XELJANZ

Tablet: 5 mg tofacitinib (as tofacitinib citrate) (White round film coated tablet with Pfizer on one side and JKI 5 on the other side)
HDPE bottles with desiccant and child-resistant caps containing 60 film-coated tablets.
Foil / foil blisters containing 56 film-coated tablets.

The tablet core contains Croscarmellose Sodium, Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose.  The film coat contains HPMC 2910/Hypromellose 6 cP, Lactose Monohydrate, Macrogol/PEG 3350, Titanium dioxide, Triacetin (Glycerol Triacetate)

Tablet: 10 mg (Blue round film coated tablet with Pfizer on one side and JKI 10 on the other side)
HDPE bottles with desiccant and child-resistant caps containing 60 film-coated tablets.
Foil / foil blisters containing 56 film-coated tablets.

The tablet core contains: Microcrystalline Cellulose, Lactose Monohydrate, croscarmellose Sodium, Magnesium Stearate. The film coat contains: HPMC 2910/Hypromellose 6cP, lactose monohydrate, macrogol/PEG3350, titanium dioxide, triacetin (glycerol triacetate), FD&C blue #2/indigo carmine aluminum lake, FD&C blue #1/brilliant blue FCF aluminum lake.

XELJANZ XR
Tablets: 11 mg tofacitinib (as tofacitinib citrate) (Pink oval extended-release-coated tablets)
HDPE bottles with desiccant and child-resistant caps containing 14 or 30 extended release film-coated tablets.

The tablet core contains: sorbitol, hydroxyethyl cellulose, copovidone, magnesium stearate. The Film Coat contains cellulose acetate, hydroxypropyl cellulose, HPMC 2910/hypromellose, titanium dioxide, triacetin, red iron oxide. The Printing ink contains shellac glaze, ammonium hydroxide, propylene glycol, ferrosoferric oxide/black iron oxide.

Control #: 230976
October 24, 2019