| NDC Code | 64597-301-60 |
|---|
| Package Description | 60 CAPSULE, GELATIN COATED in 1 BOTTLE (64597-301-60) |
|---|
| Product NDC | 64597-301 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Nuedexta |
|---|
| Non-Proprietary Name | Dextromethorphan Hydrobromide And Quinidine Sulfate |
|---|
| Dosage Form | CAPSULE, GELATIN COATED |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20101201 |
|---|
| Marketing Category Name | NDA |
|---|
| Application Number | NDA021879 |
|---|
| Manufacturer | Avanir Pharmaceuticals, Inc. |
|---|
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE |
|---|
| Strength | 20; 10 |
|---|
| Strength Unit | mg/1; mg/1 |
|---|
| Pharmacy Classes | Antiarrhythmic [EPC], Cytochrome P450 2D6 Inhibitor [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA] |
|---|