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Prescription medicine

Nateglinide First approved as Starlix

Nateglinide (Starlix) is a prescription medicine with an FDA approval on record since 2000. FDA's NDC Directory lists it from 9 generic labelers, and pharmacies paid $0.179 per nateglinide 60 mg tablet in the October 7, 2026 NADAC survey.

  • Generic listed

Check it at the source: the nateglinide FDA label on DailyMed (effective February 24, 2025, Strides Pharma Science Limited); the NDA 21204 record on Drugs@FDA; every nateglinide label on DailyMed.

Highlights of the record

FDA label of February 24, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026

Used for

From the label: indications and usage

Nateglinide is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Forms and strengths

  • 60 mg
  • 120 mg

Tablet; coated tablet; film-coated tablet.

On the market

Earliest approval on file
December 22, 2000 Starlix, Novartis; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals
7 first September 9, 2009; 6 with a marketed status in Drugs@FDA
Labelers listed (NDC)
9 of which 9 under generic applications, 0 under brand applications, repackagers included

Supply and safety

Pharmacy cost (NADAC)
$0.179 per tablet Nateglinide 60 mg tablet
Shortage (FDA)
No current entry
Recalls by its makers (FDA)
No recall recorded
FAERS reports
1,333 through July 30, 2026

What is nateglinide used for?

From the label: indications and usage

Nateglinide is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use: Nateglinide should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Nateglinide is a glinide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1) Limitations of Use: Not for treating type 1 diabetes mellitus or diabetes ketoacidosis

Conditions named in the indications of nateglinide's FDA labels, with every medicine labeled for each:

FDA pharmacologic class: Glinide.

Source: FDA drug label (Nateglinide), Strides Pharma Science Limited, effective February 24, 2025 (SPL set 0ccf9b07-3c21-482d-abeb-a06ceb482c7b), via openFDA; the full label on DailyMed

Is there a generic for nateglinide (Starlix)?

The FDA approved the first generic nateglinide on September 9, 2009. 7 generic applications are approved; 6 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 nateglinide from 9 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.

  • 2000 earliest approval on file
  • 2009 first generic approved

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do pharmacies pay for nateglinide (Starlix)?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.179 per Nateglinide 60 mg tablet, down 3% from $0.186 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.

  • Nateglinide 60 mg tablet (generic)
$0.243
$0.165
January 2024October 2026
NADAC per unit, October 7, 2026
Strength and formBrand or genericPharmacy cost30 tablets, or one pen or vial12-month change
Nateglinide 120 mg tabletGeneric$0.222 per tablet$6.67-9%
Nateglinide 60 mg tabletGeneric$0.179 per tablet$5.38-3%

Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price

What does the nateglinide label say about other medicines?

