| NDC Code | 60846-901-01 |
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| Package Description | 100 TABLET, FILM COATED in 1 BOTTLE (60846-901-01) |
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| Product NDC | 60846-901 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Reprexain |
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| Non-Proprietary Name | Hydrocodone Bitartrate And Ibuprofen |
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| Dosage Form | TABLET, FILM COATED |
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| Usage | ORAL |
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| Start Marketing Date | 20131227 |
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| End Marketing Date | 20181031 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA076642 |
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| Manufacturer | Gemini Laboratories, LLC |
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| Substance Name | HYDROCODONE BITARTRATE; IBUPROFEN |
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| Strength | 5; 200 |
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| Strength Unit | mg/1; mg/1 |
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| Pharmacy Classes | Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] |
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| DEA Schedule | CII |
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