FDA-filed SPL labeling · retrieved through openFDA

Metformin / Sitagliptin

Metformin and sitagliptin is a two-ingredient oral combination used alongside diet and exercise to improve blood sugar control in adults with type 2 diabetes.

Brand names JanumetJanumet XrZituvimetZituvimet Xr
Drug class ⓘ Dipeptidyl Peptidase 4 Inhibitor
Rx Forms 2 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 17 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveAug 31, 2024
Clinical labels in scope ⓘ17
AvailabilityRx
Earliest approval/marketing year ⓘ2007
FDA-listed product records ⓘ83
Boxed warningYes
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 22, 2026
⭐ Metformin / Sitagliptin at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Metformin/sitagliptin is an oral combination pill used with diet and exercise to manage blood sugar in adults with type 2 diabetes. It works through two different mechanisms to lower blood sugar more effectively together than either ingredient alone. The most important safety concern is lactic acidosis from the metformin component — know the warning signs, avoid excessive alcohol, and keep your kidney function monitored regularly.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Lactic acidosis is a rare but serious and potentially fatal side effect of the metformin in this medication. It happens when lactic acid builds up in your blood faster than your body can clear it. The early symptoms can be vague — muscle aches, tiredness, stomach pain, trouble breathing, or feeling unusually sleepy. If this happens, stop the medication and go to the hospital immediately. Prompt treatment (including hemodialysis to remove metformin from the blood) can be life-saving.

You are at higher risk if you have kidney problems, liver disease, heart failure, are 65 or older, drink heavily, are having surgery, or are getting a procedure with iodinated contrast dye. Steps to reduce this risk are built into how the medication is prescribed and monitored.

Read the full warning on DailyMed →

📖 Metformin / Sitagliptin: Patient Information Guide

A plain-language walkthrough of Metformin / Sitagliptin — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Metformin/sitagliptin is a combination of two blood sugar-lowering medicines used in adults with type 2 diabetes.

  • Used as an adjunct to diet and exercise to improve blood sugar (glycemic) control in adults with type 2 diabetes — supported by all tablet and extended-release tablet products (Janumet, Janumet XR, Zituvimet, Zituvimet XR, and generic sitagliptin and metformin hydrochloride products)
  • Not recommended for people with type 1 diabetes
  • Not studied in people with a history of pancreatitis — whether this increases risk is unknown
⚙️How it works▾

This medication works through two complementary pathways. Sitagliptin is a DPP-4 inhibitor — it blocks the enzyme that breaks down natural gut hormones called incretins (GLP-1 and GIP). Keeping these hormones active longer causes the pancreas to release more insulin after meals and reduces the liver's output of sugar, both in a glucose-dependent way (meaning it mainly acts when blood sugar is elevated). Metformin reduces the amount of sugar the liver makes, slows sugar absorption from the gut, and helps the body's cells respond better to insulin — without directly stimulating insulin secretion on its own.

Together, the two ingredients have an additive effect on raising active incretin hormone levels, giving a broader attack on high blood sugar than either drug alone.

💊How it's taken▾

How you take this medication depends on which product you are prescribed.

  • Tablet forms (Janumet, Zituvimet, generic sitagliptin and metformin hydrochloride tablets): taken twice daily with meals to help reduce stomach side effects; do not split or crush the tablets
  • Extended-release tablet forms (Janumet XR, Zituvimet XR, generic extended-release tablets): taken once daily with a meal; if you take two tablets, take them together at the same time
  • Your prescriber will individualize your dose based on your current regimen, how well your blood sugar is controlled, and how well you tolerate the medication
  • If you miss a dose, take it as soon as you remember with food — but do not double up to make up for a missed dose
🤒Side effects — in detail▾

The most common side effects reported are stomach-related and tend to be more common when starting the medication:

  • Diarrhea
  • Nausea
  • Vomiting
  • Stomach pain or discomfort
  • Headache
  • Upper respiratory tract infection (cold symptoms)
  • Nasopharyngitis (runny nose, sore throat)
  • Low blood sugar — more likely if you also take insulin or a sulfonylurea

More serious reactions — including lactic acidosis, pancreatitis, severe allergic reactions, and acute kidney injury — are rare but require immediate medical attention. See the warnings section for details on what to watch for.

