What this pack is
RITUXAN is the brand name in this record; rituximab is the generic name. Read both together with the dosage form (injectable product).
PACK CHECK · MARKET FIRST
RITUXANGeneric namerituximab
Mainland China pack-name cue美罗华®Historical or public source cue · verify the current target-market record · Open reference ↗
How this medicine works
The FDA RITUXAN label describes rituximab as a monoclonal antibody that binds CD20 on mature and pre-B lymphocytes; it also describes complement-dependent cytotoxicity, antibody-dependent cytotoxicity and direct apoptosis induction as possible pathways. This explains action pathways, not individual disease suitability, infection risk, vaccine planning, combination treatment or timing.
Read source: United States ↗Historical public record · reviewed 2026-08-20More about its action and precautions →Check the market, names, dosage form and route together
A medicine may use different brand names across markets. Keep the market, brand, generic name, dosage form and route together; one matching field does not prove that two packs are the same or interchangeable.
Open the complete product-identity record
Use these fields when the pack, market name or package image needs closer checking. They are evidence boundaries, not substitution instructions.
- Mainland China pack-name cue
- 美罗华®
- International brand name
- RITUXAN
- Generic name
- rituximab
- Dosage-form class
- Injection for intravenous infusion
- Route
- Intravenous infusion
- Package-image status
- A source-linked public label image is available below
Mainland China trade-name search cue:美罗华®. This is a historical/public cue for reading pack text. It does not establish current approval, holder, supply or sale eligibility. Open reference ↗
FOR EVERYDAY QUESTIONS
After the leaflet, continue with the question you still need to check
What this page can show
This is a source-traceable public record. It helps you read the product identity and its listed source documents; each market still needs its own current record check.
What to bring to the next conversation
Bring the actual pack, the label or prescription, and a complete medicine list when you speak with a pharmacist or clinician.
NEXT SAFE STEP
Choose the next safe check
A question about changing, combining or splitting?Put the exact packs on one list before a pharmacist or prescriber checks the full context.Open the family medicine list →A question about cost, reimbursement or availability?First lock the market, exact presentation and date. Use local official reimbursement, hospital or pharmacy channels for a current answer rather than a web estimate.Open regulator and market-record entry points →Unsure about a pack or a cross-border product?Photo reading can return possible record matches only. Check the actual product against the current regulator record for its market.Identify pack text locally →Saw a recall, approval or procurement headline?Open the original publisher, then match its product, market and date. Do not make a stop or switch decision from a headline.Read primary-source news →
PRODUCT PRESENTATION IDENTITY
Strength, pack and device identity
A vial concentration, unit-per-mL value or device marking identifies the exact labelled product. It does not calculate an individual's amount, timing, administration, missed-use action, combination or switch.
100 mg/10 mL and 500 mg/50 mL are two single-dose vial identities with the same 10 mg/mL concentration. Matching concentration does not make vial totals interchangeable or determine an individual's vial count, dilution, infusion, combination or switch; unused contents are not a later-use supply.
2 source-backed strength, pack or device records — open the full list
First match the market, dosage form and labelled amount on the pack in hand. The number of tablets, sachets or devices in a pack is not a personal dose or schedule.
United States label · DailyMed U.S. public label (Genentech; page updated Jan 2025)
Rituximab 100 mg/10 mL (10 mg/mL) per single-dose vial; one vial per carton
- Product code
- NDC 50242-051-21
- Form and route
- RITUXAN rituximab injection for intravenous infusion · intravenous infusion after dilution (label identity only; not a procedure instruction)
- Labelled concentration
- 10 mg/mL (the same concentration in both vial sizes)Product identity, not an individual dose
- Container
- preservative-free single-dose vial · 10 mL
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-28; actual marketing, stock and availability are not established.
