| NDC Code | 58716-433-04 |
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| Package Description | 118 mL in 1 BOTTLE (58716-433-04) |
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| Product NDC | 58716-433 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Obredon |
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| Non-Proprietary Name | Hydrocodone Bitartrate And Guaifenesin |
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| Dosage Form | SOLUTION |
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| Usage | ORAL |
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| Start Marketing Date | 20141230 |
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| Marketing Category Name | NDA |
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| Application Number | NDA205474 |
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| Manufacturer | Sovereign Pharmaceuticals, LLC |
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| Substance Name | GUAIFENESIN; HYDROCODONE BITARTRATE |
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| Strength | 200; 2.5 |
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| Strength Unit | mg/5mL; mg/5mL |
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| Pharmacy Classes | Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Opioid Agonist [EPC], Opioid Agonists [MoA] |
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| DEA Schedule | CII |
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