FDA.reportPublic FDA data

Adalimumab-adbm

Product NDC
0597-0545
11-digit product format
005970545
Labeler code
0597
Product ID
0597-0545_0d5e7bae-4147-49a4-8dd6-7763e9402614
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Adalimumab-adbm
Dosage form
KIT
Labeler
Boehringer Ingelheim Pharmaceuticals, Inc.
Application
BLA761058
Marketing category
BLA
Marketing start
2023-10-01
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0597-05450597-0545-44DDiscontinued by firm2026-07-31
excluded packagepackage0597-05450597-0545-66DDiscontinued by firm2026-07-31

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CyltezoADALIMUMAB-ADBMBoehringer Ingelheim Pharmaceuticals, Inc.115ea79b-7209-7f19-b35d-36ec0828fbf52026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761058
Adalimumab-adbmADALIMUMAB-ADBMBoehringer Ingelheim Pharmaceuticals, Inc.62f39a7c-00df-4519-a8d4-39bbd0a649ed2025-11-12Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761058
ndc (product): 0597-0545
Adalimumab-adbmADALIMUMAB-ADBMQUALLENT PHARMACEUTICALS HEALTH LLCf9986706-9c75-4335-a54f-09d7716dbcef2024-11-12Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761058

Additional Listing Data#

Finished product
Yes
Brand name base
Adalimumab-adbm
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 11 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
797544Internal RxNorm lookup
2640883Internal RxNorm lookup
2640891Internal RxNorm lookup
2640893Internal RxNorm lookup
2640895Internal RxNorm lookup
2640900Internal RxNorm lookup
2640902Internal RxNorm lookup
2680743Internal RxNorm lookup
2680748Internal RxNorm lookup
2680756Internal RxNorm lookup
2680759Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
62f39a7c-00df-4519-a8d4-39bbd0a649edAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
58819a18-327d-463b-9e5e-26cc1dd9870dProduct name120230313
c1c5a070-0e2e-43dd-af9c-a21585200342Product name120230104
2a463079-cd68-4798-a3d6-55c4c8578d57Product name120220728
652f8f6b-479d-477c-848a-374d5b0145b7Product name220151203

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
0597-0545-22Adalimumab-adbm2 in 1 CARTONKIT25
0597-0545-22Adalimumab-adbm1 in 1 KITKIT15
0597-0545-44Adalimumab-adbm4 in 1 CARTONKIT45
0597-0545-44Adalimumab-adbm1 in 1 KITKIT15
0597-0545-66Adalimumab-adbm1 in 1 KITKIT15
0597-0545-66Adalimumab-adbm6 in 1 CARTONKIT65

