| NDC Code | 57664-281-18 |
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| Package Description | 1000 TABLET, FILM COATED in 1 BOTTLE (57664-281-18) |
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| Product NDC | 57664-281 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Hydrocodone Bitartrate And Ibuprofen |
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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 | 20130528 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA091633 |
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| Manufacturer | Sun Pharmaceutical Industries, Inc. |
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| Substance Name | HYDROCODONE BITARTRATE; IBUPROFEN |
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| Strength | 2.5; 200 |
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| Strength Unit | mg/1; mg/1 |
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| Pharmacy Classes | Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Opioid Agonist [EPC],Opioid Agonists [MoA] |
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| DEA Schedule | CII |
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