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sitagliptin phosphate

Pharmaranks rates Sitagliptin Phosphate 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Sitagliptin Phosphate is a dipeptidyl peptidase 4 inhibitor used to treat Type 2 Diabetes Mellitus.

Dipeptidyl Peptidase 4 Inhibitor · by Ajanta Pharma Ltd

Generic of Januvia

70/100Limited · 1 source

Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →

Rated against independent regulatory sources·Last updated August 21, 2026·How we rate
Verified againstopenFDANIH DailyMedRxClass
~$110.51 /30
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Key facts

Active ingredient
Sitagliptin Phosphate
Form
Tablet
Strength
Sitagliptin Phosphate EQ 100MG Base · Sitagliptin Phosphate EQ 25MG Base · Sitagliptin Phosphate EQ 50MG Base
Type
Prescription (Rx)
Brand or generic
Generic
Manufacturer
Ajanta Pharma Ltd
Half-life
about 12.4 hours (apparent terminal half-life after a single 100 mg oral dose in healthy volunteers) (how long it stays in your system)
What the pharmacy pays
~$110.51 for 30 — not your price
FDA application
ANDA214784
Availability
Discontinued (per FDA)

How long does Sitagliptin Phosphate stay in your body?

The elimination half-life of sitagliptin phosphate is about 12.4 hours (apparent terminal half-life after a single 100 mg oral dose in healthy volunteers) — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. This is the apparent terminal (elimination) half-life the label reports; it does not describe a separate distribution phase. Sitagliptin is not a prodrug and has no active metabolite that outlasts it — metabolism is a minor pathway (about 16% of the dose), and the label states that the six metabolites detected were at trace levels and are not expected to contribute to DPP-4 inhibition. About 79% of the drug is excreted unchanged in the urine, so the kidneys drive elimination: the label reports an approximately 2-fold higher sitagliptin AUC in moderate renal impairment (eGFR 30 to under 45 mL/min/1.73 m2) and an approximately 4-fold higher AUC in severe impairment and end-stage renal disease on hemodialysis, versus healthy controls — the label quantifies these as exposure (AUC) increases rather than restating a longer half-life. Older adults (65 to 80 years) had about 19% higher plasma concentrations than younger subjects, and the label says that once the effect of age on renal function is accounted for, age alone has no clinically meaningful impact on sitagliptin pharmacokinetics. Moderate hepatic impairment (Child-Pugh 7 to 9) raised AUC by only about 21% and Cmax by about 13%, which the label calls not clinically meaningful; there is no clinical experience in severe hepatic impairment (Child-Pugh over 9).

This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: JANUVIA (sitagliptin) tablet, film coated — Merck Sharp & Dohme LLC, DailyMed SPL, §12.3 Pharmacokinetics.

Drug class

How this class works, per Dipeptidyl Peptidase IV (DPP IV) Inhibitors - StatPearls - NCBI Bookshelf.

May treat (source: NIH RxClass)

See how Sitagliptin Phosphate ranks — best-rated dipeptidyl peptidase 4 inhibitor for:

Dosage forms

Tablet

The forms currently marketed in the U.S., per the FDA National Drug Code Directory.

Ways to save

Ask for the generic

Same active ingredient, far cheaper. Is there a generic? →

Request a 90-day supply

Bulk fills usually lower the per-dose price vs monthly refills.

Use copay cards

Manufacturer copay cards & patient-assistance programs — especially for brand drugs.

Compare alternatives

A same-class option may cost less. See alternatives →

Frequently asked questions

What does Sitagliptin Phosphate treat?
Sitagliptin Phosphate (Sitagliptin Phosphate) may be used to treat type 2 diabetes mellitus, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
How does Sitagliptin Phosphate work?
Sitagliptin Phosphate is a dipeptidyl peptidase 4 inhibitor. DPP-4 inhibitors block the enzyme that quickly destroys the body's own gut hormones (incretins like GLP-1). With these hormones lasting longer, the pancreas releases more insulin and less glucagon after meals, which lowers blood sugar.
How is Sitagliptin Phosphate rated?
pharmaranks gives Sitagliptin Phosphate a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
How much does Sitagliptin Phosphate cost?
Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $110.51 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
Is there a coupon or discount for Sitagliptin Phosphate?
pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Sitagliptin Phosphate. To pay less, Sitagliptin Phosphate is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
Who makes Sitagliptin Phosphate?
Sitagliptin Phosphate is marketed by Ajanta Pharma Ltd. You can see Ajanta Pharma Ltd's full profile, rating, and other products on pharmaranks.
Is Sitagliptin Phosphate a brand-name or generic drug?
Sitagliptin Phosphate is a generic medication; its active ingredient is Sitagliptin Phosphate. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
Is Sitagliptin Phosphate available over the counter?
No. Sitagliptin Phosphate is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
What forms does Sitagliptin Phosphate come in?
Sitagliptin Phosphate is currently marketed as tablet, per the FDA's National Drug Code Directory.
What class of drug is Sitagliptin Phosphate?
Sitagliptin Phosphate is classified as dipeptidyl peptidase 4 inhibitor, per the FDA's Established Pharmacologic Class.
Is Sitagliptin Phosphate FDA-registered?
Sitagliptin Phosphate is on record with the U.S. FDA under application number ANDA214784. You can verify this on its official FDA label.
Has Sitagliptin Phosphate been recalled by the FDA?
Sitagliptin Phosphate has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
Is Sitagliptin Phosphate safe?
There's no single safe-or-not verdict. pharmaranks gives Sitagliptin Phosphate a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.

Information is sourced from public FDA regulatory data. Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.

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