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0597-0545-22EA - Each0597-0545075d61ca-20a7-4106-829c-be5175e1d44512023-10-16
0597-0545-44EA - Each0597-0545edc1607a-4db6-4e04-bd33-80fe3638245412023-10-16
0597-0545-66EA - Each0597-0545ecdaa604-4fb8-4326-981d-62026a53e4ba12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0597-0545ADALIMUMAB-ADBM KIT [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]2Current NDC, 8 package rows20240507_62f39a7c-00df-4519-a8d4-39bbd0a649ed.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761058Cyltezoadalimumab-adbm351(k) InterchangeableRx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2680756{4 (0.4 ML adalimumab-adbm 100 MG/ML Auto-Injector) } PackGPCK62f39a7c-00df-4519-a8d4-39bbd0a649ed5
2640900{4 (0.8 ML adalimumab-adbm 50 MG/ML Auto-Injector) } PackGPCK62f39a7c-00df-4519-a8d4-39bbd0a649ed5
2680759{6 (0.4 ML adalimumab-adbm 100 MG/ML Auto-Injector) } PackGPCK62f39a7c-00df-4519-a8d4-39bbd0a649ed5
2640902{6 (0.8 ML adalimumab-adbm 50 MG/ML Auto-Injector) } PackGPCK62f39a7c-00df-4519-a8d4-39bbd0a649ed5
2640891adalimumab-adbm 10 MG in 0.2 ML Prefilled SyringePSN62f39a7c-00df-4519-a8d4-39bbd0a649ed5
2640893adalimumab-adbm 20 MG in 0.4 ML Prefilled SyringePSN62f39a7c-00df-4519-a8d4-39bbd0a649ed5
2680748adalimumab-adbm 40 MG in 0.4 ML Auto-InjectorPSN62f39a7c-00df-4519-a8d4-39bbd0a649ed5
2680743adalimumab-adbm 40 MG in 0.4 ML Prefilled SyringePSN62f39a7c-00df-4519-a8d4-39bbd0a649ed5
2640895adalimumab-adbm 40 MG in 0.8 ML Auto-InjectorPSN62f39a7c-00df-4519-a8d4-39bbd0a649ed5
2640883adalimumab-adbm 40 MG in 0.8 ML Prefilled SyringePSN62f39a7c-00df-4519-a8d4-39bbd0a649ed5
2680759adalimumab-adbm Pen 40 MG/0.4 ML - Starter Pack for Crohn's Disease, Ulcerative Colitis or Hidradenitis Suppurativa (6 count)PSN62f39a7c-00df-4519-a8d4-39bbd0a649ed5
2680756adalimumab-adbm Pen 40 MG/0.4 ML Starter Pack - Psoriasis/Uveitis (4 count)PSN62f39a7c-00df-4519-a8d4-39bbd0a649ed5
2640902adalimumab-adbm Pen 40 MG/0.8 ML - Starter Pack for Crohn's Disease, Ulcerative Colitis or Hidradenitis Suppurativa (6 count)PSN62f39a7c-00df-4519-a8d4-39bbd0a649ed5
2640900adalimumab-adbm Pen 40 MG/0.8 ML Starter Pack - Psoriasis/Uveitis (4 count)PSN62f39a7c-00df-4519-a8d4-39bbd0a649ed5
797544isopropyl alcohol 70 % Medicated PadPSN62f39a7c-00df-4519-a8d4-39bbd0a649ed5
26408910.2 ML adalimumab-adbm 50 MG/ML Prefilled SyringeSCD62f39a7c-00df-4519-a8d4-39bbd0a649ed5
26807480.4 ML adalimumab-adbm 100 MG/ML Auto-InjectorSCD62f39a7c-00df-4519-a8d4-39bbd0a649ed5
26807430.4 ML adalimumab-adbm 100 MG/ML Prefilled SyringeSCD62f39a7c-00df-4519-a8d4-39bbd0a649ed5
26408930.4 ML adalimumab-adbm 50 MG/ML Prefilled SyringeSCD62f39a7c-00df-4519-a8d4-39bbd0a649ed5
26408950.8 ML adalimumab-adbm 50 MG/ML Auto-InjectorSCD62f39a7c-00df-4519-a8d4-39bbd0a649ed5
26408830.8 ML adalimumab-adbm 50 MG/ML Prefilled SyringeSCD62f39a7c-00df-4519-a8d4-39bbd0a649ed5
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD62f39a7c-00df-4519-a8d4-39bbd0a649ed5
2640891adalimumab-adbm 10 MG per 0.2 ML Prefilled SyringeSY62f39a7c-00df-4519-a8d4-39bbd0a649ed5
2640893adalimumab-adbm 20 MG per 0.4 ML Prefilled SyringeSY62f39a7c-00df-4519-a8d4-39bbd0a649ed5
2680748adalimumab-adbm 40 MG per 0.4 ML Auto-InjectorSY62f39a7c-00df-4519-a8d4-39bbd0a649ed5
2680743adalimumab-adbm 40 MG per 0.4 ML Prefilled SyringeSY62f39a7c-00df-4519-a8d4-39bbd0a649ed5
2640895adalimumab-adbm 40 MG per 0.8 ML Auto-InjectorSY62f39a7c-00df-4519-a8d4-39bbd0a649ed5
2640883adalimumab-adbm 40 MG per 0.8 ML Prefilled SyringeSY62f39a7c-00df-4519-a8d4-39bbd0a649ed5
2680759adalimumab-adbm Pen 40 MG/0.4 ML - Starter Pack for Crohn's Disease, Ulcerative Colitis or Hidradenitis Suppurativa (6 count)SY62f39a7c-00df-4519-a8d4-39bbd0a649ed5
2680756adalimumab-adbm Pen 40 MG/0.4 ML Starter Pack - Psoriasis/Uveitis (4 count)SY62f39a7c-00df-4519-a8d4-39bbd0a649ed5
2640902adalimumab-adbm Pen 40 MG/0.8 ML - Starter Pack for Crohn's Disease, Ulcerative Colitis or Hidradenitis Suppurativa (6 count)SY62f39a7c-00df-4519-a8d4-39bbd0a649ed5
2640900adalimumab-adbm Pen 40 MG/0.8 ML Starter Pack - Psoriasis/Uveitis (4 count)SY62f39a7c-00df-4519-a8d4-39bbd0a649ed5
797544isopropyl alcohol 70 % Medicated PadSY62f39a7c-00df-4519-a8d4-39bbd0a649ed5
797544isopropyl alcohol 70 % Topical ClothSY62f39a7c-00df-4519-a8d4-39bbd0a649ed5
797544isopropyl alcohol 70 % Topical SwabSY62f39a7c-00df-4519-a8d4-39bbd0a649ed5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0597-0540-10005970540101 in 1 TRAYHistorical
0597-0545-22005970545222 KIT in 1 CARTON (0597-0545-22) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY (0597-0540-10) / .8 mL in 1 SYRINGE * 2 PACKET in 1 TRAY / 1 mL in 1 PACKET2 kit2023-10-01NoNoCurrent
0597-0545-44005970545444 in 1 CARTONHistorical
0597-0545-66005970545661 in 1 KITHistorical