FDA.reportPublic FDA data

Cyltezo

Product NDC
0597-0375
Requested package NDC
0597-0375-48
11-digit product format
005970375
Labeler code
0597
Product ID
0597-0375_72dd9ccf-66f7-47a4-b6e4-4bb2f9a1caa3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
adalimumab-adbm
Dosage form
KIT
Labeler
Boehringer Ingelheim Pharmaceuticals, Inc.
Application
BLA761058
Marketing category
BLA
Marketing start
2023-07-01
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0597-03750597-0375-48DDiscontinued 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
ndc (package): 0597-0375-48
ndc (product): 0597-0375
ndc11 (package): 00597037548
Adalimumab-adbmADALIMUMAB-ADBMBoehringer Ingelheim Pharmaceuticals, Inc.62f39a7c-00df-4519-a8d4-39bbd0a649ed2025-11-12Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761058
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
Cyltezo
Listing expiration
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 2 · 21 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
797544Internal RxNorm lookup
2640883Internal RxNorm lookup
2640889Internal RxNorm lookup
2640891Internal RxNorm lookup
2640892Internal RxNorm lookup
2640893Internal RxNorm lookup
2640894Internal RxNorm lookup
2640895Internal RxNorm lookup
2640898Internal RxNorm lookup
2640900Internal RxNorm lookup
2640901Internal RxNorm lookup
2640902Internal RxNorm lookup
2640903Internal RxNorm lookup
2680743Internal RxNorm lookup
2680746Internal RxNorm lookup
2680748Internal RxNorm lookup
2680750Internal RxNorm lookup
2680756Internal RxNorm lookup
2680757Internal 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
115ea79b-7209-7f19-b35d-36ec0828fbf5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
0597-0375-16Cyltezo1 in 1 KITKIT117
0597-0375-16Cyltezo6 in 1 CARTONKIT617
0597-0375-23Cyltezo4 in 1 CARTONKIT417
0597-0375-23Cyltezo1 in 1 KITKIT117
0597-0375-48Cyltezo1 in 1 KITKIT117
0597-0375-48Cyltezo1 in 1 CARTONKIT117
0597-0375-53Cyltezo1 in 1 CARTONKIT117
0597-0375-53Cyltezo1 in 1 KITKIT117
0597-0375-97Cyltezo2 in 1 CARTONKIT217
0597-0375-97Cyltezo1 in 1 KITKIT117

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0597-0375-16EA - Each0597-0375a91b1272-eb28-40b0-8427-c3b24374898112023-07-06
0597-0375-23EA - Each0597-03756942f5c6-4067-4679-a1be-5e18dd4e065e12023-07-06
0597-0375-97EA - Each0597-037565a825cf-d280-4ea9-b7c0-28b0e0e8297912023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0597-0375CYLTEZO (ADALIMUMAB-ADBM) KIT [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]13Current NDC, 10 package rows20240507_115ea79b-7209-7f19-b35d-36ec0828fbf5.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