The nateglinide label names 9 other medicines in its interaction, contraindication or warning sections. The labels of 5 other medicines name nateglinide. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Medicine namedSectionWhat the label says
Amiodaronedrug interactions… methandrostenolone), guanethidine, gymnema sylvestre, glucomannan, thioctic acid, and inhibitors of CYP2C9 (e.g., amiodarone, fluconazole, voriconazole, sulfinpyrazone) or in patients known to be poor metabolizers of CYP2C9 substrates, alcohol. …
Clonidinedrug interactionsDrugs That May Blunt Signs and Symptoms of Hypoglycemia Drugs: beta-blockers, clonidine, guanethidine, and reserpine Intervention: Increased frequency of glucose monitoring may be required when nateglinide is coadministered with these drugs.
Fluconazoledrug interactions… methandrostenolone), guanethidine, gymnema sylvestre, glucomannan, thioctic acid, and inhibitors of CYP2C9 (e.g., amiodarone, fluconazole, voriconazole, sulfinpyrazone) or in patients known to be poor metabolizers of CYP2C9 substrates, alcohol. …
Lanreotidedrug interactionsDrugs and Herbals That May Reduce the Blood-Glucose-Lowering Effect of Nateglinide and Increase Susceptibility to Hyperglycemia Drugs: Thiazides, corticosteroids, thyroid products, sympathomimetics, somatropin, somatostatin analogues (e.g., lanreotide, octreotide), and CYP inducers (e.g., rifampin, phenytoin and St …
Octreotidedrug interactionsDrugs and Herbals That May Reduce the Blood-Glucose-Lowering Effect of Nateglinide and Increase Susceptibility to Hyperglycemia Drugs: Thiazides, corticosteroids, thyroid products, sympathomimetics, somatropin, somatostatin analogues (e.g., lanreotide, octreotide), and CYP inducers (e.g., rifampin, phenytoin and St …
Phenytoindrug interactions… sympathomimetics, somatropin, somatostatin analogues (e.g., lanreotide, octreotide), and CYP inducers (e.g., rifampin, phenytoin and St John's Wort). Intervention: Dose increases and increased frequency of glucose monitoring may be required when nateglinide is coadministered with these drugs.
Rifampindrug interactions… sympathomimetics, somatropin, somatostatin analogues (e.g., lanreotide, octreotide), and CYP inducers (e.g., rifampin, phenytoin and St John's Wort). Intervention: Dose increases and increased frequency of glucose monitoring may be required when nateglinide is coadministered with these drugs.
Somatropindrug interactionsDrugs and Herbals That May Reduce the Blood-Glucose-Lowering Effect of Nateglinide and Increase Susceptibility to Hyperglycemia Drugs: Thiazides, corticosteroids, thyroid products, sympathomimetics, somatropin, somatostatin analogues (e.g., lanreotide, octreotide), and CYP inducers (e.g., rifampin, phenytoin and St …
Voriconazoledrug interactions… guanethidine, gymnema sylvestre, glucomannan, thioctic acid, and inhibitors of CYP2C9 (e.g., amiodarone, fluconazole, voriconazole, sulfinpyrazone) or in patients known to be poor metabolizers of CYP2C9 substrates, alcohol. …

Other labels that name nateglinide

Check nateglinide against other medicines

Source: FDA drug label (Nateglinide), Strides Pharma Science Limited, effective February 24, 2025 (SPL set 0ccf9b07-3c21-482d-abeb-a06ceb482c7b), via openFDA; the full label on DailyMed

What do FAERS reports show for nateglinide?

The FDA Adverse Event Reporting System holds 1,333 reports that list nateglinide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 149 are coded as a death and 548 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

  • Blood Glucose Increased76
  • Diarrhoea (named in the label)65
  • Drug Ineffective (a use or a product term, not a reaction)65
  • Dyspnoea64
  • Fatigue58
  • Nausea57
  • Renal Failure51
  • Death (an outcome recorded in the report)49

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as nateglinide?

33 other medicines are given the same way (oral) and in the same FDA class as nateglinide 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.

MedicineShared indicationGeneric labelers (oral)Pharmacy costShortage
RepaglinideType 2 diabetes7 labelers$0.0987 per tablet 1 mg tabletNo current entry
MetforminType 2 diabetes83 labelers$0.0145 per tablet 500 mg tabletNo current entry
GlipizideType 2 diabetes31 labelers$0.0339 per tablet 5 mg tabletNo current entry
GlimepirideType 2 diabetes29 labelers$0.0507 per tablet 4 mg tabletNo current entry
PioglitazoneType 2 diabetes22 labelers$0.0675 per tablet 15 mg tabletNo current entry
GlyburideType 2 diabetes16 labelers$0.0643 per tablet 5 mg tabletA presentation being discontinued
Dapagliflozin and metforminType 2 diabetes8 labelers$0.720 per tablet 10-1,000 mg tabletNo current entry
Metformin and sitagliptinType 2 diabetes4 labelers$1.76 per tablet 50 mg-1,000 mg tabletNo current entry

Every medicine labeled for the same conditions as nateglinide

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

How does nateglinide compare with medicines for the same use?

1 side-by-side page set nateglinide beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.

What next?

Alternatives to nateglinide
33 medicines for the same use
Other glinides
the pharmacologic class, with prices and generics
Nateglinide side effects
the label's list beside FAERS reports
Check an interaction
what two or more labels say about each other