Generic Janumet (Sitagliptin and Metformin): Now in US Pharmacies, Strengths, Doses and Cost

Janumet is Merck's tablet that combines sitagliptin, a DPP-4 inhibitor, with metformin for adults with type 2 diabetes. Until 2026, no generic copy of Janumet approved through the FDA's generic (ANDA) route was on sale in the US. That changed in 2026: FDA-approved generic sitagliptin and metformin tablets from Sandoz and Apotex were listed for sale from 28 May 2026, and an extended-release generic from Par Health followed in July. In the federal NADAC price survey for 21 October 2026, US pharmacies paid about $2.51 for a generic 50 mg/1,000 mg tablet against about $5.28 for a Janumet tablet.

This guide explains who makes generic Janumet, what the strength numbers mean, how Janumet and Janumet XR differ, how much the combination lowered A1C in the trials behind the label, the safety rules (including the boxed warning on lactic acidosis and the kidney limits), and what a month of each option costs. We sell Indian Janumet packs made by MSD Pharmaceuticals, so we have a commercial interest; every figure comes from the FDA label, FDA databases, a published trial and federal price data listed under Sources. Do not change a diabetes medicine without your doctor.

The short answer

Yes, generic Janumet now exists in the US. Three generic makers hold full FDA approval for sitagliptin and metformin tablets: Sandoz and Apotex for the twice-daily tablets, and Par Health (application held by PH Health) for the once-daily extended-release tablets. Another 20 generic applications have only tentative approval and cannot be sold yet. Zydus also sells Zituvimet and Zituvimet XR, which reached the market through their own new drug applications rather than as generics of Janumet. The generics contain the same two medicines at the same strengths: sitagliptin 50 mg with metformin 500 mg or 1,000 mg, taken twice daily with meals, or the extended-release strengths taken once daily. The maximum is 100 mg of sitagliptin and 2,000 mg of metformin a day.

What Janumet is

Janumet combines two medicines that lower blood sugar in different ways. Sitagliptin (sold alone as Januvia) blocks the DPP-4 enzyme, so the body's own incretin hormones last longer and the pancreas releases more insulin when blood sugar is high. Metformin mainly reduces the amount of glucose the liver releases. The US label approves Janumet as an addition to diet and exercise to improve blood sugar control in adults with type 2 diabetes. It is not for type 1 diabetes, and it has not been studied in people with a history of pancreatitis.

Janumet was approved by the FDA on 30 March 2007 (NDA 022044). Janumet XR, the once-daily version, was approved on 2 February 2012 (NDA 202270).

Is there a generic Janumet?

Yes. FDA approval and actual sale are separate steps, so here is each one with its date:

• Sandoz (ANDA 202388): full approval recorded on 2 December 2025 for sitagliptin and metformin tablets; its listing in the FDA's NDC directory gives a marketing start date of 28 May 2026.
• Apotex (ANDA 202426): full approval recorded on 30 April 2026; marketing start date 28 May 2026.
• Par Health (ANDA 204144, held by PH Health): extended-release tablets, full approval recorded on 4 June 2025; marketing start date 24 July 2026.

The generic twice-daily tablets first appeared in the federal NADAC price file on 5 August 2026, and the extended-release generic on 21 October 2026. Drugs@FDA lists 20 further generic applications from companies including Teva, Zydus, Aurobindo, MSN, Macleods, Mankind, Ajanta and Inventia with tentative approval only. A tentative approval means the product meets the FDA's standards but cannot be marketed yet, usually because of patents or exclusivity, so availability may widen over the coming months.

Zituvimet: a different route to the same pair of medicines

Zydus Lifesciences sells Zituvimet (approved 3 November 2023, NDA 216743) and Zituvimet XR (approved 18 July 2024, NDA 216778). These were approved through their own new drug applications, not as generic copies of Janumet, so pharmacists may not treat them as automatically interchangeable with Janumet. DailyMed also lists unbranded sitagliptin and metformin tablets from Zydus. Ask your pharmacist which product your prescription allows.

The strengths and what the numbers mean

The first number is sitagliptin, the second metformin hydrochloride. The US label describes the tablets as follows:

Product	Strength (sitagliptin/metformin)	How often	Brand tablet
Janumet	50 mg/500 mg	Twice daily with meals	Light pink, capsule-shaped, "575"
Janumet	50 mg/1,000 mg	Twice daily with meals	Red, capsule-shaped, "577"
Janumet XR	50 mg/500 mg	Two tablets once daily with a meal	Light blue oval, "78"
Janumet XR	50 mg/1,000 mg	Two tablets once daily with a meal	Light green oval, "80"
Janumet XR	100 mg/1,000 mg	One tablet once daily with a meal	Blue oval, "81"

Generic tablets look different from the brand; each maker's label describes its own tablet. Because sitagliptin is fixed at 50 mg per twice-daily tablet, almost everyone on Janumet takes 100 mg of sitagliptin a day. The choice of strength is really a choice of metformin dose.

