Cellular therapy · BLA
Yescarta (Axicabtagene ciloleucel) NDC 71287-119
Axicabtagene ciloleucel 2000000 1/68mL · Suspension · Intravenous · Kite Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71287-119-02 | 71287011902 | 1 BAG in 1 PACKAGE (71287-119-02) / 68 mL in 1 BAG (71287-119-01)Marketed from Oct 18, 2017 |
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)
- Yescarta
- Generic name (nonproprietary)
- axicabtagene ciloleucel
- Active ingredients
- Axicabtagene ciloleucel — 2000000 1/68mL
- Dosage form
- Suspension
- Route
- Intravenous
- Labeler
- Kite Pharma, Inc.NDC labeler code 71287
- Product type
- Cellular therapy
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125643
- Marketing start
- Listing expires
- Other FDA classes
- CD19 Receptor Interactions (Mechanism)CD19-specific Chimeric Antigen Receptor (Chemical structure)Increased T Lymphocyte Activation (Physiologic effect)Genetically-modified (EXT)
- Identifiers
- Product ID 71287-119_23cad324-9e01-4dba-8152-354dadb7b1e5SPL ID 23cad324-9e01-4dba-8152-354dadb7b1e5SPL set ID 9b70606e-b99c-4272-a0f1-b5523cce0c59RxCUI 1987402, 1987407UNII U2I8T43Y7R
- Pharmacologic class
- CD19-directed Chimeric Antigen Receptor; Genetically-modified Autologous T Cells
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
N471287011902followed by a unit qualifier and the quantityPackage 71287-0119-02. 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)
YESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: Adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. ( 1.1 ) Adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. ( 1.1 ) Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy…
Excerpt only. Read the full label for complete information.
About NDC 71287-119
- What is NDC 71287-119?
- 71287-119 is the product NDC for Yescarta (axicabtagene ciloleucel), Axicabtagene ciloleucel 2000000 1/68mL suspension, listed with the FDA by Kite Pharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Yescarta (Axicabtagene ciloleucel).
- What is the active ingredient?
- Axicabtagene ciloleucel.
- Who is the labeler?
- Kite Pharma, Inc., NDC labeler code 71287. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Yescarta?
- 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.