FDA.reportPublic FDA data

NDC 0597-0580 - Adalimumab-adbm

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
0597-0580
Package NDCs from labels
0597-0580-37
Manufacturer
Boehringer Ingelheim Pharmaceuticals, Inc.
Effective date
2025-11-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Adalimumab-adbm - Boehringer Ingelheim Pharmaceuticals, Inc.Boehringer Ingelheim Pharmaceuticals, Inc.2025-11-12HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0597-0580-37Adalimumab-adbm0.2 mL in 1 SYRINGEINJECTION, SOLUTION0.2 mL10 mg in 0.2mL5
0597-0580-37Adalimumab-adbm1 in 1 TRAYINJECTION, SOLUTION10 mg in 0.2mL5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0597-0580ADALIMUMAB-ADBM KIT [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]2Unmatched20240507_62f39a7c-00df-4519-a8d4-39bbd0a649ed.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 23 of 45 · 887 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alcohol WipeISOPROPYL ALCOHOLWalmart Inc.067c3983-d450-e86b-e063-6294a90ab7582025-10-23WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLC24337cc6-98fe-ca0b-e063-6394a90a8b7b2025-10-23WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Alcohol Prep PadsISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLCa225426a-c4d5-459c-bc11-2b521e08e5102025-10-23WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Alcohol SwabsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLC1516d90b-4879-eb2f-e063-6294a90aa9142025-10-23WarningsExact identifier
rxcui: 797544
unii: ND2M416302
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213, LLC8541a1ed-2a92-1fab-e053-2a91aa0a29d12025-10-23WarningsExact identifier
unii: ND2M416302
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
American Red Cross 70% Isopropyl AlcoholISOPROPYL ALCOHOL(70%CONC.)Zhejiang Guoyao Jingyue Aerosol Co., Ltd.41b6ee3f-55f4-0502-e063-6394a90aa3572025-10-21WarningsExact identifier
unii: ND2M416302
AdalimumabADALIMUMAB-ADAZSandoz Inc3468792f-63ef-4916-8ed1-8214f327d9dd2025-10-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: FYS6T7F842
CVS Alcohol PrepISOPROPYL ALCOHOLCVS Pharmacy7abc66f2-faf6-421c-9c3c-b69f5a5872462025-10-20WarningsExact identifier
rxcui: 797544
unii: ND2M416302
PROHEAL ALCOHOL XXL PREP PADSISOPROPYL ALCOHOLClick Industries LLCec81be59-94a5-4675-9047-e3e82d7ad7612025-10-20WarningsExact identifier
rxcui: 797544
unii: ND2M416302
ALCOHOL PREP PADISOPROPYL ALCOHOLGuangdong Comfort Medical Products Co., Ltd.3a2dea43-8123-3fb7-e063-6294a90a5e502025-10-19WarningsExact identifier
rxcui: 797544
unii: ND2M416302
HYRIMOZADALIMUMAB-ADAZCordavis Limited3e303a4a-980b-4f2a-9d03-7869287586372025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: FYS6T7F842
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213, LLC85790749-5a95-7f18-e053-2a91aa0a1a022025-10-17WarningsExact identifier
unii: ND2M416302
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213, LLC85791e13-4103-19fe-e053-2991aa0a647f2025-10-17WarningsExact identifier
unii: ND2M416302
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213, LLC85794f6b-d1ea-40f9-e053-2991aa0a88232025-10-17WarningsExact identifier
unii: ND2M416302
ChloraPrep SwabstickCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213 LLC1666069b-38f6-bfde-e063-6394a90ad1b82025-10-17WarningsExact identifier
unii: ND2M416302
HYRIMOZADALIMUMAB-ADAZSandoz Inc1ac7d061-3380-468c-b077-c05f8dfbc8292025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: FYS6T7F842
Adalimumab-bwwdADALIMUMAB-BWWDCordavis Limitedc24655e5-796e-4127-b716-92f08d649c832025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: FYS6T7F842
Medline Alcohol Prep Sterile, LargeISOPROPYL ALCOHOLMedline Industries, LPc9fae7b6-2f4b-490b-9b17-a7297e7380692025-10-16WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Medline Alcohol Prep Sterile, MediumISOPROPYL ALCOHOLMedline Industries, LP9a8584e1-b422-4b77-8464-4e022d578fad2025-10-16WarningsExact identifier
rxcui: 797544
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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