FDA.reportPublic FDA data

Yuflyma

Product NDC
72606-039
Requested package NDC
72606-039-01
11-digit product format
726060039
Labeler code
72606
Product ID
72606-039_860d1892-56f2-4fd7-9ca7-145fae43fd34
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
adalimumab-aaty
Dosage form
KIT
Labeler
CELLTRION USA, Inc.
Application
BLA761219
Marketing category
BLA
Marketing start
2023-09-29
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage72606-03972606-039-01DDiscontinued by firm2026-08-07

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
58819a18-327d-463b-9e5e-26cc1dd9870dProduct name120230313
c1c5a070-0e2e-43dd-af9c-a21585200342Product name120230104
2a463079-cd68-4798-a3d6-55c4c8578d57Product name120220728
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
652f8f6b-479d-477c-848a-374d5b0145b7Product name220151203
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72606-039-01Yuflyma2 in 1 CARTONKIT213
72606-039-01Yuflyma1 in 1 KITKIT113

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72606-039YUFLYMA (ADALIMUMAB-AATY) KIT [CELLTRION USA, INC.]11Current NDC, 2 package rows20250515_526d626f-8c9f-496c-b838-00a73bb36383.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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
ndc (package): 72606-039-01
ndc (product): 72606-039
ndc11 (package): 72606003901
AdalimumabADALIMUMAB-AATYCELLTRION USA, Inc.c44365e9-d470-4e35-978d-8565a9e3471e2026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761219

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
2671099{1 (0.4 ML adalimumab-aaty 100 MG/ML Prefilled Syringe [Yuflyma]) / 1 (0.8 ML adalimumab-aaty 100 MG/ML Prefilled Syringe [Yuflyma]) } Pack [Yuflyma Prefilled Syringe 80 MG/0.8 ML and 40 MG/0.4 ML Starter Package for Pediatric Crohn's Disease]BPCK526d626f-8c9f-496c-b838-00a73bb3638313
2668494{2 (0.4 ML adalimumab-aaty 100 MG/ML Auto-Injector [Yuflyma]) / 1 (0.8 ML adalimumab-aaty 100 MG/ML Auto-Injector [Yuflyma]) } Pack [Yuflyma Auto-Injector 80 MG/0.8 ML and 40 MG/0.4 ML Starter Pack - Plaque Psoriasis]BPCK526d626f-8c9f-496c-b838-00a73bb3638313
2668490{3 (0.8 ML adalimumab-aaty 100 MG/ML Auto-Injector [Yuflyma]) } Pack [Yuflyma Auto-Injector 80 MG/0.8 ML Starter Package for Crohn's Disease, Ulcerative Colitis or Hidradenitis Suppurativa]BPCK526d626f-8c9f-496c-b838-00a73bb3638313
2668492{3 (0.8 ML adalimumab-aaty 100 MG/ML Prefilled Syringe [Yuflyma]) } Pack [Yuflyma Pediatric Crohn's Disease Starter Package (3 count)]BPCK526d626f-8c9f-496c-b838-00a73bb3638313
2639665{4 (0.4 ML adalimumab-aaty 100 MG/ML Auto-Injector [Yuflyma]) } Pack [Yuflyma Auto-Injector 40 MG/0.4 ML Starter Pack - Plaque Psoriasis]BPCK526d626f-8c9f-496c-b838-00a73bb3638313
2639667{6 (0.4 ML adalimumab-aaty 100 MG/ML Auto-Injector [Yuflyma]) } Pack [Yuflyma Auto-Injector 40 MG/0.4 ML Starter Package for Crohn's Disease, Pediatric Crohn's Disease, Ulcerative Colitis or Hidradenitis Suppurativa]BPCK526d626f-8c9f-496c-b838-00a73bb3638313
