Otulfi

NDC 65219-824 · Fresenius Kabi USA, LLC

Generic nameustekinumab-aauz

Dosage formINJECTION, SOLUTION

RouteSUBCUTANEOUS

Active ingredient(s)USTEKINUMAB

Strength45 mg/.5mL

Pharmacologic classInterleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]

Marketing categoryBLA

Packages

65219-824-01 — 1 SYRINGE in 1 CARTON (65219-824-01) / .5 mL in 1 SYRINGE

Billed under HCPCS

Q9999 — Injection, ustekinumab-aauz (otulfi), biosimilar, 1 mg Medicare Part B payment limit (ASP + 6%): $13.15

Related Codes

Same active ingredient

FDA lists these products with the same active ingredient.

57894-054 — ustekinumab, 57894-060 — ustekinumab, 57894-061 — ustekinumab, 57894-440 — ustekinumab, 57894-441 — ustekinumab, 57894-444 — ustekinumab, 61314-651 — ustekinumab-ttwe, 61314-652 — ustekinumab-ttwe, 61314-654 — ustekinumab-ttwe, 65219-822 — ustekinumab-aauz, 65219-826 — ustekinumab-aauz, 65219-828 — ustekinumab-aauz, 65219-862 — ustekinumab-aauz, 65219-866 — ustekinumab-aauz, 72606-027 — ustekinumab-stba, 72606-028 — ustekinumab-stba, 72606-029 — ustekinumab-stba, 72606-060 — ustekinumab-stba, 82009-160 — ustekinumab-ttwe, 82009-161 — ustekinumab-ttwe, +20 more

From the FDA National Drug Code Directory, retrieved 2026-08-24. Product listings are submitted by labelers; FDA does not verify them.