Quick answers
- What is Sitagliptin used for?
- The FDA-approved label (Januvia, A-S Medication Solutions, July 8, 2026) says: “JANUVIA ® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. JANUVIA is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Sitagliptin have a boxed warning?
- No. None of the 16 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Sitagliptin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Sitagliptin been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Sitagliptin?
- 10 companies list prescription products of Sitagliptin in the FDA NDC Directory, including A-S Medication Solutions, Zydus Pharmaceuticals USA Inc. and Zydus Lifesciences Limited.
What Sitagliptin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
JANUVIA ® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. JANUVIA is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use …
— FDA label: Januvia, A-S Medication Solutions, effective July 8, 2026. Read the full label on DailyMed →
The FDA has 16 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.
The label quoted above has no boxed warning.
0 of 16 FDA labels for this medicine have a boxed warning.
Forms and how it is given
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 |
|---|---|---|
| sitagliptin 100 mg tablet | Brand: Zituvio | $10.08 per tablet |
| sitagliptin 25 mg tablet | Brand: Zituvio | $10.07 per tablet |
| sitagliptin 50 mg tablet | Brand: Zituvio | $10.06 per tablet |
| sitagliptin phosphate 100 mg tablet, film coated | Generic | $3.85 per tablet |
| sitagliptin phosphate 100 mg tablet, film coated | Brand: Januvia | $10.55 per tablet |
| sitagliptin phosphate 25 mg tablet, film coated | Generic | $3.61 per tablet |
| sitagliptin phosphate 25 mg tablet, film coated | Brand: Januvia | $10.54 per tablet |
| sitagliptin phosphate 50 mg tablet, film coated | Generic | $3.72 per tablet |
| sitagliptin phosphate 50 mg tablet, film coated | Brand: Januvia | $10.55 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 this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- A-S Medication Solutions6 products
- Zydus Pharmaceuticals USA Inc.6 products
- Zydus Lifesciences Limited6 products
- Apotex Corp.3 products
- Teva Pharmaceuticals, Inc.3 products
- Merck Sharp & Dohme LLC3 products
- Golden State Medical Supply, Inc.3 products
- Sandoz Inc3 products
- Cardinal Health 107, LLC2 products
- Azurity Pharmaceuticals, Inc.1 product
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 |
|---|---|---|---|
| NDA021995 JANUVIA | Msd | October 16, 2006 | 35, latest December 28, 2023 2023: Manufacturing (CMC) · 2022: Labeling · 2020: Efficacy |
| NDA211566 ZITUVIO | Zydus Lifesciences | October 18, 2023 | — |
| NDA219122 BRYNOVIN | Azurity | January 16, 2025 | — |
Generic approvals (3)
- ANDA202327Watson Labs Inc · December 29, 2025
- ANDA202387Sandoz · January 14, 2026
- ANDA202425Apotex · January 20, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Januvia, A-S Medication Solutions, effective July 8, 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 →