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XELJANZ / XELJANZ XR (tofacitinib) How Supplied/Storage and Handling

16 HOW SUPPLIED/STORAGE AND HANDLING

How supplied information for XELJANZ/XELJANZ XR is shown in Table 19.

Table 19: How Supplied Information for XELJANZ/XELJANZ XR
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
28NDC 0069-1001-03
60NDC 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
28NDC 0069-1002-03
60NDC 0069-1002-01
180NDC 0069-1002-02
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
14NDC 0069-0501-14
30NDC 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
30NDC 0069-0502-30

How supplied information for XELJANZ Oral Solution is shown in Table 20.

Table 20: How Supplied Information for XELJANZ Oral Solution
Bottle Fill
(volume mL)
NDC Number
XELJANZ Oral Solution
1 mg/mL tofacitinib oral solution
Clear, colorless solution
240 mLNDC 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.

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