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Metformin Hydrochloride 500 mg Tablet, Film Coated, 100-count — NDC 24658-0790-01 package photo

Metformin Hydrochloride 500 mg Tablet, Film Coated, 100-count

by PuraCap Laboratories LLC dba Blu Pharmaceuticals · 100 TABLET, FILM COATED in 1 BOTTLE (24658-790-01)
NDC 24658-0790-01
🏷️ FDA NDC (as labeled) 24658-790-01 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$0.0170 NADAC Per package$1.70 / 100 tablets Pack sizes2 compare ↓
Also priced by: Part D plans $0.0671/unit — full pricing hub ↓
Also comes in: 1000 tablets 24658-0790-10
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

⚠️
Other active recalls for Metformin Hydrochloride (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 13, 2025 — CGMP Deviations (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0328-2025
Class II · Feb 25, 2025 — Presence of Foreign Tablets/Capsules. (A-S Medication Solutions LLC) · FDA recall D-0292-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 24658-790-01
Product NDC 24658-790
11-digit billing NDC 24658079001
NCPDP billing unit EA — each (per item)
RxCUI 861004, 861007, 861010
UNII 786Z46389E
UPC 0324658792057, 0324658790015, 0324658791050
Application # ANDA075965
SPL Set ID 5c2581e3-2b30-4da5-8bed-228173ca20d2
Established class (EPC) Biguanide
Chemical class Biguanides
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-04-01
Route ORAL
Dosage form TABLET, FILM COATED
Substance METFORMIN HYDROCHLORIDE
GPI-14 27250050000320
GPI class metFORMIN HCl
GCN Seq No 013318
GCN 10810
HICL code 004763
Ingredient (HICL) Metformin Hcl
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C4
Therapeutic class — intermediate (HIC2) Antihyperglycemics
HIC3 code C4L
Therapeutic class — specific (HIC3) Antihyperglycemic, Biguanide Type
AHFS code 68:20.04.00
AHFS class Biguanides
FDB label name METFORMIN HCL 500 MG TABLET
FDB brand name Metformin Hcl
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 24658-790-01 — 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 → 24658-0790-01. 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 Biguanide class.

Pharmacologic class Biguanide
Drug family (ATC) Biguanides
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

LabelerPuraCap Laboratories LLC dba Blu Pharmaceuticals
Application holderEPIC PHARMA LLC
FDA applicationANDA075965 (ANDA)
Labeler code24658
First marketedApr 2016
Product typeHuman Prescription Drug
Portfolio36 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

Label name METFORMIN HCL 500 MG TABLET Ingredient Metformin Hcl
📖 What it is MedlinePlus · NLM

Metformin is used alone or with other medications, including insulin, 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). Metformin is in a class of drugs called biguanides. Metformin helps to control the amount of glucose (sugar) in your blood. It decreases the amount of glucose you absorb from your food and the amount of glucose made by your liver. Metformin also increases your body's response to insulin, a natural substance that controls the amount of glucose in the blood. Metformin is not used...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Metformin works in three ways: it lowers the amount of sugar your liver dumps into your bloodstream, slows how much sugar your gut absorbs from food, and helps your body respond to...
  • What exactly is metformin doing for my diabetes?
  • Yes, this is very common — diarrhea, nausea, and stomach discomfort are the most frequently reported side effects, and they're often worst when you first start or when your dose go...
  • My stomach has been a mess since I started metformin. Is that normal? Will it get better?
📖 Read our full Metformin guide →
4
Nutrient depletion considerations

Metformin Hydrochloride may be associated with lower levels of 4 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Metformin Hydrochloride 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
ImprintE221
Size19 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 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • 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.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • 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.
  • 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.

