YESCARTA
- Product NDC
- 71287-119
- 11-digit product format
- 712870119
- Labeler code
- 71287
- Product ID
- 71287-119_218926d3-232d-4c27-b42b-8421e7d70d86
- Type
- CELLULAR THERAPY
- Nonproprietary name
- axicabtagene ciloleucel
- Dosage form
- SUSPENSION
- Route
- INTRAVENOUS
- Labeler
- Kite Pharma, Inc.
- Application
- BLA125643
- Marketing category
- BLA
- Marketing start
- 2017-10-18
- Substance
- AXICABTAGENE CILOLEUCEL
- Active strength
- 2000000 1/68mL
- Pharmacologic classes
- CD19 Receptor Interactions [MoA], CD19-directed Chimeric Antigen Receptor [EPC], CD19-specific Chimeric Antigen Receptor [CS], Genetically-modified Autologous T Cells [EPC], Increased T Lymphocyte Activation [PE], T Lymphocytes, Cultured, Autologous, Genetically-modified [EXT]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- YESCARTA
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AXICABTAGENE CILOLEUCEL | 2000000 1/68mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U2I8T43Y7R |
| Rxcui | 1987402, 1987407 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71287-119-01 | YESCARTA | 68 mL in 1 BAG | SUSPENSION | 68 | | 21 |
| 71287-119-02 | YESCARTA | 1 in 1 PACKAGE | SUSPENSION | 1 | | 21 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71287-119 | YESCARTA (AXICABTAGENE CILOLEUCEL) SUSPENSION [KITE PHARMA, INC.] | 17 | Current NDC, Legacy NDC, 2 package rows | 20241215_9b70606e-b99c-4272-a0f1-b5523cce0c59.zip |
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 1987402 | axicabtagene ciloleucel 200,000,000 CELLS in 68 mL Injection | PSN | 9b70606e-b99c-4272-a0f1-b5523cce0c59 | 21 |
| 1987407 | YESCARTA 200,000,000 CELLS in 68 mL Injection | PSN | 9b70606e-b99c-4272-a0f1-b5523cce0c59 | 21 |
| 1987407 | 68 ML axicabtagene ciloleucel 2940000 CELLS/ML Injection [Yescarta] | SBD | 9b70606e-b99c-4272-a0f1-b5523cce0c59 | 21 |
| 1987402 | 68 ML axicabtagene ciloleucel 2940000 CELLS/ML Injection | SCD | 9b70606e-b99c-4272-a0f1-b5523cce0c59 | 21 |
| 1987407 | 68 ML Yescarta 2940000 CELLS/ML Injection | SY | 9b70606e-b99c-4272-a0f1-b5523cce0c59 | 21 |
| 1987402 | axicabtagene ciloleucel 200,000,000 CELLS per 68 ML Injection | SY | 9b70606e-b99c-4272-a0f1-b5523cce0c59 | 21 |
| 1987407 | Yescarta 200,000,000 CELLS per 68 ML Injection | SY | 9b70606e-b99c-4272-a0f1-b5523cce0c59 | 21 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71287-119-01 | 71287011901 | 68 mL in 1 BAG | 68 ml | | | | | Historical |
| 71287-119-02 | 71287011902 | 1 BAG in 1 PACKAGE (71287-119-02) / 68 mL in 1 BAG (71287-119-01) | 1 bag | 2017-10-18 | 0000-00-00 | No | No | Current |