BREYANZI
- Product NDC
- 73153-900
- 11-digit product format
- 731530900
- Labeler code
- 73153
- Product ID
- 73153-900_6e83a5e5-a286-42e0-b22b-7d5f0b2cb920
- Type
- CELLULAR THERAPY
- Nonproprietary name
- Lisocabtagene maraleucel
- Dosage form
- KIT
- Labeler
- Juno Therapeutics, Inc.
- Application
- BLA125714
- Marketing category
- BLA
- Marketing start
- 2021-02-05
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BREYANZI
- Listing expiration
- 2027-12-31
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Rxcui | 2479140, 2479145 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 73153-900-01 | BREYANZI | 1 in 1 CARTON | KIT | 1 | | 15 |
| 73153-901-08 | BREYANZI | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SUSPENSION | 5 mL | 50000000 in 5mL | 15 |
| 73153-902-04 | BREYANZI | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SUSPENSION | 5 mL | 50000000 in 5mL | 15 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 73153-900 | BREYANZI (LISOCABTAGENE MARALEUCEL) KIT [JUNO THERAPEUTICS, INC.] | 12 | Current NDC, Legacy NDC, 3 package rows | 20240612_594bb413-af3b-4b97-afb3-bfe2b174f2ed.zip |
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 2479145 | Breyanzi 70,000,000 CELLS/mL in 4.6 mL Injection | PSN | 594bb413-af3b-4b97-afb3-bfe2b174f2ed | 15 |
| 2479140 | lisocabtagene maraleucel 70,000,000 CELLS/mL in 4.6 mL Injection | PSN | 594bb413-af3b-4b97-afb3-bfe2b174f2ed | 15 |
| 2479145 | 4.6 ML lisocabtagene maraleucel 70000000 CELLS/ML Injection [Breyanzi] | SBD | 594bb413-af3b-4b97-afb3-bfe2b174f2ed | 15 |
| 2479140 | 4.6 ML lisocabtagene maraleucel 70000000 CELLS/ML Injection | SCD | 594bb413-af3b-4b97-afb3-bfe2b174f2ed | 15 |
| 2479145 | 4.6 ML Breyanzi 70,000,000 CELLS/ML Injection | SY | 594bb413-af3b-4b97-afb3-bfe2b174f2ed | 15 |
| 2479145 | Breyanzi 70,000,000 CELLS/ML per 4.6 ML Injection | SY | 594bb413-af3b-4b97-afb3-bfe2b174f2ed | 15 |
| 2479140 | lisocabtagene maraleucel 70,000,000 CELLS/ML per 4.6 ML Injection | SY | 594bb413-af3b-4b97-afb3-bfe2b174f2ed | 15 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 73153-900-01 | 73153090001 | 1 KIT in 1 CARTON (73153-900-01) * 5 mL in 1 VIAL, SINGLE-DOSE (73153-902-04) * 5 mL in 1 VIAL, SINGLE-DOSE (73153-901-08) | 1 kit | 2021-02-05 | 0000-00-00 | No | No | Current |
| 73153-901-08 | 73153090108 | 5 mL in 1 VIAL, SINGLE-DOSE | 5 ml | | | | | Historical |
| 73153-902-04 | 73153090204 | 5 mL in 1 VIAL, SINGLE-DOSE | 5 ml | | | | | Historical |