AMJEVITA
These highlights do not include all the information needed to use AMJEVITA™ safely and effectively. See full prescribing information for AMJEVITA. AMJEVITA (adalimumab-atto) injection, for subcutaneous use Initial U.S. Approval: 2016 AMJEVITA (adalimumab-atto) is biosimilar to HUMIRA (adalimumab).
Approved
Approval ID
b7178e36-6787-45ab-8fee-be59bc6a4aa4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 14, 2023
Manufacturers
FDA
Amgen USA Inc.
DUNS: 962075045
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
adalimumab-atto
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72511-400
Application NumberBLA761024
Product Classification
M
Marketing Category
C73585
G
Generic Name
adalimumab-atto
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateAugust 14, 2023
FDA Product Classification
INGREDIENTS (6)
SUCROSEInactive
Quantity: 72 mg in 0.8 mL
Code: C151H8M554
Classification: IACT
ADALIMUMABActive
Quantity: 40 mg in 0.8 mL
Code: FYS6T7F842
Classification: ACTIB
POLYSORBATE 80Inactive
Quantity: 0.8 mg in 0.8 mL
Code: 6OZP39ZG8H
Classification: IACT
ACETIC ACIDInactive
Quantity: 0.48 mg in 0.8 mL
Code: Q40Q9N063P
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
adalimumab-atto
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72511-482
Application NumberBLA761024
Product Classification
M
Marketing Category
C73585
G
Generic Name
adalimumab-atto
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateAugust 14, 2023
FDA Product Classification
INGREDIENTS (6)
POLYSORBATE 80Inactive
Quantity: 0.4 mg in 0.4 mL
Code: 6OZP39ZG8H
Classification: IACT
ACETIC ACIDInactive
Quantity: 0.9 mg in 0.4 mL
Code: Q40Q9N063P
Classification: IACT
ADALIMUMABActive
Quantity: 40 mg in 0.4 mL
Code: FYS6T7F842
Classification: ACTIB
SUCROSEInactive
Quantity: 34 mg in 0.4 mL
Code: C151H8M554
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT