stelara

Generic: ustekinumab

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

Drug Facts

Product Profile

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

ustekinumab 45 mg/.5mL

Manufacturer
Janssen Biotech, Inc.

Identifiers & Regulatory

Product NDC 57894-060
Product ID 57894-060_289aa660-521c-4323-b9a9-2a995e23d65c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125261
Listing Expiration 2027-12-31
Marketing Start 2009-09-25

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 57894060
Hyphenated Format 57894-060

Supplemental Identifiers

RxCUI
853350 853354 853355 853356 1654077 1654079 1811255 1811257
UPC
0357894060031 0357894054276
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 stelara (source: ndc)
Generic Name ustekinumab (source: ndc)
Application Number BLA125261 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 45 mg/.5mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (57894-060-02) / .5 mL in 1 VIAL, SINGLE-USE
  • 1 SYRINGE in 1 CARTON (57894-060-03) / .5 mL in 1 SYRINGE
  • 1 SYRINGE in 1 CARTON (57894-060-04) / .5 mL in 1 SYRINGE
source: ndc

Packages (3)

57894-060-02 1 VIAL, SINGLE-USE in 1 CARTON (57894-060-02) / .5 mL in 1 VIAL, SINGLE-USE 57894-060-03 1 SYRINGE in 1 CARTON (57894-060-03) / .5 mL in 1 SYRINGE 57894-060-04 1 SYRINGE in 1 CARTON (57894-060-04) / .5 mL in 1 SYRINGE

Ingredients (1)

ustekinumab (45 mg/.5mL)

Linked Drug Pages (1)

Stelara, STELARA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "289aa660-521c-4323-b9a9-2a995e23d65c", "openfda": {"nui": ["N0000192797", "N0000192796", "N0000192799", "N0000192798"], "upc": ["0357894060031", "0357894054276"], "unii": ["FU77B4U5Z0"], "rxcui": ["853350", "853354", "853355", "853356", "1654077", "1654079", "1811255", "1811257"], "spl_set_id": ["c77a9664-e3bb-4023-b400-127aa53bca2b"], "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 CARTON (57894-060-02)  / .5 mL in 1 VIAL, SINGLE-USE", "package_ndc": "57894-060-02", "marketing_start_date": "20090925"}, {"sample": false, "description": "1 SYRINGE in 1 CARTON (57894-060-03)  / .5 mL in 1 SYRINGE", "package_ndc": "57894-060-03", "marketing_start_date": "20090925"}, {"sample": true, "description": "1 SYRINGE in 1 CARTON (57894-060-04)  / .5 mL in 1 SYRINGE", "package_ndc": "57894-060-04", "marketing_start_date": "20090925"}], "brand_name": "STELARA", "product_id": "57894-060_289aa660-521c-4323-b9a9-2a995e23d65c", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Interleukin-12 Antagonist [EPC]", "Interleukin-12 Antagonists [MoA]", "Interleukin-23 Antagonist [EPC]", "Interleukin-23 Antagonists [MoA]"], "product_ndc": "57894-060", "generic_name": "ustekinumab", "labeler_name": "Janssen Biotech, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "STELARA", "active_ingredients": [{"name": "USTEKINUMAB", "strength": "45 mg/.5mL"}], "application_number": "BLA125261", "marketing_category": "BLA", "marketing_start_date": "20090925", "listing_expiration_date": "20271231"}