Starjemza

Product NDC: 0143-9171
11-digit product format: 001439171
Labeler code: 0143
Product ID: 0143-9171_4f0ed512-9cd1-4280-af36-37ed3090d632
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ustekinumab-hmny
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Hikma Pharmaceuticals USA Inc.
Application: BLA761419
Marketing category: BLA
Marketing start: 2025-10-27
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: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Starjemza
Listing expiration: 2026-12-31

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
2725087	Internal RxNorm lookup
2725094	Internal RxNorm lookup
2725099	Internal RxNorm lookup
2725100	Internal RxNorm lookup
2725102	Internal RxNorm lookup
2725106	Internal RxNorm lookup
2725111	Internal RxNorm lookup
2725114	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
8b72aa27-82cc-4c1b-be43-8b50e5e3d737	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
0143-9171-01	Starjemza	26 mL in 1 VIAL	INJECTION	26		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0143-9171-01	ML - Milliliter	0143-9171	d4f8d96d-d51f-4f8f-956a-6d019b57d9ae	1	2025-11-13

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Starjemza	USTEKINUMAB-HMNY	Hikma Pharmaceuticals USA Inc.	8b72aa27-82cc-4c1b-be43-8b50e5e3d737	2025-10-24	Warnings, Adverse reactions	Exact identifier application number: BLA761419 ndc (product): 0143-9171

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
761419	Starjemza	ustekinumab-hmny	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
2725114	Starjemza 130 MG in 26 ML Injection	PSN	8b72aa27-82cc-4c1b-be43-8b50e5e3d737	5
2725106	Starjemza 45 MG in 0.5 ML Injection	PSN	8b72aa27-82cc-4c1b-be43-8b50e5e3d737	5
2725094	Starjemza 45 MG in 0.5 ML Prefilled Syringe	PSN	8b72aa27-82cc-4c1b-be43-8b50e5e3d737	5
2725100	Starjemza 90 MG in 1 ML Prefilled Syringe	PSN	8b72aa27-82cc-4c1b-be43-8b50e5e3d737	5
2725111	ustekinumab-hmny 130 MG in 26 ML Injection	PSN	8b72aa27-82cc-4c1b-be43-8b50e5e3d737	5
2725102	ustekinumab-hmny 45 MG in 0.5 ML Injection	PSN	8b72aa27-82cc-4c1b-be43-8b50e5e3d737	5
2725087	ustekinumab-hmny 45 MG in 0.5 ML Prefilled Syringe	PSN	8b72aa27-82cc-4c1b-be43-8b50e5e3d737	5
2725099	ustekinumab-hmny 90 MG in 1 ML Prefilled Syringe	PSN	8b72aa27-82cc-4c1b-be43-8b50e5e3d737	5
2725106	0.5 ML ustekinumab-hmny 90 MG/ML Injection [Starjemza]	SBD	8b72aa27-82cc-4c1b-be43-8b50e5e3d737	5
2725094	0.5 ML ustekinumab-hmny 90 MG/ML Prefilled Syringe [Starjemza]	SBD	8b72aa27-82cc-4c1b-be43-8b50e5e3d737	5
2725100	1 ML ustekinumab-hmny 90 MG/ML Prefilled Syringe [Starjemza]	SBD	8b72aa27-82cc-4c1b-be43-8b50e5e3d737	5
2725114	26 ML ustekinumab-hmny 5 MG/ML Injection [Starjemza]	SBD	8b72aa27-82cc-4c1b-be43-8b50e5e3d737	5
2725102	0.5 ML ustekinumab-hmny 90 MG/ML Injection	SCD	8b72aa27-82cc-4c1b-be43-8b50e5e3d737	5
2725087	0.5 ML ustekinumab-hmny 90 MG/ML Prefilled Syringe	SCD	8b72aa27-82cc-4c1b-be43-8b50e5e3d737	5
2725099	1 ML ustekinumab-hmny 90 MG/ML Prefilled Syringe	SCD	8b72aa27-82cc-4c1b-be43-8b50e5e3d737	5
2725111	26 ML ustekinumab-hmny 5 MG/ML Injection	SCD	8b72aa27-82cc-4c1b-be43-8b50e5e3d737	5
2725114	Starjemza 130 MG per 26 ML Injection	SY	8b72aa27-82cc-4c1b-be43-8b50e5e3d737	5
2725106	Starjemza 45 MG per 0.5 ML Injection	SY	8b72aa27-82cc-4c1b-be43-8b50e5e3d737	5
2725094	Starjemza 45 MG per 0.5 ML Prefilled Syringe	SY	8b72aa27-82cc-4c1b-be43-8b50e5e3d737	5
2725100	Starjemza 90 MG per 1 ML Prefilled Syringe	SY	8b72aa27-82cc-4c1b-be43-8b50e5e3d737	5
2725111	ustekinumab-hmny 130 MG per 26 ML Injection	SY	8b72aa27-82cc-4c1b-be43-8b50e5e3d737	5
2725102	ustekinumab-hmny 45 MG per 0.5 ML Injection	SY	8b72aa27-82cc-4c1b-be43-8b50e5e3d737	5
2725087	ustekinumab-hmny 45 MG per 0.5 ML Prefilled Syringe	SY	8b72aa27-82cc-4c1b-be43-8b50e5e3d737	5
2725099	ustekinumab-hmny 90 MG per 1 ML Prefilled Syringe	SY	8b72aa27-82cc-4c1b-be43-8b50e5e3d737	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0143-9171-01	00143917101	26 mL in 1 VIAL (0143-9171-01)	26 ml	2025-10-27	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Starjemza - Hikma Pharmaceuticals USA Inc.	Hikma Pharmaceuticals USA Inc.	2025-10-24	HUMAN PRESCRIPTION DRUG LABEL	5