| NDC Code | 50458-864-01 |
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| Package Description | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50458-864-01) |
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| Product NDC | 50458-864 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Nucynta |
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| Proprietary Name Suffix | Er |
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| Non-Proprietary Name | Tapentadol Hydrochloride |
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| Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
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| Usage | ORAL |
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| Start Marketing Date | 20110825 |
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| End Marketing Date | 20200331 |
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| Marketing Category Name | NDA |
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| Application Number | NDA200533 |
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| Manufacturer | Janssen Pharmaceuticals, Inc. |
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| Substance Name | TAPENTADOL HYDROCHLORIDE |
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| Strength | 250 |
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| Strength Unit | mg/1 |
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| Pharmacy Classes | Opioid Agonist [EPC],Opioid Agonists [MoA] |
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| DEA Schedule | CII |
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