Home NDC 57894-054 Stelara
Product NDC 57894-054
11-digit product format 578940054
Labeler code 57894
Product ID 57894-054_ff62ab2e-9413-4e22-95ad-74b582c14dc6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ustekinumab
Dosage form SOLUTION
Route INTRAVENOUS
Labeler Janssen Biotech, Inc.
Application BLA761044
Marketing category BLA
Marketing start 2016-09-23
Substance USTEKINUMAB
Active strength 130 mg/26mL
Pharmacologic classes Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Stelara
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength USTEKINUMAB 130 mg/26mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination FU77B4U5Z0 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 853350 Internal RxNorm lookup 853354 Internal RxNorm lookup 853355 Internal RxNorm lookup 853356 Internal RxNorm lookup 1654077 Internal RxNorm lookup 1654079 Internal RxNorm lookup 1811255 Internal RxNorm lookup 1811257 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 57894-054-16 Stelara 26 mL in 1 VIAL, SINGLE-USE SOLUTION 26 47 57894-054-16 Stelara 1 in 1 BOX SOLUTION 1 47 57894-054-27 Stelara 26 mL in 1 VIAL, SINGLE-USE SOLUTION 26 47 57894-054-27 Stelara 1 in 1 BOX SOLUTION 1 47
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ustekinumab ACTIVE INGREDIENT FU77B4U5Z0 STELARA (USTEKINUMAB) INJECTION, SOLUTION [JANSSEN BIOTECH, INC.] 16 ustekinumab ACTIVE MOIETY FU77B4U5Z0 STELARA (USTEKINUMAB) INJECTION, SOLUTION [JANSSEN BIOTECH, INC.] 16 HISTIDINE INACTIVE INGREDIENT 4QD397987E STELARA (USTEKINUMAB) INJECTION, SOLUTION [JANSSEN BIOTECH, INC.] 16 HISTIDINE MONOHYDROCHLORIDE MONOHYDRATE INACTIVE INGREDIENT X573657P6P STELARA (USTEKINUMAB) INJECTION, SOLUTION [JANSSEN BIOTECH, INC.] 16 polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H STELARA (USTEKINUMAB) INJECTION, SOLUTION [JANSSEN BIOTECH, INC.] 16 sucrose INACTIVE INGREDIENT C151H8M554 STELARA (USTEKINUMAB) INJECTION, SOLUTION [JANSSEN BIOTECH, INC.] 16 water INACTIVE INGREDIENT 059QF0KO0R STELARA (USTEKINUMAB) INJECTION, SOLUTION [JANSSEN BIOTECH, INC.] 16
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57894-054 STELARA (USTEKINUMAB) INJECTION, SOLUTION STELARA (USTEKINUMAB) SOLUTION [JANSSEN BIOTECH, INC.] 43 Current NDC, Legacy NDC, 4 package rows 20250410_c77a9664-e3bb-4023-b400-127aa53bca2b.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761044 Stelara ustekinumab 351(a) Rx 2026-07-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 57894-054-16 57894005416 1 VIAL, SINGLE-USE in 1 BOX (57894-054-16) / 26 mL in 1 VIAL, SINGLE-USE 2017-05-01 0000-00-00 Yes No Current 57894-054-27 57894005427 1 VIAL, SINGLE-USE in 1 BOX (57894-054-27) / 26 mL in 1 VIAL, SINGLE-USE 2016-09-23 0000-00-00 No No Current