What this pack is
JANUMET XR is the brand name in this record; sitagliptin and metformin hydrochloride extended-release tablets is the generic name. Read both together with the dosage form (oral tablet).
PACK CHECK · MARKET FIRST
JANUMET XRGeneric namesitagliptin and metformin hydrochloride extended-release tablets
How this medicine works
The label identifies sitagliptin as a DPP-4 inhibitor and metformin as a biguanide. The two pathways explain the fixed combination but cannot determine an individual's strength, suitability, interruption or combination with another glucose-lowering medicine.
Read source: United States ↗reviewed 2026-08-30More 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
- JANUMET XR
- Generic name
- sitagliptin and metformin hydrochloride extended-release tablets
- Dosage-form class
- Dosage form and presentation as documented in the linked primary label
- Route
- Oral
- 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.
How to read a score line: ‘scored’ or ‘unscored’ first identifies this labelled presentation. A score line by itself does not permit self-splitting, reducing or changing the product. Only an explicit statement in the current label for this exact presentation, checked with a pharmacist against the prescription, can support any further handling.
3 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 · U.S. DailyMed public label SPL v43 (effective 25 Mar 2025); exact displayed pack, not real-time availability
50 mg sitagliptin + 500 mg metformin HCl per tablet; 60-tablet bottle
- Product code
- NDC 0006-0078-61
- Form and route
- JANUMET XR sitagliptin/metformin hydrochloride film-coated extended-release tablet · oral; extended-release tablet is swallowed whole
- Container
- plastic bottle
- sitagliptin
- 50 mglabelled amount of the first active ingredient per tablet; not an individual tablet count or conversion instruction
- metformin hydrochloride extended-release component
- 500 mglabelled amount of the second active ingredient per tablet; not an individual tablet count or conversion instruction
- Package
- 60 tablets per bottle
- Labelled appearance
- light blue · oval, biconvex, unscored film-coated tablet · imprint 78Unscored in this labelled presentation
United States label · U.S. DailyMed public label SPL v43 (effective 25 Mar 2025); exact displayed pack, not real-time availability
50 mg sitagliptin + 1,000 mg metformin HCl per tablet; 60-tablet bottle
- Product code
- NDC 0006-0080-61
- Form and route
- JANUMET XR sitagliptin/metformin hydrochloride film-coated extended-release tablet · oral; extended-release tablet is swallowed whole
- Container
- plastic bottle
- sitagliptin
- 50 mglabelled amount of the first active ingredient per tablet; not an individual tablet count or conversion instruction
- metformin hydrochloride extended-release component
- 1000 mglabelled amount of the second active ingredient per tablet; not an individual tablet count or conversion instruction
- Package
- 60 tablets per bottle
- Labelled appearance
- light green · oval, biconvex, unscored film-coated tablet · imprint 80Unscored in this labelled presentation
United States label · U.S. DailyMed public label SPL v43 (effective 25 Mar 2025); exact displayed pack, not real-time availability
100 mg sitagliptin + 1,000 mg metformin HCl per tablet; 30-tablet bottle
- Product code
- NDC 0006-0081-31
- Form and route
- JANUMET XR sitagliptin/metformin hydrochloride film-coated extended-release tablet · oral; extended-release tablet is swallowed whole
- Container
- plastic bottle
- sitagliptin
- 100 mglabelled amount of the first active ingredient per tablet; not an individual tablet count or conversion instruction
- metformin hydrochloride extended-release component
- 1000 mglabelled amount of the second active ingredient per tablet; not an individual tablet count or conversion instruction
- Package
- 30 tablets per bottle
- Labelled appearance
- blue · oval, biconvex, unscored film-coated tablet · imprint 81Unscored in this labelled presentation
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
JANUMET XR label reading: two ingredients in one tablet; do not break, cut, crush or chew the XR tablet
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.
The U.S. label lists three strengths. Confirm the exact NDC and both ingredient figures; do not add the numbers, estimate and split from appearance, or self-add JANUVIA/sitagliptin, GLUCOPHAGE or metformin products.
- For example, 50 mg/1,000 mg means 50 mg sitagliptin and 1,000 mg metformin HCl per tablet. It is not a comparable 1,050 mg strength or two times of day.
- The label requires swallowing whole and says not to break, cut, crush or chew. The site explains that text only; it does not select an individual's time, frequency, tablet count or alternative dosage form.
- The boxed warning covers metformin-associated lactic acidosis, and the label also requires review of kidney function, dehydration, alcohol, surgery and iodinated contrast. People aged 65 or older and those with several conditions or medicines should especially bring the full medicine list and planned investigations for review.
- Severe weakness, breathing difficulty, persistent vomiting, marked altered awareness, severe abdominal pain or another acute serious concern requires local emergency help with every medicine pack. Do not wait for a webpage to decide interruption or make-up use.
