(tofacitinib)
How Supplied Information for XELJANZ Tablets and XELJANZ XR
How supplied information for XELJANZ tablets and XELJANZ XR (extended-release tablets) is shown in Table 23.
| Dosage Form, Strength, and Description | Bottle Size (number of tablets) | NDC Number |
|---|---|---|
XELJANZ (tofacitinib) tablets, | 60 | NDC 0069-1001-01 |
XELJANZ (tofacitinib) tablets, 10 mg | 60 | NDC 0069-1002-01 |
XELJANZ XR (tofacitinib) extended-release tablets, 11 mg | 30 | NDC 0069-0501-30 |
XELJANZ XR (tofacitinib) extended-release tablets, 22 mg | 30 | NDC 0069-0502-30 |
How Supplied Information for XELJANZ Oral Solution
XELJANZ (tofacitinib) oral solution, 1 mg/mL is supplied in bottles (240 mL fill volume) (NDC 0069-1029-02) and is a clear, colorless solution that contains 1 mg of tofacitinib. Each high-density polyethylene (HDPE) bottle contains one press-in bottle adapter and one 5 mL oral dosing syringe with 3.2 mL, 4 mL, and 5 mL gradations. The press-in bottle adapter and oral dosing syringe are not made with natural rubber latex.
Storage and Handling for XELJANZ Tablets/XELJANZ XR
Store XELJANZ tablets and XELJANZ XR at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature].
Do not repackage.
Storage and Handling for XELJANZ Oral Solution
Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). [See USP Controlled Room Temperature].
Store in the original bottle and carton to protect from light.
Use contents of bottle within 60 days of opening.
Discard unused oral solution after 60 days.
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