FDA.reportPublic FDA data

Humira

Product NDC
0074-0616
11-digit product format
000740616
Labeler code
0074
Product ID
0074-0616_8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Adalimumab
Dosage form
KIT
Labeler
AbbVie Inc.
Application
BLA125057
Marketing category
BLA
Marketing start
2017-04-28
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 3 · 41 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
727703Internal RxNorm lookup
727705Internal RxNorm lookup
763564Internal RxNorm lookup
763565Internal RxNorm lookup
797544Internal RxNorm lookup
825169Internal RxNorm lookup
825170Internal RxNorm lookup
1594352Internal RxNorm lookup
1594357Internal RxNorm lookup
1594358Internal RxNorm lookup
1655726Internal RxNorm lookup
1655728Internal RxNorm lookup
1656703Internal RxNorm lookup
1726844Internal RxNorm lookup
1726846Internal RxNorm lookup
1801277Internal RxNorm lookup
1801278Internal RxNorm lookup
1855523Internal RxNorm lookup
1855524Internal RxNorm lookup
1855526Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
608d4f0d-b19f-46d3-749a-7159aa5f933dAvailable 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0074-0616-02Humira2 in 1 CARTONKIT22154
0074-0616-02Humira1 in 1 KITKIT12154
0074-0616-71Humira1 in 1 KITKIT12154
0074-0616-71Humira2 in 1 CARTONKIT22154

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0074-0616-02EA - Each0074-0616ec543f8d-af55-4a2e-b73b-25848e727e0512018-05-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ADALIMUMABACTIVE INGREDIENTFYS6T7F842HUMIRA (ADALIMUMAB) KIT HUMIRA (ADALIMUMAB) INJECTION, SOLUTION [ABBVIE INC.]1805
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M416302HUMIRA (ADALIMUMAB) KIT HUMIRA (ADALIMUMAB) INJECTION, SOLUTION [ABBVIE INC.]1805
ADALIMUMABACTIVE MOIETYFYS6T7F842HUMIRA (ADALIMUMAB) KIT HUMIRA (ADALIMUMAB) INJECTION, SOLUTION [ABBVIE INC.]1805
ISOPROPYL ALCOHOLACTIVE MOIETYND2M416302HUMIRA (ADALIMUMAB) KIT HUMIRA (ADALIMUMAB) INJECTION, SOLUTION [ABBVIE INC.]1805
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPHUMIRA (ADALIMUMAB) KIT HUMIRA (ADALIMUMAB) INJECTION, SOLUTION [ABBVIE INC.]1805
MANNITOLINACTIVE INGREDIENT3OWL53L36AHUMIRA (ADALIMUMAB) KIT HUMIRA (ADALIMUMAB) INJECTION, SOLUTION [ABBVIE INC.]1805
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HHUMIRA (ADALIMUMAB) KIT HUMIRA (ADALIMUMAB) INJECTION, SOLUTION [ABBVIE INC.]1805
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XHUMIRA (ADALIMUMAB) KIT HUMIRA (ADALIMUMAB) INJECTION, SOLUTION [ABBVIE INC.]1805
SODIUM CITRATE, UNSPECIFIED FORMINACTIVE INGREDIENT1Q73Q2JULRHUMIRA (ADALIMUMAB) KIT HUMIRA (ADALIMUMAB) INJECTION, SOLUTION [ABBVIE INC.]1805
