ustekinumab NDC 57894-440 · J-Code J3357

NDC codes

FDA NDC Directory

Product NDC (as listed)57894-440Labeler and product segments. Claims need a package NDC.

Product NDC at billing width57894-0440Add 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
57894-440-01	57894044001	1 SYRINGE in 1 CARTON (57894-440-01) / .5 mL in 1 SYRINGEMarketed from Apr 1, 2025
57894-440-03	57894044003	1 VIAL, SINGLE-USE in 1 CARTON (57894-440-03) / .5 mL in 1 VIAL, SINGLE-USEMarketed from Apr 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): ustekinumab
Generic name (nonproprietary): ustekinumab
Active ingredients: Ustekinumab — 45 mg/.5mL
Dosage form: Injection, Solution
Route: Subcutaneous
Labeler: Janssen Biotech, Inc.
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 125261
Marketing start: Apr 1, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Interleukin-12 Antagonists (Mechanism)Interleukin-23 Antagonists (Mechanism)
Identifiers: Product ID 57894-440_2e2c7c8d-c54a-43c7-bbb9-8aeb40088a06SPL ID 2e2c7c8d-c54a-43c7-bbb9-8aeb40088a06SPL set ID 23b486eb-f48d-47d4-815e-1313d4ebfbfaRxCUI 853350, 853355, 1654077, 1811255UNII FU77B4U5Z0UPC 0357894444015
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

N457894044001 followed by a unit qualifier and the quantity

Package 57894-0440-01. 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 Aug 31, 2026.

Indications (excerpt from the label)

Ustekinumab is a human interleukin-12 and -23 antagonist indicated for the treatment of: Moderate to severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for phototherapy or systemic therapy. ( 1.1 ) Active psoriatic arthritis in adults and pediatric patients 6 years of age and older. ( 1.2 ) Moderately to severely active Crohn's disease in adults and pediatric patients 2 years of age and older. ( 1.3 ) Moderately to severely active ulcerative colitis in adults and pediatric patients 2 years of age and older. ( 1.4 ) 1.1 Plaque Psoriasis (PsO) Ustekinumab is indicated for the treatment of adults and pediatric patients 6 years of age and older w…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under BLA 125261

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

FDA NDC Directory listings under BLA 125261
Product	Strength	Form · route	Labeler	Product NDC
Stelaraustekinumab	Ustekinumab 90 mg/mL	Injection, SolutionSubcutaneous	Janssen Biotech, Inc.	57894-061
Stelaraustekinumab	Ustekinumab 45 mg/.5mL	Injection, SolutionSubcutaneous	Janssen Biotech, Inc.	57894-060
ustekinumab	Ustekinumab 90 mg/mL	Injection, SolutionSubcutaneous	Janssen Biotech, Inc.	57894-441