Wezlana (ustekinumab-auub) NDC 84612-876 · J-Code J3357

NDC codes

FDA NDC Directory

Product NDC (as listed)84612-876Labeler and product segments. Claims need a package NDC.

Product NDC at billing width84612-0876Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
84612-876-01	84612087601	1 SYRINGE in 1 CARTON (84612-876-01) / .5 mL in 1 SYRINGEMarketed from Jan 1, 2025

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Wezlana
Generic name (nonproprietary): ustekinumab-auub
Active ingredients: Ustekinumab — 45 mg/.5mL
Dosage form: Injection, Solution
Route: Subcutaneous
Labeler: Nuvaila Limited
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 761285
Marketing start: Jan 1, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Interleukin-12 Antagonists (Mechanism)Interleukin-23 Antagonists (Mechanism)
Identifiers: Product ID 84612-876_4feadcb0-90b7-4e84-90c2-2eaaa8868ca8SPL ID 4feadcb0-90b7-4e84-90c2-2eaaa8868ca8SPL set ID a6c23978-09f0-4796-88f7-d0ce7e3ed04eRxCUI 2700669, 2700676, 2700679, 2700682, 2700685, 2700689, 2700691, 2700692UNII FU77B4U5Z0
Pharmacologic class: Interleukin-12 Antagonist; Interleukin-23 Antagonist

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeMed-Code curated

J3357 — Injection, ustekinumab, for subcutaneous injection, 1 mg

Billing unit: 1 mg. Units on the claim = dose given ÷ 1 mg.

J3357 covers the subcutaneous formulation. The intravenous formulation has a separate code (J3358). Ustekinumab biosimilars are listed under their own names.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N484612087601 followed by a unit qualifier and the quantity

Package 84612-0876-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Jun 3, 2026.

Indications (excerpt from the label)

WEZLANA is a human interleukin -12 and -23 antagonist indicated for the treatment of: Moderate to severe plaque psoriasis in adult and pediatric patients 6 years of age and older who are candidates for phototherapy or systemic therapy. ( 1.1 ) Active psoriatic arthritis in adult and pediatric patients 6 years of age and older. ( 1.2 ) Moderately to severely active Crohn's disease in adult patients. ( 1.3 ) Moderately to severely active ulcerative colitis in adult patients . ( 1.4 ) 1.1 Plaque Psoriasis (PsO) WEZLANA is indicated for the treatment of adults and pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under BLA 761285

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under BLA 761285
Product	Strength	Form · route	Labeler	Product NDC
Wezlanaustekinumab-auub	Ustekinumab 45 mg/.5mL	Injection, SolutionSubcutaneous	Nuvaila Limited	84612-055
Wezlanaustekinumab-auub	Ustekinumab 45 mg/.5mL	Injection, SolutionSubcutaneous	Nuvaila Limited	84612-076
Wezlanaustekinumab-auub	Ustekinumab 90 mg/mL	Injection, SolutionSubcutaneous	Nuvaila Limited	84612-089
Wezlanaustekinumab-auub	Ustekinumab 45 mg/.5mL	Injection, SolutionSubcutaneous	Nuvaila Limited	84612-855
Wezlanaustekinumab-auub	Ustekinumab 90 mg/mL	Injection, SolutionSubcutaneous	Nuvaila Limited	84612-889