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Yuflyma

These highlights do not include all the information needed to use YUFLYMA safely and effectively. See full prescribing information for YUFLYMA. YUFLYMA (adalimumab-aaty) injection, for subcutaneous use Initial U.S. Approval: 2023YUFLYMA (adalimumab-aaty) is biosimilar to HUMIRA (adalimumab).

Approved
Approval ID

526d626f-8c9f-496c-b838-00a73bb36383

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 2, 2024

Manufacturers
FDA

CELLTRION USA, Inc.

DUNS: 116587378

Products 5

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

adalimumab

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72606-024
Application NumberBLA761219
Product Classification
M
Marketing Category
C73585
G
Generic Name
adalimumab
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 1, 2023
FDA Product Classification

INGREDIENTS (2)

adalimumabActive
Quantity: 20 mg in 0.2 mL
Code: FYS6T7F842
Classification: ACTIB
WaterInactive
Code: 059QF0KO0R
Classification: IACT

adalimumab

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72606-039
Application NumberBLA761219
Product Classification
M
Marketing Category
C73585
G
Generic Name
adalimumab
Product Specifications
Effective DateDecember 1, 2023
FDA Product Classification

adalimumab

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72606-023
Application NumberBLA761219
Product Classification
M
Marketing Category
C73585
G
Generic Name
adalimumab
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 1, 2023
FDA Product Classification

INGREDIENTS (2)

adalimumabActive
Quantity: 80 mg in 0.8 mL
Code: FYS6T7F842
Classification: ACTIB
WaterInactive
Code: 059QF0KO0R
Classification: IACT

adalimumab

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72606-046
Application NumberBLA761219
Product Classification
M
Marketing Category
C73585
G
Generic Name
adalimumab
Product Specifications
Effective DateDecember 1, 2023
FDA Product Classification

adalimumab

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72606-030
Application NumberBLA761219
Product Classification
M
Marketing Category
C73585
G
Generic Name
adalimumab
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 1, 2023
FDA Product Classification

INGREDIENTS (2)

adalimumabActive
Quantity: 40 mg in 0.4 mL
Code: FYS6T7F842
Classification: ACTIB
WaterInactive
Code: 059QF0KO0R
Classification: IACT

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Yuflyma - FDA Drug Approval Details