⚠️Warnings & precautions▾
  • Lactic acidosis (metformin component): A rare but potentially fatal buildup of lactic acid in the blood. Higher risk in people with kidney problems, liver disease, heart failure, age 65+, excessive alcohol use, or those undergoing surgery or contrast imaging. Symptoms can be subtle — muscle pain, weakness, stomach pain, trouble breathing, feeling cold or dizzy. Stop the medication and go to a hospital immediately if these occur.
  • Pancreatitis (sitagliptin component): Postmarketing reports of acute pancreatitis, including fatal cases. Stop the medication and contact your doctor immediately if you develop severe, persistent stomach pain.
  • Heart failure: An association with heart failure has been seen with other DPP-4 inhibitors. Report shortness of breath, leg swelling, or unusual fatigue to your doctor promptly.
  • Acute kidney injury: Worsening kidney function has been reported. Kidney function is checked before starting and at least once a year during treatment.
  • Vitamin B12 deficiency: Metformin can gradually lower vitamin B12 levels over time. Blood counts and B12 levels are monitored periodically.
  • Serious allergic reactions (sitagliptin component): Rare but serious reactions including anaphylaxis (severe allergic shock), angioedema (deep-tissue swelling), and Stevens-Johnson syndrome (severe skin reaction) have been reported, sometimes after the first dose.
  • Severe joint pain: Disabling arthralgia (joint pain) has been reported with DPP-4 inhibitors; it may resolve when the medication is stopped.
  • Bullous pemphigoid: A blistering skin condition requiring hospitalization has been reported; tell your doctor about any new blisters or skin sores.
🔀What it interacts with▾

Several drugs and substances can interact with metformin/sitagliptin in meaningful ways:

  • Carbonic anhydrase inhibitors (topiramate, zonisamide, acetazolamide, dichlorphenamide) — increase the risk of lactic acidosis; more frequent monitoring is needed
  • Drugs that reduce metformin clearance (ranolazine, vandetanib, dolutegravir, cimetidine) — can cause metformin to build up to higher levels, raising the risk of lactic acidosis
  • Insulin and sulfonylureas (e.g., glimepiride, glyburide) — increase the risk of low blood sugar; doses of insulin or the sulfonylurea may need to be lowered
  • Alcohol — potentiates metformin's effect on lactic acid metabolism; avoid excessive intake
  • Drugs that raise blood sugar (thiazide diuretics, corticosteroids, thyroid medications, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blockers, isoniazid) — may reduce how well this medication controls blood sugar; your doctor will monitor you more closely if these are added or removed
  • Iodinated contrast dye (used in certain imaging scans) — can impair kidney function and increase the risk of lactic acidosis; your prescriber may pause this medication around the time of any contrast procedure

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it▾
  • Severe kidney disease (eGFR below 30): This medication is contraindicated — do not use it
  • Moderate kidney impairment (eGFR 30–45): Starting this medication is not recommended; if your kidney function falls into this range while on the medication, your doctor will weigh the risks and benefits carefully
  • Liver disease: Avoid this medication — liver impairment can reduce the body's ability to clear lactic acid, increasing the risk of lactic acidosis
  • Metabolic acidosis or diabetic ketoacidosis: This medication is contraindicated
  • History of serious allergic reaction to sitagliptin, metformin, or any ingredient in these products: contraindicated
  • History of pancreatitis: This medication has not been studied in those patients; discuss the risks with your doctor
  • Pregnancy: Poorly controlled diabetes in pregnancy carries serious risks; the safety of this combination during pregnancy is not fully established — talk to your doctor
  • Breastfeeding: Metformin passes into breast milk in small amounts; sitagliptin may also be present in breast milk — discuss the risks and benefits with your doctor
  • Premenopausal women: Metformin can trigger ovulation in women who do not regularly ovulate — discuss birth control with your doctor if pregnancy is not planned
  • Children and adolescents: Safety and effectiveness have not been established in patients under 18
  • Adults age 65 and older: More frequent kidney function monitoring is needed due to a higher risk of lactic acidosis; start at the lower end of dosing
  • Heart failure or cardiovascular disease: Discuss your history with your prescriber before starting — DPP-4 inhibitors have been associated with heart failure in some trials
🚑If you take too much▾

