| NDC Code | 69442-480-20 |
| Package Description | 25 mL in 1 BOTTLE (69442-480-20) |
| Product NDC | 69442-480 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Tuzistra Xr |
| Non-Proprietary Name | Codeine Polistirex And Chlorpheniramine Polistirex |
| Dosage Form | SUSPENSION, EXTENDED RELEASE |
| Usage | ORAL |
| Start Marketing Date | 20150531 |
| Marketing Category Name | NDA |
| Application Number | NDA207768 |
| Manufacturer | Vernalis Therapeutics, Inc. |
| Substance Name | CODEINE PHOSPHATE ANHYDROUS; CHLORPHENIRAMINE MALEATE |
| Strength | 14.7; 2.8 |
| Strength Unit | mg/5mL; mg/5mL |
| Pharmacy Classes | Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] |
| DEA Schedule | CIII |