STELARA

Product NDC: 57894-061
11-digit product format: 578940061
Labeler code: 57894
Product ID: 57894-061_ff62ab2e-9413-4e22-95ad-74b582c14dc6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ustekinumab
Dosage form: INJECTION, SOLUTION
Route: SUBCUTANEOUS
Labeler: Janssen Biotech, Inc.
Application: BLA125261
Marketing category: BLA
Marketing start: 2009-09-25
Substance: USTEKINUMAB
Active strength: 90 mg/mL
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	57894-061	57894-061-02	D	Discontinued by firm		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Additional Listing Data#

Finished product: Yes
Brand name base: STELARA
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
USTEKINUMAB	90 mg/mL

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
c77a9664-e3bb-4023-b400-127aa53bca2b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9101c6a6-2dd0-4586-9db6-ccb20dc679c9	Product name	2	20171206
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
57894-061-02	STELARA	1 mL in 1 VIAL, SINGLE-USE	INJECTION, SOLUTION	1	47
57894-061-02	STELARA	1 in 1 CARTON	INJECTION, SOLUTION	1	47
57894-061-03	STELARA	1 mL in 1 SYRINGE	INJECTION, SOLUTION	1	47
57894-061-03	STELARA	1 in 1 CARTON	INJECTION, SOLUTION	1	47
57894-061-04	STELARA	1 in 1 CARTON	INJECTION, SOLUTION	1	47
57894-061-04	STELARA	1 mL in 1 SYRINGE	INJECTION, SOLUTION	1	47

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57894-061-03	ML - Milliliter	57894-061	f4f9cf85-7447-41a3-8352-7aec3603238f	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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
57894-061	STELARA (USTEKINUMAB) INJECTION, SOLUTION STELARA (USTEKINUMAB) SOLUTION [JANSSEN BIOTECH, INC.]	43	Current NDC, Legacy NDC, 6 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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ustekinumab	USTEKINUMAB	Janssen Biotech, Inc.	23b486eb-f48d-47d4-815e-1313d4ebfbfa	2026-07-23	Warnings, Adverse reactions	Exact identifier application number: BLA125261
Stelara	USTEKINUMAB	Janssen Biotech, Inc.	c77a9664-e3bb-4023-b400-127aa53bca2b	2026-07-21	Warnings, Adverse reactions	Exact identifier application number: BLA125261 ndc (product): 57894-061

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
125261	Stelara	ustekinumab	351(a)	Rx	2026-07-01

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
FU77B4U5Z0	USTEKINUMAB	815610-63-0	USTEKINUMAB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1811257	Stelara 130 MG in 26 ML Injection	PSN	c77a9664-e3bb-4023-b400-127aa53bca2b	47
1654079	Stelara 45 MG in 0.5 mL Injection	PSN	c77a9664-e3bb-4023-b400-127aa53bca2b	47
853354	Stelara 45 MG in 0.5 mL Prefilled Syringe	PSN	c77a9664-e3bb-4023-b400-127aa53bca2b	47
853356	Stelara 90 MG in 1 ML Prefilled Syringe	PSN	c77a9664-e3bb-4023-b400-127aa53bca2b	47
1811255	ustekinumab 130 MG in 26 ML Injection	PSN	c77a9664-e3bb-4023-b400-127aa53bca2b	47
1654077	ustekinumab 45 MG in 0.5 mL Injection	PSN	c77a9664-e3bb-4023-b400-127aa53bca2b	47
853350	ustekinumab 45 MG in 0.5 mL Prefilled Syringe	PSN	c77a9664-e3bb-4023-b400-127aa53bca2b	47
853355	ustekinumab 90 MG in 1 ML Prefilled Syringe	PSN	c77a9664-e3bb-4023-b400-127aa53bca2b	47
1654079	0.5 ML ustekinumab 90 MG/ML Injection [Stelara]	SBD	c77a9664-e3bb-4023-b400-127aa53bca2b	47
853354	0.5 ML ustekinumab 90 MG/ML Prefilled Syringe [Stelara]	SBD	c77a9664-e3bb-4023-b400-127aa53bca2b	47
853356	1 ML ustekinumab 90 MG/ML Prefilled Syringe [Stelara]	SBD	c77a9664-e3bb-4023-b400-127aa53bca2b	47
1811257	26 ML ustekinumab 5 MG/ML Injection [Stelara]	SBD	c77a9664-e3bb-4023-b400-127aa53bca2b	47
1654077	0.5 ML ustekinumab 90 MG/ML Injection	SCD	c77a9664-e3bb-4023-b400-127aa53bca2b	47
853350	0.5 ML ustekinumab 90 MG/ML Prefilled Syringe	SCD	c77a9664-e3bb-4023-b400-127aa53bca2b	47
853355	1 ML ustekinumab 90 MG/ML Prefilled Syringe	SCD	c77a9664-e3bb-4023-b400-127aa53bca2b	47
1811255	26 ML ustekinumab 5 MG/ML Injection	SCD	c77a9664-e3bb-4023-b400-127aa53bca2b	47
1654079	0.5 ML Stelara 90 MG/ML Injection	SY	c77a9664-e3bb-4023-b400-127aa53bca2b	47
853354	0.5 ML Stelara 90 MG/ML Prefilled Syringe	SY	c77a9664-e3bb-4023-b400-127aa53bca2b	47
853356	1 ML Stelara 90 MG/ML Prefilled Syringe	SY	c77a9664-e3bb-4023-b400-127aa53bca2b	47
1811257	26 ML Stelara 5 MG/ML Injection	SY	c77a9664-e3bb-4023-b400-127aa53bca2b	47
1811257	Stelara 130 MG per 26 ML Injection	SY	c77a9664-e3bb-4023-b400-127aa53bca2b	47
1654079	Stelara 45 MG per 0.5 ML Injection	SY	c77a9664-e3bb-4023-b400-127aa53bca2b	47
853354	Stelara 45 MG per 0.5 ML Prefilled Syringe	SY	c77a9664-e3bb-4023-b400-127aa53bca2b	47
853356	Stelara 90 MG per 1 ML Prefilled Syringe	SY	c77a9664-e3bb-4023-b400-127aa53bca2b	47
1811255	ustekinumab 130 MG per 26 ML Injection	SY	c77a9664-e3bb-4023-b400-127aa53bca2b	47
1654077	ustekinumab 45 MG per 0.5 ML Injection	SY	c77a9664-e3bb-4023-b400-127aa53bca2b	47
853350	ustekinumab 45 MG per 0.5 ML Prefilled Syringe	SY	c77a9664-e3bb-4023-b400-127aa53bca2b	47
853355	ustekinumab 90 MG per 1 ML Prefilled Syringe	SY	c77a9664-e3bb-4023-b400-127aa53bca2b	47

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57894-061-02	57894006102	1 mL in 1 VIAL, SINGLE-USE	1 ml					Historical
57894-061-03	57894006103	1 SYRINGE in 1 CARTON (57894-061-03) / 1 mL in 1 SYRINGE	1 syringe	2009-09-25	0000-00-00	No	No	Current
57894-061-04	57894006104	1 SYRINGE in 1 CARTON (57894-061-04) / 1 mL in 1 SYRINGE	1 syringe	2009-09-25	0000-00-00	Yes	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
STELARA	Janssen Biotech, Inc. \| Janssen Biologics B.V. \| Cilag AG \| Simtra US LLC \| PPD Development Ireland Ltd. \| Janssen Sciences Ireland UC	2026-07-21	HUMAN PRESCRIPTION DRUG LABEL	48