| Product NDC: | 16590-292 |
| Proprietary Name: | Promethazine DM |
| Non Proprietary Name: | Promethazine DM |
| Active Ingredient(s): | 15; 6.25 mg/5mL; mg/5mL & nbsp; Promethazine DM |
| Administration Route(s): | ORAL |
| Dosage Form(s): | SYRUP |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 16590-292 |
| Labeler Name: | Stat Rx USA |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA040649 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20060214 |
| Package NDC: | 16590-292-04 |
| Package Description: | 118 mL in 1 BOTTLE (16590-292-04) |
| NDC Code | 16590-292-04 |
| Proprietary Name | Promethazine DM |
| Package Description | 118 mL in 1 BOTTLE (16590-292-04) |
| Product NDC | 16590-292 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Promethazine DM |
| Dosage Form Name | SYRUP |
| Route Name | ORAL |
| Start Marketing Date | 20060214 |
| Marketing Category Name | ANDA |
| Labeler Name | Stat Rx USA |
| 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] |