FDA.reportPublic FDA data

Cyltezo

Product NDC
0597-0495
11-digit product format
005970495
Labeler code
0597
Product ID
0597-0495_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
2024-04-30
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cyltezo
Listing expiration
2027-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui797544, 2640883, 2640889, 2640891, 2640892, 2640893, 2640894, 2640895, 2640898, 2640900, 2640901, 2640902, 2640903, 2680743, 2680746, 2680748, 2680750, 2680756, 2680757, 2680759

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
0597-0490-32Cyltezo0.4 mL in 1 SYRINGEINJECTION, SOLUTION0.4 mL40 mg in 0.4mL17
0597-0490-32Cyltezo1 in 1 TRAYINJECTION, SOLUTION40 mg in 0.4mL17
0597-0495-40Cyltezo4 in 1 CARTONKIT417
0597-0495-40Cyltezo1 in 1 KITKIT117
0597-0495-47Cyltezo1 in 1 CARTONKIT117
0597-0495-47Cyltezo1 in 1 KITKIT117
0597-0495-50Cyltezo1 in 1 KITKIT117
0597-0495-50Cyltezo2 in 1 CARTONKIT217
0597-0495-60Cyltezo1 in 1 KITKIT117
0597-0495-60Cyltezo6 in 1 CARTONKIT617

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0597-0495-40EA - Each0597-0495cae50b52-72db-4b6a-8bf6-27205aff779d12024-06-10
0597-0495-50EA - Each0597-04956f76b1b2-a7fd-4a6c-ba62-4af364c40ea312024-06-10
0597-0495-60EA - Each0597-04950a82621e-0e8e-4c1c-9c92-47e55bedf86612024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0597-0495CYLTEZO (ADALIMUMAB-ADBM) KIT [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]13Current NDC, 10 package rows20240507_115ea79b-7209-7f19-b35d-36ec0828fbf5.zip

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
0597-0490-32005970490320.4 mL in 1 SYRINGE0.4 mlHistorical
0597-0495-40005970495404 in 1 CARTONHistorical
0597-0495-47005970495471 in 1 CARTONHistorical
0597-0495-50005970495502 KIT in 1 CARTON (0597-0495-50) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY (0597-0490-32) / .4 mL in 1 SYRINGE * 2 PACKET in 1 TRAY / 1 mL in 1 PACKET2 kit2024-04-30NoNoHistorical
0597-0495-60005970495601 in 1 KITHistorical