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 Identifiers#

Field, Values table
FieldValues
Rxcui797544, 1655726, 1655728

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

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