Skip to content
ppharmaranks
Menu

sitagliptin and metformin hydrochloride

Pharmaranks rates Sitagliptin and Metformin Hydrochloride 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Sitagliptin and Metformin Hydrochloride is a combination medicine containing Sitagliptin and Metformin Hydrochloride.

Generic · by Ajanta Pharma Ltd

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

Key facts

Active ingredient
Sitagliptin and Metformin Hydrochloride
Form
Tablet, Tablet, extended release
Strength
Sitagliptin 50MG/1000MG
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)
FDA application
ANDA215220
Availability
Discontinued (per FDA)

How long does Sitagliptin and Metformin Hydrochloride stay in your body?

The elimination half-life of sitagliptin and metformin hydrochloride 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.

Dosage forms

Tablet and Tablet, extended release

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

How is Sitagliptin and Metformin Hydrochloride rated?
pharmaranks gives Sitagliptin and Metformin Hydrochloride 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.
Is there a coupon or discount for Sitagliptin and Metformin Hydrochloride?
pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Sitagliptin and Metformin Hydrochloride. To pay less, Sitagliptin and Metformin Hydrochloride 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 and Metformin Hydrochloride?
Sitagliptin and Metformin Hydrochloride is marketed by Ajanta Pharma Ltd. You can see Ajanta Pharma Ltd's full profile, rating, and other products on pharmaranks.
Is Sitagliptin and Metformin Hydrochloride a brand-name or generic drug?
Sitagliptin and Metformin Hydrochloride is a generic medication; its active ingredient is Sitagliptin and Metformin Hydrochloride. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
Is Sitagliptin and Metformin Hydrochloride available over the counter?
No. Sitagliptin and Metformin Hydrochloride 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 and Metformin Hydrochloride come in?
Sitagliptin and Metformin Hydrochloride is currently marketed as tablet and tablet, extended release, per the FDA's National Drug Code Directory.
Is Sitagliptin and Metformin Hydrochloride FDA-registered?
Sitagliptin and Metformin Hydrochloride is on record with the U.S. FDA under application number ANDA215220. You can verify this on its official FDA label.
Has Sitagliptin and Metformin Hydrochloride been recalled by the FDA?
Sitagliptin and Metformin Hydrochloride 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 and Metformin Hydrochloride safe?
There's no single safe-or-not verdict. pharmaranks gives Sitagliptin and Metformin Hydrochloride 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.

Reviews

No reviews yet. Be the first to write one.

Write a review

Reviews are user opinions, not medical advice. Consult a licensed professional.

People also viewed

Compare Sitagliptin and Metformin Hydrochloride head-to-head

Guides for this medication

Identify a pill by its imprint →Check a drug interaction →Drug recalls →

Browse medications A–Z

Research products from A to Z, compare independent ratings, and find alternatives.

sitagliptin and metformin hydrochloride

70/100