| NDC Code | 69442-480-01 |
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| Package Description | 473 mL in 1 BOTTLE (69442-480-01) |
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| Product NDC | 69442-480 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Tuzistra Xr |
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| Non-Proprietary Name | Codeine Polistirex And Chlorpheniramine Polistirex |
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| Dosage Form | SUSPENSION, EXTENDED RELEASE |
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| Usage | ORAL |
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| Start Marketing Date | 20150531 |
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| End Marketing Date | 20190531 |
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| Marketing Category Name | NDA |
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| Application Number | NDA207768 |
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| Manufacturer | Vernalis Therapeutics, Inc. |
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| Substance Name | CODEINE PHOSPHATE ANHYDROUS; CHLORPHENIRAMINE MALEATE |
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| Strength | 14.7; 2.8 |
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| Strength Unit | mg/5mL; mg/5mL |
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| Pharmacy Classes | Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] |
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| DEA Schedule | CIII |
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