16 HOW SUPPLIED/STORAGE AND HANDLING
How supplied information for XELJANZ/XELJANZ XR is shown in Table 22.
Bottle Size (number of tablets) | NDC Number | |
---|---|---|
XELJANZ 5 mg tofacitinib tablets White, round, immediate-release film-coated tablets, debossed with "Pfizer" on one side, and "JKI 5" on the other side | 60 | NDC 0069-1001-01 |
XELJANZ 10 mg tofacitinib tablets Blue, round, immediate-release film-coated tablets, debossed with "Pfizer" on one side, and "JKI 10" on the other side | 60 | NDC 0069-1002-01 |
XELJANZ XR 11 mg tofacitinib tablets Pink, oval, extended-release film-coated tablets with a drilled hole at one end of the tablet band and "JKI 11" printed on one side of the tablet | 30 | NDC 0069-0501-30 |
XELJANZ XR 22 mg tofacitinib tablets Beige, oval, extended-release film-coated tablets with a drilled hole at one end of the tablet band and "JKI 22" printed on one side of the tablet | 30 | NDC 0069-0502-30 |
How supplied information for XELJANZ Oral Solution is shown in Table 23.
Bottle Fill (volume mL) | NDC Number | |
---|---|---|
XELJANZ Oral Solution 1 mg/mL tofacitinib oral solution Clear, colorless solution | 240 mL | NDC 0069-1029-02 |
XELJANZ/XELJANZ XR
Store XELJANZ/XELJANZ XR at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature].
Do not repackage.
XELJANZ Oral Solution
XELJANZ 1 mg/ mL oral solution is a clear, colorless solution that contains 1 mg of tofacitinib. It is packaged in HDPE bottles as follows:
Each bottle is packaged with 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.
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 remaining oral solution after 60 days.