FDA.reportPublic FDA data

NDC 83457-615 - Humira

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
83457-615
Package NDCs from labels
83457-615-01
Manufacturer
Cordavis Limited
Effective date
2025-12-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Humira - Cordavis LimitedCordavis Limited2025-12-23HUMAN PRESCRIPTION DRUG LABEL

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83457-615HUMIRA (ADALIMUMAB) KIT [CORDAVIS LIMITED]1Unmatched20240217_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 8 of 46 · 907 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ABRILADAADALIMUMAB-AFZBPfizer Laboratories Div Pfizer Inc5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f2026-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 797544
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
caring mill Alcohol WipesISOPROPYL ALCOHOLFSA Store Inc.80997bb6-b878-45d4-a6e9-4ae37442d67e2026-05-06WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Redicare Alcohol Prep PadsMEDIUM ALCOHOL PREP PADSRedicare LLC3cb7fba1-1d2d-f4da-e063-6394a90a4b212026-05-01WarningsExact identifier
rxcui: 797544
unii: ND2M416302
70%ISOPROPYL ALCOHOLYour Military Exchanges3dcb8422-827d-479b-ba18-eee8dbb762e12026-04-30Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLPerrigo Direct, Inc11d89d11-103e-4ef6-a996-65cff67f9b322026-04-29Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLWalmart Inc.1fd3d29f-7da0-c5ba-e063-6294a90add162026-04-29Warnings, Adverse reactionsExact identifier
unii: ND2M416302
leuprolide acetateLEUPROLIDE ACETATESun Pharmaceutical Industries, Inc.a3b01473-30c7-4945-bd60-2484221aaaad2026-04-24Warnings, Adverse reactionsExact identifier
rxcui: 797544
Leuprolide AcetateLEUPROLIDE ACETATEMeitheal Pharmaceuticals Incd6bd26bd-b8d8-4c5a-bc5c-7b8a1efaa5842026-04-23Warnings, Adverse reactionsExact identifier
rxcui: 797544
3M DuraPrep SurgicalIODINE POVACRYLEX AND ISOPROPYL ALCOHOLSolventum US LLC22a10a54-6a04-48b3-9ec4-b26526183daf2026-04-23WarningsExact identifier
unii: ND2M416302
3M SoluPrep SCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLSolventum US LLC084aa305-5863-441a-a94d-36bc1b05195a2026-04-23WarningsExact identifier
unii: ND2M416302
MannitolMANNITOLHospira, Inc.8ad3145e-00e7-4412-b9a5-06f00f264f302026-04-21Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
ALCOHOL PREP PADS LARGE STERILEISOPROPYL ALCOHOL CLOTHJINHUA JINGDI MEDICAL SUPPLIES CO.,LTD4f8ba6c8-5155-c491-e063-6394a90adde92026-04-15WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLPerrigo Direct, Incec43a3f5-c5f3-439b-8764-ca92fefb45c92026-04-10Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLMSC Industrial Supplyb248ad4a-ed92-4d03-b0da-9639c46e19492026-04-10Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Verifine Alcohol SwabsALCOHOL SWABSPromisemed Hangzhou Meditech Co.,LTD.4ef56b6c-ad46-2d02-e063-6294a90ad4072026-04-08WarningsExact identifier
rxcui: 797544
unii: ND2M416302
70%ISOPROPYL ALCOHOLPerrigo Direct, Incf953a249-07ad-40a1-8aea-b2d419fd3d4d2026-04-07Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLWinCo Foods, LLCc22a5fc3-78f5-4660-96a6-479ca6f776022026-04-06Warnings, Adverse reactionsExact identifier
unii: ND2M416302
70% Isopropyl Rubbing AlcoholISOPROPYL RUBBING ALCOHOLWinCo Foods, LLC2b48ee19-8f0c-4b36-855d-7909dde5c8712026-04-06Warnings, Adverse reactionsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.