In case of overdose, call Poison Control (1-800-222-1222) or seek emergency care immediately. With metformin overdose, lactic acidosis is a significant concern and has been reported in a substantial portion of overdose cases; hemodialysis can help remove metformin from the body. Sitagliptin is only partially removed by hemodialysis, but prolonged dialysis may be considered if clinically appropriate.

📡Pharmacodynamics — effects in the body▾

In people with type 2 diabetes, sitagliptin blocks the DPP-4 enzyme for a full 24-hour period, causing a two- to threefold rise in active incretin hormones (GLP-1 and GIP) after meals. This leads to more insulin being released, less glucagon (a hormone that raises blood sugar) being secreted, and lower blood sugar levels both fasting and after eating. Metformin lowers both fasting and post-meal blood sugar primarily by reducing the liver's glucose output and improving how well body tissues respond to insulin, without directly increasing insulin release on its own. Together, the two ingredients have an additive effect on raising active GLP-1 levels.

🔬Pharmacokinetics — how your body processes it▾

Sitagliptin is rapidly absorbed after an oral dose, reaching peak blood levels within 1–4 hours and staying active for about 12 hours (half-life). It is about 87% bioavailable and is primarily eliminated by the kidneys, so reduced kidney function leads to higher sitagliptin exposure. Metformin's absorption is somewhat lower (around 50–60% from tablets under fasting conditions) and is slowed by food, though taking it with food is still recommended to reduce stomach side effects. Metformin is not metabolized by the liver and is cleared almost entirely by the kidneys — making kidney function a critical factor in how much of the drug accumulates in the body. For the extended-release forms, steady-state levels of both ingredients are typically reached within 4–5 days of once-daily dosing with an evening meal.

📦How to store it▾

Store at 20-25°C (68-77°F), excursions permitted to 15-30°C (59-86°F). Store in a dry place with cap tightly closed. dispense into a USP tightly closed, moisture-resistant container.

