Prescription drug · BLA
Datroway (Datopotamab deruxtecan) NDC 65597-801
Datopotamab deruxtecan 100 mg/5mL · Injection, Powder, Lyophilized, For solution · Intravenous · Daiichi Sankyo Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65597-801-01 | 65597080101 | 1 VIAL, SINGLE-DOSE in 1 CARTON (65597-801-01) / 5 mL in 1 VIAL, SINGLE-DOSEMarketed from Jan 17, 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)
- Datroway
- Generic name (nonproprietary)
- datopotamab deruxtecan
- Active ingredients
- Datopotamab deruxtecan — 100 mg/5mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Daiichi Sankyo Inc.NDC labeler code 65597
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761394
- Marketing start
- Listing expires
- Identifiers
- Product ID 65597-801_c5c6cd04-1bea-4809-a830-b1fb1ba94e97SPL ID c5c6cd04-1bea-4809-a830-b1fb1ba94e97SPL set ID 2950227c-6230-4ca4-a135-46e44d9424a0RxCUI 2703040, 2703046UNII GD2OWY1DTK
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.
- NDC on a medical claim
N465597080101followed by a unit qualifier and the quantityPackage 65597-0801-01. 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 .
Indications (excerpt from the label)
DATROWAY is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of: adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy. ( 1.1 ) This indication is approved under accelerated approval based on objective response rate and duration of response [see Clinical Studies (14.1) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial. adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) wh…
Excerpt only. Read the full label for complete information.
About NDC 65597-801
- What is NDC 65597-801?
- 65597-801 is the product NDC for Datroway (datopotamab deruxtecan), Datopotamab deruxtecan 100 mg/5mL injection, powder, lyophilized, for solution, listed with the FDA by Daiichi Sankyo Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Datroway (Datopotamab Deruxtecan).
- What is the active ingredient?
- Datopotamab deruxtecan.
- Who is the labeler?
- Daiichi Sankyo Inc., NDC labeler code 65597. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Datroway?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.