2680757{4 (0.4 ML adalimumab-adbm 100 MG/ML Auto-Injector [Cyltezo]) } Pack [Cyltezo Pen 40 MG/0.4 ML Starter Pack - Psoriasis]BPCK115ea79b-7209-7f19-b35d-36ec0828fbf517
2640901{4 (0.8 ML adalimumab-adbm 50 MG/ML Auto-Injector [Cyltezo]) } Pack [Cyltezo Pen 40 MG/0.8 ML Starter Pack - Psoriasis]BPCK115ea79b-7209-7f19-b35d-36ec0828fbf517
2680760{6 (0.4 ML adalimumab-adbm 100 MG/ML Auto-Injector [Cyltezo]) } Pack [Cyltezo Pen 40 MG/0.4 ML Starter Pack - Crohn's Disease or Ulcerative Colitis]BPCK115ea79b-7209-7f19-b35d-36ec0828fbf517
2640903{6 (0.8 ML adalimumab-adbm 50 MG/ML Auto-Injector [Cyltezo]) } Pack [Cyltezo Pen 40 MG/0.8 ML Starter Package for Crohn's Disease or Ulcerative Colitis]BPCK115ea79b-7209-7f19-b35d-36ec0828fbf517
2680756{4 (0.4 ML adalimumab-adbm 100 MG/ML Auto-Injector) } PackGPCK115ea79b-7209-7f19-b35d-36ec0828fbf517
2640900{4 (0.8 ML adalimumab-adbm 50 MG/ML Auto-Injector) } PackGPCK115ea79b-7209-7f19-b35d-36ec0828fbf517
2680759{6 (0.4 ML adalimumab-adbm 100 MG/ML Auto-Injector) } PackGPCK115ea79b-7209-7f19-b35d-36ec0828fbf517
2640902{6 (0.8 ML adalimumab-adbm 50 MG/ML Auto-Injector) } PackGPCK115ea79b-7209-7f19-b35d-36ec0828fbf517
2640891adalimumab-adbm 10 MG in 0.2 ML Prefilled SyringePSN115ea79b-7209-7f19-b35d-36ec0828fbf517
2640893adalimumab-adbm 20 MG in 0.4 ML Prefilled SyringePSN115ea79b-7209-7f19-b35d-36ec0828fbf517
2680748adalimumab-adbm 40 MG in 0.4 ML Auto-InjectorPSN115ea79b-7209-7f19-b35d-36ec0828fbf517
2680743adalimumab-adbm 40 MG in 0.4 ML Prefilled SyringePSN115ea79b-7209-7f19-b35d-36ec0828fbf517
2640895adalimumab-adbm 40 MG in 0.8 ML Auto-InjectorPSN115ea79b-7209-7f19-b35d-36ec0828fbf517
2640883adalimumab-adbm 40 MG in 0.8 ML Prefilled SyringePSN115ea79b-7209-7f19-b35d-36ec0828fbf517
2680759adalimumab-adbm Pen 40 MG/0.4 ML - Starter Pack for Crohn's Disease, Ulcerative Colitis or Hidradenitis Suppurativa (6 count)PSN115ea79b-7209-7f19-b35d-36ec0828fbf517
2680756adalimumab-adbm Pen 40 MG/0.4 ML Starter Pack - Psoriasis/Uveitis (4 count)PSN115ea79b-7209-7f19-b35d-36ec0828fbf517
2640902adalimumab-adbm Pen 40 MG/0.8 ML - Starter Pack for Crohn's Disease, Ulcerative Colitis or Hidradenitis Suppurativa (6 count)PSN115ea79b-7209-7f19-b35d-36ec0828fbf517
2640900adalimumab-adbm Pen 40 MG/0.8 ML Starter Pack - Psoriasis/Uveitis (4 count)PSN115ea79b-7209-7f19-b35d-36ec0828fbf517
2640892CYLTEZO 10 MG in 0.2 ML Prefilled SyringePSN115ea79b-7209-7f19-b35d-36ec0828fbf517
2640894CYLTEZO 20 MG in 0.4 ML Prefilled SyringePSN115ea79b-7209-7f19-b35d-36ec0828fbf517
2680750CYLTEZO 40 MG in 0.4 ML Auto-InjectorPSN115ea79b-7209-7f19-b35d-36ec0828fbf517
