Sitagliptin Phosphate 50 mg/1
Sitagliptin Phosphate · TABLET, FILM COATED · Sandoz Inc
Sitagliptin is an oral medication used to help control blood sugar levels in people with type 2 diabetes. It works by increasing the body's ability to produce insulin when blood sugar rises after eating.
Key Facts
- Brand Name
- Sitagliptin Phosphate
- Generic Name
- Sitagliptin Phosphate
- NDC Code (Product)
0781-5768- Manufacturer
- Sandoz Inc
- Strength
- 50 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA202387
- Marketing Start
- 01/14/2026
Recall History
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Labeling: Label Mixup: sitaGLIPtin PHOSPHATE, Tablet, 50 mg may be potentially mis-labeled as one of the following drugs: LACTOBACILLUS, Tablet, 0 mg, NDC 64980012950, Pedigree: AD62992_1, EXP: 5/23/2014; CYANOCOBALAMIN, Tablet, 500 mcg, NDC 00536355101, Pedigree: W002860, EXP: 6/7/2014.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Sitagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Sitagliptin tablets should not be used in patients with type 1 diabetes. Sitagliptin tablets have not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using sitagliptin tablets. [See Warnings and Precautions ( 5.1 ).] Sitagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Limitations of Use: • Sitagliptin tablets should not be used in patients with type 1 diabetes. ( 1 ) • Sitagliptin tablets have not been studied in patients with a history of pancreatitis. ( 1 , 5.1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION The recommended dose of sitagliptin tablets is 100 mg once daily. Sitagliptin tablets can be taken with or without food. ( 2.1 ) Dosage adjustment is recommended for patients with eGFR less than 45 mL/min/1.73 m 2 . ( 2.2 ) Dosage Adjustment in Patients with Renal Impairment ( 2.2 ) eGFR greater than or equal to 30 mL/min/1.73 m 2 to less than 45 mL/min/1.73 m 2 eGFR less than 30 mL/min/1.73 m 2 (including patients with end stage renal disease [ESRD] on dialysis) 50 mg once daily 25 mg once daily 2.1 Recommended Dosing The recommended dose of sitagliptin tablets are 100 mg once daily. Sitagliptin tablets can be taken with or without food. 2.2 Recommendations for Use in Renal Impairment Assess renal function prior to initiation of sitagliptin tablets and periodically thereafter. For patients with an estimated glomerular filtration rate [eGFR] greater than or equal to 45 mL/min/1.73 m 2 to less than 90 mL/min/1.73 m 2 , no dosage adjustment for sitagliptin tablets are required. For patients with moderate renal impairment (eGFR greater than or equal to 30 mL/min/1.73 m 2 to less than 45 mL/min/1.73 m 2 ), the dose of sitagliptin tablets is 50 mg once daily.…
Contraindications
4 CONTRAINDICATIONS History of a serious hypersensitivity reaction to sitagliptin, such as anaphylaxis or angioedema. [See Warnings and Precautions ( 5.5 ); Adverse Reactions ( 6.2 ).] History of a serious hypersensitivity reaction to sitagliptin, such as anaphylaxis or angioedema ( 5.5 , 6.2 )
Drug Interactions
7 DRUG INTERACTIONS 7.1 Insulin Secretagogues or Insulin Coadministration of sitagliptin with an insulin secretagogue (e.g., sulfonylurea) or insulin may require lower doses of the insulin secretagogue or insulin to reduce the risk of hypoglycemia. [See Warnings and Precautions ( 5.4 ).]
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are also discussed elsewhere in the labeling: • Pancreatitis [see Warnings and Precautions ( 5.1 )] • Heart Failure [see Warnings and Precautions ( 5.2 )] • Acute Renal Failure [see Warnings and Precautions ( 5.3 )] • Hypoglycemia with Concomitant Use with Insulin or Insulin Secretagogues [see Warnings and Precautions ( 5.4 )] • Hypersensitivity Reactions [see Warnings and Precautions ( 5.5 )] • Severe and Disabling Arthralgia [see Warnings and Precautions ( 5.6 )] • Bullous Pemphigoid [see Warnings and Precautions ( 5.7 )] Adverse reactions reported in ≥5% of patients treated with sitagliptin and more commonly than in patients treated with placebo are: upper respiratory tract infection, nasopharyngitis and headache. In the add-on to sulfonylurea and add-on to insulin studies, hypoglycemia was also more commonly reported in patients treated with sitagliptin compared to placebo. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 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 ra…
Frequently Asked Questions
What is Sitagliptin Phosphate used for?
Sitagliptin is an oral medication used to help control blood sugar levels in people with type 2 diabetes. It works by increasing the body's ability to produce insulin when blood sugar rises after eating.
Is Sitagliptin Phosphate a controlled substance?
Sitagliptin Phosphate is not classified as a controlled substance by the DEA.
What is the generic name for Sitagliptin Phosphate?
The generic name for Sitagliptin Phosphate is Sitagliptin Phosphate. There are no other listed brand versions of Sitagliptin Phosphate.
What is the NDC code for Sitagliptin Phosphate 50 mg/1?
The NDC (National Drug Code) for Sitagliptin Phosphate 50 mg/1 is 0781-5768, listed by Sandoz Inc.
Other Sitagliptin Phosphate Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)