Glipizide and Metformin HCl 2.5 mg; 250 mg Tablet, Film Coated, 1,000-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Sulfonylurea class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Glipizide is used along with diet and exercise, and sometimes with other medications, to treat type 2 diabetes (condition in which the body does not use insulin normally and, therefore, cannot control the amount of sugar in the blood). Glipizide is in a class of medications called sulfonylureas. Glipizide lowers blood sugar by causing the pancreas to produce insulin (a natural substance that is needed to break down sugar in the body) and helping the body use insulin efficiently. This medication will only help lower blood sugar in people whose bodies produce insulin naturally. Glipizide is not...
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII 1K09F3G675
Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
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UNII 36SFW2JZ0W
Hypromellose 2910 is a plant-based thickening agent derived from cellulose. In medicines, it forms a protective coating on tablets or capsules and controls how quickly the drug dissolves and releases into your body.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII 30IQX730WE
Polyethylene glycol 6000 is a synthetic polymer made from ethylene glycol units. It acts as a binder, filler, and solubilizer in medicines to help hold ingredients together, add bulk, and improve how well active drugs dissolve and absorb.
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UNII FZ989GH94E
Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
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UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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UNII 5856J3G2A2
A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
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UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
11 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.3628 | $362.80 / 1000 tablets |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Glipizide and Metformin Hydrochloride 2.5 mg/1; 250 mg 00093-7455-01 | Teva | 100 tablets | $0.280 | AB | Availability likely | — |
| Glipizide and metformin hcl 2.5 mg/1; 250 mg 62135-0731-60 | Chartwell | 60 tablets | $0.280 | AB | Availability likely | — |
| Glipizide and Metformin Hydrochloride 2.5 mg/1; 250 mg 68382-0184-01 | Zydus | 100 tablets | $0.280 | AB | Availability likely | — |
| Glipizide and Metformin HCl 2.5 mg/1; 250 mgthis 23155-0115-10 | Heritage | 1000 tablets | — | AB | FDA listed | — |
| Glipizide and Metformin Hydrochloride 2.5 mg/1; 250 mg 65841-0659-01 | Zydus | 100 tablets | — | AB | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 23155-0115-01 | 100 TABLET, FILM COATED in 1 BOTTLE (23155-115-01) | $0.2803 / ea | $28.03 | 2010-06-29 | Active |
| 23155-0115-10 You're viewing this | 1000 TABLET, FILM COATED in 1 BOTTLE (23155-115-10) | — | — | 2010-06-29 | Active |
You're viewing the largest of 2 pack sizes for this product.
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What quantity is in NDC 23155-0115-10?
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What NDC number is used to bill for this package of Glipizide and Metformin HCl 2.5 mg; 250 mg Tablet, Film Coated?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
🧭 About this NDC listing & data coverage
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: LACTIC ACIDOSIS Post-marketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (>5 mmol/Liter), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/ pyruvate ratio; and metformin plasma levels generally >5 mcg/mL [see PRECAUTIONS] Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g., carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, hepatic impairment, and mitochondrial disease.
Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided [see PRECAUTIONS] . If metformin-associated lactic acidosis is suspected, immediately discontinue glipizide and metformin hydrochloride tablets and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended [see PRECAUTIONS] .
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Glipizide and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION General Considerations Dosage of glipizide and metformin hydrochloride tablets must be individualized on the basis of both effectiveness and tolerance while not exceeding the maximum recommended daily dose of 20 mg glipizide/2000 mg metformin. Glipizide and metformin hydrochloride tablets should be given with meals and should be initiated at a low dose, with gradual dose escalation as described below, in order to avoid hypoglycemia (largely due to glipizide), reduce GI side effects (largely due to metformin), and permit determination of the minimum effective dose for adequate control of blood glucose for the individual patient.
With initial treatment and during dose titration, appropriate blood glucose monitoring should be used to determine the therapeutic response to glipizide and metformin hydrochloride tablets and to identify the minimum effective dose for the patient. Thereafter, HbA 1c should be measured at intervals of approximately 3 months to assess the effectiveness of therapy. The therapeutic goal in all patients with type 2 diabetes is to decrease FPG, PPG, and HbA 1c to normal or as near normal as possible.
