FDA.reportPublic FDA data

Stelara

Product NDC
57894-054
11-digit product format
578940054
Labeler code
57894
Product ID
57894-054_ff62ab2e-9413-4e22-95ad-74b582c14dc6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ustekinumab
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
Janssen Biotech, Inc.
Application
BLA761044
Marketing category
BLA
Marketing start
2016-09-23
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
Stelara
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
USTEKINUMAB130 mg/26mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFU77B4U5Z0
Rxcui853350, 853354, 853355, 853356, 1654077, 1654079, 1811255, 1811257

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
57894-054-16Stelara26 mL in 1 VIAL, SINGLE-USESOLUTION2647
57894-054-16Stelara1 in 1 BOXSOLUTION147
57894-054-27Stelara26 mL in 1 VIAL, SINGLE-USESOLUTION2647
57894-054-27Stelara1 in 1 BOXSOLUTION147

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57894-054-27ML - Milliliter57894-0540a499100-150d-4e4d-b945-92b8846abff512016-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ustekinumabACTIVE INGREDIENTFU77B4U5Z0STELARA (USTEKINUMAB) INJECTION, SOLUTION [JANSSEN BIOTECH, INC.]16
ustekinumabACTIVE MOIETYFU77B4U5Z0STELARA (USTEKINUMAB) INJECTION, SOLUTION [JANSSEN BIOTECH, INC.]16
HISTIDINEINACTIVE INGREDIENT4QD397987ESTELARA (USTEKINUMAB) INJECTION, SOLUTION [JANSSEN BIOTECH, INC.]16
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEINACTIVE INGREDIENTX573657P6PSTELARA (USTEKINUMAB) INJECTION, SOLUTION [JANSSEN BIOTECH, INC.]16
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HSTELARA (USTEKINUMAB) INJECTION, SOLUTION [JANSSEN BIOTECH, INC.]16
sucroseINACTIVE INGREDIENTC151H8M554STELARA (USTEKINUMAB) INJECTION, SOLUTION [JANSSEN BIOTECH, INC.]16
waterINACTIVE INGREDIENT059QF0KO0RSTELARA (USTEKINUMAB) INJECTION, SOLUTION [JANSSEN BIOTECH, INC.]16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57894-054STELARA (USTEKINUMAB) INJECTION, SOLUTION STELARA (USTEKINUMAB) SOLUTION [JANSSEN BIOTECH, INC.]43Current NDC, Legacy NDC, 4 package rows20250410_c77a9664-e3bb-4023-b400-127aa53bca2b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1811257Stelara 130 MG in 26 ML InjectionPSNc77a9664-e3bb-4023-b400-127aa53bca2b47
1654079Stelara 45 MG in 0.5 mL InjectionPSNc77a9664-e3bb-4023-b400-127aa53bca2b47
853354Stelara 45 MG in 0.5 mL Prefilled SyringePSNc77a9664-e3bb-4023-b400-127aa53bca2b47
853356Stelara 90 MG in 1 ML Prefilled SyringePSNc77a9664-e3bb-4023-b400-127aa53bca2b47
1811255ustekinumab 130 MG in 26 ML InjectionPSNc77a9664-e3bb-4023-b400-127aa53bca2b47
1654077ustekinumab 45 MG in 0.5 mL InjectionPSNc77a9664-e3bb-4023-b400-127aa53bca2b47
853350ustekinumab 45 MG in 0.5 mL Prefilled SyringePSNc77a9664-e3bb-4023-b400-127aa53bca2b47
853355ustekinumab 90 MG in 1 ML Prefilled SyringePSNc77a9664-e3bb-4023-b400-127aa53bca2b47
16540790.5 ML ustekinumab 90 MG/ML Injection [Stelara]SBDc77a9664-e3bb-4023-b400-127aa53bca2b47
8533540.5 ML ustekinumab 90 MG/ML Prefilled Syringe [Stelara]SBDc77a9664-e3bb-4023-b400-127aa53bca2b47
8533561 ML ustekinumab 90 MG/ML Prefilled Syringe [Stelara]SBDc77a9664-e3bb-4023-b400-127aa53bca2b47
181125726 ML ustekinumab 5 MG/ML Injection [Stelara]SBDc77a9664-e3bb-4023-b400-127aa53bca2b47
16540770.5 ML ustekinumab 90 MG/ML InjectionSCDc77a9664-e3bb-4023-b400-127aa53bca2b47
8533500.5 ML ustekinumab 90 MG/ML Prefilled SyringeSCDc77a9664-e3bb-4023-b400-127aa53bca2b47
8533551 ML ustekinumab 90 MG/ML Prefilled SyringeSCDc77a9664-e3bb-4023-b400-127aa53bca2b47
181125526 ML ustekinumab 5 MG/ML InjectionSCDc77a9664-e3bb-4023-b400-127aa53bca2b47
16540790.5 ML Stelara 90 MG/ML InjectionSYc77a9664-e3bb-4023-b400-127aa53bca2b47
8533540.5 ML Stelara 90 MG/ML Prefilled SyringeSYc77a9664-e3bb-4023-b400-127aa53bca2b47
8533561 ML Stelara 90 MG/ML Prefilled SyringeSYc77a9664-e3bb-4023-b400-127aa53bca2b47
181125726 ML Stelara 5 MG/ML InjectionSYc77a9664-e3bb-4023-b400-127aa53bca2b47
1811257Stelara 130 MG per 26 ML InjectionSYc77a9664-e3bb-4023-b400-127aa53bca2b47
1654079Stelara 45 MG per 0.5 ML InjectionSYc77a9664-e3bb-4023-b400-127aa53bca2b47
853354Stelara 45 MG per 0.5 ML Prefilled SyringeSYc77a9664-e3bb-4023-b400-127aa53bca2b47
853356Stelara 90 MG per 1 ML Prefilled SyringeSYc77a9664-e3bb-4023-b400-127aa53bca2b47
1811255ustekinumab 130 MG per 26 ML InjectionSYc77a9664-e3bb-4023-b400-127aa53bca2b47
1654077ustekinumab 45 MG per 0.5 ML InjectionSYc77a9664-e3bb-4023-b400-127aa53bca2b47
853350ustekinumab 45 MG per 0.5 ML Prefilled SyringeSYc77a9664-e3bb-4023-b400-127aa53bca2b47
853355ustekinumab 90 MG per 1 ML Prefilled SyringeSYc77a9664-e3bb-4023-b400-127aa53bca2b47

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57894-054-16578940054161 VIAL, SINGLE-USE in 1 BOX (57894-054-16) / 26 mL in 1 VIAL, SINGLE-USE2017-05-010000-00-00YesNoCurrent
57894-054-27578940054271 VIAL, SINGLE-USE in 1 BOX (57894-054-27) / 26 mL in 1 VIAL, SINGLE-USE2016-09-230000-00-00NoNoCurrent