5 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 eaPer package
Retail pharmacies payNADAC · weekly $0.017 $1.70 / 100 tablets
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 $0.0671 $6.71 / 100 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Mar 2022 Jul 2022 Nov 2022 $0.018 $0.015
▲ Up 6% over the last 12 months.
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
Metformin Hydrochloride 500 mg 71093-0132-04 ACI 100 tablets $0.014 AB Availability likely save 18%
Metformin Hydrochloride 500 mg 00378-7185-05 Mylan 500 tablets $0.014 AB Availability likely save 16%
Metformin Hydrochloride 500 mg 00904-7162-61 Major 100 tablets $0.014 AB Availability likely save 16%
Metformin Hydrochloride 500 mg 23155-0841-01 Heritage 100 tablets $0.014 AB Availability likely save 16%
Metformin Hydrochloride 500 mg 42385-0947-01 Laurus 100 tablets $0.014 AB Availability likely save 16%
Metformin HCl 500 mg 49483-0622-01 TIME 100 tablets $0.014 AB Availability likely save 16%
Metformin Hydrochloride 500 mg 59651-0854-01 Aurobindo 100 tablets $0.014 AB Availability likely save 16%
Metformin Hydrochloride 500 mg 60687-0155-01 American 1 tablet $0.014 AB Availability likely save 16%
Metformin Hydrochloride 500 mg 62135-0680-05 Chartwell 500 tablets $0.014 AB Availability likely save 16%
Metformin Hydrochloride 500 mg 65862-0008-01 Aurobindo 100 tablets $0.014 AB Availability likely save 16%
Metformin HCl 500 mg 67877-0561-01 Ascend 100 tablets $0.014 AB Availability likely save 16%
Metformin Hydrochloride 500 mg 67877-0930-01 Ascend 100 tablets $0.014 AB Availability likely save 16%
Metformin Hydrochloride 500 mg 68094-0688-60 Precision 500 tablets $0.014 AB Availability likely save 16%
Metformin Hydrochloride 500 mg 68382-0758-01 Zydus 100 tablets $0.014 AB Availability likely save 16%
Metformin hydrochloride 500 mg 68645-0582-59 Legacy 60 tablets $0.014 AB Availability likely save 16%
Metformin Hydrochloride 500 mg 69367-0180-01 Westminster 100 tablets $0.014 AB Availability likely save 16%
Metformin Hydrochloride 500 mg 69367-0381-01 Westminster 100 tablets $0.014 AB Availability likely save 16%
Metformin Hydrochloride 500 mg 70010-0063-01 Granules 100 tablets $0.014 AB Availability likely save 16%
Metformin Hydrochloride 500 mg 82009-0046-10 Quallent 1000 tablets $0.014 AB Availability likely save 16%
Metformin Hydrochloride 500 mg 82009-0174-10 Quallent 1000 tablets $0.014 AB Availability likely save 16%
Metformin Hydrochloride 500 mg 83301-0008-01 Mullan 100 tablets $0.014 AB Availability likely save 16%
Metformin Hydrochloride 500 mgthis 24658-0790-01 PuraCap 100 tablets $0.017 AB FDA listed —
Metformin Hydrochloride 500 mg 00615-8015-05 NCS 15 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 00615-8629-05 NCS 15 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 25000-0134-03 MARKSANS 30 tablets — AB FDA listed —
Metformin hydrochloride 500 mg 33342-0141-10 Macleods 90 tablets — — FDA listed —
Metformin HCl 500 mg 42708-0009-60 QPharma, 60 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 42806-0313-01 Epic 100 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 43063-0527-14 PD-Rx 14 tablets — — FDA listed —
Metformin Hydrochloride 500 mg 43353-0982-30 Aphena 30 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 50090-2081-00 A-S 60 tablets — AB FDA listed —
Metformin HCl 500 mg 50090-3064-00 A-S 60 tablets — AB FDA listed —
Metformin HCl 500 mg 50090-4891-00 A-S 90 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 50090-6485-00 A-S 90 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 50090-6858-00 A-S 60 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 50090-6859-00 A-S 90 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 50090-7010-00 A-S 60 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 50090-7011-00 A-S 100 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 50090-7013-00 A-S 100 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 50090-7278-00 A-S 60 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 50090-7280-00 A-S 90 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 50090-7595-00 A-S 60 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 50090-7597-00 A-S 90 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 50228-0105-00 ScieGen 9000 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 51655-0556-25 Northwind 60 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 53746-0218-01 Amneal 100 tablets — — FDA listed —
Metformin Hydrochloride 500 mg 55154-4172-00 Cardinal 10 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 60429-0111-01 Golden 100 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 62207-0440-43 Granules 100 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 63187-0238-90 Proficient 90 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 63629-8501-01 Bryant 500 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 63629-8502-01 Bryant 100 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 67046-0298-03 Coupler 30 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 67046-1594-03 Coupler 30 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 67877-0217-01 Ascend 100 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 68071-3518-08 NuCare 180 tablets — AB FDA listed —
Metformin HCl 500 mg 68071-3541-06 NuCare 60 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 68071-3739-01 NuCare 100 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 68071-3900-06 NuCare 60 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 68788-4076-01 Preferred 100 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 68788-8498-01 Preferred 100 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 68788-8564-01 Preferred 100 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 68788-8652-01 Preferred 100 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 70518-1149-01 REMEDYREPACK 1 tablet — AB Discontinued —
Metformin Hydrochloride 500 mg 70518-1951-01 REMEDYREPACK 30 tablets — AB Discontinued —
Metformin Hydrochloride 500 mg 70518-2833-00 REMEDYREPACK 30 tablets — AB FDA listed —
Metformin HCl 500 mg 70882-0124-56 Cambridge 56 tablets — AB Discontinued —
Metformin HCl 500 mg 71205-0562-00 Proficient 100 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 71205-0622-30 Proficient 30 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 71205-0784-30 Proficient 30 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 71205-0882-00 Proficient 100 tablets — AB FDA listed —
Metformin HCl 500 mg 71335-1072-00 Bryant 25 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 71335-1834-00 Bryant 25 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 71335-2224-00 Bryant 25 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 71335-2466-00 Bryant 25 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 71335-3132-00 Bryant 25 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 71610-0917-30 Aphena 30 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 71610-0920-53 Aphena 60 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 71610-0929-30 Aphena 30 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 71709-0110-06 Metcure 500 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 72162-1522-01 Bryant 100 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 72189-0219-30 direct 30 tablets — AB FDA listed —
Metformin HCL 500 mg 72189-0617-30 Direct_Rx 30 tablets — AB FDA listed —
Metformin HCL 500 mg 72189-0658-30 Direct_Rx 30 tablets — AB FDA listed —
Metformin HCl 500 mg 72789-0192-20 PD-Rx 20 tablets — AB FDA listed —
Metformin HCl 500 mg 72789-0531-42 PD-Rx 42 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 72789-0561-20 PD-Rx 20 tablets — AB FDA listed —
Metformin HCl 500 mg 82868-0049-90 Northwind 90 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 65841-0809-01 Zydus 100 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 70518-4698-00 REMEDYREPACK 30 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 68071-5306-08 NuCare 180 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 82804-0309-78 Proficient 180 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 42708-0203-60 QPharma,Inc. 60 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 50090-8041-00 A-S 60 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 50090-8043-00 A-S 90 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

🏛️
2016
On the market since
Apr 2016
📍
2026
Currently FDA-listed
10 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.

🔬 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 Metformin hydrochloride — the ingredient across all brands.

Top reported reactions

Diarrhoea6,315
Nausea5,349
Lactic Acidosis5,184
Fatigue4,441
Acute Kidney Injury4,285
Blood Glucose Increased4,045
Vomiting3,924

Reporter sex

0 reports

Serious outcomes

Hospitalization33,199
Life-threatening6,855
Disabling2,592
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 8,466 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 Per unit Per pack Marketing startStatus
24658-0790-01 You're viewing this 100 TABLET, FILM COATED in 1 BOTTLE (24658-790-01) $0.0170 / ea $1.70 2016-04-01 Active
24658-0790-10 1000 TABLET, FILM COATED in 1 BOTTLE (24658-790-10) — — 2016-04-01 Active

You're viewing the smallest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 24658-0790-01?
NDC 24658-0790-01 is a 100-count package — 100 tablet, film coated in 1 bottle.
What is the difference between NDC 24658-0790-01 and NDC 24658-0790-10?
Both are Metformin Hydrochloride 500 mg Tablet, Film Coated — the drug itself is identical. NDC 24658-0790-01 is the 100-count package, while NDC 24658-0790-10 is the 1000 tablets package.
What NDC number is used to bill for this package of Metformin Hydrochloride 500 mg Tablet, Film Coated?
Bill NDC 24658-0790-01 — the 11-digit billing format is 24658079001. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

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.