Ideally, the response to therapy should be evaluated using HbA 1c , which is a better indicator of long-term glycemic control than FPG alone. No studies have been performed specifically examining the safety and efficacy of switching to glipizide and metformin hydrochloride tablets therapy in patients taking concomitant glipizide (or other sulfonylurea) plus metformin. Changes in glycemic control may occur in such patients, with either hyperglycemia or hypoglycemia possible.
Any change in therapy of type 2 diabetes should be undertaken with care and appropriate monitoring. When colesevelam is coadministered with glipizide ER, maximum plasma concentration and total exposure to glipizide is reduced. Therefore, glipizide and metformin hydrochloride tablets should be administered at least 4 hours prior to colesevelam.
Glipizide and Metformin Hydrochloride Tablets in Patients with Inadequate Glycemic Control on Diet and Exercise Alone For patients with type 2 diabetes whose hyperglycemia cannot be satisfactorily managed with diet and exercise alone, the recommended starting dose of glipizide and metformin hydrochloride tablets are 2.5 mg/250 mg once a day with a meal. For patients whose FPG is 280 mg/dL to 320 mg/dL a starting dose of glipizide and metformin hydrochloride tablets 2.5 mg/500 mg twice daily should be considered. The efficacy of glipizide and metformin hydrochloride tablets in patients whose FPG exceeds 320 mg/dL has not been established.
Dosage increases to achieve adequate glycemic control should be made in increments of 1 tablet per day every 2 weeks up to maximum of 10 mg/1000 mg or 10 mg/2000 mg glipizide and metformin hydrochloride tablets per day given in divided doses. In clinical trials of glipizide and metformin hydrochloride tablets as initial therapy, there was no experience with total daily doses >10 mg/2000 mg per day. Glipizide and Metformin Hydrochloride Tablets in Patients with Inadequate Glycemic Control on a Sulfonylurea and/or Metformin For patients not adequately controlled on either glipizide (or another sulfonylurea) or metformin alone, the recommended starting dose of glipizide and metformin hydrochloride tablets are 2.5 mg/500 mg or 5 mg/500 mg twice daily with the morning and evening meals.
In order to avoid hypoglycemia, the starting dose of glipizide and metformin hydrochloride tablets should not exceed the daily doses of glipizide or metformin already being taken. The daily dose should be titrated in increments of no more than 5 mg/500 mg up to the minimum effective dose to achieve adequate control of blood glucose or to a maximum dose of 20 mg/2000 mg per day. Patients previously treated with combination therapy of glipizide (or another sulfonylurea) plus metformin may be switched to glipizide and metformin hydrochloride tablets 2.5 mg/500 mg or 5 m…
⛔ Contraindications ▾
CONTRAINDICATIONS glipizide and metformin hydrochloride tablets are contraindicated in patients with: 1. Severe renal impairment (eGFR below 30 mL/min/1.73 m 2 )(see WARNINGS and PRECAUTIONS ). 2. Known hypersensitivity to glipizide or metformin hydrochloride. 3. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin.
⚠️ Warnings ▾
WARNINGS SPECIAL WARNING ON INCREASED RISK OF CARDIOVASCULAR MORTALITY The administration of oral hypoglycemic drugs has been reported to be associated with increased cardiovascular mortality as compared to treatment with diet alone or diet plus insulin. This warning is based on the study conducted by the University Group Diabetes Program (UGDP), a long-term prospective clinical trial designed to evaluate the effectiveness of glucose-lowering drugs in preventing or delaying vascular complications in patients with non-insulin-dependent diabetes.
The study involved 823 patients who were randomly assigned to 1 of 4 treatment groups ( Diabetes 19 (Suppl. 2):747-830, 1970). UGDP reported that patients treated for 5 to 8 years with diet plus a fixed dose of tolbutamide (1.5 grams per day) had a rate of cardiovascular mortality approximately 2½ times that of patients treated with diet alone.
A significant increase in total mortality was not observed, but the use of tolbutamide was discontinued based on the increase in cardiovascular mortality, thus limiting the opportunity for the study to show an increase in overall mortality. Despite controversy regarding the interpretation of these results, the findings of the UGDP study provide an adequate basis for this warning. The patient should be informed of the potential risks and benefits of glipizide and of alternative modes of therapy.
