Otulfi (ustekinumab-aauz) NDC 65219-824

NDC codes

FDA NDC Directory

Product NDC (as listed)65219-824Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65219-0824Add 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
65219-824-01	65219082401	1 SYRINGE in 1 CARTON (65219-824-01) / .5 mL in 1 SYRINGEMarketed from Feb 22, 2024

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): Otulfi
Generic name (nonproprietary): ustekinumab-aauz
Active ingredients: Ustekinumab — 45 mg/.5mL
Dosage form: Injection, Solution
Route: Subcutaneous
Labeler: Fresenius Kabi USA, LLC
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 761379
Marketing start: Feb 22, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Interleukin-12 Antagonists (Mechanism)Interleukin-23 Antagonists (Mechanism)
Identifiers: Product ID 65219-824_6d4382de-5c0c-4603-b7e0-40acb62f9368SPL ID 6d4382de-5c0c-4603-b7e0-40acb62f9368SPL set ID 853130e5-7406-4fd6-8138-ff2179195927RxCUI 2702606, 2702613, 2702615, 2702616, 2702619, 2702624, 2724429, 2724431UNII 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

N465219082401 followed by a unit qualifier and the quantity

Package 65219-0824-01. 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 Feb 16, 2026.

Indications (excerpt from the label)

OTULFI is a human interleukin-12 and -23 antagonist indicated for the treatment of: Adult patients with: • moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. ( 1.1 ) • active psoriatic arthritis (PsA) . ( 1.2 ) • moderately to severely active Crohn's disease (CD) . ( 1.3 ) • moderately to severely active ulcerative colitis. ( 1.4 ) Pediatric patients 6 years and older with: • moderate to severe plaque psoriasis (PsO) , who are candidates for phototherapy or systemic therapy. ( 1.1 ) • active psoriatic arthritis (PsA) . ( 1.2 ) 1.1 Plaque Psoriasis (PsO) OTULFI is indicated for the treatment of adults and pediatric patients 6 years of age and ol…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under BLA 761379

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

FDA NDC Directory listings under BLA 761379
Product	Strength	Form · route	Labeler	Product NDC
Otulfiustekinumab-aauz	Ustekinumab 45 mg/.5mL	Injection, SolutionSubcutaneous	Fresenius Kabi USA, LLC	65219-822
Ustekinumab-Aauz	Ustekinumab 90 mg/mL	Injection, SolutionSubcutaneous	Fresenius Kabi USA, LLC	65219-866
Otulfiustekinumab-aauz	Ustekinumab 90 mg/mL	Injection, SolutionSubcutaneous	Fresenius Kabi USA, LLC	65219-826
Otulfiustekinumab-aauz	Ustekinumab 130 mg/26mL	SolutionIntravenous	Fresenius Kabi USA, LLC	65219-828
Ustekinumab-Aauz	Ustekinumab 45 mg/.5mL	Injection, SolutionSubcutaneous	Fresenius Kabi USA, LLC	65219-862