Janumet or Janumet XR

Both deliver the same daily amounts. The differences are practical:

• Janumet is taken twice daily with meals. The label says not to split or divide the tablets.
• Janumet XR is taken once daily with a meal; if you take two tablets, take them together. The tablets must be swallowed whole, never split, crushed or chewed.
• With XR, incompletely dissolved tablets may appear in the stool. The label asks patients to tell their doctor if this happens repeatedly, so blood sugar control can be checked.
• When switching between the two, the label says to keep the same total daily dose of sitagliptin and metformin.

How the dose is chosen

The Janumet label sets these starting points:

• Not taking metformin yet: 50 mg/500 mg twice daily, increased gradually to limit the stomach side effects of metformin.
• Already taking metformin: sitagliptin 50 mg twice daily plus the metformin dose already being taken.
• Taking metformin 850 mg twice daily: start with 50 mg/1,000 mg twice daily.
• Maximum: 100 mg sitagliptin and 2,000 mg metformin a day.

For Janumet XR, the label's start for people not on metformin is 100 mg/1,000 mg once daily, and people taking metformin 850 mg or 1,000 mg twice daily start on two 50 mg/1,000 mg XR tablets once daily. Our metformin dosage guide covers metformin titration in more detail.

How much it lowers A1C

The label's main evidence for the combination is a 24-week factorial study of 1,091 adults whose type 2 diabetes was not controlled on diet and exercise (A1C 7.5% to 11%). Patients took placebo, sitagliptin alone, metformin alone at two doses, or sitagliptin 50 mg twice daily with metformin 500 mg or 1,000 mg twice daily. The label notes that these studies used sitagliptin and metformin as separate tablets, not Janumet itself, but that Janumet was shown to be bioequivalent to the two taken together.

Treatment (24 weeks)	Change in A1C	Difference from placebo	Reached A1C below 7%
Placebo	+0.2	n/a	9%
Sitagliptin 100 mg once daily	-0.7	-0.8	20%
Metformin 500 mg twice daily	-0.8	-1.0	23%
Metformin 1,000 mg twice daily	-1.1	-1.3	38%
Sitagliptin 50 mg + metformin 500 mg twice daily	-1.4	-1.6	43%
Sitagliptin 50 mg + metformin 1,000 mg twice daily	-1.9	-2.1	66%

Average baseline A1C was about 8.7% to 8.9%. Fasting glucose fell by 64 mg/dL on the higher combination against a rise of 6 mg/dL on placebo. The label adds that A1C fell more in people who started with a higher A1C, and that body weight changed similarly on the combinations and on metformin alone or placebo.

How many people reached their target

An A1C below 7% is a common treatment target. In the same study, two in three people on sitagliptin with metformin 1,000 mg twice daily reached it, against 38% on metformin 1,000 mg twice daily alone and 9% on placebo. Fewer people on the combinations needed rescue treatment with glyburide: 2% on the higher combination against 32% on placebo.

Adding sitagliptin to metformin you already take

Most people come to Janumet already on metformin. In a separate 24-week trial of 701 patients taking at least 1,500 mg of metformin a day, adding sitagliptin 100 mg once daily lowered A1C by 0.7 points against no change with placebo. 47% reached an A1C below 7% with sitagliptin, against 18% with placebo, and rescue treatment was needed by 5% against 14%. Body weight fell similarly in both groups.

Side effects

In the factorial study, the adverse reactions reported in at least 5% of people on the combination (and more often than on placebo) were:

Adverse reaction	Placebo	Sitagliptin alone	Metformin alone	Sitagliptin + metformin
Diarrhea	4.0%	2.8%	7.7%	7.5%
Upper respiratory tract infection	5.1%	4.5%	5.2%	6.2%
Headache	2.8%	1.1%	3.8%	5.9%

The label says stomach side effects with the combination were similar to those with metformin alone; most come from metformin and are reduced by starting low and taking the tablets with meals. In the factorial study, hypoglycemia was reported in 1.6% of people on sitagliptin with metformin, against 0.8% on metformin alone and 0.6% on placebo. The label warns that it can increase the risk of hypoglycemia when used with insulin or a sulfonylurea such as glimepiride or glyburide, and a lower dose of those may be needed. Our guides to metformin vs glimepiride and glyburide explain that risk.

