ustekinumab

Generic: ustekinumab

Labeler: janssen biotech, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name ustekinumab
Generic Name ustekinumab
Labeler janssen biotech, inc.
Dosage Form SOLUTION
Routes
INTRAVENOUS
Active Ingredients

ustekinumab 130 mg/26mL

Manufacturer
Janssen Biotech, Inc.

Identifiers & Regulatory

Product NDC 57894-444
Product ID 57894-444_c26186ee-aa04-4423-b784-65c0413a2c40
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761044
Listing Expiration 2027-12-31
Marketing Start 2025-04-01

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 57894444
Hyphenated Format 57894-444

Supplemental Identifiers

RxCUI
853350 853355 1654077 1811255
UPC
0357894444015
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 ustekinumab (source: ndc)
Generic Name ustekinumab (source: ndc)
Application Number BLA761044 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 130 mg/26mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 BOX (57894-444-01) / 26 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

57894-444-01 1 VIAL, SINGLE-USE in 1 BOX (57894-444-01) / 26 mL in 1 VIAL, SINGLE-USE

Ingredients (1)

ustekinumab (130 mg/26mL)

Linked Drug Pages (1)

ustekinumab ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "c26186ee-aa04-4423-b784-65c0413a2c40", "openfda": {"nui": ["N0000192797", "N0000192796", "N0000192799", "N0000192798"], "upc": ["0357894444015"], "unii": ["FU77B4U5Z0"], "rxcui": ["853350", "853355", "1654077", "1811255"], "spl_set_id": ["23b486eb-f48d-47d4-815e-1313d4ebfbfa"], "pharm_class_epc": ["Interleukin-12 Antagonist [EPC]", "Interleukin-23 Antagonist [EPC]"], "pharm_class_moa": ["Interleukin-12 Antagonists [MoA]", "Interleukin-23 Antagonists [MoA]"], "manufacturer_name": ["Janssen Biotech, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 BOX (57894-444-01)  / 26 mL in 1 VIAL, SINGLE-USE", "package_ndc": "57894-444-01", "marketing_start_date": "20250401"}], "brand_name": "ustekinumab", "product_id": "57894-444_c26186ee-aa04-4423-b784-65c0413a2c40", "dosage_form": "SOLUTION", "pharm_class": ["Interleukin-12 Antagonist [EPC]", "Interleukin-12 Antagonists [MoA]", "Interleukin-23 Antagonist [EPC]", "Interleukin-23 Antagonists [MoA]"], "product_ndc": "57894-444", "generic_name": "ustekinumab", "labeler_name": "Janssen Biotech, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ustekinumab", "active_ingredients": [{"name": "USTEKINUMAB", "strength": "130 mg/26mL"}], "application_number": "BLA761044", "marketing_category": "BLA", "marketing_start_date": "20250401", "listing_expiration_date": "20271231"}