2671098{1 (0.4 ML adalimumab-aaty 100 MG/ML Prefilled Syringe) / 1 (0.8 ML adalimumab-aaty 100 MG/ML Prefilled Syringe) } PackGPCK526d626f-8c9f-496c-b838-00a73bb3638313
2668493{2 (0.4 ML adalimumab-aaty 100 MG/ML Auto-Injector) / 1 (0.8 ML adalimumab-aaty 100 MG/ML Auto-Injector) } PackGPCK526d626f-8c9f-496c-b838-00a73bb3638313
2668489{3 (0.8 ML adalimumab-aaty 100 MG/ML Auto-Injector) } PackGPCK526d626f-8c9f-496c-b838-00a73bb3638313
2668491{3 (0.8 ML adalimumab-aaty 100 MG/ML Prefilled Syringe) } PackGPCK526d626f-8c9f-496c-b838-00a73bb3638313
2639664{4 (0.4 ML adalimumab-aaty 100 MG/ML Auto-Injector) } PackGPCK526d626f-8c9f-496c-b838-00a73bb3638313
2639666{6 (0.4 ML adalimumab-aaty 100 MG/ML Auto-Injector) } PackGPCK526d626f-8c9f-496c-b838-00a73bb3638313
2727422adalimumab-aaty 10 MG in 0.1 ML Prefilled SyringePSN526d626f-8c9f-496c-b838-00a73bb3638313
2668483adalimumab-aaty 20 MG in 0.2 ML Prefilled SyringePSN526d626f-8c9f-496c-b838-00a73bb3638313
2639651adalimumab-aaty 40 MG in 0.4 ML Auto-InjectorPSN526d626f-8c9f-496c-b838-00a73bb3638313
2639659adalimumab-aaty 40 MG in 0.4 ML Prefilled SyringePSN526d626f-8c9f-496c-b838-00a73bb3638313
2668487adalimumab-aaty 80 MG in 0.8 ML Auto-InjectorPSN526d626f-8c9f-496c-b838-00a73bb3638313
2668485adalimumab-aaty 80 MG in 0.8 ML Prefilled SyringePSN526d626f-8c9f-496c-b838-00a73bb3638313
2668493adalimumab-aaty Auto-Injector 80 MG/0.8 ML and 40 MG/0.4 ML Starter Pack - Plaque Psoriasis (3 count)PSN526d626f-8c9f-496c-b838-00a73bb3638313
2668489adalimumab-aaty Auto-Injector 80 MG/0.8 ML Starter Package for Crohn's Disease, Ulcerative Colitis or Hidradenitis Suppurativa (3 count)PSN526d626f-8c9f-496c-b838-00a73bb3638313
2668491adalimumab-aaty Pediatric Crohn's Disease Starter Package (3 count)PSN526d626f-8c9f-496c-b838-00a73bb3638313
2671098adalimumab-aaty Prefilled Syringe 80 MG/0.8 ML and 40 MG/0.4 ML Starter Pack for Pediatric Crohn's Disease, Patient Weight 17 - 40 KGPSN526d626f-8c9f-496c-b838-00a73bb3638313
2639664adalimumab-aaty starter pack 40 MG/0.4 ML Auto-Injector (4 count)PSN526d626f-8c9f-496c-b838-00a73bb3638313
2639666adalimumab-aaty starter pack 40 MG/0.4 ML Auto-Injector (6 count)PSN526d626f-8c9f-496c-b838-00a73bb3638313
797544isopropyl alcohol 70 % Medicated PadPSN526d626f-8c9f-496c-b838-00a73bb3638313
2727423Yuflyma 10 MG in 0.1 ML Prefilled SyringePSN526d626f-8c9f-496c-b838-00a73bb3638313
2668484Yuflyma 20 MG in 0.2 ML Prefilled SyringePSN526d626f-8c9f-496c-b838-00a73bb3638313
2639657Yuflyma 40 MG in 0.4 ML Auto-InjectorPSN526d626f-8c9f-496c-b838-00a73bb3638313
2639662Yuflyma 40 MG in 0.4 ML Prefilled SyringePSN526d626f-8c9f-496c-b838-00a73bb3638313
2668488Yuflyma 80 MG in 0.8 ML Auto-InjectorPSN526d626f-8c9f-496c-b838-00a73bb3638313