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IHUMIRA (ADALIMUMAB) KIT HUMIRA (ADALIMUMAB) INJECTION, SOLUTION [ABBVIE INC.]1805
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENT94255I6E2THUMIRA (ADALIMUMAB) KIT HUMIRA (ADALIMUMAB) INJECTION, SOLUTION [ABBVIE INC.]1805
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATEINACTIVE INGREDIENT5QWK665956HUMIRA (ADALIMUMAB) KIT HUMIRA (ADALIMUMAB) INJECTION, SOLUTION [ABBVIE INC.]1805
WATERINACTIVE INGREDIENT059QF0KO0RHUMIRA (ADALIMUMAB) KIT HUMIRA (ADALIMUMAB) INJECTION, SOLUTION [ABBVIE INC.]1805

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0074-0616HUMIRA (ADALIMUMAB) KIT HUMIRA (ADALIMUMAB) INJECTION, SOLUTION [ABBVIE INC.]2148Current NDC, Legacy NDC, 4 package rows20240210_608d4f0d-b19f-46d3-749a-7159aa5f933d.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
ndc (product): 0074-0616
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
1855527{1 (0.4 ML adalimumab 100 MG/ML Prefilled Syringe [Humira]) / 1 (0.8 ML adalimumab 100 MG/ML Prefilled Syringe [Humira]) } Pack [Humira Pediatric Crohn's Disease Starter Package (2 count)]BPCK608d4f0d-b19f-46d3-749a-7159aa5f933d2154
1921468{2 (0.4 ML adalimumab 100 MG/ML Auto-Injector [Humira]) / 1 (0.8 ML adalimumab 100 MG/ML Auto-Injector [Humira]) } Pack [Humira Pen 80 MG/0.8 ML and 40 MG/0.4 ML - Psoriasis/Uveitis Starter Package]BPCK608d4f0d-b19f-46d3-749a-7159aa5f933d2154
1921245{3 (0.8 ML adalimumab 100 MG/ML Auto-Injector [Humira]) } Pack [Humira Pen 80 MG/0.8 ML - Starter Package for Crohn's Disease, Ulcerative Colitis or Hidradenitis Suppurativa]BPCK608d4f0d-b19f-46d3-749a-7159aa5f933d2154
1873087{3 (0.8 ML adalimumab 100 MG/ML Prefilled Syringe [Humira]) } Pack [Humira Prefilled Syringe 80 MG/0.8 ML Starter Pack - Pediatric Crohn's Disease]BPCK608d4f0d-b19f-46d3-749a-7159aa5f933d2154
1594358{3 (0.8 ML adalimumab 50 MG/ML Prefilled Syringe [Humira]) } Pack [Humira Pediatric Crohn's Disease Starter Package (3 count)]BPCK608d4f0d-b19f-46d3-749a-7159aa5f933d2154
1872986{4 (0.4 ML adalimumab 100 MG/ML Auto-Injector [Humira]) } Pack [Humira Pen 40 MG/0.4 ML Starter Pack - Psoriasis]BPCK608d4f0d-b19f-46d3-749a-7159aa5f933d2154
2531134{4 (0.8 ML adalimumab 100 MG/ML Auto-Injector [Humira]) } Pack [Humira Pen 80 MG/0.8 ML - Starter Package for Pediatric Ulcerative Colitis]BPCK608d4f0d-b19f-46d3-749a-7159aa5f933d2154
1801278{4 (0.8 ML adalimumab 50 MG/ML Auto-Injector [Humira]) } Pack [Humira Pen - Psoriasis Starter Pack]BPCK608d4f0d-b19f-46d3-749a-7159aa5f933d2154
1872984{6 (0.4 ML adalimumab 100 MG/ML Auto-Injector [Humira]) } Pack [Humira Pen 40 MG/0.4 ML Starter Pack - Crohn's Disease]BPCK608d4f0d-b19f-46d3-749a-7159aa5f933d2154
