Enhertu (fam-trastuzumab deruxtecan-nxki) NDC 65597-406

NDC codes

FDA NDC Directory

Product NDC (as listed)65597-406Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65597-0406Add 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
65597-406-01	65597040601	1 VIAL, SINGLE-DOSE in 1 CARTON (65597-406-01) / 5 mL in 1 VIAL, SINGLE-DOSEMarketed from Dec 20, 2019

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): Enhertu
Generic name (nonproprietary): fam-trastuzumab deruxtecan-nxki
Active ingredients: Trastuzumab deruxtecan — 100 mg/5mL
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intravenous
Labeler: Daiichi Sankyo Inc.
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 761139
Marketing start: Dec 20, 2019
Listing expires: Dec 31, 2027
Identifiers: Product ID 65597-406_a4106ba4-f398-4663-980c-2b7195283eddSPL ID a4106ba4-f398-4663-980c-2b7195283eddSPL set ID 7e67e73e-ddf4-4e4d-8b50-09d7514910b6RxCUI 2267576, 2267581UNII 5384HK7574

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

N465597040601 followed by a unit qualifier and the quantity

Package 65597-0406-01. 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 May 15, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for: HER2-Positive Early Breast Cancer as neoadjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer, as determined by an FDA-authorized test followed by a taxane, trastuzumab, and pertuzumab (THP). ( 1.1 ) as adjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) breast cancer who have residual invasive disease following neoadjuvant trastuzumab (with or without pertuzumab) and taxane-based treatment. ( 1.1 ) HER2-Positive Metastatic Breast Cancer in combination with pertuzumab as first-line treatment of adult patients with unresectable or metas…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)