FDA.reportPublic FDA data

Humira

Product NDC
83457-554
11-digit product format
834570554
Labeler code
83457
Product ID
83457-554_5fe81b1a-cc31-444e-a0f1-1ea4f7334b89
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Adalimumab
Dosage form
KIT
Labeler
Cordavis Limited
Application
BLA125057
Marketing category
BLA
Marketing start
2024-02-14
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui797544, 1726844, 1726846, 1872979, 1872980, 1921009, 1921010, 1921016, 1921017, 1921238, 1921240

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
58819a18-327d-463b-9e5e-26cc1dd9870dProduct name120230313
c1c5a070-0e2e-43dd-af9c-a21585200342Product name120230104
2a463079-cd68-4798-a3d6-55c4c8578d57Product name120220728
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
652f8f6b-479d-477c-848a-374d5b0145b7Product name220151203
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83457-554-022025-07-31C16284748780-13b156c62-2930-fb37-e063-e6dba90a4e07These 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
83457-554-022025-07-31C16284748780-13b156c62-2930-fb37-e063-e6dba90a4e07These 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
83457-554-022025-07-29C16284748780-13b156c62-2930-fb37-e063-e6dba90a4e07These 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
83457-554-022025-07-29C16284748780-13b156c62-2930-fb37-e063-e6dba90a4e07These 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
83457-553-01Humira1 in 1 TRAYINJECTION, SOLUTION40 mg in 0.4mL4
83457-553-01Humira0.4 mL in 1 SYRINGEINJECTION, SOLUTION0.8 mL in 240 mg in 0.4mL4
83457-554-02Humira1 in 1 KITKIT14
83457-554-02Humira2 in 1 CARTONKIT24
83457-927-01Humira1 mL in 1 PACKETSWAB2 mL in 20.70 mL in 1mL4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83457-554-02EA - Each83457-554bd66066c-a93f-40fe-93e6-9949209da86612024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83457-554HUMIRA (ADALIMUMAB) KIT [CORDAVIS LIMITED]1Current NDC, 5 package rows20240217_4977567e-3525-44ac-9ff5-f1e74b053950.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1921009adalimumab 10 MG in 0.1 ML Prefilled SyringePSN4977567e-3525-44ac-9ff5-f1e74b0539504
1921016adalimumab 20 MG in 0.2 ML Prefilled SyringePSN4977567e-3525-44ac-9ff5-f1e74b0539504
1872979adalimumab 40 MG in 0.4 ML Auto-InjectorPSN4977567e-3525-44ac-9ff5-f1e74b0539504
1726844adalimumab 40 MG in 0.4 ML Prefilled SyringePSN4977567e-3525-44ac-9ff5-f1e74b0539504
1921238adalimumab 80 MG in 0.8 mL Auto-InjectorPSN4977567e-3525-44ac-9ff5-f1e74b0539504
1921010Humira 10 MG in 0.1 ML Prefilled SyringePSN4977567e-3525-44ac-9ff5-f1e74b0539504
1921017Humira 20 MG in 0.2 ML Prefilled SyringePSN4977567e-3525-44ac-9ff5-f1e74b0539504
1872980Humira 40 MG in 0.4 ML Auto-InjectorPSN4977567e-3525-44ac-9ff5-f1e74b0539504
1726846Humira 40 MG in 0.4 ML Prefilled SyringePSN4977567e-3525-44ac-9ff5-f1e74b0539504
1921240Humira 80 MG in 0.8 mL Auto-InjectorPSN4977567e-3525-44ac-9ff5-f1e74b0539504
797544isopropyl alcohol 70 % Medicated PadPSN4977567e-3525-44ac-9ff5-f1e74b0539504
