Prescription drug · BLA
Tivdak (Tisotumab vedotin) NDC 51144-003
Tisotumab vedotin 40 mg/4mL · Injection, Powder, For solution · Intravenous · SEAGEN INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51144-003-01 | 51144000301 | 1 VIAL in 1 CARTON (51144-003-01) / 4 mL in 1 VIALMarketed from Sep 20, 2021 |
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)
- Tivdak
- Generic name (nonproprietary)
- tisotumab vedotin
- Active ingredients
- Tisotumab vedotin — 40 mg/4mL
- Dosage form
- Injection, Powder, For solution
- Route
- Intravenous
- Labeler
- SEAGEN INC.NDC labeler code 51144
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761208
- Marketing start
- Listing expires
- Identifiers
- Product ID 51144-003_62959a22-02f7-463c-80bb-3c5e621b1f58SPL ID 62959a22-02f7-463c-80bb-3c5e621b1f58SPL set ID c9fe3f32-4219-466e-acb9-3f609b4f4df1RxCUI 2571099, 2571104UNII T41737F88AUPC 0351144003014
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
N451144000301followed by a unit qualifier and the quantityPackage 51144-0003-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
TIVDAK ® is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. TIVDAK is a tissue factor-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 51144-003
- What is NDC 51144-003?
- 51144-003 is the product NDC for Tivdak (tisotumab vedotin), Tisotumab vedotin 40 mg/4mL injection, powder, for solution, listed with the FDA by SEAGEN INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tivdak (Tisotumab vedotin).
- What is the active ingredient?
- Tisotumab vedotin.
- Who is the labeler?
- SEAGEN INC., NDC labeler code 51144. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tivdak?
- 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.