RITUXAN Solution for injection Ref.[11139] Active ingredients: Rituximab

Source: FDA, National Drug Code (US) Revision Year: 2020

Product description

Rituximab is a genetically engineered chimeric murine/human monoclonal IgG₁ kappa antibody directed against the CD20 antigen. Rituximab has an approximate molecular weight of 145 kD.

Rituximab is produced by mammalian cell (Chinese Hamster Ovary) suspension culture in a nutrient medium that may contain the antibiotic gentamicin. Gentamicin is not detectable in the final product.

RITUXAN (rituximab) injection is a sterile, preservative-free, clear, colorless solution for intravenous infusion. RITUXAN is supplied at a concentration of 10 mg/mL in either 100 mg/10 mL or 500 mg/50 mL single-dose vials. Each mL of solution contains 10 mg rituximab, polysorbate 80 (0.7 mg), sodium chloride (9 mg), sodium citrate dihydrate (7.35 mg), and Water for Injection, USP. The pH is 6.5.

Dosage Forms and Strengths
Injection: RITUXAN is a colorless, clear solution for intravenous infusion: 100 mg/10 mL (10 mg/mL) in a single-dose vial 500 mg/50 mL (10 mg/mL) in a single-dose vial

How Supplied

RITUXAN (rituximab) injection is a sterile, preservative-free, clear, colorless solution for intravenous infusion supplied as follows:

Carton contents	NDC number
One 100 mg/10 mL (10 mg/mL) single-dose vial	NDC 50242-051-21
Ten 100 mg/10 mL (10 mg/mL) single-dose vials	NDC 50242-051-10
One 500 mg/50 mL (10 mg/mL) single-dose vial	NDC 50242-053-06

Manufactured by: Genentech, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990

Drugs

Drug	Countries
RITUXAN	Canada, Japan, United States

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