📄 Written from Metformin / Sitagliptin’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Metformin / Sitagliptin — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is this medication doing to help my blood sugar? ▾
It's a two-in-one pill that tackles high blood sugar in two different ways. The sitagliptin part helps your body hold onto natural gut hormones that tell your pancreas to release more insulin after meals — and it tells your liver to calm down on pumping out sugar. The metformin part mainly works on the liver too, reducing how much sugar it produces, and it helps your body's cells use insulin more effectively. Together, they're more effective than either one alone.
What stomach side effects should I expect when I start this medication? ▾
Diarrhea, nausea, and stomach discomfort are the most common complaints, especially in the first few weeks. Taking it with meals — not on an empty stomach — is the single most important thing you can do to reduce this. These effects usually settle down as your body adjusts. If they're still bothering you after a few weeks, talk to your doctor — they may be able to adjust your dose gradually.
I've heard metformin can cause something called lactic acidosis. Should I be worried? ▾
It's rare, but it is a real risk worth knowing about. Lactic acidosis happens when lactic acid builds up in your blood — and if left untreated, it can be very serious. The warning signs can be subtle: unusual muscle aches, feeling very tired, stomach pain, trouble breathing, or feeling cold or dizzy. If you ever get those symptoms, stop the medication and go to the ER. You're at higher risk if you have kidney problems, drink heavily, or are having surgery or a scan with contrast dye — so always tell your care team you're on this medication.
Do I need to worry about low blood sugar on this medication? ▾
On its own, this combination rarely causes low blood sugar. But if you also take insulin or a sulfonylurea (like glimepiride or glyburide), the risk goes up significantly. Know the signs of low blood sugar — shakiness, sweating, fast heartbeat, confusion — and keep a fast-acting sugar source handy. Your doctor may need to lower your insulin or sulfonylurea dose when you start this medication.
Is there anything I need to do before having an X-ray or CT scan with contrast dye? ▾
Yes — this is important. The contrast dye used in certain imaging scans can temporarily affect your kidneys, which can cause metformin to build up to unsafe levels. Your doctor may ask you to stop this medication before the procedure and for 48 hours afterward. Always tell the radiology team that you take metformin, so they can take the right precautions.
Can I drink alcohol while taking this medication? ▾
You should avoid excessive alcohol while on this medication. Alcohol makes it harder for your body to clear lactic acid, which raises the risk of lactic acidosis from the metformin. An occasional drink may be fine for some people, but drinking heavily is not safe with this medication. Talk to your doctor if you have questions about what's appropriate for you.
Is Metformin / Sitagliptin available over the counter? ▾
Metformin / Sitagliptin is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Metformin / Sitagliptin first available? ▾
Metformin / Sitagliptin has been available in the United States since at least 2007, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Metformin / Sitagliptin? ▾
Metformin / Sitagliptin is supplied by 15 manufacturers listed in the FDA NDC Directory, including Merck Sharp & Dohme LLC, Zydus Lifesciences Limited, A-S Medication Solutions.

💬 Answers drafted from Metformin / Sitagliptin’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

🌿Drug & Supplement CheckerMetformin / Sitagliptin vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Metformin / Sitagliptin NDCs & costs 🅰️Browse Drugs A–ZLook up any medication

💊 How Metformin / Sitagliptin comes

Metformin / Sitagliptin is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
Brands Janumet Zituvimet
How this form is used
What it may be used for
  • Janumet tablets are used alongside diet and exercise to improve blood sugar control in adults with type 2 diabetes
  • Zituvimet tablets are used alongside diet and exercise to improve blood sugar control in adults with type 2 diabetes
  • Sitagliptin and metformin hydrochloride tablets are used alongside diet and exercise to improve blood sugar control in adults with type 2 diabetes
Important instructions
  • Janumet tablets are taken twice daily with meals to reduce stomach side effects
  • Zituvimet tablets are taken twice daily with meals; do not split or divide the tablets
  • Sitagliptin and metformin hydrochloride tablets are taken twice daily with meals
  • Kidney function should be assessed before starting and at least annually during treatment with all tablet-form products
Available strengths 6 strengths
50 mg / 500 mg 50 mg / 1000 mg 50 mg / 850 mg 500 mg / 50 mg 850 mg / 50 mg 1000 mg / 50 mg
47 FDA-listed product records ⓘ

Extended-release tablet

By mouth
Brands Janumet Janumet Xr Zituvimet Xr
How this form is used
What it may be used for
  • Janumet XR extended-release tablets are used alongside diet and exercise to improve blood sugar control in adults with type 2 diabetes
  • Zituvimet XR extended-release tablets are used alongside diet and exercise to improve blood sugar control in adults with type 2 diabetes
  • Sitagliptin and metformin hydrochloride extended-release tablets are used alongside diet and exercise to improve blood sugar control in adults with type 2 diabetes
Important instructions
  • Janumet XR is taken once daily with a meal; patients taking two tablets should take them together at the same time
  • Zituvimet XR is taken once daily with a meal; patients taking two tablets should take them together
  • Sitagliptin and metformin hydrochloride extended-release tablets are taken once daily with a meal
  • When switching between the immediate-release and extended-release forms, maintain the same total daily dose of both ingredients as directed by your prescriber
Available strengths 6 strengths
50 mg / 500 mg 50 mg / 1000 mg 100 mg / 1000 mg 500 mg / 50 mg 1000 mg / 100 mg 1000 mg / 50 mg
36 FDA-listed product records ⓘ

