FDA.reportPublic FDA data

Adalimumab

Product NDC
72606-041
11-digit product format
726060041
Labeler code
72606
Product ID
72606-041_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

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
YuflymaADALIMUMAB-AATYCELLTRION USA, Inc.526d626f-8c9f-496c-b838-00a73bb363832026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761219
AdalimumabADALIMUMAB-AATYCELLTRION USA, Inc.c44365e9-d470-4e35-978d-8565a9e3471e2026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761219
ndc (product): 72606-041

Additional Listing Data#

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 7 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
797544Internal RxNorm lookup
2639651Internal RxNorm lookup
2639659Internal RxNorm lookup
2668483Internal RxNorm lookup
2668485Internal RxNorm lookup
2668487Internal RxNorm lookup
2668489Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c44365e9-d470-4e35-978d-8565a9e3471eAvailable 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
72606-041-01Adalimumab1 in 1 KITKIT16
72606-041-01Adalimumab2 in 1 CARTONKIT26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72606-041-01EA - Each72606-041c372c10d-b0d2-46d8-838e-b248e4b3a72112024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72606-041ADALIMUMAB (ADALIMUMAB-AATY) KIT [CELLTRION USA, INC.]4Current NDC, 2 package rows20250515_c44365e9-d470-4e35-978d-8565a9e3471e.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761219Yuflymaadalimumab-aaty351(k) InterchangeableRx2026-06-01

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
72606-041-01726060041012 KIT in 1 CARTON (72606-041-01) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .2 mL in 1 SYRINGE * 1 mL in 1 PACKET2 kit2023-11-30NoNoCurrent