- rituximab
- 100 mglabelled total per single-dose vial; not an individual's infusion amount, vial count, dilution or infusion plan
- Package
- 1 single-dose vial per carton
- Labelled appearance
- clear, colourless solution (label description) · 10 mL single-dose glass vial and carton
United States label · DailyMed U.S. public label (Genentech; page updated Jan 2025)
Rituximab 500 mg/50 mL (10 mg/mL) per single-dose vial; one vial per carton
- Product code
- NDC 50242-053-06
- Form and route
- RITUXAN rituximab injection for intravenous infusion · intravenous infusion after dilution (label identity only; not a procedure instruction)
- Labelled concentration
- 10 mg/mL (the same concentration in both vial sizes)Product identity, not an individual dose
- Container
- preservative-free single-dose vial · 50 mL
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-28; actual marketing, stock and availability are not established.
- rituximab
- 500 mglabelled total per single-dose vial; not an individual's infusion amount, vial count, dilution or infusion plan
- Package
- 1 single-dose vial per carton
- Labelled appearance
- clear, colourless solution (label description) · 50 mL single-dose glass vial and carton
PUBLIC LABEL IMAGE
Appearance and package-text clues
This dated or historical public-label image is for checking the brand, generic-name, strength and dosage-form clues only. It does not authenticate a product or establish originator status, a current label, current packaging, target-market approval or sale eligibility.
Open the public label source ↗LABEL READING · NOT A PRESCRIPTION
RITUXAN label reading: a 10 mg/mL single-dose vial is not for home infusion or dose sharing
Reading level: drug-specific label reading. This record has been expanded around its dosage form or a higher-risk reading question; the current target-market label and professional review still apply.
This module uses Genentech's January 2025 U.S. DailyMed public label for RITUXAN as a reading entry point. It helps check RITUXAN, rituximab, injection for intravenous use, 100 mg/10 mL or 500 mg/50 mL (both 10 mg/mL) single-dose vials and target market; it does not turn concentration, vial count, infusion sequence or a disease name into an individual plan.
- 100 mg/10 mL and 500 mg/50 mL are product-identity clues for two single-dose vials, and 10 mg/mL is a concentration; these numbers are not “how many vials to use,” permission to save leftovers or share product. The RITUXAN label states it is to be given intravenously only by professionals with medical support for severe infusion reactions; actual preparation, infusion and remaining-product handling belong to the treating facility.
- Being called an antibody, a CD20-related treatment or an intravenous medicine does not make RITUXAN self-combinable, alternatable or substitutable with another rituximab product, chemotherapy, immunosuppressant, steroid or biologic. Disease setting, prior course, infection risk, vaccinations, the full medicine list and the target-market label need integrated review by the prescribing team.
- The label carries explicit warnings about severe infusion reactions, severe skin/mucosal reactions, hepatitis B virus reactivation, progressive multifocal leukoencephalopathy, infection and other risks. With breathing difficulty, chest symptoms, marked rash/mucosal injury, fever or infection signs, jaundice-like changes, mental/neurologic change, severe abdominal pain or another acute concern during or after infusion, contact the treatment team promptly or use local urgent medical support.
- Terms such as “CD20-positive,” lymphoma, arthritis or autoimmune disease cannot be turned into a suitability conclusion by a webpage. Relevant testing, pathology, infection/hepatitis B record, prior treatment and current label require interpretation by the appropriate specialty team; do not self-start, pause or switch because names or indications look similar.
PHARMACOVIGILANCE · OFFICIAL ROUTES
Check safety information in the right market
Start with the public label or product record linked to this dossier, then use the official safety routes below for the market that applies to the medicine in hand.
Match five details before using a safety record
- Brand and generic nameBoth must match the medicine named by the record.
- Dosage form and strengthTablet, capsule, injection, inhaler, patch and eye drop are not interchangeable.
- Market and notice dateA record applies only to the country or region and date it names.
- Lot, pack and manufacturerRecord these only when the official notice specifically names them.
- Current product informationA historical record may have been superseded by the current label.
This checklist only helps organise the right question. It does not create a personal conclusion about stopping, switching, dose, combination or suitability.
