otulfi

Generic: ustekinumab-aauz

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name otulfi
Generic Name ustekinumab-aauz
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

ustekinumab 45 mg/.5mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 65219-824
Product ID 65219-824_75383700-b55b-4c0b-bc2e-8df4bf292ae2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761379
Listing Expiration 2026-12-31
Marketing Start 2024-02-22

Pharmacologic Class

Established (EPC)
interleukin-12 antagonist [epc] interleukin-23 antagonist [epc]
Mechanism of Action
interleukin-12 antagonists [moa] interleukin-23 antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65219824
Hyphenated Format 65219-824

Supplemental Identifiers

RxCUI
2702606 2702613 2702615 2702616 2702619 2702624 2724429 2724431
UNII
FU77B4U5Z0
NUI
N0000192797 N0000192796 N0000192799 N0000192798

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name otulfi (source: ndc)
Generic Name ustekinumab-aauz (source: ndc)
Application Number BLA761379 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 45 mg/.5mL
source: ndc
Packaging
  • 1 SYRINGE in 1 CARTON (65219-824-01) / .5 mL in 1 SYRINGE
source: ndc

Packages (1)

65219-824-01 1 SYRINGE in 1 CARTON (65219-824-01) / .5 mL in 1 SYRINGE

Ingredients (1)

ustekinumab (45 mg/.5mL)

Linked Drug Pages (1)

Otulfi ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "75383700-b55b-4c0b-bc2e-8df4bf292ae2", "openfda": {"nui": ["N0000192797", "N0000192796", "N0000192799", "N0000192798"], "unii": ["FU77B4U5Z0"], "rxcui": ["2702606", "2702613", "2702615", "2702616", "2702619", "2702624", "2724429", "2724431"], "spl_set_id": ["853130e5-7406-4fd6-8138-ff2179195927"], "pharm_class_epc": ["Interleukin-12 Antagonist [EPC]", "Interleukin-23 Antagonist [EPC]"], "pharm_class_moa": ["Interleukin-12 Antagonists [MoA]", "Interleukin-23 Antagonists [MoA]"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE in 1 CARTON (65219-824-01)  / .5 mL in 1 SYRINGE", "package_ndc": "65219-824-01", "marketing_start_date": "20240222"}], "brand_name": "Otulfi", "product_id": "65219-824_75383700-b55b-4c0b-bc2e-8df4bf292ae2", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Interleukin-12 Antagonist [EPC]", "Interleukin-12 Antagonists [MoA]", "Interleukin-23 Antagonist [EPC]", "Interleukin-23 Antagonists [MoA]"], "product_ndc": "65219-824", "generic_name": "ustekinumab-aauz", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Otulfi", "active_ingredients": [{"name": "USTEKINUMAB", "strength": "45 mg/.5mL"}], "application_number": "BLA761379", "marketing_category": "BLA", "marketing_start_date": "20240222", "listing_expiration_date": "20261231"}