Cellular therapy · BLA
Tecartus (Brexucabtagene autoleucel) NDC 71287-219
Brexucabtagene autoleucel 2000000 1/68mL · Suspension · Intravenous · Kite Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71287-219-02 | 71287021902 | 1 BAG in 1 PACKAGE (71287-219-02) / 68 mL in 1 BAG (71287-219-01)Marketed from Jul 24, 2020 |
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)
- Tecartus
- Generic name (nonproprietary)
- brexucabtagene autoleucel
- Active ingredients
- Brexucabtagene autoleucel — 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 125703
- Marketing start
- Listing expires
- Identifiers
- Product ID 71287-219_17c4a716-a22e-486d-b633-4be6c2453266SPL ID 17c4a716-a22e-486d-b633-4be6c2453266SPL set ID a16108c2-7ca7-45af-965e-54bda4713022RxCUI 2387347, 2387352, 2572002, 2572005UNII 4MD2J2T8SJ
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
N471287021902followed by a unit qualifier and the quantityPackage 71287-0219-02. 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)
TECARTUS is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: Adult patients with relapsed or refractory mantle cell lymphoma (MCL). Adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). 1.1 Mantle Cell Lymphoma TECARTUS is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). 1.2 Acute Lymphoblastic Leukemia TECARTUS is indicated for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
Excerpt only. Read the full label for complete information.
About NDC 71287-219
- What is NDC 71287-219?
- 71287-219 is the product NDC for Tecartus (brexucabtagene autoleucel), Brexucabtagene autoleucel 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?
- Tecartus (Brexucabtagene autoleucel).
- What is the active ingredient?
- Brexucabtagene autoleucel.
- 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 Tecartus?
- 1 other product NDC are listed under this name. See all Tecartus NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tecartus products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tecartusbrexucabtagene autoleucel | Brexucabtagene autoleucel 1000000 1/68mL | SuspensionIntravenous | Kite Pharma, Inc. | 71287-220 | 71287-0220-02 |
Other NDCs under BLA 125703
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 |
|---|---|---|---|---|
| Tecartusbrexucabtagene autoleucel | Brexucabtagene autoleucel 1000000 1/68mL | SuspensionIntravenous | Kite Pharma, Inc. | 71287-220 |