Truxima
These highlights do not include all the information needed to use TRUXIMA safely and effectively. See full prescribing information for TRUXIMA.TRUXIMA® (rituximab-abbs) injection, for intravenous useInitial U.S. Approval: 2018TRUXIMA (rituximab-abbs) is biosimilar* to RITUXAN® (rituximab).
Approved
Approval ID
9af3ddc7-4217-417a-ac89-8704edc5bc44
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 20, 2023
Manufacturers
FDA
Cephalon, Inc.
DUNS: 183236314
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
rituximab-abbs
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63459-103
Application NumberBLA761088
Product Classification
M
Marketing Category
C73585
G
Generic Name
rituximab-abbs
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 2, 2022
FDA Product Classification
INGREDIENTS (5)
Sodium ChlorideInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
Trisodium Citrate DihydrateInactive
Quantity: 7.35 mg in 1 mL
Code: B22547B95K
Classification: IACT
rituximabActive
Quantity: 10 mg in 1 mL
Code: 4F4X42SYQ6
Classification: ACTIB
Polysorbate 80Inactive
Quantity: 0.7 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
rituximab-abbs
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63459-104
Application NumberBLA761088
Product Classification
M
Marketing Category
C73585
G
Generic Name
rituximab-abbs
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 2, 2022
FDA Product Classification
INGREDIENTS (5)
Sodium ChlorideInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
rituximabActive
Quantity: 10 mg in 1 mL
Code: 4F4X42SYQ6
Classification: ACTIB
Trisodium Citrate DihydrateInactive
Quantity: 7.35 mg in 1 mL
Code: B22547B95K
Classification: IACT
Polysorbate 80Inactive
Quantity: 0.7 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT