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Promethazine Hydrochloride and Dextromethorphan Hydrobromide
Promethazine Hydrochloride and Dextromethorphan Hydrobromide - 50383-803-16 - (Promethazine Hydrochloride and Dextromethorphan Hydrobromide)
Drug Information of Promethazine Hydrochloride and Dextromethorphan Hydrobromide
| Product NDC: | 50383-803 |
| Proprietary Name: | Promethazine Hydrochloride and Dextromethorphan Hydrobromide |
| Non Proprietary Name: | Promethazine Hydrochloride and Dextromethorphan Hydrobromide |
| Active Ingredient(s): | 15; 6.25 mg/5mL; mg/5mL & nbsp; Promethazine Hydrochloride and Dextromethorphan Hydrobromide |
| Administration Route(s): | ORAL |
| Dosage Form(s): | SOLUTION |
| Coding System: | National Drug Codes(NDC) |
Labeler Information of Promethazine Hydrochloride and Dextromethorphan Hydrobromide
| Product NDC: | 50383-803 |
| Labeler Name: | Hi-Tech Pharmacal Co., Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA040027 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 19960731 |
Package Information of Promethazine Hydrochloride and Dextromethorphan Hydrobromide
| Package NDC: | 50383-803-16 |
| Package Description: | 473 mL in 1 BOTTLE (50383-803-16) |
NDC Information of Promethazine Hydrochloride and Dextromethorphan Hydrobromide
| NDC Code | 50383-803-16 |
| Proprietary Name | Promethazine Hydrochloride and Dextromethorphan Hydrobromide |
| Package Description | 473 mL in 1 BOTTLE (50383-803-16) |
| Product NDC | 50383-803 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Promethazine Hydrochloride and Dextromethorphan Hydrobromide |
| Dosage Form Name | SOLUTION |
| Route Name | ORAL |
| Start Marketing Date | 19960731 |
| Marketing Category Name | ANDA |
| Labeler Name | Hi-Tech Pharmacal Co., Inc. |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE |
| Strength Number | 15; 6.25 |
| Strength Unit | mg/5mL; mg/5mL |
| Pharmaceutical Classes | Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA] |