825170{6 (0.8 ML adalimumab 50 MG/ML Auto-Injector [Humira]) } Pack [Humira Pen - Crohn's Disease Starter Pack]BPCK608d4f0d-b19f-46d3-749a-7159aa5f933d2154
1594352{6 (0.8 ML adalimumab 50 MG/ML Prefilled Syringe [Humira]) } Pack [Humira Pediatric Crohn's Disease Starter Package (6 count)]BPCK608d4f0d-b19f-46d3-749a-7159aa5f933d2154
1855526{1 (0.4 ML adalimumab 100 MG/ML Prefilled Syringe) / 1 (0.8 ML adalimumab 100 MG/ML Prefilled Syringe) } PackGPCK608d4f0d-b19f-46d3-749a-7159aa5f933d2154
1921467{2 (0.4 ML adalimumab 100 MG/ML Auto-Injector) / 1 (0.8 ML adalimumab 100 MG/ML Auto-Injector) } PackGPCK608d4f0d-b19f-46d3-749a-7159aa5f933d2154
1921244{3 (0.8 ML adalimumab 100 MG/ML Auto-Injector) } PackGPCK608d4f0d-b19f-46d3-749a-7159aa5f933d2154
1873086{3 (0.8 ML adalimumab 100 MG/ML Prefilled Syringe) } PackGPCK608d4f0d-b19f-46d3-749a-7159aa5f933d2154
1594357{3 (0.8 ML adalimumab 50 MG/ML Prefilled Syringe) } PackGPCK608d4f0d-b19f-46d3-749a-7159aa5f933d2154
1872985{4 (0.4 ML adalimumab 100 MG/ML Auto-Injector) } PackGPCK608d4f0d-b19f-46d3-749a-7159aa5f933d2154
2531133{4 (0.8 ML adalimumab 100 MG/ML Auto-Injector) } PackGPCK608d4f0d-b19f-46d3-749a-7159aa5f933d2154
1801277{4 (0.8 ML adalimumab 50 MG/ML Auto-Injector) } PackGPCK608d4f0d-b19f-46d3-749a-7159aa5f933d2154
1872983{6 (0.4 ML adalimumab 100 MG/ML Auto-Injector) } PackGPCK608d4f0d-b19f-46d3-749a-7159aa5f933d2154
1656703{6 (0.8 ML adalimumab 50 MG/ML Auto-Injector) } PackGPCK608d4f0d-b19f-46d3-749a-7159aa5f933d2154
825169{6 (0.8 ML adalimumab 50 MG/ML Prefilled Syringe) } PackGPCK608d4f0d-b19f-46d3-749a-7159aa5f933d2154
1921009adalimumab 10 MG in 0.1 ML Prefilled SyringePSN608d4f0d-b19f-46d3-749a-7159aa5f933d2154
1921016adalimumab 20 MG in 0.2 ML Prefilled SyringePSN608d4f0d-b19f-46d3-749a-7159aa5f933d2154
763564adalimumab 20 MG in 0.4 ML Prefilled SyringePSN608d4f0d-b19f-46d3-749a-7159aa5f933d2154
1872979adalimumab 40 MG in 0.4 ML Auto-InjectorPSN608d4f0d-b19f-46d3-749a-7159aa5f933d2154
1726844adalimumab 40 MG in 0.4 ML Prefilled SyringePSN608d4f0d-b19f-46d3-749a-7159aa5f933d2154
1655726adalimumab 40 MG in 0.8 ML Auto-InjectorPSN608d4f0d-b19f-46d3-749a-7159aa5f933d2154
727703adalimumab 40 MG in 0.8 ML Prefilled SyringePSN608d4f0d-b19f-46d3-749a-7159aa5f933d2154
1921238adalimumab 80 MG in 0.8 mL Auto-InjectorPSN608d4f0d-b19f-46d3-749a-7159aa5f933d2154
1855523adalimumab 80 MG in 0.8 ML Prefilled SyringePSN608d4f0d-b19f-46d3-749a-7159aa5f933d2154
1594357adalimumab pediatric starter pack 40 MG/0.8 ML Prefilled Syringe (3 count)PSN608d4f0d-b19f-46d3-749a-7159aa5f933d2154
825169adalimumab pediatric starter pack 40 MG/0.8 ML Prefilled Syringe (6 count)PSN608d4f0d-b19f-46d3-749a-7159aa5f933d2154
