FDA.reportPublic FDA data

Humira

Product NDC
83457-616
11-digit product format
834570616
Labeler code
83457
Product ID
83457-616_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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 11 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
797544Internal RxNorm lookup
1726844Internal RxNorm lookup
1726846Internal RxNorm lookup
1872979Internal RxNorm lookup
1872980Internal RxNorm lookup
1921009Internal RxNorm lookup
1921010Internal RxNorm lookup
1921016Internal RxNorm lookup
1921017Internal RxNorm lookup
1921238Internal RxNorm lookup
1921240Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4977567e-3525-44ac-9ff5-f1e74b053950Available on FDA.report

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#

Effective, Related label table
EffectiveRelated label
2025-07-31These 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
2025-07-31These 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
2025-07-29These 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
2025-07-29These 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
83457-615-01Humira1 in 1 TRAYINJECTION, SOLUTION20 mg in 0.2mL4
83457-615-01Humira0.2 mL in 1 SYRINGEINJECTION, SOLUTION0.4 mL in 220 mg in 0.2mL4
83457-616-02Humira2 in 1 CARTONKIT24
83457-616-02Humira1 in 1 KITKIT14
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
83457-616-02EA - Each83457-616321340bd-4e87-442e-8451-053a67b4c6ca12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83457-616HUMIRA (ADALIMUMAB) KIT [CORDAVIS LIMITED]1Current NDC, 5 package rows20240217_4977567e-3525-44ac-9ff5-f1e74b053950.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
ndc (product): 83457-616
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

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
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
83457-615-01834570615011 in 1 TRAYHistorical
83457-616-02834570616022 KIT in 1 CARTON (83457-616-02) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY (83457-615-01) / .2 mL in 1 SYRINGE * 1 mL in 1 PACKET (83457-927-01) 2 kit2024-02-14NoNoCurrent
83457-927-01834570927011 mL in 1 PACKET1 mlHistorical