| NDC Code | 59148-053-98 |
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| Package Description | 4 CARTON in 1 BOX (59148-053-98) / 1 BOTTLE in 1 CARTON (59148-053-07) / 13 CAPSULE, GELATIN COATED in 1 BOTTLE |
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| Product NDC | 59148-053 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Nuedexta |
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| Non-Proprietary Name | Dextromethorphan Hydrobromide And Quinidine Sulfate |
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| Dosage Form | CAPSULE, GELATIN COATED |
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| Usage | ORAL |
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| Start Marketing Date | 20230103 |
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| Marketing Category Name | NDA |
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| Application Number | NDA021879 |
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| Manufacturer | Otsuka America Pharmaceutical, Inc |
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| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE |
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| Strength | 20; 10 |
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| Strength Unit | mg/1; mg/1 |
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| 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] |
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