NDC 0597-0540 - 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
0597-0540
Package NDCs from labels
0597-0540-10
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
0597-0540-10Adalimumab-adbm1 in 1 TRAYINJECTION, SOLUTION40 mg in 0.8mL5
0597-0540-10Adalimumab-adbm0.8 mL in 1 SYRINGEINJECTION, SOLUTION0.8 mL40 mg in 0.8mL5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0597-0540ADALIMUMAB-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 22 of 45 · 887 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alcohol Prep PadsISOPROPYL ALCOHOLHtl-Strefa, Inc.d72ddf5a-72e7-c37d-e053-2995a90ad48b2025-10-23WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLCc92524fd-8b91-592d-e053-2a95a90a88c62025-10-23WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Alcohol PrepISOPROPYL ALCOHOLCardinal Health89852887-ae62-4277-b615-75663afb54362025-10-23WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Alcohol Prep PadsISOPROPYL ALCOHOLHenry Schein, Inc.b9826baa-b976-14c6-e053-2995a90a7d092025-10-23WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLCc9261c7f-9f8f-6476-e053-2a95a90a0e932025-10-23WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Alcohol Prep PadISOPROPYL ALCOHOLRugby Laboratoriesea28b27a-456e-4042-b769-f060727599332025-10-23WarningsExact identifier
rxcui: 797544
unii: ND2M416302
School Health Sterile Alcohol Prep PadISOPROPYL ALCOHOLSchool Health Corporation718640e1-826b-4b65-a021-3f82cd4c983a2025-10-23WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Alcohol Prep PadsISOPROPYL ALCOHOLHenry Schein, Inc.215fa8ac-c9b6-42b6-ae9d-a08d7ff0900f2025-10-23WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Alcohol Prep PadsISOPROPYL ALCOHOLCardinal Health5459a0b4-65ca-455e-80b2-3fe1b24e01372025-10-23WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Alcohol PrepISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLCa7d77afc-588d-47d7-be2f-686ff3d75da22025-10-23WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Alcohol Prep PadsISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLC50b24287-4c91-43d2-9c2e-42d3c086b3b32025-10-23WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Alcohol PrepISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLC51b707c6-df09-441b-a3d1-3f0c1b0886cc2025-10-23WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Alcohol Prep PadsISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLC9c34be37-b6e2-4c08-96a5-d9bb0e738f2d2025-10-23WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Alcohol Swab SticksISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLC91a9d6f7-d16c-46bf-8389-a6771e3ebfba2025-10-23WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Alcohol PrepISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLC9d79480c-ceef-49f7-a830-171c2a2629392025-10-23WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Alcohol Prep PadsISOPROPYL ALCOHOLCardinal Health 200, Inc.a1bccbf5-9cee-46c0-890c-02eb3577c1932025-10-23WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Alcohol WipesISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLC04c2ac54-1f44-a5d2-e063-6394a90a99cc2025-10-23WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Alcohol PrepISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLC2a160c89-c438-455d-910d-ac359d46786f2025-10-23WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLCe917b371-3ca9-94f0-e053-2a95a90af8ad2025-10-23WarningsExact identifier
rxcui: 797544
unii: ND2M416302
CareTouch Alcohol Prep PadISOPROPYL ALCOHOLFuture Diagnostics Llc91cfd7bf-9f42-49d5-b20d-281779d5272d2025-10-23WarningsExact identifier
rxcui: 797544
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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