Idacio
These highlights do not include all the information needed to use IDACIO safely and effectively. See full prescribing information for IDACIO. IDACIO® (adalimumab-aacf) injection, for subcutaneous use Initial U.S. Approval: 2022 IDACIO® (adalimumab-aacf) is biosimilar to HUMIRA® (adalimumab).
Approved
Approval ID
43de75ac-1a37-4609-9edd-68bda2448a47
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 22, 2023
Manufacturers
FDA
Fresenius Kabi USA, LLC
DUNS: 013547657
Products 2
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 Code65219-554
Application NumberBLA761255
Product Classification
M
Marketing Category
C73585
G
Generic Name
adalimumab
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 31, 2022
FDA Product Classification
INGREDIENTS (7)
acetic acidInactive
Code: Q40Q9N063P
Classification: IACT
adalimumabActive
Quantity: 40 mg in 0.8 mL
Code: FYS6T7F842
Classification: ACTIB
trehalose dihydrateInactive
Code: 7YIN7J07X4
Classification: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
Sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
adalimumab
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65219-556
Application NumberBLA761255
Product Classification
M
Marketing Category
C73585
G
Generic Name
adalimumab
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 31, 2022
FDA Product Classification
INGREDIENTS (7)
acetic acidInactive
Code: Q40Q9N063P
Classification: IACT
trehalose dihydrateInactive
Code: 7YIN7J07X4
Classification: IACT
adalimumabActive
Quantity: 40 mg in 0.8 mL
Code: FYS6T7F842
Classification: ACTIB
waterInactive
Code: 059QF0KO0R
Classification: IACT
Sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT