| NDC Code | 50991-540-16 |
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| Package Description | 473 mL in 1 BOTTLE (50991-540-16) |
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| Product NDC | 50991-540 |
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| Product Type Name | HUMAN OTC DRUG |
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| Proprietary Name | Duratuss Ac |
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| Non-Proprietary Name | Codeine Phosphate, Dexbrompheniramine Maleate |
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| Dosage Form | LIQUID |
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| Usage | ORAL |
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| Start Marketing Date | 20250908 |
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| Marketing Category Name | OTC MONOGRAPH DRUG |
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| Application Number | M012 |
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| Manufacturer | Poly Pharmaceuticals, Inc. |
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| Substance Name | CODEINE PHOSPHATE; DEXBROMPHENIRAMINE MALEATE |
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| Strength | 10; 1 |
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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 | CV |
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