📊 Metformin / Sitagliptin across the U.S. market

How Metformin / Sitagliptin appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

2
Dose forms ⓘ
15
Manufacturers
5
Brand names
83
FDA-listed product records ⓘ
2007
First marketed ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Merck Sharp & Dohme LLC24%
Zydus Lifesciences Limited17%
A-S Medication Solutions12%
Zydus Pharmaceuticals (USA) Inc.10%
Zydus Pharmaceuticals USA Inc.7%
Patheon Puerto Rico, Inc.5%
Other makers25%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Metformin / Sitagliptin is used

A general measure of how commonly Metformin / Sitagliptin is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Metformin / Sitagliptin is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

203,107
Medicaid prescriptions filled (Q1–Q4 2025)
$94.7M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Metformin / Sitagliptin prescribed? Of the 1,596 medications we measure, Metformin / Sitagliptin ranks #391 by Medicaid prescriptions — more than 76% of them.

Where Metformin / Sitagliptin ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #391 of 1,596
#386 Amantadine 210,143 Rx #387 Valsartan and Hydrochl... 208,319 Rx #388 Fremanezumab-vfrm Inje... 205,598 Rx #389 Solifenacin 205,369 Rx #390 Water 204,877 Rx #391 Metformin / Sitaglipti... 203,107 Rx #392 Silver Sulfadiazine 202,248 Rx #393 Levalbuterol Oral Inha... 197,722 Rx #394 Hydromorphone Injectio... 195,712 Rx #395 Chlorpromazine 195,153 Rx #396 Amlodipine and Benazep... 194,518 Rx

Utilization by Metformin / Sitagliptin product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 1000 mg / 50 mg oral tablet is the most-dispensed Metformin / Sitagliptin product — about 61% of these Medicaid prescriptions.

metformin hydrochloride 1000 MG / sitagliptin phosphate 50 MG Oral Tablet Most dispensed

124,232 Medicaid prescriptions (Q1–Q4 2025) 61% of Metformin / Sitagliptin prescriptions shown $59.7M gross reimbursement (before rebates) ≈ $481 per prescription (gross)

Summed across the 3 of 14 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2709488

metformin hydrochloride 500 MG / sitagliptin phosphate 50 MG Oral Tablet

31,367 Medicaid prescriptions (Q1–Q4 2025) 15% of Metformin / Sitagliptin prescriptions shown $14M gross reimbursement (before rebates) ≈ $445 per prescription (gross)

Summed across the 3 of 14 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2709491

24 HR metformin hydrochloride 1000 MG / sitagliptin phosphate 50 MG Extended Release Oral Tablet

23,834 Medicaid prescriptions (Q1–Q4 2025) 12% of Metformin / Sitagliptin prescriptions shown $10.1M gross reimbursement (before rebates) ≈ $425 per prescription (gross)

Summed across the 3 of 7 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2709477

24 HR metformin hydrochloride 1000 MG / sitagliptin phosphate 100 MG Extended Release Oral Tablet

18,221 Medicaid prescriptions (Q1–Q4 2025) 9% of Metformin / Sitagliptin prescriptions shown $9M gross reimbursement (before rebates) ≈ $494 per prescription (gross)

Summed across the 2 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2709470

24 HR metformin hydrochloride 500 MG / sitagliptin phosphate 50 MG Extended Release Oral Tablet

4,042 Medicaid prescriptions (Q1–Q4 2025) 2% of Metformin / Sitagliptin prescriptions shown $1.5M gross reimbursement (before rebates) ≈ $361 per prescription (gross)

