Abecma

Product NDC: 59572-515
Requested package NDC: 59572-515-02
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	59572-515	59572-515-02	I	Inactivated by FDA		excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`

Additional Listing Data#

Finished product: Yes
Brand name base: Abecma
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IDECABTAGENE VICLEUCEL	300000000 1/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8PX1X7UG4D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2536434	Internal RxNorm lookup
2536439	Internal RxNorm lookup
2536443	Internal RxNorm lookup
2536445	Internal RxNorm lookup
2536449	Internal RxNorm lookup
2536451	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
b90c1fe7-f5cc-464e-958a-af36e9c26d7c	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
59572-515-01	2022-10-13	These 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
59572-515-01	2022-10-13	These 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
59572-515-01	2022-10-13	These 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
59572-515-01	2022-10-13	These 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
59572-515-02	2022-10-13	These 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
59572-515-02	2022-10-13	These 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
59572-515-02	2022-10-13	These 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
59572-515-02	2022-10-13	These 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
59572-515-03	2022-10-13	These 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
59572-515-03	2022-10-13	These 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
59572-515-03	2022-10-13	These 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
59572-515-03	2022-10-13	These 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
59572-515-01	2022-07-29	These 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
59572-515-01	2022-07-29	These 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
59572-515-01	2022-07-29	These 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
59572-515-01	2022-07-29	These 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
59572-515-02	2022-07-29	These 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
59572-515-02	2022-07-29	These 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
59572-515-02	2022-07-29	These 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
59572-515-02	2022-07-29	These 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
59572-515-03	2022-07-29	These 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
59572-515-03	2022-07-29	These 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
59572-515-03	2022-07-29	These 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
59572-515-03	2022-07-29	These 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 NDC	Product	Description	Form	Quantity	SPL version
59572-515-01	Abecma	1 in 1 BAG	SUSPENSION	1	19
59572-515-02	Abecma	1 in 1 BAG	SUSPENSION	1	19
59572-515-03	Abecma	1 in 1 BAG	SUSPENSION	1	19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59572-515-01	EA - Each	59572-515	0a0198eb-63d5-4007-8e42-0583446a0672	1	2021-05-05
59572-515-02	EA - Each	59572-515	40b643b6-50de-44e1-8d0c-e60dd4edecd6	1	2021-05-05
59572-515-03	EA - Each	59572-515	88275471-6e24-48ac-902e-52e0d558d493	1	2021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59572-515	ABECMA (IDECABTAGENE VICLEUCEL) SUSPENSION [CELGENE CORPORATION]	16	Current NDC, Legacy NDC, 3 package rows	20250416_b90c1fe7-f5cc-464e-958a-af36e9c26d7c.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Abecma	IDECABTAGENE VICLEUCEL	Celgene Corporation	b90c1fe7-f5cc-464e-958a-af36e9c26d7c	2025-11-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA125736 ndc (package): 59572-515-02 ndc (product): 59572-515 ndc11 (package): 59572051502

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
125736	Abecma	idecabtagene vicleucel	351(a)	Rx	2026-06-01