📄 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.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🚨 Boxed Warning ~3 min read ▾

LACTIC ACIDOSIS Lactic acidosis is a rare, but serious, metabolic complication that can occur due to metformin accumulation during treatment with metformin; when it occurs, it is fatal in approximately 50% of cases. Lactic acidosis may also occur in association with a number of pathophysiologic conditions, including diabetes mellitus, and whenever there is significant tissue hypoperfusion and hypoxemia. Lactic acidosis is characterized by elevated blood lactate levels (>5 mmol/L), decreased blood pH, electrolyte disturbances with an increased anion gap, and an increased lactate/pyruvate ratio.

When metformin is implicated as the cause of lactic acidosis, metformin plasma levels > 5 µg/mL are generally found. The reported incidence of lactic acidosis in patients receiving metformin hydrochloride is very low (approximately 0.03 cases/1000 patient-years, with approximately 0.015 fatal cases/1000 patient-years). In more than 20,000 patient-years exposure to metformin in clinical trials, there were no reports of lactic acidosis.

Reported cases have occurred primarily in diabetic patients with significant renal insufficiency, including both intrinsic renal disease and renal hypoperfusion, often in the setting of multiple concomitant medical/surgical problems and multiple concomitant medications. Patients with congestive heart failure requiring pharmacologic management, in particular those with unstable or acute congestive heart failure who are at risk of hypoperfusion and hypoxemia are at increased risk of lactic acidosis. The risk of lactic acidosis increases with the degree of renal dysfunction and the patient’s age.

The risk of lactic acidosis may, therefore, be significantly decreased by regular monitoring of renal function in patients taking metformin and by use of the minimum effective dose of metformin. In particular, treatment of the elderly should be accompanied by careful monitoring of renal function. Metformin treatment should not be initiated in patients ≥ 80 years of age unless measurement of creatinine clearance demonstrates that renal function is not reduced, as these patients are more susceptible to developing lactic acidosis.

In addition, metformin should be promptly withheld in the presence of any condition associated with hypoxemia, dehydration or sepsis. Because impaired hepatic function may significantly limit the ability to clear lactate, metformin should generally be avoided in patients with clinical or laboratory evidence of hepatic disease. Patients should be cautioned against excessive alcohol intake, either acute or chronic, when taking metformin hydrochloride tablets, since alcohol potentiates the effects of metformin hydrochloride on lactate metabolism.

In addition, metformin should be temporarily discontinued prior to any intravascular radiocontrast study and for any surgical procedure (see also PRECAUTIONS ). The onset of lactic acidosis often is subtle, and accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, increasing somnolence and nonspecific abdominal distress. There may be associated hypothermia, hypotension and resistant bradyarrhythmias with more marked acidosis.

The patient and the patient’s physician must be aware of the possible importance of such symptoms and the patient should be instructed to notify the physician immediately if they occur (see also PRECAUTIONS ). Metformin hydrochloride tablets should be withdrawn until the situation is clarified. Serum electrolytes, ketones, blood glucose and, if indicated, blood pH, lactate levels and even blood metformin levels may be useful.

Once a patient is stabilized on any dose level of metformin, gastrointestinal symptoms, which are common during initiation of therapy, are unlikely to be drug related. Later occurrence of gastrointestinal symptoms could be due to lactic acidosis or other serious disease. Levels of fasting venous plasma lactate above the upper limit of normal but less than 5 mmol/L in patients…

🎯 Indications and Usage 53 words ▾

INDICATIONS AND USAGE Metformin hydrochloride tablets USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus. Metformin hydrochloride tablets USP 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 hyperglycemia in patients with type 2 diabetes with metformin or any other pharmacologic agent. Dosage of metformin must be individualized on the basis of both effectiveness and tolerance, while not exceeding the maximum recommended daily dose. The maximum recommended daily dose of metformin hydrochloride tablets is 2550 mg in adults and 2000 mg in pediatric patients (10 to 16 years of age).

