Prescription drug · NDA
Yondelis (Trabectedin) NDC 59676-610
Trabectedin .05 mg/mL · Injection, Powder, Lyophilized, For solution · Intravenous · Janssen Products, LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59676-610-01 | 59676061001 | 20 mL in 1 VIAL, SINGLE-USE (59676-610-01)Marketed from Oct 23, 2015 |
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)
- Yondelis
- Generic name (nonproprietary)
- trabectedin
- Active ingredients
- Trabectedin — .05 mg/mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Janssen Products, LPNDC labeler code 59676
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 207953
- Marketing start
- Listing expires
- Other FDA classes
- Alkylating Activity (Mechanism)
- Identifiers
- Product ID 59676-610_354fa826-08c3-4ce1-b1fb-16e63ad09253SPL ID 354fa826-08c3-4ce1-b1fb-16e63ad09253SPL set ID 472bd78e-be17-4b9d-90f4-9482c3aec9ffRxCUI 1718589, 1718594UNII ID0YZQ2TCP
- Pharmacologic class
- Alkylating Drug
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
N459676061001followed by a unit qualifier and the quantityPackage 59676-0610-01. 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)
YONDELIS ® is indicated for the treatment of adult patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen [see Clinical Studies (14) ] . YONDELIS is an alkylating drug indicated for the treatment of adult patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 59676-610
- What is NDC 59676-610?
- 59676-610 is the product NDC for Yondelis (trabectedin), Trabectedin .05 mg/mL injection, powder, lyophilized, for solution, listed with the FDA by Janssen Products, LP. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Yondelis (Trabectedin).
- What is the active ingredient?
- Trabectedin.
- Who is the labeler?
- Janssen Products, LP, NDC labeler code 59676. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Yondelis?
- 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.