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Rituxan

These highlights do not include all the information needed to use RITUXAN safely and effectively. See full prescribing information for RITUXAN. RITUXAN (rituximab) injection, for intravenous use Initial U.S. Approval: 1997

Approved
Approval ID

b172773b-3905-4a1c-ad95-bab4b6126563

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 6, 2023

Manufacturers
FDA

Genentech, Inc.

DUNS: 080129000

Products 2

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

rituximab

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50242-051
Application NumberBLA103705
Product Classification
M
Marketing Category
C73585
G
Generic Name
rituximab
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 6, 2023
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

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50242-053
Application NumberBLA103705
Product Classification
M
Marketing Category
C73585
G
Generic Name
rituximab
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 6, 2023
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

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Rituxan - FDA Drug Approval Details