| NDC Code | 50458-650-60 |
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| Package Description | 100 TABLET, COATED in 1 BOTTLE (50458-650-60) |
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| Product NDC | 50458-650 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Ultracet |
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| Non-Proprietary Name | Tramadol Hydrochloride And Acetaminophen |
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| Dosage Form | TABLET, COATED |
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| Usage | ORAL |
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| Start Marketing Date | 20010815 |
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| Marketing Category Name | NDA |
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| Application Number | NDA021123 |
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| Manufacturer | Janssen Pharmaceuticals, Inc. |
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| Substance Name | ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE |
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| Strength | 325; 37.5 |
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| Strength Unit | mg/1; mg/1 |
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| Pharmacy Classes | Full Opioid Agonists [MoA], Opioid Agonist [EPC] |
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| DEA Schedule | CIV |
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