NDC 0713-0823
Promethazine Hydrochloride and Codeine Phosphate 10 mg per 5 mL / 6.25 mg per 5 mL solution
On the label: Cosette Pharmaceuticals, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Tris Pharma Inc | Monmouth Junction, NJ, United States | Makes it, tests it and packages it | Problems found, fixed voluntarilyNov 21, 2025 · 14 inspections, 2 with FDA action |
Product details
- Generic drug
- Codeine and Promethazine: every company that makes it
- Form
- solution, oral
- Strength
- 10 mg per 5 mL / 6.25 mg per 5 mL
- Approval
- ANDA ANDA200386
- On the market since
- Dec 19, 2025
- Package NDCs
0713-0823-75- Official label
- DailyMed (National Library of Medicine), updated Dec 18, 2025
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