FDA.reportPublic FDA data

USTEKINUMAB-AAUZ

Product NDC
65219-866
11-digit product format
652190866
Labeler code
65219
Product ID
65219-866_0feb664c-65a6-4759-9848-e0d80fde360f
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
2025-11-15
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-AAUZ
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
USTEKINUMAB90 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
FU77B4U5Z0Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2702606Internal RxNorm lookup
2702615Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a6d75316-c9a7-49cf-83be-b7b6c6cecf7aAvailable on FDA.report

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
65219-866-26USTEKINUMAB-AAUZ1 in 1 CARTONINJECTION, SOLUTION14
65219-866-26USTEKINUMAB-AAUZ1 mL in 1 SYRINGEINJECTION, SOLUTION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65219-866-26ML - Milliliter65219-866cdf64e3e-0a52-42da-868b-3bf60bf8684c12025-12-16

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
USTEKINUMAB-AAUZUSTEKINUMAB-AAUZFresenius Kabi USA, LLCa6d75316-c9a7-49cf-83be-b7b6c6cecf7a2026-02-26Warnings, Adverse reactionsExact identifier
application number: BLA761379
ndc (product): 65219-866
OtulfiUSTEKINUMAB-AAUZFresenius Kabi USA, LLC853130e5-7406-4fd6-8138-ff21791959272026-02-16Warnings, Adverse reactionsExact identifier
application number: BLA761379

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761379Otulfiustekinumab-aauz351(k) InterchangeableRx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2702615ustekinumab-aauz 45 MG in 0.5 ML Prefilled SyringePSNa6d75316-c9a7-49cf-83be-b7b6c6cecf7a4
2702606ustekinumab-aauz 90 MG in 1 ML Prefilled SyringePSNa6d75316-c9a7-49cf-83be-b7b6c6cecf7a4
27026150.5 ML ustekinumab-aauz 90 MG/ML Prefilled SyringeSCDa6d75316-c9a7-49cf-83be-b7b6c6cecf7a4
27026061 ML ustekinumab-aauz 90 MG/ML Prefilled SyringeSCDa6d75316-c9a7-49cf-83be-b7b6c6cecf7a4
2702615ustekinumab-aauz 45 MG per 0.5 ML Prefilled SyringeSYa6d75316-c9a7-49cf-83be-b7b6c6cecf7a4
2702606ustekinumab-aauz 90 MG per 1 ML Prefilled SyringeSYa6d75316-c9a7-49cf-83be-b7b6c6cecf7a4
2702615ustekinumab-aauz 90 MG/ML per 0.5 ML Prefilled SyringeSYa6d75316-c9a7-49cf-83be-b7b6c6cecf7a4
2702606ustekinumab-aauz 90 MG/ML per 1 ML Prefilled SyringeSYa6d75316-c9a7-49cf-83be-b7b6c6cecf7a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65219-866-26652190866261 SYRINGE in 1 CARTON (65219-866-26) / 1 mL in 1 SYRINGE1 syringe2025-11-15NoNoCurrent