FDA.reportPublic FDA data

NDC 65219-610 - Adalimumab-aacf

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
65219-610
Package NDCs from labels
65219-610-02
Manufacturer
Fresenius Kabi USA, LLC | Fresenius Kabi Austria | Merck Serono SPA
Effective date
2026-01-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
adalimumab - Fresenius Kabi USA, LLC | Fresenius Kabi Austria | Merck Serono SPAFresenius Kabi USA, LLC | Fresenius Kabi Austria | Merck Serono SPA2026-01-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65219-610-02Adalimumab-aacf0.8 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION1.6 mL40 mg in 0.8mL6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65219-610ADALIMUMAB-AACF (ADALIMUMAB) KIT [FRESENIUS KABI USA, LLC]5Unmatched20240826_2488b0bc-7b8f-4cc8-91ea-48e7ea5e8915.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 63 of 87 · 1,736 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LACTATED RINGERSSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEBecton Dickinson and Companybb2ad9cd-5d9a-4337-be61-0842d738c79e2024-10-16Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Elliotts BSODIUM CATION, SODIUM BICARBONATE, ANHYDROUS DEXTROSE, MAGNESIUM SULFATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM PHOSPHATELukare Medical, LLC08036dbd-55b3-47b9-9890-000f253544f32024-10-16Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
LACTATED RINGERSSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEFresenius Kabi USA, LLC8fce1477-991f-4b43-bf05-a80bad8972622024-10-16Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
IDACIOADALIMUMAB-AACFFresenius Kabi USA, LLC08dbaffe-9d05-43cf-b24b-b44ade8685fc2024-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761255
ndc (package): 65219-332-95
rxcui: 797544
Genuine First Aid Alcohol Cleansing PadISOPROPYL ALCOHOLGFA Production (Xiamen) Co., Ltd.af090168-f9b3-c2fa-e053-2a95a90a1b762024-10-15WarningsExact identifier
rxcui: 797544
unii: ND2M416302
EyS Eye WashWATEREyes-Plus LLC1443f6bf-3a77-4a19-8585-0ec58efe042f2024-10-15WarningsExact identifier
unii: 059QF0KO0R
Eye WashWATER SOLUTIONKroger Company354402ad-581d-47e7-9fd3-933bef281ff42024-10-11WarningsExact identifier
unii: 059QF0KO0R
Isopropyl Alcohol Cleansing PadISOPROPYL ALCOHOLHubei Changjian Medical Products Co., Ltd.e6f9a23b-ae6e-4fce-b66d-b602038dc7462024-10-11WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Eye WashWATERHubei Changjian Medical Products Co., Ltd.d57e1c5b-1edc-4a94-88bc-f9ecf347b7ea2024-10-11WarningsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLCc44b0fdb-33df-4747-b443-5fb4deb456cb2024-10-11Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Bacteriostatic Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLCe5e325d1-0d58-40c9-9645-3ae402ff9d922024-10-11Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Vamousse Lice DefenseEUCALYPTUS GLOBULUS, NATRUM MURIATICUMAlliance Pharma Inc.c87ce5d3-c200-421e-88be-bc8060a5993a2024-10-08WarningsExact identifier
unii: 451W47IQ8X
Physicians EZ Use B-12 CompliancePHYSICIANS EZ USE B-12 COMPLIANCEAsclemed USA, Inc.168f94ea-2faf-4aeb-88a5-8753ad60a1c42024-10-05Warnings, Adverse reactionsExact identifier
rxcui: 797544
Enoxiluv KitENOXAPARIN SODIUM, ISOPROPYL ALCOHOLAsclemed USA, Inc.e8855fae-f70d-4099-969e-a1d9f29292592024-10-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 797544
Dyural 80-LMMETHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOLAsclemed USA, Inc.c4071146-7d89-4c3a-9278-389d801cf66d2024-10-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 797544
HyronanSODIUM HYALURONATE, LIDOCAINE, ISOPROPYL ALCOHOLAsclemed USA, Inc.be8102bb-1250-4d08-b78b-7073ab704e662024-10-04Warnings, Adverse reactionsExact identifier
rxcui: 797544
Energy CatalystVISCUM ALBUM, COBALT GLUCONATE, CUPRUM SULPHURICUM, FERROUS FUMARATE, MAGNESIUM ASPARTATE, MANGANESE GLUCONATE, PHOSPHORUS, POTASSIUM ASPARTATE, SODIUM MOLYBDATE, ADENOSINUM, CYCLOPHOSPHORICUM, CERIUM OXALICUM, NICKEL ACETATE, ALUMINIUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, ARSENICUM ALBUM, AURUM METALLICUM, BARYTA CARBONICA, BERYLLIUM METALLICUM, BISMUTHUM METALLICUM, BROMIUM, CADMIUM METALLICUM, CERIUM METALLICUM, CESIUM CHLORIDE, DYSPROSIUM METALLICUM, ERBIUM METALLICUM, ALUMINA,Deseret Biologicals, Inc.99529dd4-f8ab-4348-8b65-dc8c89e1ad542024-10-04WarningsExact identifier
unii: 451W47IQ8X
Isopropyl AlcoholISOPROPYL ALCOHOLBecton Dickinson and Company7ae72375-ffed-42c8-9506-051861ea68fc2024-10-03WarningsExact identifier
ndc (product): 8290-3268
rxcui: 797544
spl id: 00aa8e3c-db3b-4059-8b00-d3776af8735a
spl set id: 7ae72375-ffed-42c8-9506-051861ea68fc
unii: ND2M416302
Thyroid HPBARYTA CARBONICA, CALCAREA CARBONICA, CALCAREA IODATA, FUCUS VESICULOSUS, IODIUM, LAPIS ALBUS, LEVOTHYROXINUM, NATRUM MURIATICUM, PULSATILLA (VULGARIS), SELENIUM METALLICUM, SPONGIA TOSTA, THYROIDINUM (SUIS)Energique, Inc.2f04e425-7160-41a7-aa1e-934db54f17512024-09-30WarningsExact identifier
unii: 451W47IQ8X
Gut Brain SpectrumABROTANUM (ARTEMISIA ABROTANUM), AETHUSA CYNAPIUM, BAPTISIA TINCTORIA, CICUTA VIROSA, CUPRUM METALLICUM, MEZEREUM, BUFO RANA, LAC MATERNA HUMANUM, SACCHARUM OFFICINALE, SEROTONIN (HYDROCHLORIDE), ALUMINA, CALCAREA PHOSPHORICA, CANDIDA ALBICANS, CARCINOSIN, HELIUM, LAC CANINUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, SULPHUR, THUJA OCCIDENTALIS, FORMALINUM, MORBILLINUMEnergique, Inc.cb1566a4-92d4-4f1a-9211-f0c538a83c272024-09-27WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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