2668486Yuflyma 80 MG in 0.8 ML Prefilled SyringePSN526d626f-8c9f-496c-b838-00a73bb3638313
2639667Yuflyma Auto-Injector 40 MG/0.4 ML - Starter Package for Crohn's Disease, Pediatric Crohn's Disease, Ulcerative Colitis or Hidradenitis Suppurativa (6 count)PSN526d626f-8c9f-496c-b838-00a73bb3638313
2639665Yuflyma Auto-Injector 40 MG/0.4 ML Starter Pack - Plaque Psoriasis (4 count)PSN526d626f-8c9f-496c-b838-00a73bb3638313
2668494Yuflyma Auto-Injector 80 MG/0.8 ML and 40 MG/0.4 ML Starter Pack - Plaque Psoriasis (3 count)PSN526d626f-8c9f-496c-b838-00a73bb3638313
2668490Yuflyma Auto-Injector 80 MG/0.8 ML Starter Package for Crohn's Disease, Ulcerative Colitis or Hidradenitis Suppurativa (3 count)PSN526d626f-8c9f-496c-b838-00a73bb3638313
2668492Yuflyma Pediatric Crohn's Disease Starter Package (3 count)PSN526d626f-8c9f-496c-b838-00a73bb3638313
2671099Yuflyma Prefilled Syringe 80 MG/0.8 ML and 40 MG/0.4 ML Starter Pack for Pediatric Crohn's Disease, Patient Weight 17 - 40 KGPSN526d626f-8c9f-496c-b838-00a73bb3638313
27274230.1 ML adalimumab-aaty 100 MG/ML Prefilled Syringe [Yuflyma]SBD526d626f-8c9f-496c-b838-00a73bb3638313
26684840.2 ML adalimumab-aaty 100 MG/ML Prefilled Syringe [Yuflyma]SBD526d626f-8c9f-496c-b838-00a73bb3638313
26396570.4 ML adalimumab-aaty 100 MG/ML Auto-Injector [Yuflyma]SBD526d626f-8c9f-496c-b838-00a73bb3638313
26396620.4 ML adalimumab-aaty 100 MG/ML Prefilled Syringe [Yuflyma]SBD526d626f-8c9f-496c-b838-00a73bb3638313
26684880.8 ML adalimumab-aaty 100 MG/ML Auto-Injector [Yuflyma]SBD526d626f-8c9f-496c-b838-00a73bb3638313
26684860.8 ML adalimumab-aaty 100 MG/ML Prefilled Syringe [Yuflyma]SBD526d626f-8c9f-496c-b838-00a73bb3638313
27274220.1 ML adalimumab-aaty 100 MG/ML Prefilled SyringeSCD526d626f-8c9f-496c-b838-00a73bb3638313
26684830.2 ML adalimumab-aaty 100 MG/ML Prefilled SyringeSCD526d626f-8c9f-496c-b838-00a73bb3638313
26396510.4 ML adalimumab-aaty 100 MG/ML Auto-InjectorSCD526d626f-8c9f-496c-b838-00a73bb3638313
26396590.4 ML adalimumab-aaty 100 MG/ML Prefilled SyringeSCD526d626f-8c9f-496c-b838-00a73bb3638313
26684870.8 ML adalimumab-aaty 100 MG/ML Auto-InjectorSCD526d626f-8c9f-496c-b838-00a73bb3638313
26684850.8 ML adalimumab-aaty 100 MG/ML Prefilled SyringeSCD526d626f-8c9f-496c-b838-00a73bb3638313
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD526d626f-8c9f-496c-b838-00a73bb3638313
26684840.2 ML Yuflyma 100 MG/ML Prefilled SyringeSY526d626f-8c9f-496c-b838-00a73bb3638313
26396570.4 ML Yuflyma 100 MG/ML Auto-InjectorSY526d626f-8c9f-496c-b838-00a73bb3638313
26396620.4 ML Yuflyma 100 MG/ML Prefilled SyringeSY526d626f-8c9f-496c-b838-00a73bb3638313
26684880.8 ML Yuflyma 100 MG/ML Auto-InjectorSY526d626f-8c9f-496c-b838-00a73bb3638313
26684860.8 ML Yuflyma 100 MG/ML Prefilled SyringeSY526d626f-8c9f-496c-b838-00a73bb3638313
2727422adalimumab-aaty 10 MG per 0.1 ML Prefilled SyringeSY526d626f-8c9f-496c-b838-00a73bb3638313
