FDA.reportPublic FDA data

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 30 of 45 · 887 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SaniiswabISOPROPYL ALCOHOLPOLLEY MED LLC303b1ad5-a104-3479-e063-6294a90abcde2025-03-20WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Bestmade Natural Products Field of Flowers FormulaAESCULUS CAR, AESCULUS HIP, AGRIMONIA EUP, BROMUS RAM, CALLUNA VULG, CARPINUS BET, CASTANEA SAT, CENTAURIUM UMB, CERATOSTIGMA WILLM, CICHORIUM INT, CLEMATIS VIT, FAGUS SYLV, GENTIANELLA AMARELLA, HELIANTHEMUM NUMMULARIUM, ILEX AQUIFOLIUM, IMPATIENS GLAND, LARIX DECIDUA, LONICERA CAPRIFOLIUM, MALUS, MIMULUS GUT, OLEA EUROP, ORNITHOGALUM UMB, PINUS SYL, POPULUS TREM, PRUNUS CERA, QUERCUS ROB, ROCK WATER, ROSA CAN, SALIX VIT, SCLERANTHUS ANNNUS, SINAPIS ARV, ULEX EURO, ULMUS PROC, VERBENA, VITIS VINBestmade Natural Products2fbf9b7c-e54f-589d-e063-6394a90a14a72025-03-07WarningsExact identifier
unii: 059QF0KO0R
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLUniversal Distribution Center LLC2f982aef-4f46-aa85-e063-6394a90a52b12025-03-05WarningsExact identifier
unii: ND2M416302
ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREENISOPROPYL ALCOHOLUniversal Distribution Center LLC2f9846ce-37ca-a95b-e063-6294a90ad2602025-03-05WarningsExact identifier
unii: ND2M416302
Isopropyl Rubbing Alcohol 70%ISOPROPYL ALCOHOLUniversal Distribution Center LLC2f988951-39e7-ec02-e063-6294a90aaad72025-03-05WarningsExact identifier
unii: ND2M416302
Isopropyl alcoholISOPROPYL ALCOHOLUniversal Distribution Center LLC2f98a900-6c7c-0161-e063-6294a90ac6752025-03-05WarningsExact identifier
unii: ND2M416302
Isopropyl alcoholISOPROPYL ALCOHOLAmerisourceBergen (Good Neighbor Pharmacy) 46122c47986e9-c851-491b-817e-fd3e0b054cd42025-02-26WarningsExact identifier
unii: ND2M416302
AeroWash EyewashEYEWASH SOLUTIONAero Healthcare US LLCa477de08-4301-0ee5-e053-2995a90af79d2025-02-26WarningsExact identifier
unii: 059QF0KO0R
Isopropyl alcoholISOPROPYL ALCOHOLAmerisourceBergen (Good Neighbor Pharmacy) 4612200737139-bab8-40be-ad85-32526b5eab102025-02-26WarningsExact identifier
unii: ND2M416302
AUM Alcohol PadALCOHOL PADSLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS632da1b7-70bb-467d-81b2-39536f9fff3c2025-02-26WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Isopropyl alcohol 91 percentISOPROPYL ALCOHOLWalgreens78ed5594-433a-4f90-ad39-51e2a7dd2e212025-02-21WarningsExact identifier
unii: ND2M416302
Isopropyl alcohol 70 percentISOPROPYL ALCOHOLWalgreens9effa6c9-020d-4a2d-ad26-449d4119b6a02025-02-21WarningsExact identifier
unii: ND2M416302
Alcohol prep padALCOHOL PREP PADTarget Corporationbc9a4f33-3eec-79e3-e053-2a95a90a90172025-02-19WarningsExact identifier
unii: ND2M416302
Isopropyl alcohol 50 percent Wintergreen ReadyInCaseISOPROPYL ALCOHOLP & L Development, LLCf9ff67b0-c4ad-4162-b3ef-27a85ed0da252025-02-18WarningsExact identifier
unii: ND2M416302
Advanced Eye Relief Eye WashWATER SOLUTIONBausch & Lomb Incorporated9caccce1-4530-441d-bf76-244edeb9dedc2025-02-17WarningsExact identifier
unii: 059QF0KO0R
50 percent Isopropyl alcoholISOPROPYL ALCOHOLWhole Foods Market6cb4ccca-96e7-43cb-ae05-95a411e712552025-02-14WarningsExact identifier
unii: ND2M416302
Rubbing Alcohol 91 percent isopropylISOPROPYL ALCOHOLWinCo Foods, LLC0ce2110d-ea9d-4d41-b0ae-6e9182f25abc2025-02-12WarningsExact identifier
unii: ND2M416302
Prevantics SwabstickCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLProfessional Disposables International, Inc.9841200b-d4c6-b40c-e053-2995a90a55962025-02-10WarningsExact identifier
unii: ND2M416302
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products, Inc.2d90c8e8-f479-3535-e063-6394a90af1222025-02-07WarningsExact identifier
unii: 059QF0KO0R
Isopropyl alcohol 70 percentISOPROPYL ALCOHOLGood Sense (Geiss, Destin & Dunn, Inc.)ac66be77-d358-44ea-8904-88186a7c2bbb2025-02-07WarningsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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