FDA.reportPublic FDA data

Otulfi

Product NDC
65219-826
11-digit product format
652190826
Labeler code
65219
Product ID
65219-826_6d4382de-5c0c-4603-b7e0-40acb62f9368
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
2024-02-22
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
Otulfi
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
USTEKINUMAB90 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFU77B4U5Z0
Rxcui2702606, 2702613, 2702615, 2702616, 2702619, 2702624, 2724429, 2724431

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
65219-826-26Otulfi1 mL in 1 SYRINGEINJECTION, SOLUTION14
65219-826-26Otulfi1 in 1 CARTONINJECTION, SOLUTION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65219-826-26ML - Milliliter65219-826351d5bb6-e906-4ae7-afe1-fb8d2c1e322b12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65219-826OTULFI (USTEKINUMAB-AAUZ) INJECTION, SOLUTION OTULFI (USTEKINUMAB-AAUZ) SOLUTION [FRESENIUS KABI USA, LLC]1Current NDC, 2 package rows20250119_853130e5-7406-4fd6-8138-ff2179195927.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2702624Otulfi 130 MG in 26 ML InjectionPSN853130e5-7406-4fd6-8138-ff21791959274
2724431Otulfi 45 MG in 0.5 ML InjectionPSN853130e5-7406-4fd6-8138-ff21791959274
2702616Otulfi 45 MG in 0.5 ML Prefilled SyringePSN853130e5-7406-4fd6-8138-ff21791959274
2702613Otulfi 90 MG in 1 ML Prefilled SyringePSN853130e5-7406-4fd6-8138-ff21791959274
2702619ustekinumab-aauz 130 MG in 26 ML InjectionPSN853130e5-7406-4fd6-8138-ff21791959274
2724429ustekinumab-aauz 45 MG in 0.5 ML InjectionPSN853130e5-7406-4fd6-8138-ff21791959274
2702615ustekinumab-aauz 45 MG in 0.5 ML Prefilled SyringePSN853130e5-7406-4fd6-8138-ff21791959274
2702606ustekinumab-aauz 90 MG in 1 ML Prefilled SyringePSN853130e5-7406-4fd6-8138-ff21791959274
27244310.5 ML ustekinumab-aauz 90 MG/ML Injection [Otulfi]SBD853130e5-7406-4fd6-8138-ff21791959274
27026160.5 ML ustekinumab-aauz 90 MG/ML Prefilled Syringe [Otulfi]SBD853130e5-7406-4fd6-8138-ff21791959274
27026131 ML ustekinumab-aauz 90 MG/ML Prefilled Syringe [Otulfi]SBD853130e5-7406-4fd6-8138-ff21791959274
270262426 ML ustekinumab-aauz 5 MG/ML Injection [Otulfi]SBD853130e5-7406-4fd6-8138-ff21791959274
27244290.5 ML ustekinumab-aauz 90 MG/ML InjectionSCD853130e5-7406-4fd6-8138-ff21791959274
27026150.5 ML ustekinumab-aauz 90 MG/ML Prefilled SyringeSCD853130e5-7406-4fd6-8138-ff21791959274
27026061 ML ustekinumab-aauz 90 MG/ML Prefilled SyringeSCD853130e5-7406-4fd6-8138-ff21791959274
270261926 ML ustekinumab-aauz 5 MG/ML InjectionSCD853130e5-7406-4fd6-8138-ff21791959274
27244310.5 ML Otulfi 90 MG/ML InjectionSY853130e5-7406-4fd6-8138-ff21791959274
2702624Otulfi 130 MG per 26 ML InjectionSY853130e5-7406-4fd6-8138-ff21791959274
2724431Otulfi 45 MG per 0.5 ML InjectionSY853130e5-7406-4fd6-8138-ff21791959274
2702616Otulfi 45 MG per 0.5 ML Prefilled SyringeSY853130e5-7406-4fd6-8138-ff21791959274
2702624Otulfi 5 MG/ML per 26 ML InjectionSY853130e5-7406-4fd6-8138-ff21791959274
2702613Otulfi 90 MG per 1 ML Prefilled SyringeSY853130e5-7406-4fd6-8138-ff21791959274
2702616Otulfi 90 MG/ML per 0.5 ML Prefilled SyringeSY853130e5-7406-4fd6-8138-ff21791959274
2702613Otulfi 90 MG/ML per 1 ML Prefilled SyringeSY853130e5-7406-4fd6-8138-ff21791959274
2702619ustekinumab-aauz 130 MG per 26 ML InjectionSY853130e5-7406-4fd6-8138-ff21791959274
2724429ustekinumab-aauz 45 MG per 0.5 ML InjectionSY853130e5-7406-4fd6-8138-ff21791959274
2702615ustekinumab-aauz 45 MG per 0.5 ML Prefilled SyringeSY853130e5-7406-4fd6-8138-ff21791959274
2702619ustekinumab-aauz 5 MG/ML per 26 ML InjectionSY853130e5-7406-4fd6-8138-ff21791959274
2702606ustekinumab-aauz 90 MG per 1 ML Prefilled SyringeSY853130e5-7406-4fd6-8138-ff21791959274
2702615ustekinumab-aauz 90 MG/ML per 0.5 ML Prefilled SyringeSY853130e5-7406-4fd6-8138-ff21791959274
2702606ustekinumab-aauz 90 MG/ML per 1 ML Prefilled SyringeSY853130e5-7406-4fd6-8138-ff21791959274

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65219-826-26652190826261 SYRINGE in 1 CARTON (65219-826-26) / 1 mL in 1 SYRINGE1 syringe2024-02-22NoNoCurrent