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 5 of 45 · 887 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMJEVITAADALIMUMAB-ATTOAmgen, Inc9c44bd5b-4464-40a4-8933-8680950f00f22026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: FYS6T7F842
Lights Medium AlcoholISOPROPYL ALCOHOLLights Medical Manufacture Co., Ltd.873e0c9d-e0aa-44bb-a1f4-4474584790232026-06-25WarningsExact identifier
rxcui: 797544
unii: ND2M416302
AMJEVITAADALIMUMAB-ATTONuvaila Limitedd7862491-2634-4402-b001-dcc1abf8dd582026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: FYS6T7F842
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R
Swab Applicator Brushes Iodine (0.7% Available Iodine) and Isopropyl Alcohol (74% w/w)IODINE, ISOPROPYL ALCOHOLXINXIANG XINDA TECHNOLOGY CO.,LTD54e83df5-bbeb-d068-e063-6394a90ad5132026-06-23WarningsExact identifier
unii: ND2M416302
70%ISOPROPYL ALCOHOLADUSA Distribution, LLCf340dd7e-6412-4621-a818-2592ca78d0f22026-06-23Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLADUSA Distribution, LLCd95a9736-345b-4b7e-9b24-23edb3cbf7e82026-06-23Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLADUSA Distribution, LLC7e066163-6629-43ad-b0b8-09c16fe94a0d2026-06-23Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
Isopropyl Rubbing Alcohol 70ISOPROPYL ALCOHOLDelon Laboratories (1990) Ltd.fb481568-0c51-421f-9b73-adb4c84645aa2026-06-22WarningsExact identifier
unii: ND2M416302
MedlineISOPROPYL ALCOHOLMedline Industries, LP495076e9-3187-6bfa-e063-6394a90a01f52026-06-22WarningsExact identifier
rxcui: 797544
unii: ND2M416302
ABRILADAADALIMUMAB-AFZBA-S Medication Solutions79943fe6-1249-4074-9aed-c53937820d0f2026-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 797544
Isopropyl alcohol 91 percentISOPROPYL ALCOHOLP & L Development, LLCfcda76cb-63c4-4e81-9e0a-13be506a81502026-06-17WarningsExact identifier
unii: ND2M416302
HumalogINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ZolgensmaONASEMNOGENE ABEPARVOVEC-XIOINovartis Innovative Technologies Inc.68cd4f06-70e1-40d8-bedb-609ec0afa4712026-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 797544
SkyriziRISANKIZUMAB-RZAAAbbVie Inc.7148c8eb-b39e-e20a-6494-a6df823928582026-06-15Warnings, Adverse reactionsExact identifier
rxcui: 797544
70%ISOPROPYL ALCOHOLMeijer, Inc.7b1f93ff-5eeb-4da1-8f02-7c47d713689a2026-06-15Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLMeijer, Inc.531cea18-9609-4d78-876d-3ba5d2d1e16f2026-06-15Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLMeijer, Inc.b0d302c2-58a0-4c3e-9c4a-fd34de40c0342026-06-15Warnings, Adverse reactionsExact identifier
unii: ND2M416302
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBTotal Operations Management LLC DBA:Bestmade Natural Products Micro54113d1f-e8e7-6b4c-e063-6394a90a0edf2026-06-12WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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