FDA.reportPublic FDA data

ustekinumab

Product NDC
57894-441
11-digit product format
578940441
Labeler code
57894
Product ID
57894-441_d7f96963-2754-4e7b-aebc-66e778c275eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ustekinumab
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Janssen Biotech, Inc.
Application
BLA125261
Marketing category
BLA
Marketing start
2025-04-01
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
ustekinumab
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
USTEKINUMAB90 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFU77B4U5Z0
Rxcui853350, 853355, 1654077, 1811255

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
57894-441-01ustekinumab1 in 1 CARTONINJECTION, SOLUTION16
57894-441-01ustekinumab1 mL in 1 SYRINGEINJECTION, SOLUTION16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57894-441USTEKINUMAB INJECTION, SOLUTION USTEKINUMAB SOLUTION [JANSSEN BIOTECH, INC.]4Current NDC, 2 package rows20250410_23b486eb-f48d-47d4-815e-1313d4ebfbfa.zip

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 formatDescriptionUnitsMarketing startSampleExclude flagStatus
57894-441-01578940441011 SYRINGE in 1 CARTON (57894-441-01) / 1 mL in 1 SYRINGE1 syringe2025-04-01NoNoCurrent