Prescription medicine
Glyburide First approved as Diabeta
Glyburide (Diabeta) is a prescription medicine with an FDA approval on record since 1984. FDA's NDC Directory lists it from 16 generic labelers, and pharmacies paid $0.0643 per glyburide 5 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- A presentation discontinued
Check it at the source: the glyburide FDA label on DailyMed (effective July 1, 2021, TEVA Pharmaceuticals USA Inc); the NDA 17532 record on Drugs@FDA; every glyburide label on DailyMed.
Highlights of the record
FDA label of July 1, 2021; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageGlyburide is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Forms and strengths
- 1.25 mg
- 2.5 mg
- 3 mg
- 5 mg
- 6 mg
Tablet.
On the market
- Earliest approval on file
- May 1, 1984 Diabeta, Sanofi Aventis Us; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 15 first August 29, 1995; 8 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 17 of which 16 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.0643 per tablet Glyburide 5 mg tablet
- Shortage (FDA)
- None current 4 past records
- Recalls by its makers (FDA)
- 0 since 2013 0 Class I among all firms' recalls; 2 more by firms not listed as its makers
- FAERS reports
- 24,067 through July 30, 2026
What is glyburide used for?
From the label: indications and usageGlyburide is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Conditions named in the indications of glyburide's FDA labels, with every medicine labeled for each:
From other glyburide labelsType 2 diabetes: INDICATIONS AND USAGE Glyburide is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
FDA pharmacologic class: Sulfonylurea.
Source: FDA drug label (Glyburide), NDA017532 (Sanofi Aventis Us), as published by TEVA Pharmaceuticals USA Inc, effective July 1, 2021 (SPL set 50d16f1d-c814-4411-8749-62561321ecce), via openFDA; the full label on DailyMed
Is there a generic for glyburide (Diabeta)?
The FDA approved the first generic glyburide on August 29, 1995. 15 generic applications are approved; 8 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists glyburide from 16 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1984 earliest approval on file
- 1995 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for glyburide (Diabeta)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0643 per Glyburide 5 mg tablet, down 2% from $0.0655 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Glyburide 5 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Glyburide 1.25 mg tablet | Generic | $0.0606 per tablet | $1.82 | -29% |
| Glyburide 2.5 mg tablet | Generic | $0.0633 per tablet | $1.90 | -23% |
| Glyburide 5 mg tablet | Generic | $0.0643 per tablet | $1.93 | -2% |
| Glyburide micro 3 mg tablet | Generic | $0.128 per tablet | $3.84 | -6% |
| Glyburide micro 6 mg tablet | Generic | $0.239 per tablet | $7.18 | +10% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is glyburide in shortage?
No glyburide presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 4 records are all marked to be discontinued, the latest updated August 10, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Diabeta, Tablet, 1.25 mg (NDC 0093-9477-53) | Sanofi-Aventis U.S. LLC | To Be Discontinued | August 10, 2026 |
| Diabeta, Tablet, 2.5 mg (NDC 0093-9433-01) | Sanofi-Aventis U.S. LLC | To Be Discontinued | August 10, 2026 |
| Diabeta, Tablet, 5 mg (NDC 0093-9364-01) | Sanofi-Aventis U.S. LLC | To Be Discontinued | August 10, 2026 |
| Diabeta, Tablet, 5 mg (NDC 0093-9364-10) | Sanofi-Aventis U.S. LLC | To Be Discontinued | August 10, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has glyburide been recalled?
The FDA's Enforcement Report lists 2 recalls naming glyburide since 2013: 0 Class I (the most serious), 2 Class II, 0 Class III; 0 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of glyburide and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: glyBURIDE, Tablet, 1.25 mg may have potentially been mislabeled as one of the following drugs: CYPROHEPTADINE HCL, Tablet, 4 mg, NDC … |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: glyBURIDE, Tablet, 2.5 mg may have potentially been mislabeled as one of the following drugs: sulfaSALAzine, Tablet, 500 mg, NDC … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the glyburide label say about other medicines?
The glyburide label names 12 other medicines in its interaction, contraindication or warning sections. The labels of 22 other medicines name glyburide. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Bosentan | contraindications | Treated with bosentan. |
| Chloramphenicol | drug interactions | … disopyramide, fluoxetine, clarithromycin, and other drugs that are highly protein bound, salicylates, sulfonamides, chloramphenicol, probenecid, monoamine oxidase inhibitors, and beta adrenergic blocking agents. |
| Clarithromycin | drug interactions | Drug Interactions The hypoglycemic action of sulfonylureas may be potentiated by certain drugs including nonsteroidal anti-inflammatory agents, ACE inhibitors, disopyramide, fluoxetine, clarithromycin, and other drugs that are highly protein bound, salicylates, sulfonamides, chloramphenicol, probenecid, monoamine … |
| Colesevelam | drug interactions | Colesevelam Concomitant administration of colesevelam and glyburide resulted in reductions in glyburide AUC and C max of 32% and 47%, respectively. |
| Cyclosporine | drug interactions | Glyburide may increase cyclosporine plasma concentration and potentially lead to its increased toxicity. |
| Disopyramide | drug interactions | Drug Interactions The hypoglycemic action of sulfonylureas may be potentiated by certain drugs including nonsteroidal anti-inflammatory agents, ACE inhibitors, disopyramide, fluoxetine, clarithromycin, and other drugs that are highly protein bound, salicylates, sulfonamides, chloramphenicol, probenecid, monoamine … |
| Fluoxetine | drug interactions | Drug Interactions The hypoglycemic action of sulfonylureas may be potentiated by certain drugs including nonsteroidal anti-inflammatory agents, ACE inhibitors, disopyramide, fluoxetine, clarithromycin, and other drugs that are highly protein bound, salicylates, sulfonamides, chloramphenicol, probenecid, monoamine … |
| Isoniazid | drug interactions | These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid. |
| Miconazole | drug interactions | A potential interaction between oral miconazole and oral hypoglycemic agents leading to severe hypoglycemia has been reported. |
| Phenytoin | drug interactions | These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid. |
| Probenecid | drug interactions | … clarithromycin, and other drugs that are highly protein bound, salicylates, sulfonamides, chloramphenicol, probenecid, monoamine oxidase inhibitors, and beta adrenergic blocking agents. |
| Rifampin | drug interactions | Rifampin may worsen glucose control of glyburide because rifampin can significantly induce metabolic isozymes of glyburide such as CYP2C9 and 3A4. |
Other labels that name glyburide
Source: FDA drug label (Glyburide), NDA017532 (Sanofi Aventis Us), as published by TEVA Pharmaceuticals USA Inc, effective July 1, 2021 (SPL set 50d16f1d-c814-4411-8749-62561321ecce), via openFDA; the full label on DailyMed
What do FAERS reports show for glyburide?
The FDA Adverse Event Reporting System holds 24,067 reports that list glyburide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,135 are coded as a death and 8,464 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as glyburide?
32 other medicines are given the same way (oral) and in the same FDA class as glyburide or labeled mainly for the same use (type 2 diabetes), the same class first. Type 2 diabetes lists all 52 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Glipizide | Type 2 diabetes | 31 labelers | $0.0339 per tablet 5 mg tablet | No current entry |
| Glimepiride | Type 2 diabetes | 29 labelers | $0.0507 per tablet 4 mg tablet | No current entry |
| Glipizide and metformin | Type 2 diabetes | 9 labelers | $0.242 per unit 2.5-250 mg | No current entry |
| Glimepiride and pioglitazone | Type 2 diabetes | none listed | $10.52 per unit 30-4 | No current entry |
| Metformin | Type 2 diabetes | 83 labelers | $0.0145 per tablet 500 mg tablet | No current entry |
| Pioglitazone | Type 2 diabetes | 22 labelers | $0.0675 per tablet 15 mg tablet | No current entry |
| Dapagliflozin and metformin | Type 2 diabetes | 8 labelers | $0.720 per tablet 10-1,000 mg tablet | No current entry |
| Metformin and sitagliptin | Type 2 diabetes | 4 labelers | $1.76 per tablet 50 mg-1,000 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does glyburide compare with medicines for the same use?
3 side-by-side pages set glyburide beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to glyburide
- 32 medicines for the same use
- Other sulfonylureas
- the pharmacologic class, with prices and generics
- Glyburide side effects
- the label's list beside FAERS reports
- Glyburide shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other