UNII, Preferred term, Matched term table
UNII	Preferred term	Matched term
8PX1X7UG4D	IDECABTAGENE VICLEUCEL	IDECABTAGENE VICLEUCEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2536451	Abecma 510,000,000 CELLS in 100 ML Injection	PSN	b90c1fe7-f5cc-464e-958a-af36e9c26d7c	19
2536439	Abecma 510,000,000 CELLS in 30 ML Injection	PSN	b90c1fe7-f5cc-464e-958a-af36e9c26d7c	19
2536445	Abecma 510,000,000 CELLS in 70 ML Injection	PSN	b90c1fe7-f5cc-464e-958a-af36e9c26d7c	19
2536449	idecabtagene vicleucel 510,000,000 CELLS in 100 ML Injection	PSN	b90c1fe7-f5cc-464e-958a-af36e9c26d7c	19
2536434	idecabtagene vicleucel 510,000,000 CELLS in 30 ML Injection	PSN	b90c1fe7-f5cc-464e-958a-af36e9c26d7c	19
2536443	idecabtagene vicleucel 510,000,000 CELLS in 70 ML Injection	PSN	b90c1fe7-f5cc-464e-958a-af36e9c26d7c	19
2536451	100 ML idecabtagene vicleucel 5100000 CELLS/ML Injection [Abecma]	SBD	b90c1fe7-f5cc-464e-958a-af36e9c26d7c	19
2536439	30 ML idecabtagene vicleucel 17000000 CELLS/ML Injection [Abecma]	SBD	b90c1fe7-f5cc-464e-958a-af36e9c26d7c	19
2536445	70 ML idecabtagene vicleucel 7285714 CELLS/ML Injection [Abecma]	SBD	b90c1fe7-f5cc-464e-958a-af36e9c26d7c	19
2536449	100 ML idecabtagene vicleucel 5100000 CELLS/ML Injection	SCD	b90c1fe7-f5cc-464e-958a-af36e9c26d7c	19
2536434	30 ML idecabtagene vicleucel 17000000 CELLS/ML Injection	SCD	b90c1fe7-f5cc-464e-958a-af36e9c26d7c	19
2536443	70 ML idecabtagene vicleucel 7285714 CELLS/ML Injection	SCD	b90c1fe7-f5cc-464e-958a-af36e9c26d7c	19
2536451	100 ML Abecma 5100000 CELLS/ML Injection	SY	b90c1fe7-f5cc-464e-958a-af36e9c26d7c	19
2536439	30 ML Abecma 17000000 CELLS/ML Injection	SY	b90c1fe7-f5cc-464e-958a-af36e9c26d7c	19
2536445	70 ML Abecma 7285714 CELLS/ML Injection	SY	b90c1fe7-f5cc-464e-958a-af36e9c26d7c	19
2536439	Abecma 17000000 CELLS/ML per 30 ML Injection	SY	b90c1fe7-f5cc-464e-958a-af36e9c26d7c	19
2536451	Abecma 510,000,000 CELLS per 100 ML Injection	SY	b90c1fe7-f5cc-464e-958a-af36e9c26d7c	19
2536439	Abecma 510,000,000 CELLS per 30 ML Injection	SY	b90c1fe7-f5cc-464e-958a-af36e9c26d7c	19
2536445	Abecma 510,000,000 CELLS per 70 ML Injection	SY	b90c1fe7-f5cc-464e-958a-af36e9c26d7c	19
2536451	Abecma 5100000 CELLS/ML per 100 ML Injection	SY	b90c1fe7-f5cc-464e-958a-af36e9c26d7c	19
2536445	Abecma 7285714 CELLS/ML per 70 ML Injection	SY	b90c1fe7-f5cc-464e-958a-af36e9c26d7c	19
2536434	idecabtagene vicleucel 17000000 CELLS/ML per 30 ML Injection	SY	b90c1fe7-f5cc-464e-958a-af36e9c26d7c	19
2536449	idecabtagene vicleucel 510,000,000 CELLS per 100 ML Injection	SY	b90c1fe7-f5cc-464e-958a-af36e9c26d7c	19
2536434	idecabtagene vicleucel 510,000,000 CELLS per 30 ML Injection	SY	b90c1fe7-f5cc-464e-958a-af36e9c26d7c	19
2536443	idecabtagene vicleucel 510,000,000 CELLS per 70 ML Injection	SY	b90c1fe7-f5cc-464e-958a-af36e9c26d7c	19
2536449	idecabtagene vicleucel 5100000 CELLS/ML per 100 ML Injection	SY	b90c1fe7-f5cc-464e-958a-af36e9c26d7c	19
2536443	idecabtagene vicleucel 7285714 CELLS/ML per 70 ML Injection	SY	b90c1fe7-f5cc-464e-958a-af36e9c26d7c	19

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59572-515-02	59572051502	1 SUSPENSION in 1 BAG (59572-515-02)	1 suspension	2021-03-26	0000-00-00	No	No	Current