This dossier’s product-level source checkFDA · United States · Regulatory product record or label archive · 2026-08-20
This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk.
Markets actually represented by the reviewed product documents
- United States · 1
This is a document-coverage summary, not a claim that the medicine is authorised, supplied, interchangeable or actively monitored in every listed market today.
This record’s label or product-record routeFDA: RITUXAN public label ↗Historical public record · reviewed 2026-08-20
This is not a conclusion that the medicine has no risk, warning, recall or newer notice in another market. Start with the checked product-level label above, then use the official market gateways below for the product in hand.
See the reviewed safety-record directory →Global official safety gateways
- NMPA Centre for Drug Reevaluation · Mainland ChinaPrimary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item.Drug-vigilance bulletins and safety notices ↗reviewed 2026-08-22
- FDA · United StatesPrimary FDA pages for important new safety issues, labelling changes and risk communications.Drug Safety Communications ↗reviewed 2026-08-22
- FDA MedWatch · United StatesU.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality.Safety information and serious-problem reporting ↗reviewed 2026-08-22
- EMA · European Union / European Economic AreaOfficial EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment.Pharmacovigilance overview and EudraVigilance ↗reviewed 2026-08-22
- MHRA · United KingdomPrimary UK MHRA medicine-safety updates for professionals and the public.Drug Safety Update ↗reviewed 2026-08-22
- PMDA · JapanPMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents.Medicine safety information ↗reviewed 2026-08-22
- MFDS · Republic of KoreaMFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case.Medicine safety letters ↗reviewed 2026-08-22
- HSA · SingaporeHSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information.Adverse-event reporting and medicine-safety information ↗reviewed 2026-08-22
- Health Canada · CanadaHealth Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item.MedEffect Canada: advisories, warnings and recalls ↗reviewed 2026-08-22
- TGA · AustraliaPrimary Australian TGA safety alerts, advisories and monitoring information for therapeutic products.Medicine safety alerts ↗reviewed 2026-08-22
- Swissmedic · SwitzerlandOfficial Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality.Pharmacovigilance and suspected adverse-reaction reporting ↗reviewed 2026-08-22
- Medsafe · New ZealandNew Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information.Medicine safety communications ↗reviewed 2026-08-22
- SAHPRA · South AfricaSAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information.Medicine safety information, alerts and pharmacovigilance ↗reviewed 2026-08-22
- WHO · GlobalWHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market.Medicine and vaccine safety-alert archive ↗reviewed 2026-08-22
- Anvisa · BrazilAnvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item.Pharmacovigilance, alerts and VigiMed ↗reviewed 2026-08-22
This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline.
For severe or rapidly worsening symptoms, suspected overdose, a severe allergic reaction, loss of consciousness or another emergency, use local emergency services. Do not wait for an online alert search or change a medicine from this page.
PRIVATE FAMILY LIST
Bring this record into a local medicine list
Only the brand, generic name, dosage form and route are added, and they stay in this browser. Copy strength, label directions, start/stop history and any concern from the actual pack; this tool does not calculate a dose or decide combination, switching or stopping.
Add to the family medicine list →PACK · LABEL · MEDICINE LIST
Six checks for this medicine pack
Use this card to organise questions about RITUXAN (rituximab). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
RITUXAN is the brand in this record and rituximab is the active-ingredient name. Check both with the dosage form (Injection for intravenous infusion) and the market on the actual pack.
Read the labelled strength in context
mg/mL, mg per vial or a total volume describes the labelled concentration or pack identity of an injectable product. It is not an individual infusion amount, preparation instruction or schedule.
Check the exact injection presentation
For an injectable or infusion presentation, verify the route, concentration, container and device in the exact current label. Do not transfer, share, prepare or substitute it from this page.
Put every product on one list
Include prescriptions, over-the-counter products, eye drops, creams, vitamins, minerals, herbs and supplements. A pharmacist or prescriber needs the whole list before any combination, alternation, switch or stop is considered.
