FDA.reportPublic FDA data

Yuflyma

Product NDC
72606-030
11-digit product format
726060030
Labeler code
72606
Product ID
72606-030_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
2023-05-23
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui797544, 2639651, 2639657, 2639659, 2639662, 2639664, 2639665, 2639666, 2639667, 2668483, 2668484, 2668485, 2668486, 2668487, 2668488, 2668489, 2668490, 2668491, 2668492, 2668493

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
72606-030-01Yuflyma1 in 1 CARTONKIT113
72606-030-01Yuflyma1 in 1 KITKIT113
72606-030-02Yuflyma2 in 1 CARTONKIT213
72606-030-02Yuflyma1 in 1 KITKIT113
72606-030-03Yuflyma1 in 1 KITKIT113
72606-030-03Yuflyma4 in 1 CARTONKIT413
72606-030-04Yuflyma6 in 1 CARTONKIT613
72606-030-04Yuflyma1 in 1 KITKIT113
72606-030-05Yuflyma1 in 1 CARTONKIT113
72606-030-05Yuflyma1 in 1 KITKIT113
72606-030-06Yuflyma1 in 1 KITKIT113
72606-030-06Yuflyma2 in 1 CARTONKIT213
72606-030-07Yuflyma1 in 1 KITKIT113
72606-030-07Yuflyma4 in 1 CARTONKIT413
72606-030-08Yuflyma1 in 1 KITKIT113
72606-030-08Yuflyma6 in 1 CARTONKIT613
72606-030-09Yuflyma1 in 1 KITKIT113
72606-030-09Yuflyma1 in 1 CARTONKIT113
72606-030-10Yuflyma2 in 1 CARTONKIT213
72606-030-10Yuflyma1 in 1 KITKIT113
72606-030-11Yuflyma4 in 1 CARTONKIT413
72606-030-11Yuflyma1 in 1 KITKIT113
72606-030-12Yuflyma6 in 1 CARTONKIT613
72606-030-12Yuflyma1 in 1 KITKIT113
72606-030-13Yuflyma4 in 1 CARTONKIT413
72606-030-13Yuflyma1 in 1 KITKIT113
72606-030-14Yuflyma6 in 1 CARTONKIT613
72606-030-14Yuflyma1 in 1 KITKIT113

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72606-030YUFLYMA (ADALIMUMAB-AATY) KIT [CELLTRION USA, INC.]11Current NDC, 28 package rows20250515_526d626f-8c9f-496c-b838-00a73bb36383.zip

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
72606-030-01726060030011 KIT in 1 CARTON (72606-030-01) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET1 kit2023-05-23NoNoCurrent
72606-030-02726060030022 KIT in 1 CARTON (72606-030-02) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET2 kit2023-05-23NoNoCurrent
72606-030-03726060030034 KIT in 1 CARTON (72606-030-03) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET4 kit2023-05-23NoNoCurrent
72606-030-04726060030046 KIT in 1 CARTON (72606-030-04) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET6 kit2023-05-23NoNoCurrent
72606-030-05726060030051 KIT in 1 CARTON (72606-030-05) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET1 kit2023-05-23NoNoCurrent
72606-030-06726060030062 KIT in 1 CARTON (72606-030-06) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET2 kit2023-05-23NoNoCurrent
72606-030-07726060030074 KIT in 1 CARTON (72606-030-07) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET4 kit2023-05-23NoNoCurrent
72606-030-08726060030086 KIT in 1 CARTON (72606-030-08) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET6 kit2023-05-23NoNoCurrent
72606-030-09726060030091 KIT in 1 CARTON (72606-030-09) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET1 kit2023-05-23NoNoCurrent
72606-030-10726060030102 KIT in 1 CARTON (72606-030-10) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET2 kit2023-05-23NoNoCurrent
72606-030-11726060030114 KIT in 1 CARTON (72606-030-11) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET4 kit2023-05-23NoNoCurrent
72606-030-12726060030126 KIT in 1 CARTON (72606-030-12) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET6 kit2023-05-23NoNoCurrent
72606-030-13726060030134 KIT in 1 CARTON (72606-030-13) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET4 kit2023-05-23NoNoCurrent
72606-030-14726060030146 KIT in 1 CARTON (72606-030-14) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET6 kit2023-05-23NoNoCurrent