FDA.reportPublic FDA data

YUSIMRY

Product NDC
70114-220
11-digit product format
701140220
Labeler code
70114
Product ID
70114-220_92fff88b-7e54-47b3-92ed-e57bbb9b6a84
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
adalimumab-aqvh
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Coherus BioSciences 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70114-220-022025-05-06C16284748780-12cef2736-5a08-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use YUSIMRY safely and effectively. See full prescribing information for YUSIMRY. YUSIMRY (adalimumab-aqvh) injection, for subcutaneous use Initial U.S. Approval: 2021 YUSIMRY (adalimumab-aqvh) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences betwee
70114-220-022025-01-30C16284748780-12cef2736-5a08-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use YUSIMRY safely and effectively. See full prescribing information for YUSIMRY. YUSIMRY (adalimumab-aqvh) injection, for subcutaneous use Initial U.S. Approval: 2021 YUSIMRY (adalimumab-aqvh) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences betwee

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70114-220-02YUSIMRY0.8 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION0.86
70114-220-02YUSIMRY2 in 1 CARTONINJECTION, SOLUTION26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70114-220-02ML - Milliliter70114-2207c536e45-7828-434f-afbb-eb47f3f5fb0912023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70114-220YUSIMRY (ADALIMUMAB-AQVH) INJECTION, SOLUTION [COHERUS BIOSCIENCES INC]6Current NDC, 2 package rows20250519_cd0e7af2-7704-49ce-bde9-f645294b6788.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2640397adalimumab-aqvh 40 MG in 0.8 ML Auto-InjectorPSNcd0e7af2-7704-49ce-bde9-f645294b67886
2640389adalimumab-aqvh 40 MG in 0.8 ML Prefilled SyringePSNcd0e7af2-7704-49ce-bde9-f645294b67886
2640400YUSIMRY 40 MG in 0.8 ML Auto-InjectorPSNcd0e7af2-7704-49ce-bde9-f645294b67886
2640395YUSIMRY 40 MG in 0.8 ML Prefilled SyringePSNcd0e7af2-7704-49ce-bde9-f645294b67886
26404000.8 ML adalimumab-aqvh 50 MG/ML Auto-Injector [Yusimry]SBDcd0e7af2-7704-49ce-bde9-f645294b67886
26403950.8 ML adalimumab-aqvh 50 MG/ML Prefilled Syringe [Yusimry]SBDcd0e7af2-7704-49ce-bde9-f645294b67886
26403970.8 ML adalimumab-aqvh 50 MG/ML Auto-InjectorSCDcd0e7af2-7704-49ce-bde9-f645294b67886
26403890.8 ML adalimumab-aqvh 50 MG/ML Prefilled SyringeSCDcd0e7af2-7704-49ce-bde9-f645294b67886
26404000.8 ML Yusimry 50 MG/ML Auto-InjectorSYcd0e7af2-7704-49ce-bde9-f645294b67886
26403950.8 ML Yusimry 50 MG/ML Prefilled SyringeSYcd0e7af2-7704-49ce-bde9-f645294b67886
2640397adalimumab-aqvh 40 MG per 0.8 ML Auto-InjectorSYcd0e7af2-7704-49ce-bde9-f645294b67886
2640389adalimumab-aqvh 40 MG per 0.8 ML Prefilled SyringeSYcd0e7af2-7704-49ce-bde9-f645294b67886
2640400Yusimry 40 MG per 0.8 ML Auto-InjectorSYcd0e7af2-7704-49ce-bde9-f645294b67886
2640395Yusimry 40 MG per 0.8 ML Prefilled SyringeSYcd0e7af2-7704-49ce-bde9-f645294b67886

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70114-220-02701140220022 SYRINGE, GLASS in 1 CARTON (70114-220-02) / .8 mL in 1 SYRINGE, GLASS2023-07-01NoNoHistorical