Otulfi

Product NDC: 65219-826
11-digit product format: 652190826
Labeler code: 65219
Product ID: 65219-826_6d4382de-5c0c-4603-b7e0-40acb62f9368
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ustekinumab-aauz
Dosage form: INJECTION, SOLUTION
Route: SUBCUTANEOUS
Labeler: Fresenius Kabi USA, LLC
Application: BLA761379
Marketing category: BLA
Marketing start: 2024-02-22
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

Additional Listing Data#

Finished product: Yes
Brand name base: Otulfi
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
2702606	Internal RxNorm lookup
2702613	Internal RxNorm lookup
2702615	Internal RxNorm lookup
2702616	Internal RxNorm lookup
2702619	Internal RxNorm lookup
2702624	Internal RxNorm lookup
2724429	Internal RxNorm lookup
2724431	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
853130e5-7406-4fd6-8138-ff2179195927	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	Strength	SPL version
65219-826-26	Otulfi	1 mL in 1 SYRINGE	INJECTION, SOLUTION	1		4
65219-826-26	Otulfi	1 in 1 CARTON	INJECTION, SOLUTION	1		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65219-826-26	ML - Milliliter	65219-826	351d5bb6-e906-4ae7-afe1-fb8d2c1e322b	1	2025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65219-826	OTULFI (USTEKINUMAB-AAUZ) INJECTION, SOLUTION OTULFI (USTEKINUMAB-AAUZ) SOLUTION [FRESENIUS KABI USA, LLC]	1	Current NDC, 2 package rows	20250119_853130e5-7406-4fd6-8138-ff2179195927.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-AAUZ	USTEKINUMAB-AAUZ	Fresenius Kabi USA, LLC	a6d75316-c9a7-49cf-83be-b7b6c6cecf7a	2026-02-26	Warnings, Adverse reactions	Exact identifier application number: BLA761379
Otulfi	USTEKINUMAB-AAUZ	Fresenius Kabi USA, LLC	853130e5-7406-4fd6-8138-ff2179195927	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: BLA761379 ndc (product): 65219-826

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
761379	Otulfi	ustekinumab-aauz	351(k) Interchangeable	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
2702624	Otulfi 130 MG in 26 ML Injection	PSN	853130e5-7406-4fd6-8138-ff2179195927	4
2724431	Otulfi 45 MG in 0.5 ML Injection	PSN	853130e5-7406-4fd6-8138-ff2179195927	4
2702616	Otulfi 45 MG in 0.5 ML Prefilled Syringe	PSN	853130e5-7406-4fd6-8138-ff2179195927	4
2702613	Otulfi 90 MG in 1 ML Prefilled Syringe	PSN	853130e5-7406-4fd6-8138-ff2179195927	4
2702619	ustekinumab-aauz 130 MG in 26 ML Injection	PSN	853130e5-7406-4fd6-8138-ff2179195927	4
2724429	ustekinumab-aauz 45 MG in 0.5 ML Injection	PSN	853130e5-7406-4fd6-8138-ff2179195927	4
2702615	ustekinumab-aauz 45 MG in 0.5 ML Prefilled Syringe	PSN	853130e5-7406-4fd6-8138-ff2179195927	4
2702606	ustekinumab-aauz 90 MG in 1 ML Prefilled Syringe	PSN	853130e5-7406-4fd6-8138-ff2179195927	4
2724431	0.5 ML ustekinumab-aauz 90 MG/ML Injection [Otulfi]	SBD	853130e5-7406-4fd6-8138-ff2179195927	4
2702616	0.5 ML ustekinumab-aauz 90 MG/ML Prefilled Syringe [Otulfi]	SBD	853130e5-7406-4fd6-8138-ff2179195927	4
2702613	1 ML ustekinumab-aauz 90 MG/ML Prefilled Syringe [Otulfi]	SBD	853130e5-7406-4fd6-8138-ff2179195927	4
2702624	26 ML ustekinumab-aauz 5 MG/ML Injection [Otulfi]	SBD	853130e5-7406-4fd6-8138-ff2179195927	4
2724429	0.5 ML ustekinumab-aauz 90 MG/ML Injection	SCD	853130e5-7406-4fd6-8138-ff2179195927	4
2702615	0.5 ML ustekinumab-aauz 90 MG/ML Prefilled Syringe	SCD	853130e5-7406-4fd6-8138-ff2179195927	4
2702606	1 ML ustekinumab-aauz 90 MG/ML Prefilled Syringe	SCD	853130e5-7406-4fd6-8138-ff2179195927	4
2702619	26 ML ustekinumab-aauz 5 MG/ML Injection	SCD	853130e5-7406-4fd6-8138-ff2179195927	4
2724431	0.5 ML Otulfi 90 MG/ML Injection	SY	853130e5-7406-4fd6-8138-ff2179195927	4
2702624	Otulfi 130 MG per 26 ML Injection	SY	853130e5-7406-4fd6-8138-ff2179195927	4
2724431	Otulfi 45 MG per 0.5 ML Injection	SY	853130e5-7406-4fd6-8138-ff2179195927	4
2702616	Otulfi 45 MG per 0.5 ML Prefilled Syringe	SY	853130e5-7406-4fd6-8138-ff2179195927	4
2702624	Otulfi 5 MG/ML per 26 ML Injection	SY	853130e5-7406-4fd6-8138-ff2179195927	4
2702613	Otulfi 90 MG per 1 ML Prefilled Syringe	SY	853130e5-7406-4fd6-8138-ff2179195927	4
2702616	Otulfi 90 MG/ML per 0.5 ML Prefilled Syringe	SY	853130e5-7406-4fd6-8138-ff2179195927	4
2702613	Otulfi 90 MG/ML per 1 ML Prefilled Syringe	SY	853130e5-7406-4fd6-8138-ff2179195927	4
2702619	ustekinumab-aauz 130 MG per 26 ML Injection	SY	853130e5-7406-4fd6-8138-ff2179195927	4
2724429	ustekinumab-aauz 45 MG per 0.5 ML Injection	SY	853130e5-7406-4fd6-8138-ff2179195927	4
2702615	ustekinumab-aauz 45 MG per 0.5 ML Prefilled Syringe	SY	853130e5-7406-4fd6-8138-ff2179195927	4
2702619	ustekinumab-aauz 5 MG/ML per 26 ML Injection	SY	853130e5-7406-4fd6-8138-ff2179195927	4
2702606	ustekinumab-aauz 90 MG per 1 ML Prefilled Syringe	SY	853130e5-7406-4fd6-8138-ff2179195927	4
2702615	ustekinumab-aauz 90 MG/ML per 0.5 ML Prefilled Syringe	SY	853130e5-7406-4fd6-8138-ff2179195927	4
2702606	ustekinumab-aauz 90 MG/ML per 1 ML Prefilled Syringe	SY	853130e5-7406-4fd6-8138-ff2179195927	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
65219-826-26	65219082626	1 SYRINGE in 1 CARTON (65219-826-26) / 1 mL in 1 SYRINGE	1 syringe	2024-02-22	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Otulfi	Fresenius Kabi USA, LLC \| Fresenius Kabi Austria	2026-02-16	HUMAN PRESCRIPTION DRUG LABEL	4