1 INDICATIONS AND USAGE Nateglinide Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use : Nateglinide Tablets should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Nateglinide Tablets are 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 ( 1 )

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied 60 mg Pink, round shaped, biconvex, film-coated tablets, debossed with “N7” on one side and plain on other side. Bottles of 90 ......................... NDC 16571-758-09 Bottles of 100 ....................... NDC 16571-758-01 Bottles of 500 ....................... NDC 16571-758-50 120 mg Yellow, oval shaped, biconvex, film-coated tablets, debossed with “N5” on one side and plain on other side. Bottles of 90 ......................... NDC 16571-759-09 Bottles of 100 ....................... NDC 16571-759-01 Bottles of 500 ....................... NDC 16571-759-50 Storage and Handling Store at 25ºC (77ºF); excursions permitted to 15ºC-30ºC (59ºF-86ºF). [See USP Controlled Room Temperature.] Dispense in a tight container, USP.

2 DOSAGE AND ADMINISTRATION The recommended dose of Nateglinide Tablets is 120 mg orally three times daily before meals. The recommended dose of Nateglinide Tablets is 60 mg orally three times daily before meals in patients who are near glycemic goal when treatment is initiated. Instruct patients to take Nateglinide Tablets 1 to 30 minutes before meals. In patients who skip meals, instruct patients to skip the scheduled dose of Nateglinide Tablets to reduce the risk of hypoglycemia [see Warnings and Precautions (5.1) ] . Recommended dose is 120 mg three times daily ( 2 ) In patients who are near glycemic goal when treatment is initiated, 60 mg three times daily may be administered. ( 2 ) Administer 1 to 30 minutes before meals ( 2 ) If a meal is skipped, skip the scheduled dose to reduce the risk of hypoglycemia. ( 2 , 5.1 )

4 CONTRAINDICATIONS Nateglinide Tablets are contraindicated in patients with a history of hypersensitivity to Nateglinide Tablets or its inactive ingredients. History of hypersensitivity to nateglinide or its inactive ingredients ( 4 )

5 WARNINGS AND PRECAUTIONS Hypoglycemia : Nateglinide Tablets may cause hypoglycemia. Administer before meals to reduce the risk of hypoglycemia. Skip the scheduled dose of Nateglinide Tablets if a meal is skipped to reduce the risk of hypoglycemia. ( 5.1 ) Macrovascular Outcomes : There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Nateglinide Tablets. ( 5.2 ) 5.1 Hypoglycemia All glinides, including Nateglinide Tablets, can cause hypoglycemia [see Adverse Reactions (6.1) ] . Severe hypoglycemia can cause seizures, may be life-threatening, or cause death. Hypoglycemia can impair concentration ability and reaction time; this may place an individual and others at risk in situations where these abilities are important (e.g., driving or operating other machinery). Hypoglycemia can happen suddenly and symptoms may differ in each individual and change over time in the same individual. Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes, in patients with diabetic neuropathy (nerve disease), in patients using medications that block the sympathetic nervous system (e.g., beta-blockers) [see Drug Interactions (7) ] , or in patients who experience recurrent hypoglycemia. Factors which may increase the risk of hypoglycemia include changes in meal pattern (e.g., macronutrient content), changes in level of physical activity, changes to coadministered medication [see Drug Interactions (7) ] , and concomitant use with other antidiabetic agents. Patients with renal or hepatic impairment may be at higher risk of hypoglycemia [see Use in Specific Populations ( 8.6 , 8.7 ), Clinical Pharmacology (12.3) ] . Patients should take Nateglinide Tablets before meals and be instructed to skip the dose of Nateglinide Tablets if a meal is skipped [see Dosage and Administration (2) ] . Patients and caregivers must be educated to recognize and manage hypoglycemia. Self-monitoring of blood glucose plays an essential role in the prevention and management of hypoglycemia. In patients at higher risk for hypoglycemia and patients who have reduced symptomatic awareness of hypoglycemia, increased frequency of blood glucose monitoring is recommended. 5.2 Macrovascular Outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Nateglinide Tablets.

