Prescription drug · BLA
Emrelis (Telisotuzumab vedotin) NDC 0074-1044
Telisotuzumab vedotin 20 mg/mL · Injection, Powder, Lyophilized, For solution · Intravenous · AbbVie Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0074-1044-01 | 00074104401 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0074-1044-01) / 1 mL in 1 VIAL, SINGLE-DOSEMarketed from May 14, 2025 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Emrelis
- Generic name (nonproprietary)
- telisotuzumab vedotin
- Active ingredients
- Telisotuzumab vedotin — 20 mg/mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- AbbVie Inc.NDC labeler code 0074
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761384
- Marketing start
- Listing expires
- Identifiers
- Product ID 0074-1044_998985bb-7cd1-4e80-bd08-8fc7c503f982SPL ID 998985bb-7cd1-4e80-bd08-8fc7c503f982SPL set ID bc04f980-3957-4e35-ab81-8ec2ffe87215RxCUI 2714245, 2714251, 2714253, 2714255UNII 976X9VXC3Z
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
N400074104401followed by a unit qualifier and the quantityPackage 00074-1044-01. 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)
EMRELIS is indicated for the treatment of adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining], as determined by an FDA-approved test [see Dosage and Administration ( 2.1 )] , who have received a prior systemic therapy . This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR) [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). EMRELIS is a c-Met-directed antibody and microtubul…
Excerpt only. Read the full label for complete information.
About NDC 0074-1044
- What is NDC 0074-1044?
- 0074-1044 is the product NDC for Emrelis (telisotuzumab vedotin), Telisotuzumab vedotin 20 mg/mL injection, powder, lyophilized, for solution, listed with the FDA by AbbVie Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Emrelis (Telisotuzumab Vedotin).
- What is the active ingredient?
- Telisotuzumab vedotin.
- Who is the labeler?
- AbbVie Inc., NDC labeler code 0074. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Emrelis?
- 1 other product NDC are listed under this name. See all Emrelis NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Emrelis products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Emrelistelisotuzumab vedotin | Telisotuzumab vedotin 100 mg/mL | Injection, Powder, Lyophilized, For solutionIntravenous | AbbVie Inc. | 0074-1055 | 00074-1055-01 |
Other NDCs under BLA 761384
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 |
|---|---|---|---|---|
| Emrelistelisotuzumab vedotin | Telisotuzumab vedotin 100 mg/mL | Injection, Powder, Lyophilized, For solutionIntravenous | AbbVie Inc. | 0074-1055 |