FDA.reportPublic FDA data

Abecma

Product NDC
59572-515
11-digit product format
595720515
Labeler code
59572
Product ID
59572-515_49b988a5-ae62-4d6e-89c0-57e6f40459bc
Type
CELLULAR THERAPY
Nonproprietary name
idecabtagene vicleucel
Dosage form
SUSPENSION
Route
INTRAVENOUS
Labeler
Celgene Corporation
Application
BLA125736
Marketing category
BLA
Marketing start
2021-03-26
Substance
IDECABTAGENE VICLEUCEL
Active strength
300000000 1/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Abecma
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IDECABTAGENE VICLEUCEL300000000 1/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8PX1X7UG4D
Rxcui2536434, 2536439, 2536443, 2536445, 2536449, 2536451

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59572-515-012022-10-13C16284748780-1e4f33bdf-ade6-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use ABECMA safely and effectively. See full prescribing information for ABECMA. ABECMA™ (idecabtagene vicleucel), suspension for intravenous infusion Initial U.S. Approval: 2021
59572-515-012022-10-13C16284748780-1e4f33bdf-ade6-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use ABECMA safely and effectively. See full prescribing information for ABECMA. ABECMA ® (idecabtagene vicleucel), suspension for intravenous infusion Initial U.S. Approval: 2021
59572-515-012022-10-13C16284748780-1e4f33bdf-ade6-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use ABECMA safely and effectively. See full prescribing information for ABECMA. ABECMA ® (idecabtagene vicleucel), suspension for intravenous infusion Initial U.S. Approval: 2021
59572-515-022022-10-13C16284748780-1e4f33bdf-ade6-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use ABECMA safely and effectively. See full prescribing information for ABECMA. ABECMA™ (idecabtagene vicleucel), suspension for intravenous infusion Initial U.S. Approval: 2021
59572-515-022022-10-13C16284748780-1e4f33bdf-ade6-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use ABECMA safely and effectively. See full prescribing information for ABECMA. ABECMA ® (idecabtagene vicleucel), suspension for intravenous infusion Initial U.S. Approval: 2021
59572-515-022022-10-13C16284748780-1e4f33bdf-ade6-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use ABECMA safely and effectively. See full prescribing information for ABECMA. ABECMA ® (idecabtagene vicleucel), suspension for intravenous infusion Initial U.S. Approval: 2021
59572-515-032022-10-13C16284748780-1e4f33bdf-ade6-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use ABECMA safely and effectively. See full prescribing information for ABECMA. ABECMA™ (idecabtagene vicleucel), suspension for intravenous infusion Initial U.S. Approval: 2021
59572-515-032022-10-13C16284748780-1e4f33bdf-ade6-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use ABECMA safely and effectively. See full prescribing information for ABECMA. ABECMA ® (idecabtagene vicleucel), suspension for intravenous infusion Initial U.S. Approval: 2021
59572-515-032022-10-13C16284748780-1e4f33bdf-ade6-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use ABECMA safely and effectively. See full prescribing information for ABECMA. ABECMA ® (idecabtagene vicleucel), suspension for intravenous infusion Initial U.S. Approval: 2021
59572-515-012022-07-29C16284748780-1e4f33bdf-ade6-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use ABECMA safely and effectively. See full prescribing information for ABECMA. ABECMA™ (idecabtagene vicleucel), suspension for intravenous infusion Initial U.S. Approval: 2021
59572-515-012022-07-29C16284748780-1e4f33bdf-ade6-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use ABECMA safely and effectively. See full prescribing information for ABECMA. ABECMA ® (idecabtagene vicleucel), suspension for intravenous infusion Initial U.S. Approval: 2021
59572-515-012022-07-29C16284748780-1e4f33bdf-ade6-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use ABECMA safely and effectively. See full prescribing information for ABECMA. ABECMA ® (idecabtagene vicleucel), suspension for intravenous infusion Initial U.S. Approval: 2021
59572-515-022022-07-29C16284748780-1e4f33bdf-ade6-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use ABECMA safely and effectively. See full prescribing information for ABECMA. ABECMA™ (idecabtagene vicleucel), suspension for intravenous infusion Initial U.S. Approval: 2021
59572-515-022022-07-29C16284748780-1e4f33bdf-ade6-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use ABECMA safely and effectively. See full prescribing information for ABECMA. ABECMA ® (idecabtagene vicleucel), suspension for intravenous infusion Initial U.S. Approval: 2021
59572-515-022022-07-29C16284748780-1e4f33bdf-ade6-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use ABECMA safely and effectively. See full prescribing information for ABECMA. ABECMA ® (idecabtagene vicleucel), suspension for intravenous infusion Initial U.S. Approval: 2021
59572-515-032022-07-29C16284748780-1e4f33bdf-ade6-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use ABECMA safely and effectively. See full prescribing information for ABECMA. ABECMA™ (idecabtagene vicleucel), suspension for intravenous infusion Initial U.S. Approval: 2021
59572-515-032022-07-29C16284748780-1e4f33bdf-ade6-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use ABECMA safely and effectively. See full prescribing information for ABECMA. ABECMA ® (idecabtagene vicleucel), suspension for intravenous infusion Initial U.S. Approval: 2021
59572-515-032022-07-29C16284748780-1e4f33bdf-ade6-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use ABECMA safely and effectively. See full prescribing information for ABECMA. ABECMA ® (idecabtagene vicleucel), suspension for intravenous infusion Initial U.S. Approval: 2021

