FDA.reportPublic FDA data

ustekinumab

Product NDC
57894-444
11-digit product format
578940444
Labeler code
57894
Product ID
57894-444_d7f96963-2754-4e7b-aebc-66e778c275eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ustekinumab
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
Janssen Biotech, Inc.
Application
BLA761044
Marketing category
BLA
Marketing start
2025-04-01
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
ustekinumab
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
USTEKINUMAB130 mg/26mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
FU77B4U5Z0Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
853350Internal RxNorm lookup
853355Internal RxNorm lookup
1654077Internal RxNorm lookup
1811255Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
23b486eb-f48d-47d4-815e-1313d4ebfbfaAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9101c6a6-2dd0-4586-9db6-ccb20dc679c9Product name220171206
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57894-444-01ustekinumab1 in 1 BOXSOLUTION16
57894-444-01ustekinumab26 mL in 1 VIAL, SINGLE-USESOLUTION266

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57894-444-01ML - Milliliter57894-44474798fcd-0f7c-4f10-ab41-195ff5ff59bc12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57894-444USTEKINUMAB INJECTION, SOLUTION USTEKINUMAB SOLUTION [JANSSEN BIOTECH, INC.]4Current NDC, 2 package rows20250410_23b486eb-f48d-47d4-815e-1313d4ebfbfa.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ustekinumabUSTEKINUMABJanssen Biotech, Inc.23b486eb-f48d-47d4-815e-1313d4ebfbfa2026-07-23Warnings, Adverse reactionsExact identifier
application number: BLA761044
ndc (product): 57894-444
StelaraUSTEKINUMABJanssen Biotech, Inc.c77a9664-e3bb-4023-b400-127aa53bca2b2026-07-21Warnings, Adverse reactionsExact identifier
application number: BLA761044

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761044Stelaraustekinumab351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1811255ustekinumab 130 MG in 26 ML InjectionPSN23b486eb-f48d-47d4-815e-1313d4ebfbfa6
1654077ustekinumab 45 MG in 0.5 mL InjectionPSN23b486eb-f48d-47d4-815e-1313d4ebfbfa6
853350ustekinumab 45 MG in 0.5 mL Prefilled SyringePSN23b486eb-f48d-47d4-815e-1313d4ebfbfa6
853355ustekinumab 90 MG in 1 ML Prefilled SyringePSN23b486eb-f48d-47d4-815e-1313d4ebfbfa6
16540770.5 ML ustekinumab 90 MG/ML InjectionSCD23b486eb-f48d-47d4-815e-1313d4ebfbfa6
8533500.5 ML ustekinumab 90 MG/ML Prefilled SyringeSCD23b486eb-f48d-47d4-815e-1313d4ebfbfa6
8533551 ML ustekinumab 90 MG/ML Prefilled SyringeSCD23b486eb-f48d-47d4-815e-1313d4ebfbfa6
181125526 ML ustekinumab 5 MG/ML InjectionSCD23b486eb-f48d-47d4-815e-1313d4ebfbfa6
1811255ustekinumab 130 MG per 26 ML InjectionSY23b486eb-f48d-47d4-815e-1313d4ebfbfa6
1654077ustekinumab 45 MG per 0.5 ML InjectionSY23b486eb-f48d-47d4-815e-1313d4ebfbfa6
853350ustekinumab 45 MG per 0.5 ML Prefilled SyringeSY23b486eb-f48d-47d4-815e-1313d4ebfbfa6
853355ustekinumab 90 MG per 1 ML Prefilled SyringeSY23b486eb-f48d-47d4-815e-1313d4ebfbfa6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
57894-444-01578940444011 VIAL, SINGLE-USE in 1 BOX (57894-444-01) / 26 mL in 1 VIAL, SINGLE-USE2025-04-01NoNoCurrent