The boxed warning: lactic acidosis

Janumet carries a boxed warning for metformin-associated lactic acidosis, a rare build-up of lactic acid that has caused deaths. Its early signs are vague: unusual tiredness, muscle pain, trouble breathing, sleepiness and stomach pain. The label lists these risk factors: kidney impairment, certain drugs (such as carbonic anhydrase inhibitors like topiramate), age 65 or older, X-ray studies with contrast dye, surgery and other procedures, low-oxygen states such as acute heart failure, heavy alcohol use, liver impairment and mitochondrial disease. If lactic acidosis is suspected, Janumet must be stopped at once and treatment given in hospital.

Kidney rules

• Kidney function should be checked before starting and regularly afterwards, at least once a year.
• Janumet is contraindicated when eGFR is below 30 mL/min/1.73 m².
• It is not recommended when eGFR is 30 to below 45, because these patients need a lower dose of sitagliptin than the fixed combination provides.
• For X-ray or CT scans with iodinated contrast, the label says to stop Janumet at the time of or before the scan in people with an eGFR of 30 to 60, liver disease, alcoholism or heart failure, or when contrast is given into an artery, and to restart only if kidney function is stable 48 hours later.

Our Januvia vs Tradjenta guide explains why sitagliptin needs kidney dose adjustment while linagliptin does not.

Other warnings in the label

• Pancreatitis: acute pancreatitis, including fatal cases, has been reported. The patient guide says to stop Janumet and call a doctor right away for stomach pain that is severe and will not go away.
• Heart failure: two other DPP-4 inhibitors were linked with heart failure in outcome trials. The label asks doctors to weigh this in people at risk, such as those with prior heart failure or kidney impairment, and patients to report shortness of breath, rapid weight gain or swelling.
• Acute kidney failure: worsening kidney function, sometimes needing dialysis, has been reported.
• Vitamin B12: in 29-week metformin trials, about 7% of patients developed low B12 levels. The label advises yearly blood counts and B12 checks every 2 to 3 years.
• Serious allergic reactions: anaphylaxis, angioedema and Stevens-Johnson syndrome have been reported with sitagliptin, with onset within the first 3 months in reported cases, sometimes after the first dose.
• Severe, disabling joint pain has been reported with DPP-4 inhibitors, starting anywhere from a day to years after the first dose; it eased after stopping, and in some people came back when the drug was restarted.
• Bullous pemphigoid, a blistering skin condition that has needed hospital treatment, has been reported with DPP-4 inhibitors. Tell your doctor about any blisters or skin erosions.

Who should not take Janumet

The label lists three contraindications: severe kidney impairment (eGFR below 30), acute or chronic metabolic acidosis including diabetic ketoacidosis, and a past serious allergic reaction to Janumet, sitagliptin or metformin. It should not be used for type 1 diabetes. The label also says Janumet is not recommended for people with mitochondrial diseases such as MELAS syndrome or MIDD, because metformin may raise their risk of lactic acidosis, or for people with an eGFR of 30 to below 45.

Heart safety: what the TECOS trial found

Sitagliptin has its own long-term heart safety trial. TECOS randomised 14,671 people with type 2 diabetes and established cardiovascular disease to sitagliptin or placebo added to usual care, for a median of 3 years. The main heart outcome occurred in 11.4% on sitagliptin and 11.6% on placebo (hazard ratio 0.98, 95% CI 0.88 to 1.09), meeting the test for not being worse than placebo. Hospitalisation for heart failure did not differ (hazard ratio 1.00, 95% CI 0.83 to 1.20). In other words, TECOS found sitagliptin neutral for the heart: it did not raise heart risk, and it did not lower it either. Our Jardiance vs Farxiga guide covers the SGLT2 option.

What Janumet and generic Janumet cost US pharmacies

NADAC, published by the Centers for Medicare and Medicaid Services, records what US pharmacies pay to buy medicines. It is not the price you pay at the counter, which adds a dispensing fee and margin and depends on insurance, but it shows the cost gap between the options. The table uses the 21 October 2026 file and a daily dose of sitagliptin 100 mg with metformin 2,000 mg.

