FDA.reportPublic FDA data

Adalimumab

Product NDC
72606-022
11-digit product format
726060022
Labeler code
72606
Product ID
72606-022_68fa51bf-22b5-4963-bc1c-9be00fb09b2a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
adalimumab-aaty
Dosage form
KIT
Labeler
CELLTRION USA, Inc.
Application
BLA761219
Marketing category
BLA
Marketing start
2023-11-30
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui797544, 2639651, 2639659, 2668483, 2668485, 2668487, 2668489

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
72606-022-01Adalimumab1 in 1 KITKIT16
72606-022-01Adalimumab1 in 1 CARTONKIT16
72606-022-02Adalimumab2 in 1 CARTONKIT26
72606-022-02Adalimumab1 in 1 KITKIT16
72606-022-03Adalimumab1 in 1 KITKIT16
72606-022-03Adalimumab4 in 1 CARTONKIT46
72606-022-04Adalimumab6 in 1 CARTONKIT66
72606-022-04Adalimumab1 in 1 KITKIT16
72606-022-05Adalimumab1 in 1 KITKIT16
72606-022-05Adalimumab1 in 1 CARTONKIT16
72606-022-06Adalimumab1 in 1 KITKIT16
72606-022-06Adalimumab2 in 1 CARTONKIT26
72606-022-07Adalimumab1 in 1 KITKIT16
72606-022-07Adalimumab4 in 1 CARTONKIT46
72606-022-08Adalimumab1 in 1 KITKIT16
72606-022-08Adalimumab6 in 1 CARTONKIT66
72606-022-09Adalimumab1 in 1 KITKIT16
72606-022-09Adalimumab1 in 1 CARTONKIT16
72606-022-10Adalimumab1 in 1 KITKIT16
72606-022-10Adalimumab2 in 1 CARTONKIT26
72606-022-11Adalimumab1 in 1 KITKIT16
72606-022-11Adalimumab4 in 1 CARTONKIT46
72606-022-12Adalimumab6 in 1 CARTONKIT66
72606-022-12Adalimumab1 in 1 KITKIT16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72606-022-06EA - Each72606-022f545e9df-ed15-479e-ab4d-4a6d02ee017d12024-05-16
72606-022-09EA - Each72606-022818ddde6-b605-4d6e-9504-ad94c149626512024-05-16
72606-022-10EA - Each72606-0221ecd52a6-30cb-4365-8852-2c6197d52af712024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72606-022ADALIMUMAB (ADALIMUMAB-AATY) KIT [CELLTRION USA, INC.]4Current NDC, 24 package rows20250515_c44365e9-d470-4e35-978d-8565a9e3471e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2668489{3 (0.8 ML adalimumab-aaty 100 MG/ML Auto-Injector) } PackGPCKc44365e9-d470-4e35-978d-8565a9e3471e6
2668483adalimumab-aaty 20 MG in 0.2 ML Prefilled SyringePSNc44365e9-d470-4e35-978d-8565a9e3471e6
2639651adalimumab-aaty 40 MG in 0.4 ML Auto-InjectorPSNc44365e9-d470-4e35-978d-8565a9e3471e6
2639659adalimumab-aaty 40 MG in 0.4 ML Prefilled SyringePSNc44365e9-d470-4e35-978d-8565a9e3471e6
2668487adalimumab-aaty 80 MG in 0.8 ML Auto-InjectorPSNc44365e9-d470-4e35-978d-8565a9e3471e6
2668485adalimumab-aaty 80 MG in 0.8 ML Prefilled SyringePSNc44365e9-d470-4e35-978d-8565a9e3471e6
2668489adalimumab-aaty Auto-Injector 80 MG/0.8 ML Starter Package for Crohn's Disease, Ulcerative Colitis or Hidradenitis Suppurativa (3 count)PSNc44365e9-d470-4e35-978d-8565a9e3471e6
797544isopropyl alcohol 70 % Medicated PadPSNc44365e9-d470-4e35-978d-8565a9e3471e6
26684830.2 ML adalimumab-aaty 100 MG/ML Prefilled SyringeSCDc44365e9-d470-4e35-978d-8565a9e3471e6
26396510.4 ML adalimumab-aaty 100 MG/ML Auto-InjectorSCDc44365e9-d470-4e35-978d-8565a9e3471e6