Although only 1 drug in the sulfonylurea class (tolbutamide) was included in this study, it is prudent from a safety standpoint to consider that this warning may also apply to other hypoglycemic drugs in this class, in view of their close similarities in mode of action and chemical structure.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Glipizide and metformin hydrochloride tablets In a double-blind 24-week clinical trial involving glipizide and metformin hydrochloride tablets as initial therapy, a total of 172 patients received glipizide and metformin hydrochloride tablets 2.5 mg/250 mg, 173 received glipizide and metformin hydrochloride tablets 2.5 mg/500 mg, 170 received glipizide, and 177 received metformin. The most common clinical adverse events in these treatment groups are listed in Table 4 . Table 4: Clinical Adverse Events >5% in any Treatment Group, by Primary Term, in Initial Therapy Study Adverse Event Number (%) of Patients Glipizide 5 mg tablets N=170 Metformin 500 mg tablets N=177 Glipizide and Metformin Hydro chloride 2.5 mg/250 mg tablets N=172 Glipizide and Metformin Hydrochloride 2.5 mg/500 mg tablets N=173 Upper respiratory infection 12 (7.1) 15 (8.5) 17 (9.9) 14 (8.1) Diarrhea 8 (4.7) 15 (8.5) 4 (2.3) 9 (5.2) Dizziness 9 (5.3) 2 (1.1) 3 (1.7) 9 (5.2) Hypertension 17 (10.0) 10 (5.6) 5 (2.9) 6 (3.5) Nausea/vomiting 6 (3.5) 9 (5.1) 1 (0.6) 3 (1.7) In a double-blind 18-week clinical trial involving glipizide and metformin hydrochloride tablets as second-line therapy, a total of 87 patients received glipizide and metformin hydrochloride tablets, 84 received glipizide, and 75 received metformin.
The most common clinical adverse events in this clinical trial are listed in Table 5 . Table 5: Clinical Adverse Events >5% in any Treatment Group, by Primary Term, in Second-Line Therapy Study Adverse Event Number (%) of Patients Glipizide 5 mg tablets a N=84 Metformin 500 mg tablets a N=75 Glipizide and Metformin Hydrochloride 5 mg/500 mg tablets a N=87 Diarrhea 11 (13.1) 13 (17.3) 16 (18.4) Headache 5 (6.0) 4 (5.3) 11 (12.6) Upper respiratory infection 11 (13.1) 8 (10.7) 9 (10.3) Musculoskeletal pain 6 (7.1) 5 (6.7) 7 (8.0) Nausea/vomiting 5 (6.0) 6 (8.0) 7 (8.0) Abdominal pain 7 (8.3) 5 (6.7) 5 (5.7) UTI 4 (4.8) 6 (8.0) 1 (1.1) a The dose of glipizide was fixed at 30 mg daily; doses of metformin and glipizide and metformin hydrochloride tablets were titrated.
Hypoglycemia In a controlled initial therapy trial of glipizide and metformin hydrochloride tablets 2.5 mg/250 mg and 2.5 mg/500 mg the numbers of patients with hypoglycemia documented by symptoms (such as dizziness, shakiness, sweating, and hunger) and a fingerstick blood glucose measurement ≤50 mg/dL were 5 (2.9%) for glipizide, 0 (0%) for metformin, 13 (7.6%) for glipizide and metformin hydrochloride tablets 2.5 mg/250 mg, and 16 (9.3%) for glipizide and metformin hydrochloride tablets 2.5 mg/500 mg. Among patients taking either glipizide and metformin hydrochloride tablets 2.5 mg/250 mg or glipizide and metformin hydrochloride tablets 2.5 mg/500 mg, 9 (2.6%) patients discontinued glipizide and metformin hydrochloride tablets due to hypoglycemic symptoms and 1 required medical intervention due to hypoglycemia.
In a controlled second-line therapy trial of glipizide and metformin hydrochloride tablets 5 mg/500 mg, the numbers of patients with hypoglycemia documented by symptoms and a fingerstick blood glucose measurement ≤50 mg/dL were 0 (0%) for glipizide, 1 (1.3%) for metformin, and 11 (12.6%) for glipizide and metformin hydrochloride tablets. One (1.1%) patient discontinued glipizide and metformin hydrochloride tablets therapy due to hypoglycemic symptoms and none required medical intervention due to hypoglycemia. (See PRECAUTIONS ) Gastrointestinal Reactions Among the most common clinical adverse events in the initial therapy trial were diarrhea and nausea/vomiting; the incidences of these events were lower with both glipizide and metformin hydrochloride tablets dosage strengths than with metformin therapy.
There were 4 (1.2%) patients in the initial therapy trial who discontinued glipizide and metformin hydrochloride tablets therapy due to gastrointestinal (GI) adverse events. Gastrointestinal symptoms of diarrhea, nausea/vomiting, and abdominal pain were comparable amo…
🆘 Overdosage ▾
OVERDOSAGE Glipizide Overdosage of sulfonylureas, including glipizide, can produce hypoglycemia. Mild hypoglycemic symptoms, without loss of consciousness or neurological findings, should be treated aggressively with oral glucose and adjustments in drug dosage and/or meal patterns. Close monitoring should continue until the physician is assured that the patient is out of danger.
Severe hypoglycemic reactions with coma, seizure, or other neurological impairment occur infrequently, but constitute medical emergencies requiring immediate hospitalization. If hypoglycemic coma is diagnosed or suspected, the patient should be given a rapid intravenous injection of concentrated (50%) glucose solution. This should be followed by a continuous infusion of a more dilute (10%) glucose solution at a rate that will maintain the blood glucose at a level above 100 mg/dL.
Patients should be closely monitored for a minimum of 24 to 48 hours, since hypoglycemia may recur after apparent clinical recovery. Clearance of glipizide from plasma would be prolonged in persons with liver disease. Because of the extensive protein binding of glipizide, dialysis is unlikely to be of benefit.
Metformin Hydrochloride Overdose of metformin hydrochloride has occurred, including ingestion of amounts >50 grams. Hypoglycemia was reported in approximately 10% of cases, but no causal association with metformin hydrochloride has been established. Lactic acidosis has been reported in approximately 32% of metformin overdose cases (see WARNINGS ).
Metformin is dialyzable with a clearance of up to 170 mL/min under good hemodynamic conditions. Therefore, hemodialysis may be useful for removal of accumulated drug from patients in whom metformin overdosage is suspected.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Mechanism of Action Glipizide and metformin hydrochloride tablets combines glipizide and metformin hydrochloride, 2 antihyperglycemic agents with complementary mechanisms of action, to improve glycemic control in patients with type 2 diabetes. Glipizide appears to lower blood glucose acutely by stimulating the release of insulin from the pancreas, an effect dependent upon functioning beta cells in the pancreatic islets. Extrapancreatic effects may play a part in the mechanism of action of oral sulfonylurea hypoglycemic drugs.
The mechanism by which glipizide lowers blood glucose during long-term administration has not been clearly established. In man, stimulation of insulin secretion by glipizide in response to a meal is undoubtedly of major importance. Fasting insulin levels are not elevated even on long-term glipizide administration, but the postprandial insulin response continues to be enhanced after at least 6 months of treatment.
Metformin hydrochloride is an antihyperglycemic agent that improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose. Metformin hydrochloride decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. Pharmacokinetics Absorption and Bioavailability Glipizide and metformin hydrochloride tablets In a single-dose study in healthy subjects, the glipizide and metformin components of glipizide and metformin hydrochloride tablets 5 mg/500 mg were bioequivalent to coadministered glipizide tablets and metformin hydrochloride tablets.
Following administration of a single glipizide and metformin hydrochloride tablets 5 mg/500 mg tablet in healthy subjects with either a 20% glucose solution or a 20% glucose solution with food, there was a small effect of food on peak plasma concentration (C max ) and no effect of food on area under the curve (AUC) of the glipizide component. Time to peak plasma concentration (T max ) for the glipizide component was delayed 1 hour with food relative to the same tablet strength administered fasting with a 20% glucose solution.
C max for the metformin component was reduced approximately 14% by food whereas AUC was not affected. T max for the metformin component was delayed 1 hour after food. Glipizide Gastrointestinal absorption of glipizide is uniform, rapid, and essentially complete.
Peak plasma concentrations occur 1 to 3 hours after a single oral dose. Glipizide does not accumulate in plasma on repeated oral administration. Total absorption and disposition of an oral dose was unaffected by food in normal volunteers, but absorption was delayed by about 40 minutes.
Metformin Hydrochloride The absolute bioavailability of a 500 mg metformin hydrochloride tablet given under fasting conditions is approximately 50% to 60%. Studies using single oral doses of metformin tablets of 500 mg and 1500 mg, and 850 mg to 2550 mg, indicate that there is a lack of dose proportionality with increasing doses, which is due to decreased absorption rather than an alteration in elimination. Food decreases the extent of and slightly delays the absorption of metformin, as shown by approximately a 40% lower peak concentration and a 25% lower AUC in plasma and a 35-minute prolongation of time to peak plasma concentration following administration of a single 850 mg tablet of metformin with food, compared to the same tablet strength administered fasting.
The clinical relevance of these decreases is unknown. Distribution Glipizide Protein binding was studied in serum from volunteers who received either oral or intravenous glipizide and found to be 98% to 99% 1 hour after either route of administration. The apparent volume of distribution of glipizide after intravenous administration was 11 liters, indicative of localization within the extracellular fluid compartment.
In mice, no glipizide or metabolites were detectable…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Glipizide and Metformin Hydrochloride Tablets USP Glipizide and metformin hydrochloride tablet 2.5 mg/250 mg is a pink coloured, capsule shape, film-coated tablet with "U 787" debossed on one side and plain on the other side. Glipizide and metformin hydrochloride tablet 2.5 mg/500 mg is a white to off white, capsule shape, film-coated tablet with "U 785" debossed on one side and plain on the other side. Glipizide and metformin hydrochloride tablet 5 mg/500 mg is a pink coloured, capsule shape, film-coated tablet with "U 786" debossed on one side and plain on the other side.
Glipizide and Metformin Hydrochloride Tablets USP NDC 23155-xxx-xx for unit of use Glipizide (mg) Metformin hydrochloride (mg) Bottle of 100's Bottle of 1000's 2.5 250 115-01 115-10 2.5 500 116-01 116-10 5.0 500 117-01 117-10 Storage Store at 20°-25° C (68°-77° F); excursions permitted to 15°-30° C (59°-86° F). [See USP Controlled Room Temperature.] Manufactured by: USV Private Limited Daman - 396210, India Manufactured for: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901.DRUG(3784) Revised: 06/2026-1 logo
📋 Description ▾
DESCRIPTION Glipizide and metformin hydrochloride tablets contain 2 oral antihyperglycemic drugs used in the management of type 2 diabetes, glipizide and metformin hydrochloride. Glipizide is an oral antihyperglycemic drug of the sulfonylurea class. The chemical name for glipizide is 1-cyclohexyl-3-[[ p -[2-(5-methylpyrazinecarboxamido) ethyl] phenyl] sulfonyl] urea.
Glipizide is a whitish, odorless powder with a molecular formula of C 21H27N5O4S, a molecular weight of 445.55 and a pK a of 5.9. It is insoluble in water and alcohols, but soluble in
0.1N NaOH; it is freely soluble in dimethylformamide. The structural formula is represented below. Metformin hydrochloride is an oral antihyperglycemic drug used in the management of type 2 diabetes.
Metformin hydrochloride (N,N -dimethylimidodicarbonimidic diamide monohydrochloride) is not chemically or pharmacologically related to sulfonylureas, thiazolidinediones, or α-glucosidase inhibitors. It is a white to off-white crystalline compound with a molecular formula of C 4H12ClN5 (monohydrochloride) and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform.
The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. The structural formula is as shown: Glipizide and metformin hydrochloride tablets are available for oral administration in tablets containing 2.5 mg glipizide with 250 mg metformin hydrochloride, 2.5 mg glipizide with 500 mg metformin hydrochloride, and 5 mg glipizide with 500 mg metformin hydrochloride.
In addition, each tablet contains the following inactive ingredients: Sodium Starch Glycolate, Corn Starch, Povidone, Magnesium Stearate, Colloidal Silicon Dioxide, Hypromellose, Talc, Titanium Dioxide, Polyethylene Glycol 6000, Propylene Glycol and Iron Oxide Red. The tablets are film coated, which provides color differentiation. glipizide struc