What this pack is
TREXALL is the brand name in this record; methotrexate is the generic name. Read both together with the dosage form (oral tablet).
PACK CHECK · MARKET FIRST
TREXALLGeneric namemethotrexate
How this medicine works
The current U.S. label says methotrexate inhibits dihydrofolate reductase, thereby interfering with pathways involving purine nucleotides and thymidylate and with DNA synthesis, repair and cellular replication; the same label states that its mechanism in rheumatoid arthritis and psoriasis is unknown. A mechanism cannot determine anyone's tablet count, day, duration, monitoring, co-use or substitution.
Read source: United States ↗Current regulatory record · reviewed 2026-08-27More 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.
- International brand name
- TREXALL
- Generic name
- methotrexate
- Dosage-form class
- TREXALL methotrexate film-coated oral tablets: 5 mg, 7.5 mg, 10 mg and 15 mg per tablet; each is listed as a 30-tablet bottle in the U.S. public label
- Route
- Oral (higher-risk exact-product identity field)
- Package-image status
- A source-linked public label image is available below
No source-verifiable mainland-China trade-name cue has been established for this record. This does not establish whether the medicine exists, is approved or is available in mainland China. Check pack text and current CDE/NMPA records item by item.
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
Package strength is not an individual dose. These fields help identify the exact labelled product; they do not calculate how much, how often, a missed-use action, splitting, switching or conversion.
4 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 · Current U.S. DailyMed public label (effective 17 Jun 2026; published 29 Jun 2026)
Methotrexate 5 mg per tablet; 30-tablet bottle
- Product code
- NDC 51285-366-01
- Form and route
- TREXALL methotrexate film-coated oral tablet · oral (product-identity field)
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-27; actual marketing, stock and availability are not established.
- methotrexate
- 5 mglabelled amount per tablet; not an individual's tablet count, frequency, course or missed-use instruction
- Package
- 30 tablets per bottle
- Labelled appearance
- green · oval, biconvex, scored film-coated tablet · imprint stylized b / 927/5
United States label · Current U.S. DailyMed public label (effective 17 Jun 2026; published 29 Jun 2026)
Methotrexate 7.5 mg per tablet; 30-tablet bottle
- Product code
- NDC 51285-367-01
- Form and route
- TREXALL methotrexate film-coated oral tablet · oral (product-identity field)
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-27; actual marketing, stock and availability are not established.
- methotrexate
- 7.5 mglabelled amount per tablet; not an individual's tablet count, frequency, course or missed-use instruction
- Package
- 30 tablets per bottle
- Labelled appearance
- blue · oval, biconvex, scored film-coated tablet · imprint stylized b / 928/7½
United States label · Current U.S. DailyMed public label (effective 17 Jun 2026; published 29 Jun 2026)
Methotrexate 10 mg per tablet; 30-tablet bottle
- Product code
- NDC 51285-368-01
- Form and route
- TREXALL methotrexate film-coated oral tablet · oral (product-identity field)
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-27; actual marketing, stock and availability are not established.
- methotrexate
- 10 mglabelled amount per tablet; not an individual's tablet count, frequency, course or missed-use instruction
- Package
- 30 tablets per bottle
- Labelled appearance
- pink · oval, biconvex, scored film-coated tablet · imprint stylized b / 929/10
United States label · Current U.S. DailyMed public label (effective 17 Jun 2026; published 29 Jun 2026)
Methotrexate 15 mg per tablet; 30-tablet bottle
- Product code
- NDC 51285-369-01
- Form and route
- TREXALL methotrexate film-coated oral tablet · oral (product-identity field)
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-27; actual marketing, stock and availability are not established.
- methotrexate
- 15 mglabelled amount per tablet; not an individual's tablet count, frequency, course or missed-use instruction
- Package
- 30 tablets per bottle
- Labelled appearance
- purple · oval, biconvex, scored film-coated tablet · imprint stylized b / 945/15
PUBLIC LABEL IMAGE
Appearance and package-text clues
This current public-label package panel helps check the brand, generic name, strength and dosage-form clues only. It does not authenticate a product in hand or establish originator status, availability, sale eligibility, another package or another market.
Open the public label source ↗LABEL READING · NOT A PRESCRIPTION
TREXALL label reading: check the exact strength, then the specific day written on the prescription
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 is a higher-risk safety reading. The current U.S. label identifies TREXALL as an oral methotrexate tablet and highlights medication-error risk: where a once-weekly regimen was prescribed, mistaken daily use has led to fatal adverse reactions. The site does not calculate an individual's frequency; it prompts an item-by-item check of the pack, strength, prescription and named day with a pharmacist or prescriber.
- Check TREXALL, methotrexate, film-coated oral-tablet form, strength per tablet, NDC, 30-tablet bottle and target market together. 5, 7.5, 10 and 15 mg identify different strengths per tablet; they are not numbers the site can add, convert, split or use to derive an individual's tablet count.
- The label warning must be read with the frequency on the actual prescription. If the prescription says once weekly, the specific day should be made explicit and confirmed by a professional; do not read once weekly as once daily. If extra doses were taken, use occurred on consecutive days, or there is uncertainty, do not wait for a web response—contact local emergency, poison-information or treating services immediately.
- Cancer, rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and severe psoriasis are indications in the U.S. label. Seeing a matching condition name does not establish suitability and cannot determine frequency, duration or stopping.
- The methotrexate label also addresses pregnancy, severe hypersensitivity, bone-marrow, gastrointestinal, liver, lung, skin and kidney toxicity and drug interactions. Have a pharmacist or prescriber review the actual prescription, relevant tests and complete medicine list; the site does not turn these points into continuation, pausing, make-up use or substitution instructions.