Option	NADAC per tablet	Tablets per 30 days	30-day cost
Janumet 50/1,000 mg twice daily	$5.27879	60	$316.73
Janumet XR 50/1,000 mg, two once daily	$5.27969	60	$316.78
Zituvimet 50/1,000 mg twice daily	$5.02933	60	$301.76
Generic extended-release 50/1,000 mg, two once daily	$4.17809	60	$250.69
Generic sitagliptin and metformin 50/1,000 mg twice daily	$2.50948	60	$150.57
Generic sitagliptin 100 mg once daily + generic metformin 1,000 mg twice daily	$3.84929 + $0.02332	30 + 60	$116.88

Two things stand out. The twice-daily generic costs pharmacies less than half of the brand, while the once-daily generic is still about four-fifths of the brand price; it had a single listing in the file. And taking generic sitagliptin and generic metformin as two separate tablets is cheaper again, because generic metformin costs pharmacies about 2 cents a tablet. The label notes that Janumet was shown to be bioequivalent to sitagliptin and metformin taken together as separate tablets, but switching from one combination tablet to two separate ones changes how many pills you take and is a decision for your prescriber. Our brand vs generic price analysis explains NADAC in more detail.

Janumet in the UK and other countries

In the UK, the electronic medicines compendium lists Janumet 50 mg/1,000 mg tablets from MSD as a prescription-only medicine, with generic sitagliptin and metformin tablets in 50 mg/850 mg and 50 mg/1,000 mg, and no extended-release version. In Canada, Health Canada's drug database lists Janumet XR and generic extended-release versions from Apotex and Sandoz as marketed prescription medicines. Strengths and names vary by country, so check the dose on any pack against your prescription.

Indian Janumet on SafeRxPills

We sell Janumet packs made for the Indian market by MSD Pharmaceuticals Pvt. Ltd.: Janumet 50 mg/500 mg and Janumet 50 mg/1,000 mg tablets, and Janumet XR CP. These are not the US-approved product. Janumet XR CP in particular is not the same as US Janumet XR: it is a combination pack (combipack) with a separate sitagliptin 100 mg tablet and a separate metformin 1,000 mg sustained-release tablet for each day, rather than one combined extended-release tablet. We also sell Januvia 100 mg (sitagliptin alone). In the US, sitagliptin and metformin are prescription medicines and FDA rules on importing medicines for personal use are strict; generic sitagliptin and metformin is now sold in US pharmacies, which is usually the simpler route for US patients.

Questions to ask your doctor or pharmacist

• Can my prescription be filled with a generic sitagliptin and metformin tablet?
• Would twice-daily tablets or once-daily extended-release suit my routine better?
• What is my latest eGFR, and how often should it be checked?
• Do I need to lower my insulin or sulfonylurea dose?
• When should my vitamin B12 be checked?

Related guides

• Januvia vs Tradjenta: sitagliptin and linagliptin compared
• Metformin dosage guide
• Metformin vs glimepiride
• Jardiance vs Farxiga
• Type 2 diabetes: treatment options

Sources

1. JANUMET (sitagliptin and metformin HCl) tablets, US prescribing information, Merck Sharp & Dohme LLC, revised 8/2026 (DailyMed setid d19c7ed0-ad5c-426e-b2df-722508f97d67): boxed warning and sections 1, 2, 3, 4, 5, 6.1, 14.
2. JANUMET XR (sitagliptin and metformin HCl extended-release) tablets, US prescribing information, Merck Sharp & Dohme LLC, revised 8/2026 (DailyMed setid 64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50): sections 2.1, 3 and 17.
3. US Food and Drug Administration. Drugs@FDA via openFDA: NDA 022044, NDA 202270, NDA 216743, NDA 216778, ANDA 202388, ANDA 202426, ANDA 204144 and tentative approvals, accessed 26 October 2026.
4. US Food and Drug Administration. NDC directory via openFDA: product NDCs 0781-5801 (Sandoz), 60505-3658 (Apotex), 10370-317 (Par Health USA), accessed 26 October 2026.
5. Green JB, Bethel MA, Armstrong PW, Buse JB, et al. Effect of sitagliptin on cardiovascular outcomes in type 2 diabetes. N Engl J Med 2015;373(3):232-42. PMID 26052984.
6. Centers for Medicare and Medicaid Services. National Average Drug Acquisition Cost (NADAC), weekly file as of 21 October 2026.
7. Electronic medicines compendium (UK). Janumet 50 mg/1000 mg film-coated tablets, summary of product characteristics, MSD, revised 14 June 2025.
8. Health Canada. Drug Product Database, sitagliptin and metformin products, accessed 22 October 2026.

This guide is for information and does not replace advice from a doctor or pharmacist who knows your medical history. Do not stop or change diabetes medicines without medical advice.