Ruxience
These highlights do not include all the information needed to use RUXIENCE safely and effectively. See full prescribing information for RUXIENCE. RUXIENCE (rituximab-pvvr) injection, for intravenous use Initial U.S. Approval: 2019 RUXIENCE (rituximab-pvvr) is biosimilar to RITUXAN (rituximab)
Approved
Approval ID
f941fc61-f7a3-4e4a-ab7c-87c1667fa05b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 3, 2024
Manufacturers
FDA
Pfizer Laboratories Div Pfizer Inc
DUNS: 134489525
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
rituximab-pvvr
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0069-0249
Application NumberBLA761103
Product Classification
M
Marketing Category
C73585
G
Generic Name
rituximab-pvvr
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 30, 2023
FDA Product Classification
INGREDIENTS (7)
RITUXIMABActive
Quantity: 500 mg in 50 mL
Code: 4F4X42SYQ6
Classification: ACTIB
EDETATE DISODIUMInactive
Quantity: 128.5 mg in 50 mL
Code: 7FLD91C86K
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 10 mg in 50 mL
Code: 6OZP39ZG8H
Classification: IACT
SUCROSEInactive
Quantity: 4250 mg in 50 mL
Code: C151H8M554
Classification: IACT
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEInactive
Quantity: 128.5 mg in 50 mL
Code: X573657P6P
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HISTIDINEInactive
Quantity: 60 mg in 50 mL
Code: 4QD397987E
Classification: IACT
rituximab-pvvr
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0069-0238
Application NumberBLA761103
Product Classification
M
Marketing Category
C73585
G
Generic Name
rituximab-pvvr
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 30, 2023
FDA Product Classification
INGREDIENTS (7)
RITUXIMABActive
Quantity: 100 mg in 10 mL
Code: 4F4X42SYQ6
Classification: ACTIB
EDETATE DISODIUMInactive
Quantity: 25.7 mg in 10 mL
Code: 7FLD91C86K
Classification: IACT
SUCROSEInactive
Quantity: 850 mg in 10 mL
Code: C151H8M554
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HISTIDINEInactive
Quantity: 12 mg in 10 mL
Code: 4QD397987E
Classification: IACT
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEInactive
Quantity: 25.7 mg in 10 mL
Code: X573657P6P
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 2 mg in 10 mL
Code: 6OZP39ZG8H
Classification: IACT