| NDC Code | 0054-4650-25 |
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| Package Description | 100 TABLET in 1 BOTTLE, PLASTIC (0054-4650-25) |
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| Product NDC | 0054-4650 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Roxicet |
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| Non-Proprietary Name | Oxycodone And Acetaminophen |
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| Dosage Form | TABLET |
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| Usage | ORAL |
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| Start Marketing Date | 19910201 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA087003 |
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| Manufacturer | Roxane Laboratories, Inc. |
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| Substance Name | OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN |
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| Strength | 5; 325 |
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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 | CII |
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