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 · 2026-08-30
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
- European Union / European Economic Area · 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 routeDailyMed (NLM): U.S. JANUMET XR public brand label, three displayed packages and Medication Guide (SPL v43) ↗reviewed 2026-08-30
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.
- EMA · European Union / European Economic Area · Regulatory product record or EU product information · 2026-08-30EMA: EU centrally authorised JANUMET page (immediate-release; separate from U.S. XR) ↗Current regulatory record · reviewed 2026-08-30
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 JANUMET XR (sitagliptin and metformin hydrochloride extended-release tablets). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
JANUMET XR is the brand in this record and sitagliptin and metformin hydrochloride extended-release tablets is the active-ingredient name. Check both with the dosage form (Dosage form and presentation as documented in the linked primary 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): U.S. JANUMET XR public brand label, three displayed packages and Medication Guide (SPL v43) ↗reviewed 2026-08-30
- EMA: EU centrally authorised JANUMET page (immediate-release; separate from U.S. XR) ↗Current regulatory record · reviewed 2026-08-30
HOW IT WORKS · NOT A TREATMENT PLAN
How the ingredients work: sitagliptin slows incretin inactivation, while metformin affects hepatic glucose production and insulin sensitivity
- “Complementary mechanisms” do not permit self-assembling JANUMET XR from JANUVIA and metformin. The extended-release structure, ingredient amounts, label and monitoring boundaries belong to the exact product.
- A shared sitagliptin or metformin name does not make JANUMET, JANUMET XR, single-ingredient products and other combinations self-combinable, alternatable or substitutable by milligrams. Dosage form, release design, kidney function and the complete medicine list require joint review.
- Genetic screening is not the site's default answer for choosing this medicine. Individual suitability requires diagnosis, kidney function, the complete medicine list, prior response and the current target-market label, reviewed by the treating team.
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): U.S. JANUMET XR public brand label, three displayed packages and Medication Guide (SPL v43) ↗reviewed 2026-08-30
- FDA Drugs@FDA: official JANUMET XR NDA 202270 search entry ↗Official lookup entry · reviewed 2026-08-20
- EMA: EU centrally authorised JANUMET page (immediate-release; separate from U.S. XR) ↗Current regulatory record · reviewed 2026-08-30
SOURCE-TRACEABLE ARCHIVE
JANUMET XRsitagliptin and metformin hydrochloride extended-release tablets
This page links to public primary-source material for JANUMET XR. 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
U.S. JANUMET XR NDA 202270 product marketing record began
DailyMed product data link JANUMET XR, NDA 202270 and a 2 Feb 2012 marketing-start record; the label also lists 2012 as the initial U.S. approval year. This establishes U.S. product history only.
DailyMed (NLM): U.S. JANUMET XR public label (NDA 202270 product record) ↗DailyMed SPL v43 label effective
This page uses that label as the primary source for exact packages, whole-tablet handling, both ingredients, kidney function, iodinated contrast and lactic-acidosis reading boundaries.
DailyMed (NLM): U.S. JANUMET XR public brand label SPL v43 (effective 25 Mar 2025) ↗
MARKET SCOPE
Market-record boundary
United States
Dated public brand label and three exact principal-display packages establishedRecords both per-tablet ingredient amounts, NDC, bottle count, colour, shape, imprint and official label panel. It does not establish channel stock, purchasing eligibility, authenticity or an individual tablet count.
European Union
JANUMET immediate-release material retained as a separate-market checkCurrent EMA JANUMET product information lists 50 mg/850 mg and 50 mg/1,000 mg immediate-release tablets. It is not a package, strength or substitution table for U.S. JANUMET XR extended-release tablets.
Mainland China, Japan and other markets
Current regulatory product records not establishedNo local approval, holder, strength, supply, originator/reference relationship or interchangeability is inferred from a U.S. or EU trade name, shared ingredients, NDA/authorisation or pack.
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
Does 50 mg/1,000 mg mean 1,050 mg, or two times of day?
Neither. One tablet contains 50 mg sitagliptin and 1,000 mg metformin HCl. The two numbers belong to two ingredients and cannot be added for comparison with another medicine or used to derive an individual's frequency or tablet count.
Can a large tablet be halved, cut or crushed?
The current U.S. label requires swallowing whole and explicitly says not to break, cut, crush or chew. If swallowing is difficult, take the exact pack to the prescriber or pharmacist to discuss another appropriate product rather than damaging the extended-release design.
The label mentions two tablets for some people; can everyone follow that?
No. The label also states that the regimen is individualised from prior treatment, effectiveness, tolerability and kidney function. The site only explains why bottle count and per-tablet strength cannot become a personal regimen; actual tablet count must follow the individual's prescription and treating-team review.
Can JANUVIA or metformin be added when JANUMET XR is already used?
A webpage cannot decide combination use. JANUMET XR already contains sitagliptin and metformin HCl. Another shared ingredient on the medicine list requires priority review, not self-combination, alternation or stopping a pack.
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.