Metformin should be given in divided doses with meals and should be started at a low dose, with gradual dose escalation, both to reduce gastrointestinal side effects and to permit identification of the minimum dose required for adequate glycemic control of the patient. During treatment initiation and dose titration (see Recommended Dosing Schedule ), fasting plasma glucose should be used to determine the therapeutic response to metformin and identify the minimum effective dose for the patient. Thereafter, glycosylated hemoglobin should be measured at intervals of approximately three months.

The therapeutic goal should be to decrease both fasting plasma glucose and glycosylated hemoglobin levels to normal or near normal by using the lowest effective dose of metformin hydrochloride tablets, either when used as monotherapy or in combination with sulfonylurea or insulin. Monitoring of blood glucose and glycosylated hemoglobin will also permit detection of primary failure, i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication, and secondary failure, i.e., loss of an adequate blood glucose lowering response after an initial period of effectiveness.

Short-term administration of metformin may be sufficient during periods of transient loss of control in patients usually well-controlled on diet alone. Recommended Dosing Schedule Adults In general, clinically significant responses are not seen at doses below 1500 mg per day. However, a lower recommended starting dose and gradually increased dosage is advised to minimize gastrointestinal symptoms.

The usual starting dose of metformin hydrochloride tablets is 500 mg twice a day or 850 mg once a day, given with meals. Dosage increases should be made in increments of 500 mg weekly or 850 mg every 2 weeks, up to a total of 2000 mg per day, given in divided doses. Patients can also be titrated from 500 mg twice a day to 850 mg twice a day after 2 weeks.

For those patients requiring additional glycemic control, metformin may be given to a maximum daily dose of 2550 mg per day. Doses above 2000 mg may be better tolerated given three times a day with meals. Pediatrics The usual starting dose of metformin tablets is 500 mg twice a day, given with meals.

Dosage increases should be made in increments of 500 mg weekly up to a maximum of 2000 mg per day, given in divided doses. Transfer from Other Antidiabetic Therapy When transferring patients from standard oral hypoglycemic agents other than chlorpropamide to metformin, no transition period generally is necessary. When transferring patients from chlorpropamide, care should be exercised during the first two weeks because of the prolonged retention of chlorpropamide in the body, leading to overlapping drug effects and possible hypoglycemia.

Concomitant Metformin and Oral Sulfonylurea Therapy in Adult Patients If patients have not responded to four weeks of the maximum dose of metformin HCl monotherapy, consideration should be given to gradual addition of an oral sulfonylurea while continuing metformin HCl tablets at the maximum dose, even if prior primary or secondary failure to a sulfonylurea has occurred. Clinical and pharmacokinetic drug-drug interaction data are currently available only for metformin plus glyburide (glibenclamide). With concomitant metformin HCl and sulfonylurea therapy, the desired control of blood glucose may be obtained by adjusting the dose of each drug.

In a clinical trial of patients with type 2 diabetes and prior failure o…

⛔ Contraindications 113 words ▾

CONTRAINDICATIONS Metformin hydrochloride tablets are contraindicated in patients with: 1. Renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels ≥1.5 mg/dL [males], ≥1.4 mg/dL [females] or abnormal creatinine clearance) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia (see WARNINGS and PRECAUTIONS ). 2.

Known hypersensitivity to metformin hydrochloride. 3. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.

Diabetic ketoacidosis should be treated with insulin. Metformin should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function. (See also PRECAUTIONS .)

⚠️ Warnings ~3 min read ▾

WARNINGS LACTIC ACIDOSIS Lactic acidosis is a rare, but serious, metabolic complication that can occur due to metformin accumulation during treatment with metformin; when it occurs, it is fatal in approximately 50% of cases. Lactic acidosis may also occur in association with a number of pathophysiologic conditions, including diabetes mellitus, and whenever there is significant tissue hypoperfusion and hypoxemia. Lactic acidosis is characterized by elevated blood lactate levels (>5 mmol/L), decreased blood pH, electrolyte disturbances with an increased anion gap, and an increased lactate/pyruvate ratio.

When metformin is implicated as the cause of lactic acidosis, metformin plasma levels > 5 µg/mL are generally found. The reported incidence of lactic acidosis in patients receiving metformin hydrochloride is very low (approximately 0.03 cases/1000 patient-years, with approximately 0.015 fatal cases/1000 patient-years). In more than 20,000 patient-years exposure to metformin in clinical trials, there were no reports of lactic acidosis.

