| NDC Code | 0054-0479-21 |
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| Package Description | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0054-0479-21) |
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| Product NDC | 0054-0479 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Dalfampridine |
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| Non-Proprietary Name | Dalfampridine |
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| Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
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| Usage | ORAL |
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| Start Marketing Date | 20200713 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA206646 |
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| Manufacturer | Hikma Pharmaceuticals USA Inc. |
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| Substance Name | DALFAMPRIDINE |
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| Strength | 10 |
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| Strength Unit | mg/1 |
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| Pharmacy Classes | Potassium Channel Antagonists [MoA], Potassium Channel Blocker [EPC] |
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