Application 125057

Type: BLA
Sponsor: ABBVIE INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
125057	Humira	adalimumab	351(a)	Rx	2026-07-01

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HUMIRA	ADALIMUMAB	SYRINGE	40MG/0.8ML	No	No
002	HUMIRA	ADALIMUMAB	VIAL	40MG/0.8ML	No	No

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Humira	ADALIMUMAB	Cordavis Limited	4977567e-3525-44ac-9ff5-f1e74b053950	2025-12-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA125057
Humira	ADALIMUMAB	AbbVie Inc.	608d4f0d-b19f-46d3-749a-7159aa5f933d	2025-12-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA125057 ndc (product): 0074-0554 ndc (product): 0074-0124 ndc (product): 0074-2540 ndc (product): 0074-0243 ndc (product): 0074-0817 ndc (product): 0074-0616 ndc (product): 0074-1539 ndc (product): 0074-0067
HUMIRA	ADALIMUMAB	A-S Medication Solutions	a06a9aec-fd5b-4c3e-a81f-eb46bb384100	2024-05-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA125057

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 115 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0074-0067	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0067	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0067	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0067	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0067	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0067	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0067	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0067	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0067	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0067	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0124	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0124	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0124	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0124	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0124	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0124	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0124	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0124	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0124	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0124	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0243	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0243	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0243	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0243	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0243	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0243	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0243	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0243	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0243	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0243	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0554	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0554	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0554	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0554	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0554	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0554	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0554	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0554	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0554	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0554	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0616	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0616	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0616	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0616	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0616	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0616	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0616	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0616	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0616	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0616	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0817	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0817	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0817	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0817	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0817	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0817	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0817	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0817	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0817	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0817	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-1539	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-1539	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-1539	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-1539	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-1539	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-1539	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-1539	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-1539	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-1539	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-1539	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-2540	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-2540	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-2540	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-2540	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-2540	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-2540	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-2540	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-2540	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-2540	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-2540	Humira	Adalimumab	AbbVie Inc.	BLA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85138	SUPPL	2026-02-24
84663	SUPPL	2026-01-06
84615	SUPPL	2025-12-31
82896	SUPPL	2025-07-21
82895	SUPPL	2025-07-21
82885	SUPPL	2025-07-17
76387	SUPPL	2023-11-06
76380	SUPPL	2023-11-06
67005	SUPPL	2021-04-07
66364	SUPPL	2021-02-25
66363	SUPPL	2021-02-25
66360	SUPPL	2021-02-25
65660	SUPPL	2020-12-21
65659	SUPPL	2020-12-21
65658	SUPPL	2020-12-21
65657	SUPPL	2020-12-21
65642	SUPPL	2020-12-21
65641	SUPPL	2020-12-21
62136	SUPPL	2020-03-12
62131	SUPPL	2020-03-12
58982	SUPPL	2019-06-06
58921	SUPPL	2019-06-03
57260	SUPPL	2019-01-18
56660	SUPPL	2018-12-07
56643	SUPPL	2018-12-07
56010	SUPPL	2018-10-18
56009	SUPPL	2018-10-18
55968	SUPPL	2018-10-17
55788	SUPPL	2018-10-03
55769	SUPPL	2018-10-01
55103	SUPPL	2018-08-03
55096	SUPPL	2018-08-03
50831	SUPPL	2017-12-22
50830	SUPPL	2017-12-22
50712	SUPPL	2017-12-15
50170	SUPPL	2017-10-24
48417	SUPPL	2017-05-17
48416	SUPPL	2017-05-17
48202	SUPPL	2017-05-02
48176	SUPPL	2017-05-01
48116	SUPPL	2017-04-26
47765	SUPPL	2017-03-29
47741	SUPPL	2017-03-28
43300	SUPPL	2016-07-28
39811	SUPPL	2016-07-05
9576	SUPPL	2016-07-01
44790	SUPPL	2016-03-11
22775	SUPPL	2016-02-03
39810	SUPPL	2015-11-25
9575	SUPPL	2015-11-24
31796	SUPPL	2015-09-14
43297	SUPPL	2015-03-11
22773	SUPPL	2015-03-09
22772	SUPPL	2015-03-09
9571	SUPPL	2015-01-08
44990	SUPPL	2014-12-24
39809	SUPPL	2014-10-02
31795	SUPPL	2014-10-02
18756	SUPPL	2014-09-26
9573	SUPPL	2014-09-25
31794	SUPPL	2014-06-03
18757	SUPPL	2014-06-03
9574	SUPPL	2014-05-20
18758	SUPPL	2014-05-15
39808	SUPPL	2014-02-27
31793	SUPPL	2014-02-27
18755	SUPPL	2013-09-24
31792	SUPPL	2013-09-20
43298	SUPPL	2013-09-09
9572	SUPPL	2013-05-15
18753	SUPPL	2013-05-13
18754	SUPPL	2013-04-29
22774	SUPPL	2013-04-09
9566	SUPPL	2012-10-03
39806	SUPPL	2012-10-02
9570	SUPPL	2012-05-30
18752	SUPPL	2012-05-29
39807	SUPPL	2012-03-15
9569	SUPPL	2012-01-05
9568	SUPPL	2012-01-05
9567	SUPPL	2012-01-05
44425	ORIG	2011-12-20
31791	SUPPL	2011-09-13
31787	SUPPL	2011-03-25
18751	SUPPL	2011-03-04
9565	SUPPL	2010-10-19
31790	SUPPL	2010-08-03
31788	SUPPL	2010-06-17
39805	SUPPL	2010-02-23
31789	SUPPL	2009-12-03
43299	SUPPL	2009-03-24
24356	SUPPL	2009-03-24
39804	SUPPL	2008-03-27
31786	SUPPL	2008-02-26
18750	SUPPL	2008-02-26
31785	SUPPL	2008-01-25
39803	SUPPL	2007-09-07
31784	SUPPL	2007-09-07
9563	SUPPL	2007-08-01
18748	SUPPL	2007-07-31