Reported cases have occurred primarily in diabetic patients with significant renal insufficiency, including both intrinsic renal disease and renal hypoperfusion, often in the setting of multiple concomitant medical/surgical problems and multiple concomitant medications. Patients with congestive heart failure requiring pharmacologic management, in particular those with unstable or acute congestive heart failure who are at risk of hypoperfusion and hypoxemia are at increased risk of lactic acidosis. The risk of lactic acidosis increases with the degree of renal dysfunction and the patient’s age.

The risk of lactic acidosis may, therefore, be significantly decreased by regular monitoring of renal function in patients taking metformin and by use of the minimum effective dose of metformin. In particular, treatment of the elderly should be accompanied by careful monitoring of renal function. Metformin treatment should not be initiated in patients ≥ 80 years of age unless measurement of creatinine clearance demonstrates that renal function is not reduced, as these patients are more susceptible to developing lactic acidosis.

In addition, metformin should be promptly withheld in the presence of any condition associated with hypoxemia, dehydration or sepsis. Because impaired hepatic function may significantly limit the ability to clear lactate, metformin should generally be avoided in patients with clinical or laboratory evidence of hepatic disease. Patients should be cautioned against excessive alcohol intake, either acute or chronic, when taking metformin hydrochloride tablets, since alcohol potentiates the effects of metformin hydrochloride on lactate metabolism.

In addition, metformin should be temporarily discontinued prior to any intravascular radiocontrast study and for any surgical procedure (see also PRECAUTIONS ). The onset of lactic acidosis often is subtle, and accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, increasing somnolence and nonspecific abdominal distress. There may be associated hypothermia, hypotension and resistant bradyarrhythmias with more marked acidosis.

The patient and the patient’s physician must be aware of the possible importance of such symptoms and the patient should be instructed to notify the physician immediately if they occur (see also PRECAUTIONS ). Metformin hydrochloride tablets should be withdrawn until the situation is clarified. Serum electrolytes, ketones, blood glucose and, if indicated, blood pH, lactate levels and even blood metformin levels may be useful.

Once a patient is stabilized on any dose level of metformin, gastrointestinal symptoms, which are common during initiation of therapy, are unlikely to be drug related. Later occurrence of gastrointestinal symptoms could be due to lactic acidosis or other serious disease. Levels of fasting venous plasma lactate above the upper limit of normal but less than 5 mmol/L in…

🤒 Adverse Reactions 207 words ▾

ADVERSE REACTIONS In a U.S. double-blind clinical study of metformin in patients with type 2 diabetes, a total of 141 patients received metformin therapy (up to 2550 mg per day) and 145 patients received placebo. Adverse reactions reported in greater than 5% of the metformin patients, and that were more common in metformin - than placebo-treated patients, are listed in Table 7 . Table 7: Most Common Adverse Reactions (>5.0%) in a Placebo-Controlled Clinical Study of Metformin Monotherapy a Metformin Monotherapy (n=141) Placebo (n=145) Adverse Reaction % of Patients Diarrhea 53.2

11.7Nausea/Vomiting 25.5

8.3Flatulence 12.1

5.5Asthenia 9.2

5.5Indigestion 7.1

4.1Abdominal Discomfort 6.4

4.8Headache 5.7 4.8 a Reactions that were more common in metformin - than placebo-treated patients. Diarrhea led to discontinuation of study medication in 6% of patients treated with metformin. Additionally, the following adverse reactions were reported in ≥1.0 to ≤ 5.0% of metformin patients and were more commonly reported with metformin than placebo: abnormal stools, hypoglycemia, myalgia, lightheaded, dyspnea, nail disorder, rash, sweating increased, taste disorder, chest discomfort, chills, flu syndrome, flushing, palpitation.

Pediatric Patients In clinical trials with metformin in pediatric patients with type 2 diabetes, the profile of adverse reactions was similar to that observed in adults.

