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Prescription medicine · generic available

Glimepiride

Drug class: Sulfonylurea

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

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
8Recalls (FDA reports)
27Companies
2005First FDA approval on file

Quick answers

What is Glimepiride used for?
The FDA-approved label (Glimepiride, St. Mary's Medical Park Pharmacy, June 22, 2026) says: “Glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus […]. Limitations of Use Glimepiride tablets should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Glimepiride have a boxed warning?
No. None of the 70 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Glimepiride?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Glimepiride been recalled?
FDA enforcement reports list 8 recalls of products of this medicine; the newest started January 18, 2024 (Class III). A recall usually concerns specific lots, not every product.
Who makes Glimepiride?
27 companies list prescription products of Glimepiride in the FDA NDC Directory, including A-S Medication Solutions, Bryant Ranch Prepack and PD-Rx Pharmaceuticals, Inc..

What Glimepiride is used for

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

Glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus […]. Limitations of Use Glimepiride tablets should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings. …

— FDA label: Glimepiride, St. Mary's Medical Park Pharmacy, effective June 22, 2026. Read the full label on DailyMed →

The FDA has 70 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 70 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsTablet
RouteOral
Prescription products105 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 Glimepiride, by strength and form
Strength and formGeneric or brandPharmacies pay
glimepiride 1 mg
tablet		 Generic $0.0249 per tablet
glimepiride 2 mg
tablet		 Generic $0.0375 per tablet
glimepiride 4 mg
tablet		 Generic $0.0464 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 (7)

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. January 18, 2024 · Class III · Ongoing · D-0312-2024

    Misprint on tablet

    Glimepiride Tablets, USP 1mg, 100-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409 INDIA, NDC: 55111-320-01 — Dr. Reddy's Laboratories, Inc.

  2. January 18, 2024 · Class III · Ongoing · D-0313-2024

    Misprint on tablet

    Glimepiride Tablets, USP 1mg, 500-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409 INDIA, NDC: 55111-320-05 — Dr. Reddy's Laboratories, Inc.

  3. March 16, 2023 · Class II · Ongoing · D-0551-2023

    CGMP Deviations

    Glimepiride Tablets, USP 2mg, packaged in a) 30-count bottles (NDC 51655-383-52), and b)90-count bottles (NDC 51655-383-26), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. — Northwind Pharmaceuticals LLC

  4. March 16, 2023 · Class II · Ongoing · D-0552-2023

    CGMP Deviations

    Glimepiride Tablets, USP 4mg, packaged in a) 30-count bottles (NDC 51655-120-52), and b) 90-count bottles (NDC 51655-120-26), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. — Northwind Pharmaceuticals LLC

  5. February 7, 2023 · Class II · Terminated · D-0393-2023

    CGMP Deviations: recalling drug products following an FDA inspection.

    Glimepiride Tablets USP, 1 mg, Rx Only, Packaged in: a) 100-count bottle NDC 16729-001-01 UPC 3 16729 00101 4; b) 500-count bottle NDC 16729-001-16 UPC 3 16729 00116 8; Manufactured for: Accord Healthcare, Inc., Durham, — Accord Healthcare, Inc.

  6. February 7, 2023 · Class II · Terminated · D-0394-2023

    CGMP Deviations: recalling drug products following an FDA inspection.

    Glimepiride Tablets USP, 2 mg, Rx Only, Packaged in: a) 100 Tablets NDC 16729-002-01 UPC 3 16729 00201 1; b) 500 Tablets NDC 16729-002-16 UPC 3 16729 00216 5; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. — Accord Healthcare, Inc.

  7. February 7, 2023 · Class II · Terminated · D-0395-2023

    CGMP Deviations: recalling drug products following an FDA inspection.

    Glimepiride Tablets USP, 4 mg, Rx Only, Packaged in: a) 100-count bottle NDC 16729-003-01 UPC 3 16729 00301 8; b) 500-count NDC 16729-003-16 UPC 3 16729 00316 2; Manufactured for: Accord Healthcare, Inc., Durham, NC 2770 — Accord Healthcare, Inc.

  8. October 9, 2014 · Class II · Terminated · D-0046-2015

    Failed Stability Specifications: Micro Labs is recalling two lots due to out of specification results during stability testing.

    GLIMEPIRIDE TABLETS, USP 2 mg, a)100 count bottle, (NDC 42571-101-01), b) 500 count Bottle (NDC 42571-101-05), Rx only, Manufactured by: Micro Labs Limited, Goa-403 722, INDIA, Manufactured for: Micro Labs USA, Inc., Pri — Micro Labs Usa, Inc S

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)153842, 199245, 199246, 199247, 1361493, 1361495
SPL set ID of the quoted labelfc9d8495-184c-3af1-e053-6394a90a5e29
FDA labels (SPL)70
FDA applications7 ANDA
Active ingredients (FDA)GLIMEPIRIDE

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Glimepiride, St. Mary's Medical Park Pharmacy, effective June 22, 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 →

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