Prescription drug · BLA
Padcev Ejfv (Enfortumab vedotin) NDC 51144-030
Enfortumab vedotin 30 mg/3mL · Injection, Powder, Lyophilized, For solution · Intravenous · SEAGEN INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51144-030-01 | 51144003001 | 1 VIAL, SINGLE-DOSE in 1 BOX (51144-030-01) / 3 mL in 1 VIAL, SINGLE-DOSEMarketed from Dec 18, 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)
- Padcev EjfvSuffix: EJFV
- Generic name (nonproprietary)
- enfortumab vedotin
- Active ingredients
- Enfortumab vedotin — 30 mg/3mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- SEAGEN INC.NDC labeler code 51144
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761137
- Marketing start
- Listing expires
- Identifiers
- Product ID 51144-030_e8e304ca-8a56-4869-96e2-427ee4a1fe3cSPL ID e8e304ca-8a56-4869-96e2-427ee4a1fe3cSPL set ID b5631d3e-4604-4363-8f20-11dfc5a4a8edRxCUI 2268311, 2268315, 2268317, 2268319UNII DLE8519RWM
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
N451144003001followed by a unit qualifier and the quantityPackage 51144-0030-01. 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)
PADCEV ® , in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, is indicated for the treatment of adult patients with muscle invasive bladder cancer (MIBC). PADCEV ® , in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC). PADCEV, as a single agent, is indicated for the treatment of adult patients with la/mUC who: • have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and platinum-con…
Excerpt only. Read the full label for complete information.
About NDC 51144-030
- What is NDC 51144-030?
- 51144-030 is the product NDC for Padcev Ejfv (enfortumab vedotin), Enfortumab vedotin 30 mg/3mL injection, powder, lyophilized, 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?
- Padcev Ejfv (Enfortumab vedotin).
- What is the active ingredient?
- Enfortumab 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 Padcev Ejfv?
- 1 other product NDC are listed under this name. See all Padcev Ejfv NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Padcev Ejfv products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Padcev Ejfvenfortumab vedotin | Enfortumab vedotin 20 mg/2mL | Injection, Powder, Lyophilized, For solutionIntravenous | SEAGEN INC. | 51144-020 | 51144-0020-01 |
Other NDCs under BLA 761137
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Padcev Ejfvenfortumab vedotin | Enfortumab vedotin 20 mg/2mL | Injection, Powder, Lyophilized, For solutionIntravenous | SEAGEN INC. | 51144-020 |