMETHAZINE DM |
| Package Description | 118 mL in 1 BOTTLE (52125-647-01) |
| Product NDC | 52125-647 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Dextromethorphan Hydrobromide and Promethazine Hydrochloride |
| Dosage Form Name | SYRUP |
| Route Name | ORAL |
| Start Marketing Date | 20130617 |
| Marketing Category Name | ANDA |
| Labeler Name | REMEDYREPACK INC. |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE |
| Strength Number | 15; 6.25 |
| Strength Unit | mg/5mL; mg/5mL |
| Pharmaceutical 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 [Chemical/Ingredient] |