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 42 of 45 · 887 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alcohol Swabsticks 1s SterileISOPROPYL ALCOHOLJianerkang Medical Co., Ltdf725587c-ed7b-48de-885a-ac464e72e6d22023-10-23WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Alcohol Swabsticks 3s SterileISOPROPYL ALCOHOLJianerkang Medical Co., Ltd6b21e472-d473-4b22-bc31-78b00c523e2d2023-10-23WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Alcohol Prep Pad Medium PadISOPROPYL ALCOHOLHenry Schein Inc.bdd02ae1-782a-dc72-e053-2a95a90a75542023-10-23WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Alcohol Prep Pad Medium PadISOPROPYL ALCOHOLHenry Schein Inc.b46933ab-41f5-7513-e053-2a95a90a0c692023-10-23WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Alcohol Prep Pad Large PadISOPROPYL ALCOHOLHenry Schein Inc.b468eefd-625b-5c27-e053-2995a90ab0f42023-10-23WarningsExact identifier
rxcui: 797544
unii: ND2M416302
HADLIMAADALIMUMAB-BWWDA-S Medication Solutions7345f276-102e-4175-b7ef-ff1706b054722023-10-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: FYS6T7F842
AlcoholISOPROPYL ALCOHOLJianerkang Medical Co., Ltd76048b01-28f3-4e43-9da9-974b2b511a102023-10-22WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Up and Up 70 Isopropyl Alcohol WipesISOPROPYL ALCOHOLTarget Corporationbecc8fe3-eaf5-4429-b462-a87dd09c4db82023-10-17WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Prevantics SwabCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLProfessional Disposables International, Inc.ff999b50-0b6b-404e-b4f1-c6694fe47a9b2023-10-13WarningsExact identifier
unii: ND2M416302
Prevantics SwabCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLProfessional Disposables International, Inc.db61e7fd-c421-4e3c-bc88-0343230273de2023-10-13WarningsExact identifier
unii: ND2M416302
GoodSense Alcohol SwabsISOPROPYL ALCOHOLGeiss, Destin and Dunn968bab9f-5b74-270b-e053-2995a90a0df42023-10-13WarningsExact identifier
rxcui: 797544
unii: ND2M416302
DUKAL STING RELIEF PADBENZOCAINEDukal LLC67c1ddc7-8fde-4431-84cb-f757682d5f3e2023-10-13WarningsExact identifier
unii: ND2M416302
First Aid Antiseptic Alcohol Pads Isopropyl Alcohol 70 Rite AidISOPROPYL ALCOHOLRite Aid Corporationaa0df5fe-62d1-407d-b8f9-a7fd9473d5692023-10-02WarningsExact identifier
rxcui: 797544
unii: ND2M416302
HADLIMAADALIMUMAB-BWWDA-S Medication Solutionsef25af7e-6267-409a-8d68-de51eb48812a2023-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: FYS6T7F842
ANUBISMEDHA HYALURONICANUBIS COSMETICS SLeac771e2-4c1b-3808-e053-2995a90ac5fc2023-09-05WarningsExact identifier
unii: 059QF0KO0R
AnubisMedSPF 50 BROAD SPECTRUM PROTECTION FLUID EMULSIONANUBIS COSMETICS SLe99d92c4-8768-9c0a-e053-2a95a90a609e2023-09-05WarningsExact identifier
unii: 059QF0KO0R
AnubisMedAZELAIC ACID, SALICYLIC ACIDANUBIS COSMETICS SLebf3153d-30f5-54e4-e053-2995a90a74b12023-09-05WarningsExact identifier
unii: 059QF0KO0R
unii: ND2M416302
AnubisMedGLYCOLIC ACID, CITRIC ACID, LACTIC ACID, KOJIC ACIDANUBIS COSMETICS SLeca95dde-cb57-2ab6-e053-2995a90af84f2023-09-05WarningsExact identifier
unii: 059QF0KO0R
unii: ND2M416302
AnubisMedSODIUM BICARBONATE, ALOE BARBADENSIS LEAF JUICE, IMIDAZOLIDINYL UREAANUBIS COSMETICS SLebf4b3ab-34e1-185a-e053-2a95a90ace3a2023-09-05WarningsExact identifier
unii: 059QF0KO0R
Anubis BarcelonaGLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICEANUBIS COSMETICS SLeb651769-4d98-2b3b-e053-2a95a90a36b02023-09-01WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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