TECARTUS
- Product NDC
- 71287-219
- 11-digit product format
- 712870219
- Labeler code
- 71287
- Product ID
- 71287-219_16fbe9a0-d7d4-43b1-aa67-3c16ff8c5f55
- Type
- CELLULAR THERAPY
- Nonproprietary name
- brexucabtagene autoleucel
- Dosage form
- SUSPENSION
- Route
- INTRAVENOUS
- Labeler
- Kite Pharma, Inc.
- Application
- BLA125703
- Marketing category
- BLA
- Marketing start
- 2020-07-24
- Substance
- BREXUCABTAGENE AUTOLEUCEL
- Active strength
- 2000000 1/68mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TECARTUS
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BREXUCABTAGENE AUTOLEUCEL | 2000000 1/68mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4MD2J2T8SJ |
| Rxcui | 2387347, 2387352, 2572002, 2572005 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71287-219-01 | TECARTUS | 68 mL in 1 BAG | SUSPENSION | 68 | | 16 |
| 71287-219-02 | TECARTUS | 1 in 1 PACKAGE | SUSPENSION | 1 | | 16 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71287-219 | TECARTUS (BREXUCABTAGENE AUTOLEUCEL) SUSPENSION [KITE PHARMA, INC.] | 12 | Current NDC, Legacy NDC, 2 package rows | 20240627_a16108c2-7ca7-45af-965e-54bda4713022.zip |
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 2572002 | brexucabtagene autoleucel 100,000,000 CELLS per 68 ML Injection | PSN | a16108c2-7ca7-45af-965e-54bda4713022 | 16 |
| 2387347 | brexucabtagene autoleucel 200,000,000 CELLS in 68 ML Injection | PSN | a16108c2-7ca7-45af-965e-54bda4713022 | 16 |
| 2572005 | Tecartus 100,000,000 CELLS in 68 ML Injection | PSN | a16108c2-7ca7-45af-965e-54bda4713022 | 16 |
| 2387352 | Tecartus 200,000,000 CELLS in 68 ML Injection | PSN | a16108c2-7ca7-45af-965e-54bda4713022 | 16 |
| 2572005 | 68 ML brexucabtagene autoleucel 1471000 CELLS/ML Injection [Tecartus] | SBD | a16108c2-7ca7-45af-965e-54bda4713022 | 16 |
| 2387352 | 68 ML brexucabtagene autoleucel 2940000 CELLS/ML Injection [Tecartus] | SBD | a16108c2-7ca7-45af-965e-54bda4713022 | 16 |
| 2572002 | 68 ML brexucabtagene autoleucel 1471000 CELLS/ML Injection | SCD | a16108c2-7ca7-45af-965e-54bda4713022 | 16 |
| 2387347 | 68 ML brexucabtagene autoleucel 2940000 CELLS/ML Injection | SCD | a16108c2-7ca7-45af-965e-54bda4713022 | 16 |
| 2572005 | 68 ML Tecartus 1471000 CELLS/ML Injection | SY | a16108c2-7ca7-45af-965e-54bda4713022 | 16 |
| 2387352 | 68 ML Tecartus 2940000 CELLS/ML Injection | SY | a16108c2-7ca7-45af-965e-54bda4713022 | 16 |
| 2572002 | brexucabtagene autoleucel 100,000,000 CELLS per 68 ML Injection | SY | a16108c2-7ca7-45af-965e-54bda4713022 | 16 |
| 2387347 | brexucabtagene autoleucel 200,000,000 CELLS per 68 ML Injection | SY | a16108c2-7ca7-45af-965e-54bda4713022 | 16 |
| 2572005 | Tecartus 100,000,000 CELLS per 68 ML Injection | SY | a16108c2-7ca7-45af-965e-54bda4713022 | 16 |
| 2387352 | Tecartus 200,000,000 CELLS per 68 ML Injection | SY | a16108c2-7ca7-45af-965e-54bda4713022 | 16 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71287-219-01 | 71287021901 | 68 mL in 1 BAG | 68 ml | | | | | Historical |
| 71287-219-02 | 71287021902 | 1 BAG in 1 PACKAGE (71287-219-02) / 68 mL in 1 BAG (71287-219-01) | 1 bag | 2020-07-24 | 0000-00-00 | No | No | Current |