Metformin Hydrochloride Extended-Release 500mg

Metformin Hydrochloride Extended-Release 500mg is an FDA-registered drug product whose active ingredient is METFORMIN HYDROCHLORIDE. It is labelled by Calvin Scott & Co., Inc. taken by oral and marketed as a human prescription drug product. Identifiers on file: NDC 17224-311, application ANDA078321, label effective 20230207. It is one of 111 FDA drug label records sharing the active ingredient METFORMIN HYDROCHLORIDE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing METFORMIN HYDROCHLORIDE are most often described in connection with: high blood, proper diet, exercise program, medications control, type diabetes, sugar helps, prevent kidney, damage blindness. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

USES: Metformin is used with a proper diet and exercise program and possibly with other medications to control high blood sugar. It is used in patients with type 2 diabetes (non-insulin-dependent diabetes). Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke. Metformin works by helping to restore your body's proper response to the insulin you naturally produce. It also decreases the amount of sugar that your liver makes and that your stomach/intestines absorb.

WARNING: Metformin can rarely cause a serious (sometimes fatal) condition called lactic acidosis. Stop taking metformin and get medical help right away if you develop any of the following symptoms of lactic acidosis: unusual tiredness, dizziness, severe drowsiness, chills, blue/cold skin, muscle pain, fast/difficult breathing, slow/irregular heartbeat, stomach pain with nausea, vomiting, or diarrhea. Lactic acidosis is more likely to occur in patients who have certain medical conditions, including kidney or liver disease, recent surgery, a serious infection, conditions that may cause a low level of oxygen in the blood or poor circulation (such as congestive heart failure, recent heart attack, recent stroke), heavy alcohol use, a severe loss of body fluids (dehydration), or X-ray or scanning procedures that require an injectable iodinated contrast drug. Tell your doctor immediately if any of these conditions occur or if you notice a big change in your overall health. You may need to stop taking this medication temporarily. The elderly are also at higher risk, especially those older than 80 years who have not had kidney tests. (See also Side Effects and Precautions sections.)

FDA lists 111 drug label records with METFORMIN HYDROCHLORIDE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Metformin Hydrochloride Extended-Release 500mg used for?
USES: Metformin is used with a proper diet and exercise program and possibly with other medications to control high blood sugar. It is used in patients with type 2 diabetes (non-insulin-dependent diabetes). Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a …

Who makes Metformin Hydrochloride Extended-Release 500mg?
Calvin Scott & Co., Inc. is the labeler of record for Metformin Hydrochloride Extended-Release 500mg. 111 FDA label records share the active ingredient METFORMIN HYDROCHLORIDE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Metformin Hydrochloride Extended-Release 500mg come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Metformin Hydrochloride Extended-Release 500mg prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing METFORMIN HYDROCHLORIDE?
Yes. 111 FDA drug label records list METFORMIN HYDROCHLORIDE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Metformin Hydrochloride Extended-Release 500mg been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.