FDA.reportPublic FDA data

NDC 0597-0490 - Cyltezo

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
0597-0490
Package NDCs from labels
0597-0490-32
Manufacturer
Boehringer Ingelheim Pharmaceuticals, Inc.
Effective date
2026-05-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cyltezo - Boehringer Ingelheim Pharmaceuticals, Inc.Boehringer Ingelheim Pharmaceuticals, Inc.2026-05-22HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0597-0490-32Cyltezo0.4 mL in 1 SYRINGEINJECTION, SOLUTION0.4 mL40 mg in 0.4mL17
0597-0490-32Cyltezo1 in 1 TRAYINJECTION, SOLUTION40 mg in 0.4mL17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0597-0490CYLTEZO (ADALIMUMAB-ADBM) KIT [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]13Unmatched20240507_115ea79b-7209-7f19-b35d-36ec0828fbf5.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 7 of 45 · 887 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Isopropyl Rubbing Alcohol WipesISOPROPYL ALCOHOLCVS PHARMACY, INC7e027210-9729-4659-8a75-b6b2ac60f7bc2026-05-19WarningsExact identifier
rxcui: 797544
unii: ND2M416302
CVS Isopropyl Rubbing Alcohol PadsISOPROPYL ALCOHOLCVS PHARMACY, INCe65b3363-71d9-47b6-a044-edac18f9858f2026-05-19WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Leuprolide AcetateLEUPROLIDE ACETATESandoz Inc8bd72c1e-2751-4498-a346-bc5e3acbba0b2026-05-19Warnings, Adverse reactionsExact identifier
rxcui: 797544
Wish Alcohol PadISOPROPYL ALCOHOL CLOTHYiwu Ori-Power Medtech Co.,Ltd.51f87ed7-04ae-136a-e063-6294a90a95002026-05-16WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Alcohol prep padISOPROPYL ALCOHOL CLOTHHubei V-Medical Products co.,Ltd.51d5780e-9039-1b66-e063-6394a90a0b8a2026-05-15WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Verifine Alcohol SwabsALCOHOL SWABSPromisemed Hangzhou Meditech Co.,LTD.4e91983f-4570-3a56-e063-6394a90a38f22026-05-15WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Swab Applicator Brushes 2% w/w chlorhexidine gluconate (CHG) and 70% v/v isopropyI alcohol (IPA)CHLORHEXIDINE GLUCONATE, ISOPROPYI ALCOHOLXINXIANG XINDA TECHNOLOGY CO.,LTD51c34af0-2b12-c5e0-e063-6394a90a41742026-05-14WarningsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLChain Drug Marketing Associationf5b99c4b-1f4b-40be-bae7-59aa92c5b52c2026-05-14Warnings, Adverse reactionsExact identifier
unii: ND2M416302
91% Isopropyl AlcoholISOPROPYL ALCOHOLChain Drug Marketing Associationf10995fd-fe94-436a-8783-4cdf10438d752026-05-14Warnings, Adverse reactionsExact identifier
unii: ND2M416302
70% Isopropyl AlcoholISOPROPYL ALCOHOLChain Drug Marketing Associationc07b7f1b-eda2-4f0f-a35d-f34ac85abab32026-05-14Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl alcoholISOPROPYL ALCOHOLHARRIS TEETERb3fa1454-25cd-4801-bbec-5da43a70ec7f2026-05-14WarningsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLHARRIS TEETERc4e816c7-a8a2-404c-9354-eaaed6dbf0f52026-05-14WarningsExact identifier
unii: ND2M416302
HADLIMAADALIMUMAB-BWWDA-S Medication Solutionsc361dd60-c88d-4f3c-b98c-79687bbc34502026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: FYS6T7F842
Lightning X Sting and Bite Relief PadsBENZOCAINE, ISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd.518698c0-a1ae-760f-e063-6394a90a51602026-05-11WarningsExact identifier
unii: ND2M416302
caring mill Lavender Alcohol WipesISOPROPYL ALCOHOLFSA Store Inc.fcbb6b34-6f0e-4b82-8b3f-1d702d88079a2026-05-11WarningsExact identifier
rxcui: 797544
unii: ND2M416302
LEUPROLIDE ACETATELEUPROLIDE ACETATEEugia US LLC49a1d0c1-304c-46f2-a780-bd940ae1ced02026-05-08Warnings, Adverse reactionsExact identifier
rxcui: 797544
Lightning X Prep PadISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd.5136065e-8dc9-0dae-e063-6294a90a3f9d2026-05-07WarningsExact identifier
rxcui: 797544
unii: ND2M416302
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

Reported adverse events (FAERS/openFDA)#

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