| NDC Code | 0054-0937-21 |
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| Package Description | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0054-0937-21) |
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| Product NDC | 0054-0937 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Tapentadol |
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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 | 20251215 |
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| Marketing Category Name | NDA AUTHORIZED GENERIC |
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| Application Number | NDA200533 |
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| Manufacturer | Hikma Pharmaceuticals USA Inc. |
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| Substance Name | TAPENTADOL HYDROCHLORIDE |
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| Strength | 100 |
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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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