Yescarta Suspension
NDC Package 71287-119-02
Package Information
Yescarta (axicabtagene ciloleucel) suspension is yESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of 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.Limitation of Use: YESCARTA is not indicated for the treatment of patients with primary central nervous system lymphoma. This formulation utilizes a suspension delivery system. Marketed by Kite Pharma, Inc., this product is identified by NDC 71287-119 and is authorized under FDA application BLA125643.
Identification & Billing
- RxCUI: 1987402 - axicabtagene ciloleucel 200,000,000 CELLS in 68 mL Injection
- RxCUI: 1987402 - 68 ML axicabtagene ciloleucel 2940000 CELLS/ML Injection
- RxCUI: 1987402 - axicabtagene ciloleucel 200,000,000 CELLS per 68 ML Injection
- RxCUI: 1987407 - YESCARTA 200,000,000 CELLS in 68 mL Injection
- RxCUI: 1987407 - 68 ML axicabtagene ciloleucel 2940000 CELLS/ML Injection [Yescarta]
Clinical Specifications
- CD19 Receptor Interactions - [MoA] (Mechanism of Action)
- CD19-directed Chimeric Antigen Receptor - [EPC] (Established Pharmacologic Class)
- CD19-specific Chimeric Antigen Receptor - [CS]
- Genetically-modified Autologous T Cells - [EPC] (Established Pharmacologic Class)
- Increased T Lymphocyte Activation - [PE] (Physiologic Effect)
- T Lymphocytes, Cultured, Autologous, Genetically-modified - [EXT]
Regulatory & Marketing
Hierarchy Structure
- 71287 - Kite Pharma, Inc.
- 71287-119 - Yescarta
- 71287-119-02 - 1 BAG in 1 PACKAGE / 68 mL in 1 BAG (71287-119-01)
- 71287-119 - Yescarta
The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 71287-119-02 identifies a specific commercial package of 1 bag in 1 package / 68 ml in 1 bag (71287-119-01) of Yescarta, a cellular therapy labeled by Kite Pharma, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This suspension is formulated for intravenous use and contains axicabtagene ciloleucel as the active substance.
Is this product currently listed with the FDA?
Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Kite Pharma, Inc. on October 18, 2017. The current certification is valid through December 31, 2027.
How is this Kite Pharma, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 71287011902. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.
11-Digit Code Conversion
Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.