FDA.reportPublic FDA data

Humira

Product NDC
0074-0243
11-digit product format
000740243
Labeler code
0074
Product ID
0074-0243_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
2015-11-23
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
Rxcui727703, 727705, 763564, 763565, 797544, 825169, 825170, 1594352, 1594357, 1594358, 1655726, 1655728, 1656703, 1726844, 1726846, 1801277, 1801278, 1855523, 1855524, 1855526

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
0074-0243-02Humira2 in 1 CARTONKIT22154
0074-0243-02Humira1 in 1 KITKIT12154
0074-0243-71Humira2 in 1 CARTONKIT22154
0074-0243-71Humira1 in 1 KITKIT12154

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0074-0243-02EA - Each0074-0243c8bdbd7a-8fc5-4375-8f8c-855d0863e3a812018-05-09

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
0074-0243HUMIRA (ADALIMUMAB) KIT HUMIRA (ADALIMUMAB) INJECTION, SOLUTION [ABBVIE INC.]2148Current NDC, Legacy NDC, 4 package rows20240210_608d4f0d-b19f-46d3-749a-7159aa5f933d.zip

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
0074-0243-02000740243022 KIT in 1 CARTON (0074-0243-02) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET2 kit2015-11-230000-00-00NoNoCurrent
0074-0243-71000740243712 KIT in 1 CARTON (0074-0243-71) > 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY > .4 mL in 1 SYRINGE * 1 mL in 1 PACKET2 kit2015-11-230000-00-00YesNoCurrent