Ask a specific pharmacogenetics question
Ask which medicine, which gene and what clinical decision a result could change. A gene–drug association does not mean broad genetic testing is needed for everyone and must not be used to change treatment without professional review.
Know when to seek urgent help
For a severe reaction, fainting, difficulty breathing or sudden worsening symptoms around an injection or infusion, use the local treatment team or emergency service now. Do not wait for a website reply or alter preparation, infusion or another medicine yourself.
This card does not calculate a dose, decide whether medicines can be combined, or replace a clinician or pharmacist. Market-specific current labels and the person's full context still need review.
MARKET DOCUMENTS · READ SEPARATELY
Enlarged market leaflets and regulator documents
Each link retains its own market, date, dosage form and document status. These documents support larger-print reading and item-by-item checking; they do not make products, strengths, packs, indications or use between countries or regions interchangeable.
- DailyMed (NLM): RITUXAN public label (Genentech, 2025-01 updated) ↗reviewed 2026-08-20
- FDA: RITUXAN public label ↗Historical public record · reviewed 2026-08-20
HOW IT WORKS · NOT A TREATMENT PLAN
How rituximab works: the label describes binding to CD20 on B cells
- “Acts on B cells” does not permit a treatment decision from a diagnosis name, partial laboratory result or mechanism, nor self-combination, alternation or stopping with another immunosuppressant, anticancer medicine, steroid or biologic.
- RITUXAN, another rituximab product, a biosimilar and different administration settings must be checked item by item for exact product, route, label, infusion plan and target-market record; a shared CD20 mechanism does not mean self-interchangeability.
- The label contains warnings about serious infusion reactions, infections and other risks. With fever, chills, breathing trouble, rash, mental-status change or another acute concern, contact the local treatment team or urgent medical support promptly; a mechanism page cannot replace risk assessment.
SOURCE EVIDENCE REGISTER
Source evidence map
Every public link is labelled with its market, document status and document type. A historical public record is not a current label, and an official lookup entry is not a product-specific record.
- FDA: Rituximab historical approval letter ↗Historical public record · reviewed 2026-08-20
- FDA: RITUXAN public label ↗Historical public record · reviewed 2026-08-20
- FDA Drugs@FDA ↗Official lookup entry · reviewed 2026-08-20
SOURCE-TRACEABLE ARCHIVE
RITUXANrituximab
This page links to public primary-source material for RITUXAN. The archive is historical or documentary evidence only; it does not by itself establish originator status, product quality, current labelling, availability or sale eligibility.
DOCUMENT TIMELINE
Document timeline
Initial U.S. approval year listed in the FDA label
The FDA label archive linked here lists Initial U.S. Approval: 1997. This historical locator is not a conclusion about current approval, availability, holder or another market.
FDA: RITUXAN label archive ↗FDA label archive version
This page links the 2019 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document.
FDA: RITUXAN label archive ↗
MARKET SCOPE
Market-record boundary
United States
Public label archive linkedOnly the FDA document listed on this page is linked.
Mainland China, EU, Japan
Market record not establishedNo local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive.
How to read this record
Read each document in its stated market, date and dosage-form context. A historical record is not a current label and does not support individual medical, substitution or purchasing conclusions.
Keep international and mainland China records separate
This page has a U.S. public history/regulatory archive but no mainland China record for this specific product. That does not establish whether the medicine exists, is approved or is available in mainland China. Verify product identity, dosage form, strength, holder and the current label item by item.
Mainland China trade-name search cue: 美罗华®
This cue helps read packaging and search official records. It does not establish current approval, holder, strength, originator relationship, supply or sale eligibility. Open historical reference ↗
RECORD FAQ
Record questions
Does a label archive represent current product information?
Not automatically. The archive locates a source; each point needs verification against the target market’s current official label.
Why are price and originator/generic conclusions not shown?
Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient.
READ NEXT
Related reading
Evidence status
The listed links are public sources selected for traceability. They must be rechecked against the current target-market record before any use beyond reading and research.