2680746CYLTEZO 40 MG in 0.4 ML Prefilled SyringePSN115ea79b-7209-7f19-b35d-36ec0828fbf517
2640898CYLTEZO 40 MG in 0.8 ML Auto-InjectorPSN115ea79b-7209-7f19-b35d-36ec0828fbf517
2640889CYLTEZO 40 MG in 0.8 ML Prefilled SyringePSN115ea79b-7209-7f19-b35d-36ec0828fbf517
2680760CYLTEZO Pen 40 MG/0.4 ML - Starter Pack for Crohn's Disease, Ulcerative Colitis or Hidradenitis Suppurativa (6 count)PSN115ea79b-7209-7f19-b35d-36ec0828fbf517
2680757CYLTEZO Pen 40 MG/0.4 ML Starter Pack - Psoriasis/Uveitis (4 count)PSN115ea79b-7209-7f19-b35d-36ec0828fbf517
2640903CYLTEZO Pen 40 MG/0.8 ML - Starter Package for Crohn's Disease, Ulcerative Colitis or Hidradenitis Suppurativa (6 count)PSN115ea79b-7209-7f19-b35d-36ec0828fbf517
2640901CYLTEZO Pen 40 MG/0.8 ML Starter Pack - Psoriasis/Uveitis (4 count)PSN115ea79b-7209-7f19-b35d-36ec0828fbf517
797544isopropyl alcohol 70 % Medicated PadPSN115ea79b-7209-7f19-b35d-36ec0828fbf517
26408920.2 ML adalimumab-adbm 50 MG/ML Prefilled Syringe [Cyltezo]SBD115ea79b-7209-7f19-b35d-36ec0828fbf517
26807500.4 ML adalimumab-adbm 100 MG/ML Auto-Injector [Cyltezo]SBD115ea79b-7209-7f19-b35d-36ec0828fbf517
26807460.4 ML adalimumab-adbm 100 MG/ML Prefilled Syringe [Cyltezo]SBD115ea79b-7209-7f19-b35d-36ec0828fbf517
26408940.4 ML adalimumab-adbm 50 MG/ML Prefilled Syringe [Cyltezo]SBD115ea79b-7209-7f19-b35d-36ec0828fbf517
26408980.8 ML adalimumab-adbm 50 MG/ML Auto-Injector [Cyltezo]SBD115ea79b-7209-7f19-b35d-36ec0828fbf517
26408890.8 ML adalimumab-adbm 50 MG/ML Prefilled Syringe [Cyltezo]SBD115ea79b-7209-7f19-b35d-36ec0828fbf517
26408910.2 ML adalimumab-adbm 50 MG/ML Prefilled SyringeSCD115ea79b-7209-7f19-b35d-36ec0828fbf517
26807480.4 ML adalimumab-adbm 100 MG/ML Auto-InjectorSCD115ea79b-7209-7f19-b35d-36ec0828fbf517
26807430.4 ML adalimumab-adbm 100 MG/ML Prefilled SyringeSCD115ea79b-7209-7f19-b35d-36ec0828fbf517
26408930.4 ML adalimumab-adbm 50 MG/ML Prefilled SyringeSCD115ea79b-7209-7f19-b35d-36ec0828fbf517
26408950.8 ML adalimumab-adbm 50 MG/ML Auto-InjectorSCD115ea79b-7209-7f19-b35d-36ec0828fbf517
26408830.8 ML adalimumab-adbm 50 MG/ML Prefilled SyringeSCD115ea79b-7209-7f19-b35d-36ec0828fbf517
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD115ea79b-7209-7f19-b35d-36ec0828fbf517
26408920.2 ML Cyltezo 50 MG/ML Prefilled SyringeSY115ea79b-7209-7f19-b35d-36ec0828fbf517
26408940.4 ML Cyltezo 50 MG/ML Prefilled SyringeSY115ea79b-7209-7f19-b35d-36ec0828fbf517
26408980.8 ML Cyltezo 50 MG/ML Auto-InjectorSY115ea79b-7209-7f19-b35d-36ec0828fbf517
26408890.8 ML Cyltezo 50 MG/ML Prefilled SyringeSY115ea79b-7209-7f19-b35d-36ec0828fbf517
2640891adalimumab-adbm 10 MG per 0.2 ML Prefilled SyringeSY115ea79b-7209-7f19-b35d-36ec0828fbf517