1855526adalimumab pediatric starter pack 80 MG/0.8 ML and 40 MG/0.4 ML Prefilled Syringe (2 count)PSN608d4f0d-b19f-46d3-749a-7159aa5f933d2154
1873086adalimumab pediatric starter pack 80 MG/0.8 ML Prefilled Syringe (3 count)PSN608d4f0d-b19f-46d3-749a-7159aa5f933d2154
1872985adalimumab starter pack 40 MG/0.4 ML Pen (4 count)PSN608d4f0d-b19f-46d3-749a-7159aa5f933d2154
1872983adalimumab starter pack 40 MG/0.4 ML Pen (6 count)PSN608d4f0d-b19f-46d3-749a-7159aa5f933d2154
1801277adalimumab starter pack 40 MG/0.8 ML Pen (4 count)PSN608d4f0d-b19f-46d3-749a-7159aa5f933d2154
1656703adalimumab starter pack 40 MG/0.8 ML Pen (6 count)PSN608d4f0d-b19f-46d3-749a-7159aa5f933d2154
1921467adalimumab starter pack 80 MG/0.8 mL and 40 MG/0.4 mL Auto-Injector (3 count)PSN608d4f0d-b19f-46d3-749a-7159aa5f933d2154
1921244adalimumab starter pack 80 MG/0.8 mL Auto-Injector (3 count)PSN608d4f0d-b19f-46d3-749a-7159aa5f933d2154
2531133adalimumab starter pack 80 MG/0.8 ML Pen (4 count)PSN608d4f0d-b19f-46d3-749a-7159aa5f933d2154
1921010Humira 10 MG in 0.1 ML Prefilled SyringePSN608d4f0d-b19f-46d3-749a-7159aa5f933d2154
1921017Humira 20 MG in 0.2 ML Prefilled SyringePSN608d4f0d-b19f-46d3-749a-7159aa5f933d2154
763565Humira 20 MG in 0.4 ML Prefilled SyringePSN608d4f0d-b19f-46d3-749a-7159aa5f933d2154
1872980Humira 40 MG in 0.4 ML Auto-InjectorPSN608d4f0d-b19f-46d3-749a-7159aa5f933d2154
1726846Humira 40 MG in 0.4 ML Prefilled SyringePSN608d4f0d-b19f-46d3-749a-7159aa5f933d2154
1655728Humira 40 MG in 0.8 ML Auto-InjectorPSN608d4f0d-b19f-46d3-749a-7159aa5f933d2154
727705Humira 40 MG in 0.8 ML Prefilled SyringePSN608d4f0d-b19f-46d3-749a-7159aa5f933d2154
1921240Humira 80 MG in 0.8 mL Auto-InjectorPSN608d4f0d-b19f-46d3-749a-7159aa5f933d2154
1855524Humira 80 MG in 0.8 ML Prefilled SyringePSN608d4f0d-b19f-46d3-749a-7159aa5f933d2154
1855527Humira Pediatric Crohn's Disease Starter Package (2 count)PSN608d4f0d-b19f-46d3-749a-7159aa5f933d2154
1594358Humira Pediatric Crohn's Disease Starter Package (3 count)PSN608d4f0d-b19f-46d3-749a-7159aa5f933d2154
1594352Humira Pediatric Crohn's Disease Starter Package (6 count)PSN608d4f0d-b19f-46d3-749a-7159aa5f933d2154
1872984Humira Pen 40 MG/0.4 ML Starter Pack - Crohn's Disease, Ulcerative Colitis or Hidradenitis Suppurativa (6 count)PSN608d4f0d-b19f-46d3-749a-7159aa5f933d2154
1872986Humira Pen 40 MG/0.4 ML Starter Pack - Psoriasis/Uveitis (4 count)PSN608d4f0d-b19f-46d3-749a-7159aa5f933d2154
825170Humira Pen 40 MG/0.8 ML - Crohn's Disease/Ulcerative Colitis Starter PackPSN608d4f0d-b19f-46d3-749a-7159aa5f933d2154
1921245Humira Pen 80 MG/0.8 ML - Starter Package for Crohn's Disease, Ulcerative Colitis or Hidradenitis Suppurativa (3 count)PSN608d4f0d-b19f-46d3-749a-7159aa5f933d2154
