FDA.reportPublic FDA data

NDC 0597-0480 - 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
0597-0480
Package NDCs from labels
0597-0480-12
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
0597-0480-12Cyltezo0.4 mL in 1 SYRINGEINJECTION, SOLUTION0.4 mL40 mg in 0.4mL17
0597-0480-12Cyltezo1 in 1 TRAYINJECTION, SOLUTION40 mg in 0.4mL17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0597-0480CYLTEZO (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 6 of 45 · 887 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBBM Private Limited53fa21d9-1f80-2e69-e063-6394a90ab9f32026-06-11WarningsExact identifier
unii: 059QF0KO0R
EVR Alcohol Prep PadsLSOPROPYL ALCOHOLJINHUA JINGDI MEDICAL SUPPLIES CO.,LTD5406ba2f-6729-b9e7-e063-6394a90ac5532026-06-11WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Isopropyl alcoholISOPROPYL ALCOHOLCVS PHARMACY, INCb30468f6-7a1b-4165-916f-36df21eb10e52026-06-09WarningsExact identifier
unii: ND2M416302
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
unii: 059QF0KO0R
MedThermal ALCOHOL PREP PADISOPROPYL ALCOHOLCarelife (USA) Inc.fc9d6344-be68-484f-984b-8c7f39b6034d2026-06-08WarningsExact identifier
rxcui: 797544
unii: ND2M416302
GeriGentle Alcohol PadsISOPROPYL ALCOHOLGeri-Gentle Corporation05cda9fa-e503-6e37-e063-6394a90a27112026-06-05WarningsExact identifier
rxcui: 797544
unii: ND2M416302
GNP Isopropyl Alcohol 70 Percent With Wintergreen OilISOPROPYL ALCOHOLAmerisource Bergen03247512-7a31-4fb4-b7e0-efc337cab6932026-06-04WarningsExact identifier
unii: ND2M416302
GNP Isopropyl Rubbing Alcohol 70 PercentISOPROPYL ALCOHOLAmerisource Bergen0ffd9643-3bc2-4b04-92c5-80fe5e429a252026-06-04WarningsExact identifier
unii: ND2M416302
OP First Aid Series Insect Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOLYiwu Ori-Power Medtech Co.,Ltd.b43af183-834a-0f64-e053-2995a90a32182026-06-03WarningsExact identifier
unii: ND2M416302
OptiSource Sterile Alcohol Prep PadsISOPROPYL ALCOHOL7051395 Canada Ince49c9ddf-7743-443e-ba85-ee90785f0c722026-06-02WarningsExact identifier
rxcui: 797544
unii: ND2M416302
leuprolide acetateLEUPROLIDE ACETATEAmneal Pharmaceuticals LLC4838c674-044e-46b2-81e7-c691b99d8fa52026-05-28Warnings, Adverse reactionsExact identifier
rxcui: 797544
MyMedic Sting Relief WipeBENZOCAINE, ISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd52b5653e-289c-d99e-e063-6294a90aa6472026-05-26WarningsExact identifier
unii: ND2M416302
LEUPROLIDE ACETATELEUPROLIDE ACETATEZydus Pharmaceuticals USA Inc.35634415-000f-47db-9bd7-9e16eef3f02e2026-05-25Warnings, Adverse reactionsExact identifier
rxcui: 797544
Swab Applicator Brushes 8.3% w/w Povidone-Iodine and 72.5% w/w Isopropyl Alcohol (IPA)POVIDONE-IODINE, ISOPROPYL ALCOHOLXINXIANG XINDA TECHNOLOGY CO.,LTD529b8ad6-081e-0ef8-e063-6294a90a67df2026-05-24WarningsExact identifier
unii: ND2M416302
Swab Stick 2% w/w chlorhexidine gluconate (CHG) and 70% v/v isopropyI alcohol (IPA)CHLORHEXIDINE GLUCONATE, ISOPROPYI ALCOHOLXINXIANG XINDA TECHNOLOGY CO.,LTD51c42761-3a7a-172d-e063-6394a90a53332026-05-24WarningsExact identifier
unii: ND2M416302
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
CyltezoADALIMUMAB-ADBMBoehringer Ingelheim Pharmaceuticals, Inc.115ea79b-7209-7f19-b35d-36ec0828fbf52026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761058
ndc (package): 0597-0370-45
ndc (package): 0597-0485-46
ndc (package): 0597-0495-50
ndc (package): 0597-0400-89
ndc (package): 0597-0375-97
ndc (package): 0597-0495-40
ndc (package): 0597-0495-47
ndc (package): 0597-0370-82
ndc (package): 0597-0485-20
ndc (package): 0597-0495-60
ndc (package): 0597-0375-23
ndc (package): 0597-0480-12
ndc (package): 0597-0370-72
ndc (package): 0597-0490-32
ndc (package): 0597-0405-10
ndc (package): 0597-0375-48
ndc (package): 0597-0375-16
ndc (package): 0597-0405-80
ndc (package): 0597-0375-53
ndc (product): 0597-0370
ndc (product): 0597-0495
ndc (product): 0597-0405
ndc (product): 0597-0375
ndc (product): 0597-0485
ndc (product): 0597-0400
rxcui: 2640900
rxcui: 2640889
rxcui: 2640903
rxcui: 2680748
rxcui: 2680759
rxcui: 2640891
rxcui: 2680746
rxcui: 2680743
rxcui: 2680750
rxcui: 2680756
rxcui: 2640893
rxcui: 2640892
rxcui: 2680757
rxcui: 797544
rxcui: 2640902
rxcui: 2640894
rxcui: 2640901
rxcui: 2680760
rxcui: 2640898
rxcui: 2640895
rxcui: 2640883
spl id: e7565b3d-b98e-46bb-906f-e821077068dc
spl set id: 115ea79b-7209-7f19-b35d-36ec0828fbf5
Walgreens 70% Isopropyl Alcohol WipesISOPROPYL ALCOHOLWalgreen Companye8b0ecc3-3a30-47c9-b7d1-518681d575b42026-05-21WarningsExact identifier
rxcui: 797544
unii: ND2M416302
70% Isopropyl Alcohol70% ISOPROPYL ALCOHOLGreatdealson, Inc.4aa809cd-500a-dd65-e063-6394a90a31442026-05-20Warnings, Adverse reactionsExact identifier
unii: ND2M416302
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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