FDA.reportPublic FDA data

YUSIMRY

Product NDC
71288-815
11-digit product format
712880815
Labeler code
71288
Product ID
71288-815_5c419a4b-5654-43dc-aefb-9e8e86bd5761
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
adalimumab-aqvh
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
BLA761216
Marketing category
BLA
Marketing start
2023-07-01
Substance
ADALIMUMAB
Active strength
40 mg/.8mL
Pharmacologic classes
Antibodies, Monoclonal [CS], Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ADALIMUMAB40 mg/.8mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFYS6T7F842
Rxcui2640389, 2640395, 2640397, 2640400

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
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71288-815-81YUSIMRY0.8 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION0.86
71288-815-81YUSIMRY2 in 1 CARTONINJECTION, SOLUTION26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-815-81ML - Milliliter71288-8153bbf0ec3-9077-409f-b578-c0eb1e0f182c12025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-815YUSIMRY (ADALIMUMAB-AQVH) INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.]5Current NDC, 2 package rows20241027_4cab600d-6950-409f-a6d8-d447da22cd95.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2640397adalimumab-aqvh 40 MG in 0.8 ML Auto-InjectorPSN4cab600d-6950-409f-a6d8-d447da22cd956
2640389adalimumab-aqvh 40 MG in 0.8 ML Prefilled SyringePSN4cab600d-6950-409f-a6d8-d447da22cd956
2640400YUSIMRY 40 MG in 0.8 ML Auto-InjectorPSN4cab600d-6950-409f-a6d8-d447da22cd956
2640395YUSIMRY 40 MG in 0.8 ML Prefilled SyringePSN4cab600d-6950-409f-a6d8-d447da22cd956
26404000.8 ML adalimumab-aqvh 50 MG/ML Auto-Injector [Yusimry]SBD4cab600d-6950-409f-a6d8-d447da22cd956
26403950.8 ML adalimumab-aqvh 50 MG/ML Prefilled Syringe [Yusimry]SBD4cab600d-6950-409f-a6d8-d447da22cd956
26403970.8 ML adalimumab-aqvh 50 MG/ML Auto-InjectorSCD4cab600d-6950-409f-a6d8-d447da22cd956
26403890.8 ML adalimumab-aqvh 50 MG/ML Prefilled SyringeSCD4cab600d-6950-409f-a6d8-d447da22cd956
26404000.8 ML Yusimry 50 MG/ML Auto-InjectorSY4cab600d-6950-409f-a6d8-d447da22cd956
26403950.8 ML Yusimry 50 MG/ML Prefilled SyringeSY4cab600d-6950-409f-a6d8-d447da22cd956
2640397adalimumab-aqvh 40 MG per 0.8 ML Auto-InjectorSY4cab600d-6950-409f-a6d8-d447da22cd956
2640389adalimumab-aqvh 40 MG per 0.8 ML Prefilled SyringeSY4cab600d-6950-409f-a6d8-d447da22cd956
2640400Yusimry 40 MG per 0.8 ML Auto-InjectorSY4cab600d-6950-409f-a6d8-d447da22cd956
2640395Yusimry 40 MG per 0.8 ML Prefilled SyringeSY4cab600d-6950-409f-a6d8-d447da22cd956

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71288-815-81712880815812 SYRINGE, GLASS in 1 CARTON (71288-815-81) / .8 mL in 1 SYRINGE, GLASS2023-07-01NoNoHistorical