FDA.reportPublic FDA data

YUSIMRY

Product NDC
71288-816
11-digit product format
712880816
Labeler code
71288
Product ID
71288-816_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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
FYS6T7F842Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2640389Internal RxNorm lookup
2640395Internal RxNorm lookup
2640397Internal RxNorm lookup
2640400Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4cab600d-6950-409f-a6d8-d447da22cd95Available 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
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71288-816-81YUSIMRY0.8 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION0.86
71288-816-81YUSIMRY2 in 1 CARTONINJECTION, SOLUTION26

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-816YUSIMRY (ADALIMUMAB-AQVH) INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.]5Current NDC, 2 package rows20241027_4cab600d-6950-409f-a6d8-d447da22cd95.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
YUSIMRYADALIMUMAB-AQVHMeitheal Pharmaceuticals Inc.4cab600d-6950-409f-a6d8-d447da22cd952025-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761216
ndc (product): 71288-816
YUSIMRYADALIMUMAB-AQVHCoherus BioSciences Inccd0e7af2-7704-49ce-bde9-f645294b67882025-05-16Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761216

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761216Yusimryadalimumab-aqvh351(k) BiosimilarRx2026-07-01

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
71288-816-81712880816812 SYRINGE, GLASS in 1 CARTON (71288-816-81) / .8 mL in 1 SYRINGE, GLASS2023-07-01NoNoCurrent