FDA.reportPublic FDA data

HUMIRA

Product NDC
50090-4487
11-digit product format
500904487
Labeler code
50090
Product ID
50090-4487_9083dedd-bfe5-47f1-b940-72101f343d9d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Adalimumab
Dosage form
KIT
Labeler
A-S Medication Solutions
Application
BLA125057
Marketing category
BLA
Marketing start
2006-06-23
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
797544Internal RxNorm lookup
1655726Internal RxNorm lookup
1655728Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a06a9aec-fd5b-4c3e-a81f-eb46bb384100Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
58819a18-327d-463b-9e5e-26cc1dd9870dProduct name120230313
c1c5a070-0e2e-43dd-af9c-a21585200342Product name120230104
2a463079-cd68-4798-a3d6-55c4c8578d57Product name120220728
652f8f6b-479d-477c-848a-374d5b0145b7Product name220151203

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4487-02023-02-07C16284748780-1f386c64a-1a86-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use HUMIRA safely and effectively. See full prescribing information for HUMIRA. HUMIRA ® (adalimumab) injection, for subcutaneous use Initial U.S. Approval: 2002
50090-4487-02023-01-30C16284748780-1f386c64a-1a86-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use HUMIRA safely and effectively. See full prescribing information for HUMIRA. HUMIRA ® (adalimumab) injection, for subcutaneous use Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4487-0HUMIRA2 in 1 CARTONKIT26
50090-4487-0HUMIRA1 in 1 KITKIT16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4487-0EA - Each50090-4487b05d1175-dcee-4886-962e-e686313b81a712022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4487HUMIRA (ADALIMUMAB) KIT [A-S MEDICATION SOLUTIONS]6Current NDC, Legacy NDC, 2 package rows20240517_a06a9aec-fd5b-4c3e-a81f-eb46bb384100.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 · 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
HUMIRAADALIMUMABA-S Medication Solutionsa06a9aec-fd5b-4c3e-a81f-eb46bb3841002024-05-16Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125057
ndc (product): 50090-4487

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125057Humiraadalimumab351(a)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1655726adalimumab 40 MG in 0.8 ML Auto-InjectorPSNa06a9aec-fd5b-4c3e-a81f-eb46bb3841006
1655728Humira 40 MG in 0.8 ML Auto-InjectorPSNa06a9aec-fd5b-4c3e-a81f-eb46bb3841006
797544isopropyl alcohol 70 % Medicated PadPSNa06a9aec-fd5b-4c3e-a81f-eb46bb3841006
16557280.8 ML adalimumab 50 MG/ML Auto-Injector [Humira]SBDa06a9aec-fd5b-4c3e-a81f-eb46bb3841006
16557260.8 ML adalimumab 50 MG/ML Auto-InjectorSCDa06a9aec-fd5b-4c3e-a81f-eb46bb3841006
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCDa06a9aec-fd5b-4c3e-a81f-eb46bb3841006
16557280.8 ML Humira 50 MG/ML Auto-InjectorSYa06a9aec-fd5b-4c3e-a81f-eb46bb3841006
1655726adalimumab 40 MG per 0.8 ML Auto-InjectorSYa06a9aec-fd5b-4c3e-a81f-eb46bb3841006
1655728Humira 40 MG per 0.8 ML Auto-InjectorSYa06a9aec-fd5b-4c3e-a81f-eb46bb3841006
797544isopropyl alcohol 70 % Medicated PadSYa06a9aec-fd5b-4c3e-a81f-eb46bb3841006
797544isopropyl alcohol 70 % Topical ClothSYa06a9aec-fd5b-4c3e-a81f-eb46bb3841006
797544isopropyl alcohol 70 % Topical SwabSYa06a9aec-fd5b-4c3e-a81f-eb46bb3841006

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4487-0500904487002 KIT in 1 CARTON (50090-4487-0) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE * 1 mL in 1 PACKET2 kit2019-08-290000-00-00NoNoCurrent