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 Identifiers#

Field, Values table
FieldValues
UniiFU77B4U5Z0
Rxcui2702606, 2702615

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

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