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] |