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59572-515-01Abecma1 in 1 BAGSUSPENSION119
59572-515-02Abecma1 in 1 BAGSUSPENSION119
59572-515-03Abecma1 in 1 BAGSUSPENSION119

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59572-515-01EA - Each59572-5150a0198eb-63d5-4007-8e42-0583446a067212021-05-05
59572-515-02EA - Each59572-51540b643b6-50de-44e1-8d0c-e60dd4edecd612021-05-05
59572-515-03EA - Each59572-51588275471-6e24-48ac-902e-52e0d558d49312021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59572-515ABECMA (IDECABTAGENE VICLEUCEL) SUSPENSION [CELGENE CORPORATION]16Current NDC, Legacy NDC, 3 package rows20250416_b90c1fe7-f5cc-464e-958a-af36e9c26d7c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2536451Abecma 510,000,000 CELLS in 100 ML InjectionPSNb90c1fe7-f5cc-464e-958a-af36e9c26d7c19
2536439Abecma 510,000,000 CELLS in 30 ML InjectionPSNb90c1fe7-f5cc-464e-958a-af36e9c26d7c19
2536445Abecma 510,000,000 CELLS in 70 ML InjectionPSNb90c1fe7-f5cc-464e-958a-af36e9c26d7c19
2536449idecabtagene vicleucel 510,000,000 CELLS in 100 ML InjectionPSNb90c1fe7-f5cc-464e-958a-af36e9c26d7c19
2536434idecabtagene vicleucel 510,000,000 CELLS in 30 ML InjectionPSNb90c1fe7-f5cc-464e-958a-af36e9c26d7c19
2536443idecabtagene vicleucel 510,000,000 CELLS in 70 ML InjectionPSNb90c1fe7-f5cc-464e-958a-af36e9c26d7c19
2536451100 ML idecabtagene vicleucel 5100000 CELLS/ML Injection [Abecma]SBDb90c1fe7-f5cc-464e-958a-af36e9c26d7c19
253643930 ML idecabtagene vicleucel 17000000 CELLS/ML Injection [Abecma]SBDb90c1fe7-f5cc-464e-958a-af36e9c26d7c19
253644570 ML idecabtagene vicleucel 7285714 CELLS/ML Injection [Abecma]SBDb90c1fe7-f5cc-464e-958a-af36e9c26d7c19
2536449100 ML idecabtagene vicleucel 5100000 CELLS/ML InjectionSCDb90c1fe7-f5cc-464e-958a-af36e9c26d7c19
253643430 ML idecabtagene vicleucel 17000000 CELLS/ML InjectionSCDb90c1fe7-f5cc-464e-958a-af36e9c26d7c19
253644370 ML idecabtagene vicleucel 7285714 CELLS/ML InjectionSCDb90c1fe7-f5cc-464e-958a-af36e9c26d7c19
2536451100 ML Abecma 5100000 CELLS/ML InjectionSYb90c1fe7-f5cc-464e-958a-af36e9c26d7c19
253643930 ML Abecma 17000000 CELLS/ML InjectionSYb90c1fe7-f5cc-464e-958a-af36e9c26d7c19
253644570 ML Abecma 7285714 CELLS/ML InjectionSYb90c1fe7-f5cc-464e-958a-af36e9c26d7c19
2536439Abecma 17000000 CELLS/ML per 30 ML InjectionSYb90c1fe7-f5cc-464e-958a-af36e9c26d7c19
2536451Abecma 510,000,000 CELLS per 100 ML InjectionSYb90c1fe7-f5cc-464e-958a-af36e9c26d7c19
2536439Abecma 510,000,000 CELLS per 30 ML InjectionSYb90c1fe7-f5cc-464e-958a-af36e9c26d7c19
2536445Abecma 510,000,000 CELLS per 70 ML InjectionSYb90c1fe7-f5cc-464e-958a-af36e9c26d7c19
2536451Abecma 5100000 CELLS/ML per 100 ML InjectionSYb90c1fe7-f5cc-464e-958a-af36e9c26d7c19
2536445Abecma 7285714 CELLS/ML per 70 ML InjectionSYb90c1fe7-f5cc-464e-958a-af36e9c26d7c19
2536434idecabtagene vicleucel 17000000 CELLS/ML per 30 ML InjectionSYb90c1fe7-f5cc-464e-958a-af36e9c26d7c19
2536449idecabtagene vicleucel 510,000,000 CELLS per 100 ML InjectionSYb90c1fe7-f5cc-464e-958a-af36e9c26d7c19
2536434idecabtagene vicleucel 510,000,000 CELLS per 30 ML InjectionSYb90c1fe7-f5cc-464e-958a-af36e9c26d7c19
2536443idecabtagene vicleucel 510,000,000 CELLS per 70 ML InjectionSYb90c1fe7-f5cc-464e-958a-af36e9c26d7c19
2536449idecabtagene vicleucel 5100000 CELLS/ML per 100 ML InjectionSYb90c1fe7-f5cc-464e-958a-af36e9c26d7c19
2536443idecabtagene vicleucel 7285714 CELLS/ML per 70 ML InjectionSYb90c1fe7-f5cc-464e-958a-af36e9c26d7c19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59572-515-01595720515011 SUSPENSION in 1 BAG (59572-515-01) 1 suspension2021-03-260000-00-00NoNoCurrent
59572-515-02595720515021 SUSPENSION in 1 BAG (59572-515-02) 1 suspension2021-03-260000-00-00NoNoCurrent
59572-515-03595720515031 SUSPENSION in 1 BAG (59572-515-03) 1 suspension2021-03-260000-00-00NoNoCurrent