Prescription medicine
Repaglinide First approved as Prandin
Repaglinide (Prandin) is a prescription medicine with an FDA approval on record since 1997. FDA's NDC Directory lists it from 7 generic labelers, and pharmacies paid $0.0987 per repaglinide 1 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the repaglinide FDA label on DailyMed (effective May 2, 2025, Chartwell RX, LLC); the NDA 20741 record on Drugs@FDA; every repaglinide label on DailyMed.
Highlights of the record
FDA label of May 2, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageRepaglinide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Forms and strengths
- 0.5 mg
- 1 mg
- 2 mg
Tablet.
On the market
- Earliest approval on file
- December 22, 1997 Prandin, Gemini Labs Llc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 8 first July 11, 2013; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 7 of which 7 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.0987 per tablet Repaglinide 1 mg tablet
- Shortage (FDA)
- No current entry
- 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
- 7,417 through July 30, 2026
What is repaglinide used for?
From the label: indications and usageRepaglinide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitation of Use: Repaglinide tablets should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Repaglinide is a glinide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus ( 1 ). Limitation of Use: Not for treatment of type 1 diabetes mellitus or diabetic ketoacidosis ( 1 ).
Conditions named in the indications of repaglinide's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Glinide.
Source: FDA drug label (Repaglinide), Chartwell RX, LLC, effective May 2, 2025 (SPL set cb995e92-295e-4638-a064-978211f5afe1), via openFDA; the full label on DailyMed
Is there a generic for repaglinide (Prandin)?
The FDA approved the first generic repaglinide on July 11, 2013. 8 generic applications are approved; 3 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists repaglinide from 7 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.
- 1997 earliest approval on file
- 2013 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 repaglinide (Prandin)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0987 per Repaglinide 1 mg tablet, about the same as a year earlier. 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.
- Repaglinide 1 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Repaglinide 0.5 mg tablet | Generic | $0.0772 per tablet | $2.32 | -13% |
| Repaglinide 1 mg tablet | Generic | $0.0987 per tablet | $2.96 | -0.5% |
| Repaglinide 2 mg tablet | Generic | $0.0925 per tablet | $2.77 | -2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has repaglinide been recalled?
The FDA's Enforcement Report lists 2 recalls naming repaglinide 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 repaglinide 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: REPAGLINIDE, Tablet, 1 mg may have potentially been mislabeled as one of the following drugs: VALSARTAN, Tablet, 40 mg, NDC 00078042315 … |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: REPAGLINIDE, Tablet, 2 mg may have potentially been mislabeled as one of the following drugs: COLCHICINE, Tablet, 0.6 mg, NDC … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the repaglinide label say about other medicines?
The repaglinide label names 27 other medicines in its interaction, contraindication or warning sections. The labels of 23 other medicines name repaglinide. 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 |
|---|---|---|
| Albuterol | drug interactions | … progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones. |
| Clarithromycin | drug interactions | … are known to inhibit CYP3A4 include antifungal agents (ketoconazole, itraconazole) and antibacterial agents (clarithromycin, erythromycin). Drugs that are known to inhibit CYP2C8 include trimethoprim, gemfibrozil, montelukast, deferasirox, and clopidiogrel. |
| Clonidine | drug interactions | Drugs That May Blunt Signs and Symptoms of Hypoglycemia Intervention: Increased frequency of glucose monitoring may be required when repaglinide tablets is co-administered with these drugs. Examples: beta-blockers, clonidine, guanethidine, and reserpine |
| Clopidogrel | drug interactions | Clopidogrel Clinical Impact: Clopidogrel increased repaglinide tablets exposures by 3.9-5.1 fold Intervention: Avoid concomitant use of repaglinide tablets with clopidogrel. If concomitant use cannot be avoided, initiate repaglinide tablets at 0.5 mg before each meal and do not exceed a total daily dose of 4 mg … |
| Clozapine | drug interactions | Drugs That May Decrease the Blood Glucose Lowering Effect of Repaglinide Tablets Intervention: Repaglinide tablets dose increases and increased frequency of glucose monitoring may be required when co-administered. … |
| Cyclosporine | drug interactions | Cyclosporine Clinical Impact: Cyclosporine increased low dose repaglinide exposures by 2.5 fold Intervention: Daily maximum repaglinide tablets dose should be limited to 6 mg, and increased frequency of glucose monitoring may be required when repaglinide tablets are co-administered with cyclosporine. |
| Danazol | drug interactions | … Examples: Atypical antipsychotics (e.g., olanzapine and clozapine), calcium channel antagonists, corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g. … |
| Deferasirox | drug interactions | … (clarithromycin, erythromycin). Drugs that are known to inhibit CYP2C8 include trimethoprim, gemfibrozil, montelukast, deferasirox, and clopidiogrel. |
| Disopyramide | drug interactions | … when co-administered. Examples: Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, nonsteroidal anti-inflammatory agents (NSAIDs), pentoxifylline, pramlintide, propoxyphene, salicylates, somatostatin analogs (e.g. … |
| Epinephrine | drug interactions | … (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones. |
| Erythromycin | drug interactions | … inhibit CYP3A4 include antifungal agents (ketoconazole, itraconazole) and antibacterial agents (clarithromycin, erythromycin). Drugs that are known to inhibit CYP2C8 include trimethoprim, gemfibrozil, montelukast, deferasirox, and clopidiogrel. |
| Fluoxetine | drug interactions | … Examples: Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, nonsteroidal anti-inflammatory agents (NSAIDs), pentoxifylline, pramlintide, propoxyphene, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide … |
| Gemfibrozil | contraindications | CONTRAINDICATIONS Repaglinide tablets are contraindicated in patients with: Concomitant use of gemfibrozil [see Drug Interactions (7.1) ]. Known hypersensitivity to repaglinide or any inactive ingredients. |
| Glucagon | drug interactions | … (e.g., olanzapine and clozapine), calcium channel antagonists, corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine … |
Every other medicine the repaglinide label names
| Medicine named | Section | What the label says |
|---|---|---|
| Isoniazid | drug interactions | … antagonists, corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors … |
| Itraconazole | drug interactions | … are known to inhibit CYP3A4 include antifungal agents (ketoconazole, itraconazole) and antibacterial agents (clarithromycin, erythromycin). … |
| Ketoconazole | drug interactions | … Drugs that are known to inhibit CYP3A4 include antifungal agents (ketoconazole, itraconazole) and antibacterial agents (clarithromycin, erythromycin). … |
| Montelukast | drug interactions | … that are known to inhibit CYP2C8 include trimethoprim, gemfibrozil, montelukast, deferasirox, and clopidiogrel. |
| Niacin | drug interactions | … corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin … |
| Octreotide | drug interactions | … pramlintide, propoxyphene, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics. |
| Olanzapine | drug interactions | … required when co-administered. Examples: Atypical antipsychotics (e.g., olanzapine and clozapine), calcium channel antagonists, corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid … |
| Pentoxifylline | drug interactions | … oxidase inhibitors, nonsteroidal anti-inflammatory agents (NSAIDs), pentoxifylline, pramlintide, propoxyphene, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics. |
| Pramlintide | drug interactions | … inhibitors, nonsteroidal anti-inflammatory agents (NSAIDs), pentoxifylline, pramlintide, propoxyphene, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics. |
| Rifampin | drug interactions | … Examples: Drugs that induce the CYP3A4 and/or 2C8 enzyme systems include rifampin, barbiturates, and carbamezapine. |
| Somatropin | drug interactions | … progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones. |
| Terbutaline | drug interactions | … somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones. |
| Trimethoprim | drug interactions | … (clarithromycin, erythromycin). Drugs that are known to inhibit CYP2C8 include trimethoprim, gemfibrozil, montelukast, deferasirox, and clopidiogrel. |
Other labels that name repaglinide
Source: FDA drug label (Repaglinide), Chartwell RX, LLC, effective May 2, 2025 (SPL set cb995e92-295e-4638-a064-978211f5afe1), via openFDA; the full label on DailyMed
What do FAERS reports show for repaglinide?
The FDA Adverse Event Reporting System holds 7,417 reports that list repaglinide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 708 are coded as a death and 4,448 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 repaglinide?
33 other medicines are given the same way (oral) and in the same FDA class as repaglinide 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 |
|---|---|---|---|---|
| Nateglinide | Type 2 diabetes | 9 labelers | $0.179 per tablet 60 mg tablet | No current entry |
| Metformin | Type 2 diabetes | 83 labelers | $0.0145 per tablet 500 mg tablet | No current entry |
| 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 |
| Pioglitazone | Type 2 diabetes | 22 labelers | $0.0675 per tablet 15 mg tablet | No current entry |
| Glyburide | Type 2 diabetes | 16 labelers | $0.0643 per tablet 5 mg tablet | A presentation being discontinued |
| 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 |
Every medicine labeled for the same conditions as repaglinide
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does repaglinide compare with medicines for the same use?
4 side-by-side pages set repaglinide beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to repaglinide
- 33 medicines for the same use
- Other glinides
- the pharmacologic class, with prices and generics
- Repaglinide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other