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] |