Summed across the 2 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2709482

metformin hydrochloride 1000 MG / sitagliptin 50 MG Oral Tablet

1,123 Medicaid prescriptions (Q1–Q4 2025) <1% of Metformin / Sitagliptin prescriptions shown $329,818 gross reimbursement (before rebates) ≈ $294 per prescription (gross)

Summed across the 2 of 8 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 861769

metformin hydrochloride 500 MG / sitagliptin 50 MG Oral Tablet

288 Medicaid prescriptions (Q1–Q4 2025) <1% of Metformin / Sitagliptin prescriptions shown $66,821 gross reimbursement (before rebates) ≈ $232 per prescription (gross)

Summed across the 2 of 8 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 861819

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Metformin / Sitagliptin, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 17 of 61 listed Metformin / Sitagliptin NDCs with Medicaid activity.

🔍 Compare Metformin / Sitagliptin products

A representative set of FDA-listed product records for Metformin / Sitagliptin — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 83 of 83 products — FDA National Drug Code Directory. See every product, package size and price: browse all 83 Metformin / Sitagliptin NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one exact multiple-ingredient concept (MIN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). A product with a different ingredient combination belongs on a different page.

Multiple ingredients (MIN) Metformin / Sitagliptin RxCUI 729717 2 dose forms · 10 strengths
  1. Dose form (SCDF) Extended Release Oral Tablet RxCUI 1243826 In current FDA listings
    Clinical drug / strength (SCD) 24 HR metformin hydrochloride 1000 MG / sitagliptin 100 MG RxCUI 1243827 24 HR metformin hydrochloride 1000 MG / sitagliptin 50 MG RxCUI 1243842 24 HR metformin hydrochloride 1000 MG / sitagliptin phosphate 100 MG RxCUI 2709470 24 HR metformin hydrochloride 1000 MG / sitagliptin phosphate 50 MG RxCUI 2709477 24 HR metformin hydrochloride 500 MG / sitagliptin 50 MG RxCUI 1243846 24 HR metformin hydrochloride 500 MG / sitagliptin phosphate 50 MG RxCUI 2709482

Look up RxCUI 729717 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Janumet Janumet Xr Zituvimet Zituvimet Xr

🏭 Manufacturers & labelers

Merck Sharp & Dohme LLC 20 Zydus Lifesciences Limited 14 A-S Medication Solutions 10 Zydus Pharmaceuticals (USA) Inc. 8 Zydus Pharmaceuticals USA Inc. 6 Patheon Puerto Rico, Inc. 4 Patheon Inc. 3 Aesica Queenborough Limited 3 AIAC International Pharma, LLC 3 Par Health USA, LLC 3 Sandoz Inc 2 MSD International GmbH (Singapore Branch) 2 Apotex Corp. 2 Golden State Medical Supply, Inc. 2 Remedyrepack Inc. 1

RxNorm drug class

Metformin / Sitagliptin belongs to the Dipeptidyl Peptidase 4 Inhibitor class.

Pharmacologic class Dipeptidyl Peptidase 4 Inhibitor
Drug family (ATC) Dipeptidyl peptidase 4 (DPP-4) inhibitors
How it works Dipeptidyl Peptidase 4 Inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Aug 31, 2024
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Metformin / Sitagliptin.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Metformin / Sitagliptin after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
17
NDC products indexed
83
Distinct labelers/manufacturers represented
15
Linked representative label ⓘ
Zydus Pharmaceuticals USA Inc.
Linked label effective
Aug 31, 2024
Composite sections available
25
Linked SPL Set ID
d3a728a0-decb-4340-8ee4-c5e27c13eb19
Linked SPL Document ID
8898638c-e4b3-4fdf-91e6-d39156e5ace9
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 17 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Zydus Pharmaceuticals USA Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.