Tofacitinib

NDC 33342-541 · Macleods Pharmaceuticals Limited

Generic nameTofacitinib

Dosage formTABLET, FILM COATED

RouteORAL

Active ingredient(s)TOFACITINIB CITRATE

Strength5 mg/1

Pharmacologic classJanus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]

Marketing categoryANDA

Packages

33342-541-09 — 60 TABLET, FILM COATED in 1 BOTTLE (33342-541-09)

33342-541-43 — 9 BLISTER PACK in 1 CARTON (33342-541-43) / 10 TABLET, FILM COATED in 1 BLISTER PACK (33342-541-66)

33342-541-54 — 120 TABLET, FILM COATED in 1 BOTTLE (33342-541-54)

FDA lists these products with the same active ingredient.

0054-0821 — tofacitinib, 0069-0501 — tofacitinib, 0069-0502 — tofacitinib, 0069-1001 — tofacitinib, 0069-1002 — tofacitinib, 0069-1029 — tofacitinib, 0574-1811 — Tofacitinib Citrate, 27241-270 — Tofacitinib, 33342-542 — Tofacitinib, 42571-268 — tofacitinib, 42571-377 — tofacitinib, 42799-970 — Tofacitinib, 50228-567 — Tofacitinib citrate, 51991-329 — Tofacitinib Citrate, 51991-963 — Tofacitinib Citrate, 59651-459 — TOFACITINIB, 59651-460 — TOFACITINIB, 59651-685 — TOFACITINIB, 60505-4858 — tofacitinib, 63539-012 — tofacitinib, +27 more

From the FDA National Drug Code Directory, retrieved August 24, 2026. Product listings are submitted by labelers; FDA does not verify them.