Ustekinumab-Ttwe NDC 82009-163

NDC codes

FDA NDC Directory

Product NDC (as listed)82009-163Labeler and product segments. Claims need a package NDC.

Product NDC at billing width82009-0163Add 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
82009-163-94	82009016394	1 VIAL, SINGLE-USE in 1 CARTON (82009-163-94) / 26 mL in 1 VIAL, SINGLE-USEMarketed from Apr 15, 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-Ttwe
Generic name (nonproprietary): ustekinumab-ttwe
Active ingredients: Ustekinumab — 130 mg/26mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: Quallent Pharmaceuticals Health LLC
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 761425
Marketing start: Apr 15, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Interleukin-12 Antagonists (Mechanism)Interleukin-23 Antagonists (Mechanism)
Identifiers: Product ID 82009-163_cb6d8d30-9458-42ed-8aee-2aae13f4760bSPL ID cb6d8d30-9458-42ed-8aee-2aae13f4760bSPL set ID 2b34392a-ecf6-41bd-8706-d4e9f0b25da8RxCUI 2705557, 2705568, 2705575, 2713885UNII 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 codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

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

N482009016394 followed by a unit qualifier and the quantity

Package 82009-0163-94. 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 Jan 12, 2026.

Indications (excerpt from the label)

USTEKINUMAB-TTWE 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) USTEKINUMAB-TTWE is indicated for the treatment of adults and pediatric patients 6 years of age an…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under BLA 761425

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

FDA NDC Directory listings under BLA 761425
Product	Strength	Form · route	Labeler	Product NDC
Pyzchivaustekinumab-ttwe	Ustekinumab 130 mg/26mL	Injection, SolutionIntravenous	SANDOZ INC	61314-654