| NDC Code | 0054-8648-16 |
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| Package Description | 10 CUP, UNIT-DOSE in 1 CARTON (0054-8648-16) > 5 mL in 1 CUP, UNIT-DOSE |
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| Product NDC | 0054-8648 |
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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 | SOLUTION |
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| Usage | ORAL |
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| Start Marketing Date | 19910117 |
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| End Marketing Date | 20160702 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA089351 |
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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/5mL; mg/5mL |
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| Pharmacy Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |
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| DEA Schedule | CII |
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