26396590.4 ML adalimumab-aaty 100 MG/ML Prefilled SyringeSCDc44365e9-d470-4e35-978d-8565a9e3471e6
26684870.8 ML adalimumab-aaty 100 MG/ML Auto-InjectorSCDc44365e9-d470-4e35-978d-8565a9e3471e6
26684850.8 ML adalimumab-aaty 100 MG/ML Prefilled SyringeSCDc44365e9-d470-4e35-978d-8565a9e3471e6
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCDc44365e9-d470-4e35-978d-8565a9e3471e6
2668483adalimumab-aaty 20 MG per 0.2 ML Prefilled SyringeSYc44365e9-d470-4e35-978d-8565a9e3471e6
2639651adalimumab-aaty 40 MG per 0.4 ML Auto-InjectorSYc44365e9-d470-4e35-978d-8565a9e3471e6
2639659adalimumab-aaty 40 MG per 0.4 ML Prefilled SyringeSYc44365e9-d470-4e35-978d-8565a9e3471e6
2668487adalimumab-aaty 80 MG per 0.8 ML Auto-InjectorSYc44365e9-d470-4e35-978d-8565a9e3471e6
2668485adalimumab-aaty 80 MG per 0.8 ML Prefilled SyringeSYc44365e9-d470-4e35-978d-8565a9e3471e6
2668489adalimumab-aaty Auto-Injector 80 MG/0.8 ML Starter Package for Crohn's Disease, Ulcerative Colitis or Hidradenitis Suppurativa (3 count)SYc44365e9-d470-4e35-978d-8565a9e3471e6
797544isopropyl alcohol 70 % Medicated PadSYc44365e9-d470-4e35-978d-8565a9e3471e6
797544isopropyl alcohol 70 % Topical ClothSYc44365e9-d470-4e35-978d-8565a9e3471e6
797544isopropyl alcohol 70 % Topical SwabSYc44365e9-d470-4e35-978d-8565a9e3471e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72606-022-01726060022011 KIT in 1 CARTON (72606-022-01) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET1 kit2023-11-30NoNoHistorical
72606-022-02726060022022 KIT in 1 CARTON (72606-022-02) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET2 kit2023-11-30NoNoHistorical
72606-022-03726060022034 KIT in 1 CARTON (72606-022-03) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET4 kit2023-11-30NoNoHistorical
72606-022-04726060022046 KIT in 1 CARTON (72606-022-04) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET6 kit2023-11-30NoNoHistorical
72606-022-05726060022051 KIT in 1 CARTON (72606-022-05) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET1 kit2023-11-30NoNoHistorical
72606-022-06726060022062 KIT in 1 CARTON (72606-022-06) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET2 kit2023-11-30NoNoHistorical
72606-022-07726060022074 KIT in 1 CARTON (72606-022-07) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET4 kit2023-11-30NoNoHistorical
72606-022-08726060022086 KIT in 1 CARTON (72606-022-08) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET6 kit2023-11-30NoNoHistorical
72606-022-09726060022091 KIT in 1 CARTON (72606-022-09) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET1 kit2023-11-30NoNoHistorical
72606-022-10726060022102 KIT in 1 CARTON (72606-022-10) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET2 kit2023-11-30NoNoHistorical
72606-022-11726060022114 KIT in 1 CARTON (72606-022-11) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET4 kit2023-11-30NoNoHistorical
72606-022-12726060022126 KIT in 1 CARTON (72606-022-12) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET6 kit2023-11-30NoNoHistorical