17 PATIENT COUNSELING INFORMATION Administration Instruct patients to take Nateglinide Tablets 1 to 30 minutes before meals. Instruct patients that skip meals to skip their dose of Nateglinide Tablets [see Dosage and Administration (2) ] . Hypoglycemia Inform patients that Nateglinide Tablets can cause hypoglycemia and instruct patients and their caregivers on self- management procedures including glucose monitoring and management of hypoglycemia. Inform patients that their ability to concentrate and react may be impaired as a result of hypoglycemia. In patients at higher risk for hypoglycemia and patients who have reduced symptomatic awareness of hypoglycemia, increased frequency of blood glucose monitoring is recommended [see Warnings and Precautions (5.1) ] . Lactation Advise patients that use of Nateglinide Tablet is not recommended while breastfeeding [see Use in Specific Populations (8.2) ]. Drug Interactions Discuss potential drug interactions with patients and inform them of potential drug-drug interactions with Nateglinide Tablets. Manufactured by: USV Private Limited H-13,16,16A,17,18,19,20,21,E-22, OIDC, Mahatma Gandhi Udyog Nagar, Dabhel, Daman 396 210, India. Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Made In India Revised: 12/2024 PIR75950-02 nateglinide-logo

7 DRUG INTERACTIONS Table 2 includes a list of drugs with clinically important drug interactions when concomitantly administered or withdrawn with Nateglinide Tablets and instructions for managing or preventing them. Table 2: Clinically Significant Drug Interactions with Nateglinide Tablets Drugs That May Increase the Blood-Glucose-Lowering Effect of Nateglinide Tablets and Susceptibility to Hypoglycemia Drugs: Nonsteroidal anti-inflammatory drugs (NSAIDs), salicylates, monoamine oxidase inhibitors, non-selective beta-adrenergic- blocking agents, anabolic hormones (e.g. 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. Intervention: Dose reductions and increased frequency of glucose monitoring may be required when Nateglinide Tablets are coadministered with these drugs. Drugs and Herbals That May Reduce the Blood-Glucose-Lowering Effect of Nateglinide Tablets 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 John’s Wort). Intervention: Dose increases and increased frequency of glucose monitoring may be required when Nateglinide Tablets are coadministered with these drugs. Drugs 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 Tablets are coadministered with these drugs. Drugs That May Increase the Potential for Hypoglycemia : Nateglinide Tablets dose reductions and increased frequency of glucose monitoring may be required when co-administered ( 7 ) Drugs That May Increase the Potential for Hyperglycemia : Nateglinide Tablets dose increases and increased frequency of glucose monitoring may be required when co-administered ( 7 ) Drugs That May Blunt Signs and Symptoms of Hypoglycemia : Increased frequency of glucose monitoring may be required when co-administered ( 7 )

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity: Nateglinide did not increase tumors in two year carcinogenicity studies conducted in mice and rats. Oral doses of Nateglinide up to 900 mg/kg in rats and 400 mg/kg in mice were tested, which produced exposures in rats approximately 30 to 40 times and in mice 10 to 30 times the human therapeutic exposure of nateglinide at a dose of 120 mg three times daily, based on AUC. Mutagenesis: Nateglinide was not genotoxic in the in vitro Ames test, mouse lymphoma assay, chromosome aberration assay or in the in vivo mouse micronucleus test. Impairment of Fertility: Fertility was unaffected by administration of nateglinide to rats at doses up to 600 mg/kg (corresponding to 16 times the MRHD of 120 mg three times per day, based on BSA).

8.1 Pregnancy Risk Summary The available data from published literature and the applicant’s pharmacovigilance with use of Nateglinide Tablets in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy ( see Clinical Considerations ). Nateglinide Tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In animal reproduction studies, there was no teratogenicity in rats and rabbits administered oral nateglinide during organogenesis at approximately 27 and 8 times the maximum recommended human dose (MRHD), respectively, based on body surface area (BSA). The estimated background risk of major birth defects is 6% to 10% in women with pre-gestational diabetes with a HbA1c > 7 and has been reported to be as high as 20% to 25% in women with a HbA1c > 10. The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. Data Animal data In embryofetal development studies, nateglinide administered orally during the period of organogenesis was not teratogenic in rats at doses up to 1,000 mg/kg (corresponding to 27 times the MRHD of 120 mg three times per day, based on BSA). In rabbits, embryonic development was adversely affected at 500 mg/kg/day and the incidence of gallbladder agenesis or small gallbladder was increased at a dose of 300 and 500 mg/kg (corresponding to 16 and 27 times the MRHD). No such effects were observed at 150 mg/kg/day (corresponding to 8 times the MRHD). In a pre- and postnatal development study in rats, nateglinide administered by oral gavage at doses of 100, 300, and 1,000 mg/kg/day from gestation day 17 to lactation day 21 resulted in lower body weight in offspring of rats administered nateglinide at 1,000 mg/kg/day (corresponding to 27 times the MHRD).

