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Prescription medicine

Rituximab-arrx

Brand names: Riabni, Ruxience, Truxima, Rituxan

Drug class: CD20-directed Cytolytic Antibody

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

YesBoxed warning
None listedFDA shortage list
0Recalls (FDA reports)
4Companies
1997First FDA approval on file

Quick answers

What is Rituximab-arrx used for?
The FDA-approved label (Rituxan, Genentech, Inc., January 6, 2025) says: “RITUXAN is a CD20-directed cytolytic antibody indicated for the treatment of: Adult patients with Non-Hodgkin's Lymphoma (NHL). Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Rituximab-arrx have a boxed warning?
Yes. The FDA label for Rituxan has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
Is there a shortage of Rituximab-arrx?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Rituximab-arrx been recalled?
No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
Who makes Rituximab-arrx?
4 companies list prescription products of Rituximab-arrx in the FDA NDC Directory, including Amgen, Inc, Pfizer Laboratories Div Pfizer Inc and Cephalon, Inc..

What Rituximab-arrx is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

RITUXAN is a CD20-directed cytolytic antibody indicated for the treatment of: Adult patients with Non-Hodgkin's Lymphoma (NHL). Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent. …

— FDA label: Rituxan, Genentech, Inc., effective January 6, 2025. Read the full label on DailyMed →

The FDA has 2 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Conditions named on the label

These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.

Rheumatoid arthritisChronic Lymphocytic LeukemiaHodgkin Lymphoma

Related medical specialties

OncologyRheumatology

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

This label has a boxed warning. Read it on the full label →

2 of 2 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsInjection, solution
RouteIntravenous
Prescription products8 in the FDA NDC Directory
Brand namesRiabni, Ruxience, Truxima, Rituxan

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
BLA103705
RITUXAN		 GenentechNovember 26, 1997 39, latest December 17, 2021
2021: Labeling · 2021: Efficacy · 2021: Labeling
BLA761088
TRUXIMA		 Celltrion IncNovember 28, 2018 8, latest June 29, 2026
2026: Bioequivalence · 2025: BIOSIMILAR · 2022: Labeling
BLA761103
RUXIENCE		 Pfizer IncJuly 23, 2019 5, latest September 28, 2026
2026: BIOSIMILAR · 2025: BIOSIMILAR · 2023: Labeling
BLA761140
RIABNI		 Amgen IncDecember 17, 2020 3, latest September 29, 2026
2026: Bioequivalence · 2025: Bioequivalence · 2022: Efficacy

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.

Official identifiers

RxCUI (RxNorm)1657862, 1657864, 1657867, 1657868, 2105826, 2105831, 2105834, 2105835
SPL set ID of the quoted labelb172773b-3905-4a1c-ad95-bab4b6126563
FDA labels (SPL)2
FDA applicationsBLA103705, BLA761088, BLA761103, BLA761140
Active ingredients (FDA)RITUXIMAB

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Rituxan, Genentech, Inc., effective January 6, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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