2727422adalimumab-aaty 100 MG/ML per 0.1 ML Prefilled SyringeSY526d626f-8c9f-496c-b838-00a73bb3638313
2668483adalimumab-aaty 20 MG per 0.2 ML Prefilled SyringeSY526d626f-8c9f-496c-b838-00a73bb3638313
2639651adalimumab-aaty 40 MG per 0.4 ML Auto-InjectorSY526d626f-8c9f-496c-b838-00a73bb3638313
2639659adalimumab-aaty 40 MG per 0.4 ML Prefilled SyringeSY526d626f-8c9f-496c-b838-00a73bb3638313
2668487adalimumab-aaty 80 MG per 0.8 ML Auto-InjectorSY526d626f-8c9f-496c-b838-00a73bb3638313
2668485adalimumab-aaty 80 MG per 0.8 ML Prefilled SyringeSY526d626f-8c9f-496c-b838-00a73bb3638313
2668493adalimumab-aaty Auto-Injector 80 MG/0.8 ML and 40 MG/0.4 ML Starter Pack - Plaque Psoriasis (3 count)SY526d626f-8c9f-496c-b838-00a73bb3638313
2668489adalimumab-aaty Auto-Injector 80 MG/0.8 ML Starter Package for Crohn's Disease, Ulcerative Colitis or Hidradenitis Suppurativa (3 count)SY526d626f-8c9f-496c-b838-00a73bb3638313
2668491adalimumab-aaty Pediatric Crohn's Disease Starter Package (3 count)SY526d626f-8c9f-496c-b838-00a73bb3638313
2671098adalimumab-aaty Prefilled Syringe 80 MG/0.8 ML and 40 MG/0.4 ML Starter Pack for Pediatric Crohn's Disease, Patient Weight 17 - 40 KGSY526d626f-8c9f-496c-b838-00a73bb3638313
2639664adalimumab-aaty starter pack 40 MG/0.4 ML Auto-Injector (4 count)SY526d626f-8c9f-496c-b838-00a73bb3638313
2639666adalimumab-aaty starter pack 40 MG/0.4 ML Auto-Injector (6 count)SY526d626f-8c9f-496c-b838-00a73bb3638313
797544isopropyl alcohol 70 % Medicated PadSY526d626f-8c9f-496c-b838-00a73bb3638313
797544isopropyl alcohol 70 % Topical ClothSY526d626f-8c9f-496c-b838-00a73bb3638313
797544isopropyl alcohol 70 % Topical SwabSY526d626f-8c9f-496c-b838-00a73bb3638313
2727423Yuflyma 10 MG per 0.1 ML Prefilled SyringeSY526d626f-8c9f-496c-b838-00a73bb3638313
2727423Yuflyma 100 MG/ML per 0.1 ML Prefilled SyringeSY526d626f-8c9f-496c-b838-00a73bb3638313
2668484Yuflyma 20 MG per 0.2 ML Prefilled SyringeSY526d626f-8c9f-496c-b838-00a73bb3638313
2639657Yuflyma 40 MG per 0.4 ML Auto-InjectorSY526d626f-8c9f-496c-b838-00a73bb3638313
2639662Yuflyma 40 MG per 0.4 ML Prefilled SyringeSY526d626f-8c9f-496c-b838-00a73bb3638313
2668488Yuflyma 80 MG per 0.8 ML Auto-InjectorSY526d626f-8c9f-496c-b838-00a73bb3638313
2668486Yuflyma 80 MG per 0.8 ML Prefilled SyringeSY526d626f-8c9f-496c-b838-00a73bb3638313
2639667Yuflyma Auto-Injector 40 MG/0.4 ML - Starter Package for Crohn's Disease, Pediatric Crohn's Disease, Ulcerative Colitis or Hidradenitis Suppurativa (6 count)SY526d626f-8c9f-496c-b838-00a73bb3638313
2639665Yuflyma Auto-Injector 40 MG/0.4 ML Starter Pack - Plaque Psoriasis (4 count)SY526d626f-8c9f-496c-b838-00a73bb3638313

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72606-039-01726060039012 KIT in 1 CARTON (72606-039-01) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE * 1 mL in 1 PACKET * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE2 kit2023-09-29NoNoHistorical