Medical emergency?Emergency? Call 911. Nearest emergency roomsNearest ERs

Español Near me My list Help
US Patient GuideUSA
Surprise me
Prescription medicine · generic available

Saxagliptin

Also listed by the FDA as: saxagliptin hydrochloride · saxagliptin hydrochloride dihydrate

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

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

At a glance

NoBoxed warning
None listedFDA shortage list
2Recalls (FDA reports)
3Companies
2023First FDA approval on file

Quick answers

What is Saxagliptin used for?
The FDA-approved label (Saxagliptin, Glenmark Pharmaceuticals Inc., USA, January 27, 2026) says: “Saxagliptin tablets are 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: • Not recommended for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Saxagliptin have a boxed warning?
No. None of the 3 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Saxagliptin?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Saxagliptin been recalled?
FDA enforcement reports list 2 recalls of products of this medicine; the newest started March 13, 2025 (Class II). A recall usually concerns specific lots, not every product.
Who makes Saxagliptin?
3 companies list prescription products of Saxagliptin in the FDA NDC Directory, including Aurobindo Pharma Limited, Glenmark Pharmaceuticals Inc., USA and Mylan Pharmaceuticals Inc..

What Saxagliptin is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

Saxagliptin tablets are 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: • Not recommended for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. …

— FDA label: Saxagliptin, Glenmark Pharmaceuticals Inc., USA, effective January 27, 2026. Read the full label on DailyMed →

The FDA has 3 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.

Diabetes

Related medical specialties

Endocrinology

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 3 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsTablet, film coated
RouteOral
Prescription products6 in the FDA NDC Directory

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 Saxagliptin, by strength and form
Strength and formGeneric or brandPharmacies pay
saxagliptin hydrochloride 2.5 mg
tablet, film coated		 Generic $1.18 per tablet
saxagliptin hydrochloride 5 mg
tablet, film coated		 Generic $1.07 per tablet
saxagliptin hydrochloride dihydrate 2.5 mg
tablet, film coated		 Generic $1.18 per tablet
saxagliptin hydrochloride dihydrate 5 mg
tablet, film coated		 Generic $1.07 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.

FDA approval history

  • ANDA: Abbreviated New Drug Application: how a generic version is approved.

Generic approvals (3)

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

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.

  1. March 13, 2025 · Class II · Ongoing · D-0345-2025

    CGMP Deviations

    Saxagliptin Tablets, USP, 2.5mg, a). 30-count bottle (NDC# 68462-726-30), b).90-count bottle(NDC# 68462-726-90), Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured fo — Glenmark Pharmaceuticals Inc., USA

  2. March 13, 2025 · Class II · Ongoing · D-0332-2025

    CGMP Deviations

    Saxagliptin Tablets 5mg, a). 30-count bottle (NDC# 68462-727-30) b.) 90-count bottle ( 68462-727-90), Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: — Glenmark Pharmaceuticals Inc., USA

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)858036, 858042
SPL set ID of the quoted labele286ffd4-c598-47fb-af06-2e15f7e6f99f
FDA labels (SPL)3
FDA applications3 ANDA
Active ingredients (FDA)SAXAGLIPTIN

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Saxagliptin, Glenmark Pharmaceuticals Inc., USA, effective January 27, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (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. 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 →

Report an error → · Information for medicine makers