Quick answers
- What is Sitagliptin and metformin hydrochloride used for?
- The FDA-approved label (Janumet, Merck Sharp & Dohme LLC, August 11, 2026) says: “JANUMET ® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use JANUMET should not be used in patients with type 1 diabetes mellitus. JANUMET has not been studied in patients with a history of pancreatitis. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Sitagliptin and metformin hydrochloride have a boxed warning?
- Yes. The FDA label for Janumet has a boxed warning (“WARNING: LACTIC ACIDOSIS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Sitagliptin and metformin hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Sitagliptin and metformin hydrochloride been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started March 31, 2022 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Sitagliptin and metformin hydrochloride?
- 8 companies list prescription products of Sitagliptin and metformin hydrochloride in the FDA NDC Directory, including Zydus Pharmaceuticals USA Inc., Zydus Lifesciences Limited and Merck Sharp & Dohme LLC.
What Sitagliptin and metformin hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
JANUMET ® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use JANUMET should not be used in patients with type 1 diabetes mellitus. JANUMET has not been studied in patients with a history of pancreatitis. …
— FDA label: Janumet, Merck Sharp & Dohme LLC, effective August 11, 2026. Read the full label on DailyMed →
The FDA has 15 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: LACTIC ACIDOSIS
. Read it on the full label →
13 of 15 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated, extended release · Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 37 in the FDA NDC Directory |
| Brand names | Zituvimet XR, Zituvimet, Janumet, Janumet XR |
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.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| metformin hydrochloride 1000 mg · sitagliptin 100 mg tablet, film coated, extended release | Brand: Zituvimet XR | $10.08 per tablet |
| metformin hydrochloride 1000 mg · sitagliptin 50 mg tablet, film coated | Brand: Zituvimet | $5.03 per tablet |
| metformin hydrochloride 1000 mg · sitagliptin 50 mg tablet, film coated, extended release | Brand: Zituvimet XR | $5.02 per tablet |
| metformin hydrochloride 1000 mg · sitagliptin phosphate 100 mg tablet, film coated, extended release | Generic | $8.34 per tablet |
| metformin hydrochloride 1000 mg · sitagliptin phosphate 100 mg tablet, film coated, extended release | Brand: Janumet XR | $10.55 per tablet |
| metformin hydrochloride 1000 mg · sitagliptin phosphate 50 mg tablet, film coated | Generic | $2.51 per tablet |
| metformin hydrochloride 1000 mg · sitagliptin phosphate 50 mg tablet, film coated | Brand: Janumet | $5.28 per tablet |
| metformin hydrochloride 1000 mg · sitagliptin phosphate 50 mg tablet, film coated, extended release | Generic | $4.18 per tablet |
| metformin hydrochloride 1000 mg · sitagliptin phosphate 50 mg tablet, film coated, extended release | Brand: Janumet XR | $5.28 per tablet |
| metformin hydrochloride 500 mg · sitagliptin 50 mg tablet, film coated | Brand: Zituvimet | $5.06 per tablet |
| metformin hydrochloride 500 mg · sitagliptin 50 mg tablet, film coated, extended release | Brand: Zituvimet XR | $5.01 per tablet |
| metformin hydrochloride 500 mg · sitagliptin phosphate 50 mg tablet, film coated | Generic | $2.51 per tablet |
| metformin hydrochloride 500 mg · sitagliptin phosphate 50 mg tablet, film coated | Brand: Janumet | $5.28 per tablet |
| metformin hydrochloride 500 mg · sitagliptin phosphate 50 mg tablet, film coated, extended release | Generic | $3.74 per tablet |
| metformin hydrochloride 500 mg · sitagliptin phosphate 50 mg tablet, film coated, extended release | Brand: Janumet XR | $5.28 per tablet |
NADAC list of November 4, 2026; these prices took effect between May 20, 2026 and 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 this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Zydus Pharmaceuticals USA Inc.10 products
- Zydus Lifesciences Limited10 products
- Merck Sharp & Dohme LLC5 products
- Par Health USA, LLC3 products
- A-S Medication Solutions3 products
- Sandoz Inc2 products
- Golden State Medical Supply, Inc.2 products
- Apotex Corp.2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA022044 JANUMET | Msd Sub Merck | March 30, 2007 | 36, latest August 11, 2026 2026: Labeling · 2022: Labeling · 2021: Labeling |
| NDA202270 JANUMET XR | Msd Sub Merck | February 2, 2012 | 19, latest August 11, 2026 2026: Labeling · 2022: Labeling · 2021: Labeling |
| NDA216743 ZITUVIMET | Zydus Lifesciences | November 3, 2023 | 2, latest August 11, 2026 2026: Labeling · 2025: Manufacturing (CMC) |
| NDA216778 ZITUVIMET XR | Zydus Lifesciences | July 18, 2024 | 2, latest August 11, 2026 2026: Labeling · 2026: Manufacturing (CMC) |
Generic approvals (3)
- ANDA204144Ph Health · June 4, 2025
- ANDA202388Sandoz · December 2, 2025
- ANDA202426Apotex · April 30, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
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
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 861769, 861771, 861819, 861821, 1243827, 1243833, 1243842, 1243843, 1243846, 1243848 … (+10) |
|---|---|
| SPL set ID of the quoted label | d19c7ed0-ad5c-426e-b2df-722508f97d67 |
| FDA labels (SPL) | 15 |
| FDA applications | NDA022044, NDA202270, NDA216743, NDA216778, 3 ANDA |
| Active ingredients (FDA) | METFORMIN / SITAGLIPTIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Janumet, Merck Sharp & Dohme LLC, effective August 11, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →