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Glipizide 10 mg Tablet, 60-count — NDC 51655-0810-25 package photo

Glipizide 10 mg Tablet, 60-count

by Northwind Health Company, LLC · 60 TABLET in 1 BOTTLE (51655-810-25)
NDC 51655-0810-25
🏷️ FDA NDC (as labeled) 51655-810-25 billing pads the product segment with a zero
This package
Contains60-count Pack sizes3 compare ↓
Also priced by: Part D plans $0.0806/unit — full pricing hub ↓
Also comes in: 30 tablets 51655-0810-52 90 tablets 51655-0810-26
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 51655-810-25
Product NDC 51655-810
11-digit billing NDC 51655081025
NCPDP billing unit EA — each (per item)
RxCUI 310488
UNII X7WDT95N5C
Application # ANDA074223
SPL Set ID 3bb3b80a-30e8-62fe-e054-00144ff8d46c
Established class (EPC) Sulfonylurea
Chemical class Sulfonylurea Compounds
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-09-30
Route ORAL
Dosage form TABLET
Substance GLIPIZIDE
GPI-14 27200030000310
GPI class glipiZIDE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 51655-810-25 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 51655-0810-25. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Sulfonylurea class.

Pharmacologic class Sulfonylurea
Drug family (ATC) Sulfonylureas
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerNorthwind Health Company, LLC
Application holderWATSON LABORATORIES INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
FDA applicationANDA074223 (ANDA)
Labeler code51655
First marketedSep 2015
Product typeHuman Prescription Drug
Portfolio578 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📖 What it is MedlinePlus · NLM

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...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Glipizide is used to help lower blood sugar in adults with type 2 diabetes. It works by telling your pancreas to release more insulin after you eat. It's meant to be used alongside...
  • What exactly is glipizide for, and how does it help my diabetes?
  • Timing really does matter with this one. If you're taking the regular tablet, aim to take it about 30 minutes before a meal — that way it's working right when your blood sugar star...
  • When should I take my glipizide, and does it matter if I eat?
📖 Read our full Glipizide guide →
1
Nutrient depletion considerations

Glipizide may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Glipizide nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color white
ShapeRound
ImprintWatson;461
Size1 mm
ScoringScored — splits in 2
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3SY5LH9PMK
    Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • 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.
  • 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.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.

6 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 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 systemPer eachPer 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 $0.0806 $4.84 / 60 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Glipizide 10 mg 00591-0461-01 Actavis 100 tablets $0.046 — Availability likely —
Glipizide 10 mg 50268-0362-15 AvPAK 50 tablets $0.046 AB Availability likely —
Glipizide 10 mg 60505-0142-00 Apotex 100 tablets $0.046 AB Availability likely —
Glipizide 10 mg 60687-0701-01 American 100 tablets $0.046 AB Availability likely —
Glipizide 10 mg 62559-0316-10 ANI 1000 tablets $0.046 AB Availability likely —
Glipizide 10 mg 68645-0575-59 Legacy 60 tablets $0.046 AB Availability likely —
Glipizide 10 mg 69584-0310-10 Oxford 100 tablets $0.046 AB Availability likely —
Glipizide 10 mg 72888-0117-00 Advagen 1000 tablets $0.046 — Availability likely —
Glipizide 10 mg 00615-8408-39 NCS 30 tablets — AB FDA listed —
Glipizide 10 mg 43063-0861-14 PD-Rx 14 tablets — AB FDA listed —
Glipizide 10 mg 50090-0505-00 A-S 30 tablets — AB FDA listed —
Glipizide 10 mg 50090-6996-00 A-S 90 tablets — AB FDA listed —
Glipizide 10 mg 50090-7197-00 A-S 90 tablets — AB FDA listed —
Glipizide 10 mg 50090-7404-00 A-S 30 tablets — AB FDA listed —
Glipizide 10 mg 50090-7405-00 A-S 90 tablets — AB FDA listed —
Glipizide 10 mg 50090-7734-00 A-S 30 tablets — — FDA listed —
Glipizide 10 mg 50090-7735-00 A-S 90 tablets — — FDA listed —
Glipizide 10 mg 51407-0621-10 Golden 1000 tablets — AB FDA listed —
Glipizide 10 mg 51655-0106-25 Northwind 60 tablets — AB FDA listed —
Glipizide 10 mgthis 51655-0810-25 Northwind 60 tablets — AB FDA listed —
Glipizide 10 mg 63187-0811-30 Proficient 30 tablets — AB FDA listed —
Glipizide 10 mg 63187-0993-30 Proficient 30 tablets — AB FDA listed —
Glipizide 10 mg 66267-0099-30 NuCare 30 tablets — AB FDA listed —
Glipizide 10 mg 67046-0367-03 Coupler 30 tablets — AB FDA listed —
Glipizide 10 mg 68071-3974-08 NuCare 180 tablets — — FDA listed —
Glipizide 10 mg 68071-4124-02 NuCare 120 tablets — AB FDA listed —
Glipizide 10 mg 68071-4232-01 NuCare 100 tablets — AB FDA listed —
Glipizide 10 mg 68071-4643-01 NuCare 100 tablets — AB FDA listed —
Glipizide 10 mg 68788-0142-01 Preferred 100 tablets — AB FDA listed —
Glipizide 10 mg 68788-4017-01 Preferred 100 tablets — — FDA listed —
Glipizide 10 mg 68788-4061-01 Preferred 100 tablets — AB FDA listed —
Glipizide 10 mg 68788-8138-01 Preferred 100 tablets — AB FDA listed —
Glipizide 10 mg 70518-0579-00 REMEDYREPACK 180 tablets — AB FDA listed —
Glipizide 10 mg 71335-0618-01 Bryant 60 tablets — AB FDA listed —
Glipizide 10 mg 71335-2540-01 Bryant 60 tablets — — FDA listed —
Glipizide 10 mg 71335-9614-01 Bryant 60 tablets — AB FDA listed —
Glipizide 10 mg 71610-0105-53 Aphena 60 tablets — AB FDA listed —
Glipizide 10 mg 71610-0668-53 Aphena 60 tablets — AB FDA listed —
Glipizide 10 mg 72162-2102-00 Bryant 1000 tablets — AB FDA listed —
Glipizide 10 mg 72162-2215-00 Bryant 1000 tablets — AB FDA listed —
Glipizide 10 mg 72789-0463-86 PD-Rx 360 tablets — — FDA listed —
Glipizide 10 mg 72789-0510-30 PD-Rx 30 tablets — — FDA listed —
Glipizide 10 mg 80425-0437-01 Advanced 30 tablets — AB FDA listed —
Glipizide 10 mg 80425-0549-01 Advanced 30 tablets — — FDA listed —
Glipizide 10 mg 82804-0960-00 Proficient 100 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2015
On the market since
Sep 2015
📍
2026
Currently FDA-listed
11 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Glipizide — the program that covers self-administered drugs. 8 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Glipizide. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$13.01M
Claims incl. refills
1.1M
Beneficiaries
795.9K
Spend / beneficiary
$16.34
Spend / claim
$12.36
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Glipizide — the ingredient across all brands.

Top reported reactions

Blood Glucose Increased6,712
Nausea4,542
Diarrhoea3,383
Fatigue3,045
Weight Decreased2,832
Dizziness2,485
Dyspnoea2,441

Reporter sex

0 reports
Male · 49%
Female · 51%
Unknown · 0%

Serious outcomes

Death5,342
Life-threatening1,473
Disabling1,284
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 4,044 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
51655-0810-25 You're viewing this 60 TABLET in 1 BOTTLE (51655-810-25) 2015-09-30 Active
51655-0810-26 90 TABLET in 1 BOTTLE (51655-810-26) 2015-09-30 Active
51655-0810-52 30 TABLET in 1 BOTTLE (51655-810-52) 2015-09-30 Active

You're viewing one of 3 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 51655-0810-25?
NDC 51655-0810-25 is a 60-count package — 60 tablet in 1 bottle.
What is the difference between NDC 51655-0810-25 and NDC 51655-0810-52?
Both are Glipizide 10 mg Tablet — the drug itself is identical. NDC 51655-0810-25 is the 60-count package, while NDC 51655-0810-52 is the 30 tablets package.
What NDC number is used to bill for this package of Glipizide 10 mg Tablet?
Bill NDC 51655-0810-25 — the 11-digit billing format is 51655081025. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
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.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 51655-810-25, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 51655-0810-25, written without dashes as 51655081025. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 51655-0810-25, the first segment (51655) is the labeler code FDA assigned to Northwind Health Company, LLC; the middle segment (0810) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (25) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Northwind Health Company, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 30 tablets (51655-0810-52), 90 tablets (51655-0810-26). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Northwind Health Company, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 25 words ▾

INDICATIONS AND USAGE Glipizide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION There is no fixed dosage regimen for the management of diabetes mellitus with glipizide or any other hypoglycemic agent. In addition to the usual monitoring of urinary glucose, the patient’s blood glucose must also be monitored periodically to determine the minimum effective dose for the patient; to detect primary failure, i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication; and to detect secondary failure, i.e., loss of an adequate blood-glucose-lowering response after an initial period of effectiveness.

Glycosylated hemoglobin levels may also be of value in monitoring the patient’s response to therapy. Short-term administration of glipizide may be sufficient during periods of transient loss of control in patients usually controlled well on diet. In general, glipizide should be given approximately 30 minutes before a meal to achieve the greatest reduction in postprandial hyperglycemia.

Initial Dose: The recommended starting dose is 5 mg, given before breakfast. Geriatric patients or those with liver disease may be started on 2.5 mg. Titration: Dosage adjustments should ordinarily be in increments of 2.5 to 5 mg, as determined by blood glucose response.

At least several days should elapse between titration steps. If response to a single dose is not satisfactory, dividing that dose may prove effective. The maximum recommended once daily dose is 15 mg.

Doses above 15 mg should ordinarily be divided and given before meals of adequate caloric content. The maximum recommended total daily dose is 40 mg. Maintenance: Some patients may be effectively controlled on a once-a-day regimen, while others show better response with divided dosing.

Total daily doses above 15 mg should ordinarily be divided. Total daily doses above 30 mg have been safely given on a b.i.d. basis to long-term patients. In elderly patients, debilitated or malnourished patients, and patients with impaired renal or hepatic function, the initial and maintenance dosing should be conservative to avoid hypoglycemic reactions (see PRECAUTIONS section).

Patients Receiving Insulin: As with other sulfonylurea-class hypoglycemics, many stable non-insulin- dependent diabetic patients receiving insulin may be safely placed on glipizide. When transferring patients from insulin to glipizide, the following general guidelines should be considered: For patients whose daily insulin requirement is 20 units or less, insulin may be discontinued and glipizide therapy may begin at usual dosages. Several days should elapse between glipizide titration steps.

For patients whose daily insulin requirement is greater than 20 units, the insulin dose should be reduced by 50% and glipizide therapy may begin at usual dosages. Subsequent reductions in insulin dosage should depend on individual patient response. Several days should elapse between glipizide titration steps.

During the insulin withdrawal period, the patient should test urine samples for sugar and ketone bodies at least three times daily. Patients should be instructed to contact the prescriber immediately if these tests are abnormal. In some cases, especially when patient has been receiving greater than 40 units of insulin daily, it may be advisable to consider hospitalization during the transition period.

Patients Receiving Other Oral Hypoglycemic Agents: As with other sulfonylurea-class hypoglycemics, no transition period is necessary when transferring patients to glipizide. Patients should be observed carefully (1 to 2 weeks) for hypoglycemia when being transferred from longer half-life sulfonylureas (e.g., chlorpropamide) to glipizide due to potential overlapping of drug effect. When colesevelam is coadministered with glipizide ER, maximum plasma concentration and total exposure to glipizide is reduced.

Therefore, glipizide should be administered at least 4 hours prior to colesevelam.

⛔ Contraindications 32 words ▾

CONTRAINDICATIONS Glipizide tablets are contraindicated in patients with: 1. Known hypersensitivity to the drug. 2. Type 1 diabetes mellitus, diabetic ketoacidosis, with or without coma. This condition should be treated with insulin.

⚠️ Warnings ~1 min read ▾

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 one of four treatment groups ( Diabetes , 19, supp. 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 2 1/2 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 advantages of glipizide and of alternative modes of therapy.

Although only one 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 oral hypoglycemic drugs in this class, in view of their close similarities in mode of action and chemical structure.

🤒 Adverse Reactions ~2 min read ▾

ADVERSE REACTIONS In U.S. and foreign controlled studies, the frequency of serious adverse reactions reported was very low. Of 702 patients, 11.8% reported adverse reactions and in only 1.5% was glipizide discontinued. Hypoglycemia: See PRECAUTIONS and OVERDOSAGE sections.

Gastrointestinal: Gastrointestinal disturbances are the most common reactions. Gastrointestinal complaints were reported with the following approximate incidence: nausea and diarrhea, one in seventy; constipation and gastralgia, one in one hundred. They appear to be dose-related and may disappear on division or reduction of dosage.

Cholestatic jaundice may occur rarely with sulfonylureas: Glipizide should be discontinued if this occurs. Dermatologic: Allergic skin reactions including erythema, morbilliform or maculopapular eruptions, urticaria, pruritus, and eczema have been reported in about one in seventy patients. These may be transient and may disappear despite continued use of glipizide; if skin reactions persist, the drug should be discontinued.

Porphyria cutanea tarda and photosensitivity reactions have been reported with sulfonylureas. Hematologic: Leukopenia, agranulocytosis, thrombocytopenia, hemolytic anemia (see PRECAUTIONS ), aplastic anemia, and pancytopenia have been reported with sulfonylureas. Metabolic: Hepatic porphyria and disulfiram-like reactions have been reported with sulfonylureas.

In the mouse, glipizide pretreatment did not cause an accumulation of acetaldehyde after ethanol administration. Clinical experience to date has shown that glipizide has an extremely low incidence of disulfiram-like alcohol reactions. Endocrine Reactions: Cases of hyponatremia and the syndrome of inappropriate antidiuretic hormone (SIADH) secretion have been reported with this and other sulfonylureas.

Miscellaneous: Dizziness, drowsiness, and headache have each been reported in about one in fifty patients treated with glipizide. They are usually transient and seldom require discontinuance of therapy. Laboratory Tests: The pattern of laboratory test abnormalities observed with glipizide was similar to that for other sulfonylureas.

Occasional mild to moderate elevations of SGOT, LDH, alkaline phosphatase, BUN, and creatinine were noted. One case of jaundice was reported. The relationship of these abnormalities to glipizide is uncertain, and they have rarely been associated with clinical symptoms.

Postmarketing Experience The following adverse events have been reported in postmarketing surveillance: Hepatobiliary: Cholestatic and hepatocellular forms of liver injury accompanied by jaundice have been reported rarely in association with glipizide; glipizide should be discontinued if this occurs. To report SUSPECTED ADVERSE EVENTS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch for voluntary reporting of adverse reactions.

🆘 Overdosage 195 words ▾

OVERDOSAGE There is no well documented experience with glipizide overdosage. The acute oral toxicity was extremely low in all species tested (LD 50 greater than 4 g/kg). Overdosage of sulfonylureas, including glipizide, can produce hypoglycemia.

Mild hypoglycemic symptoms without loss of consciousness or neurologic 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.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Mechanism of Action: The primary mode of action of glipizide in experimental animals appears to be the stimulation of insulin secretion from the beta cells of pancreatic islet tissue and is thus dependent on functioning beta cells in the pancreatic islets. In humans, glipizide appears to lower the blood glucose acutely by stimulating the release of insulin from the pancreas, an effect dependent upon functioning beta cells in the pancreatic islets. 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. The insulinotropic response to a meal occurs within 30 minutes after an oral dose of glipizide in diabetic patients, but elevated insulin levels do not persist beyond the time of the meal challenge.

Extrapancreatic effects may play a part in the mechanism of action of oral sulfonylurea hypoglycemic drugs. Blood sugar control persists in some patients for up to 24 hours after a single dose of glipizide, even though plasma levels have declined to a small fraction of peak levels by that time (see Pharmacokinetics below). Some patients fail to respond initially, or gradually lose their responsiveness to sulfonylurea drugs, including glipizide.

Alternatively, glipizide may be effective in some patients who have not responded or have ceased to respond to other sulfonylureas. Other Effects: It has been shown that glipizide therapy was effective in controlling blood sugar without deleterious changes in the plasma lipoprotein profiles of patients treated for NIDDM. In a placebo-controlled, crossover study in normal volunteers, glipizide had no antidiuretic activity and, in fact, led to a slight increase in free water clearance.

Pharmacokinetics: Gastrointestinal absorption of glipizide in man is uniform, rapid, and essentially complete. Peak plasma concentrations occur 1 to 3 hours after a single oral dose. The half-life of elimination ranges from 2 to 4 hours in normal subjects, whether given intravenously or orally.

The metabolic and excretory patterns are similar with the two routes of administration, indicating that first-pass metabolism is not significant. 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.

Thus, glipizide was more effective when administered about 30 minutes before, rather than with, a test meal in diabetic patients. Protein binding was studied in serum from volunteers who received either oral or intravenous glipizide and found to be 98 to 99% one 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 autoradiographically in the brain or spinal cord of males or females, nor in the fetuses of pregnant females. In another study, however, very small amounts of radioactivity were detected in the fetuses of rats given labelled drug. The metabolism of glipizide is extensive and occurs mainly in the liver.

The primary metabolites are inactive hydroxylation products and polar conjugates and are excreted mainly in the urine. Less than 10% unchanged glipizide is found in the urine.

📦 How Supplied / Storage and Handling 89 words ▾

HOW SUPPLIED Glipizide tablets USP, 10 mg are white, scored, round tablets debossed with Watson 461 and are available in bottles of 30 (NDC 51655-810-52), 60 (NDC 51655-810-25) and 90 (NDC 51655-810-26). Bottles of 100 are supplied with child-resistant closures. Store below 30°C (86°F).

Dispense in a tight container as defined in the USP. Keep this and all medication out of the reach of children. Manufactured In India By: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev.

C 12/2023

📋 Description 117 words ▾

DESCRIPTION Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazine-carboxamido) ethyl]phenyl]sulfonyl]urea. The molecular formula is C 21 H 27 N 5 O 4 S; the molecular weight is 445.55; the structural formula is shown below: Glipizide, USP is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in

0.1N NaOH; it is freely soluble in dimethylformamide. Each tablet, for oral administration, contains 5 mg or 10 mg glipizide, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide; croscarmellose sodium; lactose anhydrous; microcrystalline cellulose; pregelatinized starch 1500 (maize) and stearic acid. Structural formula of glipizide

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.