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NUEDEXTA
NUEDEXTA - 64597-301-60 - (dextromethorphan hydrobromide and quinidine sulfate)
Drug Information of NUEDEXTA
| Product NDC: | 64597-301 |
| Proprietary Name: | NUEDEXTA |
| Non Proprietary Name: | dextromethorphan hydrobromide and quinidine sulfate |
| Active Ingredient(s): | 20; 10 mg/1; mg/1 & nbsp; dextromethorphan hydrobromide and quinidine sulfate |
| Administration Route(s): | ORAL |
| Dosage Form(s): | CAPSULE, GELATIN COATED |
| Coding System: | National Drug Codes(NDC) |
Labeler Information of NUEDEXTA
| Product NDC: | 64597-301 |
| Labeler Name: | Avanir Pharmaceuticals, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA021879 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20101201 |
Package Information of NUEDEXTA
| Package NDC: | 64597-301-60 |
| Package Description: | 60 CAPSULE, GELATIN COATED in 1 BOTTLE (64597-301-60) |
NDC Information of NUEDEXTA
| NDC Code | 64597-301-60 |
| Proprietary Name | NUEDEXTA |
| Package Description | 60 CAPSULE, GELATIN COATED in 1 BOTTLE (64597-301-60) |
| Product NDC | 64597-301 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | dextromethorphan hydrobromide and quinidine sulfate |
| Dosage Form Name | CAPSULE, GELATIN COATED |
| Route Name | ORAL |
| Start Marketing Date | 20101201 |
| Marketing Category Name | NDA |
| Labeler Name | Avanir Pharmaceuticals, Inc. |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE |
| Strength Number | 20; 10 |
| Strength Unit | mg/1; mg/1 |
| Pharmaceutical Classes | Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA],Antiarrhythmic [EPC],Cytochrome P450 2D6 Inhibitor [EPC],Cytochrome P450 2D6 Inhibitors [MoA] |
