| NDC Code | 16590-609-60 |
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| Package Description | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16590-609-60) |
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| Product NDC | 16590-609 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Opana |
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| Proprietary Name Suffix | Er |
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| Non-Proprietary Name | Oxymorphone 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 | 20060622 |
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| Marketing Category Name | NDA |
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| Application Number | NDA021610 |
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| Manufacturer | STAT RX USA LLC |
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| Substance Name | OXYMORPHONE HYDROCHLORIDE |
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| Strength | 40 |
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| Strength Unit | mg/1 |
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| Pharmacy Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |
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| DEA Schedule | CII |
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