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 46 of 46 · 907 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dukal Sterile Alcohol Prep PadISOPROPYL ALCOHOLDukal Corporation54586d75-a0a1-46aa-9cc9-631094320bff2019-02-28WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Dynamic Eyewash with EyecupWATERDynamic Safety International7d3af0f4-0e1f-9ea5-e053-2991aa0af7a22018-12-17WarningsExact identifier
unii: 059QF0KO0R
Bio Rock WaterROCK WATERBioActive Nutritional, Inc.178bd16d-0d4f-49d8-866b-8ab3a3c6889d2018-07-30WarningsExact identifier
unii: 059QF0KO0R
ENT Essentials All Dry Ear Drying DropsISOPROPYL ALCOHOLWisconsin Pharmacal Company5f0bb412-577e-3155-e053-2a91aa0a7f532017-11-28WarningsExact identifier
unii: ND2M416302
Sterile WaterWATERBaxter Healthcare Corporationef3e79c5-3f58-4b36-a296-64b7d9a651c12017-10-17Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye WashWATERCVS Pharmacy049cee29-7ec2-4d5b-8308-f522acde43a72017-03-29WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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