Cellular therapy · BLA
Amtagvi (Lifileucel) NDC 73776-001
Lifileucel 72000000000 1/500mL · Suspension · Intravenous · Iovance Biotherapeutics Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 73776-001-12 | 73776000112 | 1 BAG in 1 CARTRIDGE (73776-001-12) / 125 mL in 1 BAG (73776-001-11)Marketed from Feb 16, 2024 |
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)
- Amtagvi
- Generic name (nonproprietary)
- lifileucel
- Active ingredients
- Lifileucel — 72000000000 1/500mL
- Dosage form
- Suspension
- Route
- Intravenous
- Labeler
- Iovance Biotherapeutics Inc.NDC labeler code 73776
- Product type
- Cellular therapy
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125773
- Marketing start
- Listing expires
- Identifiers
- Product ID 73776-001_4120d6b2-93d7-e0bf-e063-6294a90a6e7fSPL ID 4120d6b2-93d7-e0bf-e063-6294a90a6e7fSPL set ID 4121bd3f-2d6e-3bdd-e063-6294a90a3088RxCUI 2675868, 2675874UNII R0835E18NHUPC 0373776001121
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
N473776000112followed by a unit qualifier and the quantityPackage 73776-0001-12. 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)
AMTAGVI is a tumor-derived autologous T cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. This indication is approved under accelerated approval based on objective response rate (ORR) [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). AMTAGVI is a tumor-derived autologous T cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic melanoma previous…
Excerpt only. Read the full label for complete information.
About NDC 73776-001
- What is NDC 73776-001?
- 73776-001 is the product NDC for Amtagvi (lifileucel), Lifileucel 72000000000 1/500mL suspension, listed with the FDA by Iovance Biotherapeutics Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Amtagvi (Lifileucel).
- What is the active ingredient?
- Lifileucel.
- Who is the labeler?
- Iovance Biotherapeutics Inc., NDC labeler code 73776. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Amtagvi?
- 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.