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Brand-name prescription medicine

Janumet

Generic name: Sitagliptin and metformin hydrochloride

FDA application holder: MSD Sub Merck

Official data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the NDC Directory, Drugs@FDA, the official labels and recall reports; pharmacy costs come from the Centers for Medicare & Medicaid Services (CMS). Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or switch any medicine, including a switch between a brand and a generic.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

Quick answers

What is Janumet?
Janumet is a brand name of Sitagliptin and metformin hydrochloride, a prescription medicine. The FDA NDC Directory lists 4 Janumet products in 2 strengths and forms.
Who makes Janumet?
MSD Sub Merck holds the FDA application for Janumet (NDA022044, approved March 30, 2007). 1 other company (repackagers or distributors) also list Janumet products.
Is there a generic or store brand of Janumet?
Yes. The FDA NDC Directory lists 6 other products with the same active ingredients, strength and form as a Janumet product, 6 of them generic. Ask your pharmacist whether one is right for you.
What do pharmacies pay for Janumet?
CMS lists a National Average Drug Acquisition Cost (NADAC) for 2 Janumet strengths and forms (see the table below). That is what pharmacies pay to buy it, not what you pay: your price depends on your insurance and your pharmacy.
Has Janumet been recalled?
FDA enforcement reports list 1 recall of Janumet products; the newest started March 31, 2022. A recall usually concerns specific lots, not every product.

What Janumet is

Each Janumet product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.

Sitagliptin and metformin hydrochloride · prescription medicine

Strength and formProduct namesSame medicine, other namesLabel
metformin hydrochloride 1000 mg · sitagliptin phosphate 50 mg
tablet, film coated (oral)
Janumet 3 products, 3 companies DailyMed
metformin hydrochloride 500 mg · sitagliptin phosphate 50 mg
tablet, film coated (oral)
Janumet 3 products, 3 companies DailyMed

Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Sitagliptin and metformin hydrochloride →

FDA approval

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
FDA applications of Janumet products (Drugs@FDA)
ApplicationHolderFirst approvedProducts
NDA022044MSD Sub MerckMarch 30, 20074

What pharmacies pay (NADAC)

The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.

This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.

NADAC per unit for Janumet, by strength and form
Strength and formGeneric or brandPharmacies pay
metformin hydrochloride 1000 mg · sitagliptin phosphate 50 mg
tablet, film coated
Brand: Janumet $5.28 per tablet
Generic of the same strength and form: $2.51 per tablet
metformin hydrochloride 500 mg · sitagliptin phosphate 50 mg
tablet, film coated
Brand: Janumet $5.28 per tablet
Generic of the same strength and form: $2.51 per tablet

NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.

Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →

Companies that list Janumet

The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Janumet products.

Recalls

From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

  1. March 31, 2022 · Class II · Terminated · D-0746-2022

    Presence of foreign substance: Presence of stainless steel particulates in tablets.

    Janumet (sitagliptin and metformin HCl) tablets, 50 mg/500 mg, 14-count bottle, packaged as 2 bottles per carton , Sample-Not For Sale, Rx Only, Manufactured for Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., In — MERCK SHARP & DOHME CORP

Sources

  1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026

Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.

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