wezlana

Generic: ustekinumab-auub

Labeler: nuvaila limited
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name wezlana
Generic Name ustekinumab-auub
Labeler nuvaila limited
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

ustekinumab 45 mg/.5mL

Manufacturer
Nuvaila Limited

Identifiers & Regulatory

Product NDC 84612-876
Product ID 84612-876_bc6353b9-cffb-4c14-b71e-0155a5294799
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761285
Listing Expiration 2027-12-31
Marketing Start 2025-01-01

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 84612876
Hyphenated Format 84612-876

Supplemental Identifiers

RxCUI
2700669 2700676 2700679 2700682 2700685 2700689 2700691 2700692
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 wezlana (source: ndc)
Generic Name ustekinumab-auub (source: ndc)
Application Number BLA761285 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 45 mg/.5mL
source: ndc
Packaging
  • 1 SYRINGE in 1 CARTON (84612-876-01) / .5 mL in 1 SYRINGE
source: ndc

Packages (1)

84612-876-01 1 SYRINGE in 1 CARTON (84612-876-01) / .5 mL in 1 SYRINGE

Ingredients (1)

ustekinumab (45 mg/.5mL)

Linked Drug Pages (1)

WEZLANA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "bc6353b9-cffb-4c14-b71e-0155a5294799", "openfda": {"nui": ["N0000192797", "N0000192796", "N0000192799", "N0000192798"], "unii": ["FU77B4U5Z0"], "rxcui": ["2700669", "2700676", "2700679", "2700682", "2700685", "2700689", "2700691", "2700692"], "spl_set_id": ["a6c23978-09f0-4796-88f7-d0ce7e3ed04e"], "pharm_class_epc": ["Interleukin-12 Antagonist [EPC]", "Interleukin-23 Antagonist [EPC]"], "pharm_class_moa": ["Interleukin-12 Antagonists [MoA]", "Interleukin-23 Antagonists [MoA]"], "manufacturer_name": ["Nuvaila Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE in 1 CARTON (84612-876-01)  / .5 mL in 1 SYRINGE", "package_ndc": "84612-876-01", "marketing_start_date": "20250101"}], "brand_name": "WEZLANA", "product_id": "84612-876_bc6353b9-cffb-4c14-b71e-0155a5294799", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Interleukin-12 Antagonist [EPC]", "Interleukin-12 Antagonists [MoA]", "Interleukin-23 Antagonist [EPC]", "Interleukin-23 Antagonists [MoA]"], "product_ndc": "84612-876", "generic_name": "ustekinumab-auub", "labeler_name": "Nuvaila Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "WEZLANA", "active_ingredients": [{"name": "USTEKINUMAB", "strength": "45 mg/.5mL"}], "application_number": "BLA761285", "marketing_category": "BLA", "marketing_start_date": "20250101", "listing_expiration_date": "20271231"}