NDC codes

FDA NDC Directory
Product NDC (as listed)83257-023Labeler and product segments. Claims need a package NDC.
Product NDC at billing width83257-0023Add 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 NDC11-digit (billing)PackageCopy
83257-023-41832570023411 SYRINGE in 1 CARTON (83257-023-41) / .5 mL in 1 SYRINGEMarketed from Feb 22, 2025 · Sample package

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)
Yesintek
Generic name (nonproprietary)
ustekinumab
Active ingredients
Ustekinumab — 45 mg/.5mL
Dosage form
Injection, Solution
Route
Subcutaneous
Product type
Prescription drug
Marketing category
BLA — Biologics License ApplicationApplication BLA 761406
Marketing start
Listing expires
Other FDA classes
Interleukin-12 Antagonists (Mechanism)Interleukin-23 Antagonists (Mechanism)
Identifiers
Product ID 83257-023_326c6710-ed89-ec68-64de-c829281376d4SPL ID 326c6710-ed89-ec68-64de-c829281376d4
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

N483257002341 followed by a unit qualifier and the quantity

Package 83257-0023-41. 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

The FDA listing for this product does not reference a label (SPL) set.

Other NDCs under BLA 761406

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

FDA NDC Directory listings under BLA 761406
ProductStrengthForm · routeLabelerProduct NDC
YesintekustekinumabUstekinumab 45 mg/.5mLInjection, SolutionSubcutaneousBiocon Biologics Inc.83257-024
YesintekustekinumabUstekinumab 90 mg/mLInjection, SolutionSubcutaneousBiocon Biologics Inc.83257-025
YesintekustekinumabUstekinumab 130 mg/26mLSolutionIntravenousBiocon Biologics Inc.83257-026

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Yesintek (ustekinumab) NDC 83257-023 · J-Code J3357 | Med-Code