8.4 Pediatric Use The safety and effectiveness of Nateglinide Tablets have not been established in pediatric patients.

8.5 Geriatric Use 436 patients 65 years and older, and 80 patients 75 years and older were exposed to Nateglinide Tablets in clinical studies. No differences were observed in safety or efficacy of Nateglinide Tablets between patients age 65 and over, and those under age 65. However, greater sensitivity of some older individuals to Nateglinide Tablets therapy cannot be ruled out.

6 ADVERSE REACTIONS The following serious adverse reaction is also described elsewhere in the labeling: Hypoglycemia [see Warnings and Precautions (5.1) ] Common adverse reactions associated with Nateglinide Tablets (3% or greater incidence) were upper respiratory tract infection, back pain, flu symptoms, dizziness, arthropathy, diarrhea. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical trials, approximately 2,600 patients with type 2 diabetes mellitus were treated with Nateglinide Tablets. Of these, approximately 1,335 patients were treated for 6 months or longer and approximately 190 patients for one year or longer. Table 1 shows the most common adverse reactions associated with Nateglinide Tablets. Table 1: Adverse Reactions other than Hypoglycemia (%) occurring Greater than or Equal to 2% in Nateglinide Tablets-Treated Patients from Pool of 12 to 64 week Placebo Controlled Trials Placebo Nateglinide Tablets N=458 N=1441 Preferred Term Upper Respiratory Infection 8.1 10.5 Back Pain 3.7 4.0 Flu Symptoms 2.6 3.6 Dizziness 2.2 3.6 Arthropathy 2.2 3.3 Diarrhea 3.1 3.2 Accidental Trauma 1.7 2.9 Bronchitis 2.6 2.7 Coughing 2.2 2.4 Hypoglycemia Episodes of severe hypoglycemia (plasma glucose less than 36 mg/dL) were reported in two patients treated with Nateglinide Tablets. Non-severe hypoglycemia occurred in 2.4 % of Nateglinide Tablets treated patients and 0.4 % of placebo-treated patients [see Warnings and Precautions (5.1) ]. Weight Gain Patients treated with Nateglinide Tablets had statistically significant mean increases in weight compared to placebo. In clinical trials, the mean weight increases with Nateglinide Tablets 60 mg (3 times daily) and Nateglinide Tablets 120 mg (3 times daily) compared to placebo were 1.0 kg and 1.6 kg respectively. Laboratory Test Increases in Uric Acid: There were increases in mean uric acid levels for patients treated with Nateglinide Tablets alone, Nateglinide Tablets in combination with metformin, metformin alone, and glyburide alone. The respective differences from placebo were 0.29 mg/dL, 0.45 mg/dL, 0.28 mg/dL, and 0.19 mg/dL. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of Nateglinide Tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Hypersensitivity Reactions: Rash, itching, and urticaria Hepatobiliary Disorders: Jaundice, cholestatic hepatitis, and elevated liver enzymes

10 OVERDOSAGE There have been no instances of overdose with Nateglinide Tablets in clinical trials. However, an overdose may result in an exaggerated glucose-lowering effect with the development of hypoglycemic symptoms. Hypoglycemic symptoms without loss of consciousness or neurological findings should be treated with oral glucose and adjustments in dosage and/or meal patterns. Severe hypoglycemic reactions with coma, seizure, or other neurological symptoms should be treated with intravenous glucose. As Nateglinide Tablets are highly protein bound, dialysis is not an efficient means of removing it from the blood.