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Active ingredient

Ustekinumab

51 finished FDA listings contain Ustekinumab as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
USTEKINUMAB, USTEKINUMAB-AEKN, USTEKINUMAB-SRLF
Dosage forms
Injection, Injection, Solution, Solution
Routes
Intravenous, Subcutaneous
Manufacturers / labelers
12
Strengths listed
130 mg/26ml · 45 mg/.5ml · 90 mg/ml
Brand names in FDA listings
Imuldosa, Otulfi, Pyzchiva, Selarsdi, Starjemza, Stelara, Steqeyma, Wezlana, Yesintek

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 847083

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
BLA 125261CENTOCOR ORTHO BIOTECH INC2009-09-254
BLA 761044JANSSEN BIOTECH2016-09-232
BLA 761331AMGEN INC2023-10-311
BLA 761285AMGEN INC2023-10-316
BLA 761343ALVOTECH USA INC2024-04-168
BLA 761373SAMSUNG BIOEPIS CO LTD2024-06-287
BLA 761425SAMSUNG BIOEPIS CO LTD2024-06-282
BLA 761379FRESENIUS KABI USA2024-09-276
BLA 761364ACCORD BIOPHARMA INC.2024-10-103
BLA 761406BIOCON BIOLOGICS INC2024-11-294
BLA 761338CELLTRION, INC.2024-12-174
BLA 761419BIO-THERA SOLUTIONS LTD2025-05-224

Official labeling on DailyMed

Showing the 12 most recent of 15 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.