2640893adalimumab-adbm 20 MG per 0.4 ML Prefilled SyringeSY115ea79b-7209-7f19-b35d-36ec0828fbf517
2680748adalimumab-adbm 40 MG per 0.4 ML Auto-InjectorSY115ea79b-7209-7f19-b35d-36ec0828fbf517
2680743adalimumab-adbm 40 MG per 0.4 ML Prefilled SyringeSY115ea79b-7209-7f19-b35d-36ec0828fbf517
2640895adalimumab-adbm 40 MG per 0.8 ML Auto-InjectorSY115ea79b-7209-7f19-b35d-36ec0828fbf517
2640883adalimumab-adbm 40 MG per 0.8 ML Prefilled SyringeSY115ea79b-7209-7f19-b35d-36ec0828fbf517
2680759adalimumab-adbm Pen 40 MG/0.4 ML - Starter Pack for Crohn's Disease, Ulcerative Colitis or Hidradenitis Suppurativa (6 count)SY115ea79b-7209-7f19-b35d-36ec0828fbf517
2680756adalimumab-adbm Pen 40 MG/0.4 ML Starter Pack - Psoriasis/Uveitis (4 count)SY115ea79b-7209-7f19-b35d-36ec0828fbf517
2640902adalimumab-adbm Pen 40 MG/0.8 ML - Starter Pack for Crohn's Disease, Ulcerative Colitis or Hidradenitis Suppurativa (6 count)SY115ea79b-7209-7f19-b35d-36ec0828fbf517
2640900adalimumab-adbm Pen 40 MG/0.8 ML Starter Pack - Psoriasis/Uveitis (4 count)SY115ea79b-7209-7f19-b35d-36ec0828fbf517
2640892Cyltezo 10 MG per 0.2 ML Prefilled SyringeSY115ea79b-7209-7f19-b35d-36ec0828fbf517
2640894Cyltezo 20 MG per 0.4 ML Prefilled SyringeSY115ea79b-7209-7f19-b35d-36ec0828fbf517
2680750Cyltezo 40 MG per 0.4 ML Auto-InjectorSY115ea79b-7209-7f19-b35d-36ec0828fbf517
2680746Cyltezo 40 MG per 0.4 ML Prefilled SyringeSY115ea79b-7209-7f19-b35d-36ec0828fbf517
2640898Cyltezo 40 MG per 0.8 ML Auto-InjectorSY115ea79b-7209-7f19-b35d-36ec0828fbf517
2640889Cyltezo 40 MG per 0.8 ML Prefilled SyringeSY115ea79b-7209-7f19-b35d-36ec0828fbf517
2680760Cyltezo Pen 40 MG/0.4 ML - Starter Pack for Crohn's Disease, Ulcerative Colitis or Hidradenitis Suppurativa (6 count)SY115ea79b-7209-7f19-b35d-36ec0828fbf517
2680757Cyltezo Pen 40 MG/0.4 ML Starter Pack - Psoriasis/Uveitis (4 count)SY115ea79b-7209-7f19-b35d-36ec0828fbf517
2640903Cyltezo Pen 40 MG/0.8 ML - Starter Package for Crohn's Disease, Ulcerative Colitis or Hidradenitis Suppurativa (6 count)SY115ea79b-7209-7f19-b35d-36ec0828fbf517
2640901Cyltezo Pen 40 MG/0.8 ML Starter Pack - Psoriasis/Uveitis (4 count)SY115ea79b-7209-7f19-b35d-36ec0828fbf517
797544isopropyl alcohol 70 % Medicated PadSY115ea79b-7209-7f19-b35d-36ec0828fbf517
797544isopropyl alcohol 70 % Topical ClothSY115ea79b-7209-7f19-b35d-36ec0828fbf517
797544isopropyl alcohol 70 % Topical SwabSY115ea79b-7209-7f19-b35d-36ec0828fbf517

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0597-0375-48005970375481 KIT in 1 CARTON (0597-0375-48) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE * 2 PACKET in 1 TRAY / 1 mL in 1 PACKET1 kit2023-07-01NoNoHistorical