19210100.1 ML adalimumab 100 MG/ML Prefilled Syringe [Humira]SBD4977567e-3525-44ac-9ff5-f1e74b0539504
19210170.2 ML adalimumab 100 MG/ML Prefilled Syringe [Humira]SBD4977567e-3525-44ac-9ff5-f1e74b0539504
18729800.4 ML adalimumab 100 MG/ML Auto-Injector [Humira]SBD4977567e-3525-44ac-9ff5-f1e74b0539504
17268460.4 ML adalimumab 100 MG/ML Prefilled Syringe [Humira]SBD4977567e-3525-44ac-9ff5-f1e74b0539504
19212400.8 ML adalimumab 100 MG/ML Auto-Injector [Humira]SBD4977567e-3525-44ac-9ff5-f1e74b0539504
19210090.1 ML adalimumab 100 MG/ML Prefilled SyringeSCD4977567e-3525-44ac-9ff5-f1e74b0539504
19210160.2 ML adalimumab 100 MG/ML Prefilled SyringeSCD4977567e-3525-44ac-9ff5-f1e74b0539504
18729790.4 ML adalimumab 100 MG/ML Auto-InjectorSCD4977567e-3525-44ac-9ff5-f1e74b0539504
17268440.4 ML adalimumab 100 MG/ML Prefilled SyringeSCD4977567e-3525-44ac-9ff5-f1e74b0539504
19212380.8 ML adalimumab 100 MG/ML Auto-InjectorSCD4977567e-3525-44ac-9ff5-f1e74b0539504
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD4977567e-3525-44ac-9ff5-f1e74b0539504
19210100.1 ML Humira 100 MG/ML Prefilled SyringeSY4977567e-3525-44ac-9ff5-f1e74b0539504
19210170.2 ML Humira 100 MG/ML Prefilled SyringeSY4977567e-3525-44ac-9ff5-f1e74b0539504
18729800.4 ML Humira 100 MG/ML Auto-InjectorSY4977567e-3525-44ac-9ff5-f1e74b0539504
17268460.4 ML Humira 100 MG/ML Prefilled SyringeSY4977567e-3525-44ac-9ff5-f1e74b0539504
19212400.8 ML Humira 100 MG/ML Auto-InjectorSY4977567e-3525-44ac-9ff5-f1e74b0539504
1921009adalimumab 10 MG per 0.1 ML Prefilled SyringeSY4977567e-3525-44ac-9ff5-f1e74b0539504
1921016adalimumab 20 MG per 0.2 ML Prefilled SyringeSY4977567e-3525-44ac-9ff5-f1e74b0539504
1872979adalimumab 40 MG per 0.4 ML Auto-InjectorSY4977567e-3525-44ac-9ff5-f1e74b0539504
1726844adalimumab 40 MG per 0.4 ML Prefilled SyringeSY4977567e-3525-44ac-9ff5-f1e74b0539504
1921238adalimumab 80 MG per 0.8 ML Auto-InjectorSY4977567e-3525-44ac-9ff5-f1e74b0539504
1921010Humira 10 MG per 0.1 ML Prefilled SyringeSY4977567e-3525-44ac-9ff5-f1e74b0539504
1921017Humira 20 MG per 0.2 ML Prefilled SyringeSY4977567e-3525-44ac-9ff5-f1e74b0539504
1872980Humira 40 MG per 0.4 ML Auto-InjectorSY4977567e-3525-44ac-9ff5-f1e74b0539504
1726846Humira 40 MG per 0.4 ML Prefilled SyringeSY4977567e-3525-44ac-9ff5-f1e74b0539504
1921240Humira 80 MG per 0.8 ML Auto-InjectorSY4977567e-3525-44ac-9ff5-f1e74b0539504
797544isopropyl alcohol 70 % Medicated PadSY4977567e-3525-44ac-9ff5-f1e74b0539504
797544isopropyl alcohol 70 % Topical ClothSY4977567e-3525-44ac-9ff5-f1e74b0539504
797544isopropyl alcohol 70 % Topical SwabSY4977567e-3525-44ac-9ff5-f1e74b0539504

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83457-553-01834570553011 in 1 TRAYHistorical
83457-554-02834570554022 KIT in 1 CARTON (83457-554-02) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY (83457-553-01) / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET (83457-927-01) 2 kit2024-02-14NoNoHistorical
83457-927-01834570927011 mL in 1 PACKET1 mlHistorical