Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Tulex Pharmaceuticals Inc | Cranbury, NJ, United States | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyMar 24, 2025 · 4 inspections |
| Gateway Analytical, LLC> | Gibsonia, PA, United States | Tests it | Problems found, fixed voluntarilyMar 20, 2026 · 4 inspections |
| New Jersey Laboratories | New Brunswick, NJ, United States | Tests it | Problems found, fixed voluntarilySep 22, 2022 · 5 inspections |
| Perritt Laboratories, Inc | Hightstown, NJ, United States | Tests it | No problems foundMay 3, 2022 · 5 inspections |
| SGS North America Inc. | Lincolnshire, IL, United States | Tests it | Problems found, fixed voluntarilyMar 20, 2026 · 9 inspections |
Product details
- Generic drug
- Hydrocortisone: every company that makes it
- Form
- solution, oral
- Strength
- 1 mg per 1 mL
- Approval
- NDA NDA218980
- On the market since
- Jun 2, 2025
- Package NDCs
71863-116-16- Official label
- DailyMed (National Library of Medicine), updated Apr 1, 2026
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