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 checkU.S. National Library of Medicine DailyMed · United States · Public medicine label · 2026-08-27
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 · 2
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 routeDailyMed (NLM): current U.S. TREXALL methotrexate public label (Teva Women's Health; SPL v14) ↗Current regulatory record · reviewed 2026-08-27
Other official market or version documents for this record
These are separately reviewed product documents for the same dossier. Their market, date, dosage form and document status must stay attached to each link; they do not establish interchangeability between products, strengths, packs, indications or countries.
- FDA · United States · Regulatory product record or label archive · 2026-08-27FDA: Methotrexate Sodium Tablets / TREXALL ANDA 040385 approval record (29 Oct 1999) ↗Historical public record · reviewed 2026-08-27
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 TREXALL (methotrexate). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
TREXALL is the brand in this record and methotrexate is the active-ingredient name. Check both with the dosage form (TREXALL methotrexate film-coated oral tablets: 5 mg, 7.5 mg, 10 mg and 15 mg per tablet; each is listed as a 30-tablet bottle in the U.S. public label) and the market on the actual pack.
Read the labelled strength in context
mg, mcg, mg/mL or a percentage describes the labelled amount in one tablet, capsule, measured volume, spray or other unit. It is not an answer to how many units a person should take.
Check before splitting or opening
Before splitting, crushing, chewing or opening anything, find an explicit instruction for this exact product in its current label and ask a pharmacist. A score line or a previous pack is not enough by itself.
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 suspected overdose, a severe allergic reaction, fainting or difficulty breathing, use the local emergency or poison-information service now. Do not wait for a website reply or alter several medicines to test what caused it.
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): current U.S. TREXALL methotrexate public label (Teva Women's Health; SPL v14) ↗Current regulatory record · reviewed 2026-08-27
- FDA: Methotrexate Sodium Tablets / TREXALL ANDA 040385 approval record (29 Oct 1999) ↗Historical public record · reviewed 2026-08-27
HOW IT WORKS · NOT A TREATMENT PLAN
How methotrexate works: inhibition of dihydrofolate reductase (a mechanism, not an individual schedule)
- “Inhibits dihydrofolate reductase” describes a pathway; it does not allow folate use, symptoms, a condition name or one test result to determine an increase, decrease, missed-use action, stop or restart.
- The label notes that actively proliferating tissues may be more sensitive. This helps explain why close monitoring matters, but it cannot be converted by a website into an individual risk prediction or an explanation for a specific symptom.
- Methotrexate products can differ in dosage form, concentration, device, market label and schedule. A shared ingredient or matching milligram number does not establish automatic interchangeability; have a professional review the exact pack, prescription and complete medicine list.
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.
- DailyMed (NLM): current U.S. TREXALL methotrexate public label (Teva Women's Health; SPL v14) ↗Current regulatory record · reviewed 2026-08-27
- FDA: Methotrexate Sodium Tablets / TREXALL ANDA 040385 approval record (29 Oct 1999) ↗Historical public record · reviewed 2026-08-27
SOURCE-TRACEABLE ARCHIVE
TREXALLmethotrexate
This page includes an exact current U.S. public-label package panel for TREXALL, alongside documentary primary-source material. It helps check product identity, but does not itself establish originator status, product quality, availability or sale eligibility.
DOCUMENT TIMELINE
Document timeline
FDA ANDA 040385 approval record
The public FDA approval record links Methotrexate Sodium Tablets / TREXALL to ANDA 040385 and the approval date 29 Oct 1999. ANDA is an Abbreviated New Drug Application; this page therefore does not describe the record as an NDA originator approval or infer originator status from the brand name.
FDA: Methotrexate Sodium Tablets / TREXALL ANDA 040385 approval record (29 Oct 1999) ↗DailyMed SPL v14 effective: medication-error warning updated
The current public label lists four strengths and four 30-tablet bottle NDCs and emphasises in the boxed warning and section 5.9 that, where once-weekly use was prescribed, mistaken daily administration of methotrexate tablets has resulted in death. This date identifies a document version, not anyone's schedule.
Primary-source record (open linked document) ↗
MARKET SCOPE
Market-record boundary
United States
Current ANDA brand label, four exact strengths and four package panels linkedThis page separately records the NDC and 30-tablet bottle panel for TREXALL 5 mg, 7.5 mg, 10 mg and 15 mg film-coated oral tablets and explicitly identifies ANDA 040385. It supports product identity and safety reading; it does not authenticate a product or establish current supply, stock, purchase, individual tablet count, frequency, stopping, switching or originator status.
Mainland China, the EU, Japan and other markets
Current market record not establishedNo local trade name, approval, packaging, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from the U.S. ANDA, DailyMed name, NDC, label warning, strength per tablet or package image; each market requires separate review against current local regulatory material.
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.
RECORD FAQ
Record questions
Can the 5, 7.5, 10 or 15 mg on a TREXALL pack tell me how many tablets to take or on which day?
No. These numbers identify labelled strength per tablet only. Frequency, named day and tablet count must come from the actual prescription and be confirmed by the prescriber or pharmacist. If extra doses were taken, once-weekly use was mistaken for daily use, use occurred on consecutive days, or there is uncertainty, contact local emergency, poison-information or treating services immediately rather than waiting for a web response.
Is TREXALL an originator medicine?
This page does not label it as a U.S. originator medicine. The current DailyMed label explicitly lists ANDA040385, and the FDA approval record also corresponds to ANDA 040385; this is the traceable application and label identity for the U.S. branded methotrexate tablet. Originator/generic relationships require exact product-, market- and application-level review and cannot be inferred from a brand name alone.
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.