2531134Humira Pen 80 MG/0.8 ML - Starter Package for Pediatric Ulcerative Colitis (4 count)PSN608d4f0d-b19f-46d3-749a-7159aa5f933d2154
1921468Humira Pen 80 MG/0.8 ML and 40 MG/0.4 ML - Psoriasis/Uveitis Starter Package (3 count)PSN608d4f0d-b19f-46d3-749a-7159aa5f933d2154
1873087Humira Prefilled Syringe 80 MG/0.8 ML Starter Pack - Pediatric Crohn's Disease (3 count)PSN608d4f0d-b19f-46d3-749a-7159aa5f933d2154
1801278Humira Psoriasis/Uveitis Starter Pack 40 MG/0.8 ML Pen (4 count)PSN608d4f0d-b19f-46d3-749a-7159aa5f933d2154
797544isopropyl alcohol 70 % Medicated PadPSN608d4f0d-b19f-46d3-749a-7159aa5f933d2154
19210100.1 ML adalimumab 100 MG/ML Prefilled Syringe [Humira]SBD608d4f0d-b19f-46d3-749a-7159aa5f933d2154
19210170.2 ML adalimumab 100 MG/ML Prefilled Syringe [Humira]SBD608d4f0d-b19f-46d3-749a-7159aa5f933d2154
18729800.4 ML adalimumab 100 MG/ML Auto-Injector [Humira]SBD608d4f0d-b19f-46d3-749a-7159aa5f933d2154
17268460.4 ML adalimumab 100 MG/ML Prefilled Syringe [Humira]SBD608d4f0d-b19f-46d3-749a-7159aa5f933d2154
7635650.4 ML adalimumab 50 MG/ML Prefilled Syringe [Humira]SBD608d4f0d-b19f-46d3-749a-7159aa5f933d2154
19212400.8 ML adalimumab 100 MG/ML Auto-Injector [Humira]SBD608d4f0d-b19f-46d3-749a-7159aa5f933d2154
18555240.8 ML adalimumab 100 MG/ML Prefilled Syringe [Humira]SBD608d4f0d-b19f-46d3-749a-7159aa5f933d2154
16557280.8 ML adalimumab 50 MG/ML Auto-Injector [Humira]SBD608d4f0d-b19f-46d3-749a-7159aa5f933d2154
7277050.8 ML adalimumab 50 MG/ML Prefilled Syringe [Humira]SBD608d4f0d-b19f-46d3-749a-7159aa5f933d2154
19210090.1 ML adalimumab 100 MG/ML Prefilled SyringeSCD608d4f0d-b19f-46d3-749a-7159aa5f933d2154
19210160.2 ML adalimumab 100 MG/ML Prefilled SyringeSCD608d4f0d-b19f-46d3-749a-7159aa5f933d2154
18729790.4 ML adalimumab 100 MG/ML Auto-InjectorSCD608d4f0d-b19f-46d3-749a-7159aa5f933d2154
17268440.4 ML adalimumab 100 MG/ML Prefilled SyringeSCD608d4f0d-b19f-46d3-749a-7159aa5f933d2154
7635640.4 ML adalimumab 50 MG/ML Prefilled SyringeSCD608d4f0d-b19f-46d3-749a-7159aa5f933d2154
19212380.8 ML adalimumab 100 MG/ML Auto-InjectorSCD608d4f0d-b19f-46d3-749a-7159aa5f933d2154
18555230.8 ML adalimumab 100 MG/ML Prefilled SyringeSCD608d4f0d-b19f-46d3-749a-7159aa5f933d2154
16557260.8 ML adalimumab 50 MG/ML Auto-InjectorSCD608d4f0d-b19f-46d3-749a-7159aa5f933d2154

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0074-0616-02000740616022 KIT in 1 CARTON (0074-0616-02) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .2 mL in 1 SYRINGE * 1 mL in 1 PACKET2 kit2017-04-280000-00-00NoNoCurrent
0074-0616-71000740616712 KIT in 1 CARTON (0074-0616-71) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .2 mL in 1 SYRINGE * 1 mL in 1 PACKET2 kit2017-04-280000-00-00YesNoCurrent