FDA.reportPublic FDA data

Application 125057

Type
BLA
Sponsor
ABBVIE INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125057Humiraadalimumab351(a)Rx2026-09-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HUMIRAADALIMUMABSYRINGE40MG/0.8MLNoNo
002HUMIRAADALIMUMABVIAL40MG/0.8MLNoNo

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HumiraADALIMUMABCordavis Limited4977567e-3525-44ac-9ff5-f1e74b0539502025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125057
HumiraADALIMUMABAbbVie Inc.608d4f0d-b19f-46d3-749a-7159aa5f933d2025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125057
ndc (product): 0074-4339
ndc (product): 0074-9374
ndc (product): 0074-3799
HUMIRAADALIMUMABA-S Medication Solutionsa06a9aec-fd5b-4c3e-a81f-eb46bb3841002024-05-16Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125057
ndc (product): 50090-4487

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0074-3799HumiraAdalimumabAbbVie Inc.BLACurrent
0074-3799HumiraAdalimumabAbbVie Inc.BLACurrent
0074-3799HumiraAdalimumabAbbVie Inc.BLACurrent
0074-3799HumiraAdalimumabAbbVie Inc.BLACurrent
0074-3799HumiraAdalimumabAbbVie Inc.BLACurrent
0074-3799HumiraAdalimumabAbbVie Inc.BLACurrent
0074-3799HumiraAdalimumabAbbVie Inc.BLACurrent
0074-3799HumiraAdalimumabAbbVie Inc.BLACurrent
0074-3799HumiraAdalimumabAbbVie Inc.BLACurrent
0074-3799HumiraAdalimumabAbbVie Inc.BLACurrent
0074-4339HumiraAdalimumabAbbVie Inc.BLACurrent
0074-4339HumiraAdalimumabAbbVie Inc.BLACurrent
0074-4339HumiraAdalimumabAbbVie Inc.BLACurrent
0074-4339HumiraAdalimumabAbbVie Inc.BLACurrent
0074-4339HumiraAdalimumabAbbVie Inc.BLACurrent
0074-4339HumiraAdalimumabAbbVie Inc.BLACurrent
0074-4339HumiraAdalimumabAbbVie Inc.BLACurrent
0074-4339HumiraAdalimumabAbbVie Inc.BLACurrent
0074-4339HumiraAdalimumabAbbVie Inc.BLACurrent
0074-4339HumiraAdalimumabAbbVie Inc.BLACurrent
0074-6347HumiraAdalimumabAbbVie Inc.BLACurrent
0074-6347HumiraAdalimumabAbbVie Inc.BLACurrent
0074-6347HumiraAdalimumabAbbVie Inc.BLACurrent
0074-6347HumiraAdalimumabAbbVie Inc.BLACurrent
0074-6347HumiraAdalimumabAbbVie Inc.BLACurrent
0074-6347HumiraAdalimumabAbbVie Inc.BLACurrent
0074-9374HumiraAdalimumabAbbVie Inc.BLACurrent
0074-9374HumiraAdalimumabAbbVie Inc.BLACurrent
0074-9374HumiraAdalimumabAbbVie Inc.BLACurrent
0074-9374HumiraAdalimumabAbbVie Inc.BLACurrent
0074-9374HumiraAdalimumabAbbVie Inc.BLACurrent
0074-9374HumiraAdalimumabAbbVie Inc.BLACurrent
50090-3530HumiraAdalimumabA-S Medication SolutionsBLACurrent
50090-4487HumiraAdalimumabA-S Medication SolutionsBLACurrent
50090-4487HumiraAdalimumabA-S Medication SolutionsBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85138SUPPL 2026-02-24
84663SUPPL 2026-01-06
84615SUPPL 2025-12-31
82896SUPPL 2025-07-21
82895SUPPL 2025-07-21
82885SUPPL 2025-07-17
76387SUPPL 2023-11-06
76380SUPPL 2023-11-06
67005SUPPL2021-04-07
66364SUPPL2021-02-25
66363SUPPL2021-02-25
66360SUPPL2021-02-25
65660SUPPL2020-12-21
65659SUPPL2020-12-21
65658SUPPL2020-12-21
65657SUPPL2020-12-21
65642SUPPL2020-12-21
65641SUPPL2020-12-21
62136SUPPL2020-03-12
62131SUPPL2020-03-12
58982SUPPL2019-06-06
58921SUPPL2019-06-03
57260SUPPL2019-01-18
56660SUPPL2018-12-07
56643SUPPL2018-12-07
56010SUPPL2018-10-18
56009SUPPL2018-10-18
55968SUPPL2018-10-17
55788SUPPL2018-10-03
55769SUPPL2018-10-01
55103SUPPL2018-08-03
55096SUPPL2018-08-03
50831SUPPL2017-12-22
50830SUPPL2017-12-22
50712SUPPL2017-12-15
50170SUPPL2017-10-24
48417SUPPL2017-05-17
48416SUPPL2017-05-17
48202SUPPL2017-05-02
48176SUPPL2017-05-01
48116SUPPL2017-04-26
47765SUPPL2017-03-29
47741SUPPL2017-03-28
43300SUPPL2016-07-28
39811SUPPL2016-07-05
9576SUPPL2016-07-01
44790SUPPL2016-03-11
22775SUPPL2016-02-03
39810SUPPL2015-11-25
9575SUPPL2015-11-24
31796SUPPL2015-09-14
43297SUPPL2015-03-11
22773SUPPL2015-03-09
22772SUPPL2015-03-09
9571SUPPL2015-01-08
44990SUPPL2014-12-24
39809SUPPL2014-10-02
31795SUPPL2014-10-02
18756SUPPL2014-09-26
9573SUPPL2014-09-25
31794SUPPL2014-06-03
18757SUPPL2014-06-03
9574SUPPL2014-05-20
18758SUPPL2014-05-15
39808SUPPL2014-02-27
31793SUPPL2014-02-27
18755SUPPL2013-09-24
31792SUPPL2013-09-20
43298SUPPL2013-09-09
9572SUPPL2013-05-15
18753SUPPL2013-05-13
18754SUPPL2013-04-29
22774SUPPL2013-04-09
9566SUPPL2012-10-03
39806SUPPL2012-10-02
9570SUPPL2012-05-30
18752SUPPL2012-05-29
39807SUPPL2012-03-15
9569SUPPL2012-01-05
9568SUPPL2012-01-05
9567SUPPL2012-01-05
44425ORIG2011-12-20
31791SUPPL2011-09-13
31787SUPPL2011-03-25
18751SUPPL2011-03-04
9565SUPPL2010-10-19
31790SUPPL2010-08-03
31788SUPPL2010-06-17
39805SUPPL2010-02-23
31789SUPPL2009-12-03
43299SUPPL2009-03-24
24356SUPPL2009-03-24
39804SUPPL2008-03-27
31786SUPPL2008-02-26
18750SUPPL2008-02-26
31785SUPPL2008-01-25
39803SUPPL2007-09-07
31784SUPPL2007-09-07
9563SUPPL2007-08-01
18748SUPPL2007-07-31