🤰 Pregnancy 134 words ▾

Pregnancy Teratogenic Effects Pregnancy Category B: Recent information strongly suggests that abnormal blood glucose levels during pregnancy are associated with a higher incidence of congenital abnormalities. Most experts recommend that insulin be used during pregnancy to maintain blood glucose levels as close to normal as possible. Because animal reproduction studies are not always predictive of human response, metformin should not be used during pregnancy unless clearly needed.

There are no adequate and well-controlled studies in pregnant women with metformin. Metformin was not teratogenic in rats and rabbits at doses up to 600 mg/kg/day. This represents an exposure of about two and six times the maximum recommended human daily dose of 2000 mg based on body surface area comparisons for rats and rabbits, respectively.

Determination of fetal concentrations demonstrated a partial placental barrier to metformin.

🧒 Pediatric Use 138 words ▾

Pediatric Use The safety and effectiveness of metformin for the treatment of type 2 diabetes have been established in pediatric patients ages 10 to 16 years (studies have not been conducted in pediatric patients below the age of 10 years). Use of metformin in this age group is supported by evidence from adequate and well-controlled studies of metformin in adults with additional data from a controlled clinical study in pediatric patients ages 10 to 16 years with type 2 diabetes, which demonstrated a similar response in glycemic control to that seen in adults (See CLINICAL PHARMACOLOGY, Pediatric Clinical Studies . ) In this study, adverse effects were similar to those described in adults.

(See ADVERSE REACTIONS, Pediatric Patients . ) A maximum daily dose of 2000 mg is recommended. (See DOSAGE ANDADMINISTRATION, Recommended Dosing Schedule, Pediatrics . )

🧓 Geriatric Use 149 words ▾

Geriatric Use Controlled clinical studies of metformin hydrochloride tablets did not include sufficient numbers of elderly patients to determine whether they respond differently from younger patients, although other reported clinical experience has not identified differences in responses between the elderly and younger patients. Metformin is known to be substantially excreted by the kidney and because the risk of serious adverse reactions to the drug is greater in patients with impaired renal function, metformin should only be used in patients with normal renal function (see CONTRAINDICATIONS , WARNINGS and CLINICAL PHARMACOLOGY, Pharmacokinetics ).

Because aging is associated with reduced renal function, metformin should be used with caution as age increases. Care should be taken in dose selection and should be based on careful and regular monitoring of renal function. Generally, elderly patients should not be titrated to the maximum dose of metformin (see also WARNINGS and DOSAGE AND ADMINISTRATION ).

🆘 Overdosage 81 words ▾

OVERDOSAGE Overdose of metformin hydrochloride has occurred, including ingestion of amounts greater than 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 ~3 min read ▾

CLINICAL PHARMACOLOGY Mechanism of Action Metformin is an antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose. Its pharmacologic mechanisms of action are different from other classes of oral antihyperglycemic agents. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.

Unlike sulfonylureas, metformin does not produce hypoglycemia in either patients with type 2 diabetes or normal subjects (except in special circumstances, see PRECAUTIONS ) and does not cause hyperinsulinemia. With metformin therapy, insulin secretion remains unchanged while fasting insulin levels and day-long plasma insulin response may actually decrease. Pharmacokinetics Absorption and Bioavailability he absolute bioavailability of a metformin hydrochloride 500 mg tablet given under fasting conditions is approximately 50% to 60%.

Studies using single oral doses of metformin tablets of 500 mg to 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 mean peak plasma concentration (C max ) and 25% lower area under the plasma concentration versus time curve (AUC), and a 35-minute prolongation of time to peak plasma concentration (T max ) 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 The apparent volume of distribution (V/F) of metformin following single oral doses of 850 mg averaged 654 ± 358 L. Metformin is negligibly bound to plasma proteins, in contrast to sulfonylureas, which are more than 90% protein bound.

Metformin partitions into erythrocytes, most likely as a function of time. At usual clinical doses and dosing schedules of metformin hydrochloride tablets, steady state plasma concentrations of metformin are reached within 24 to 48 hours and are generally <1 µg/mL. During controlled clinical trials of metformin hydrochloride, maximum metformin plasma levels did not exceed 5 µg/mL, even at maximum doses.

Metabolism and Elimination Intravenous single-dose studies in normal subjects demonstrate that metformin is excreted unchanged in the urine and does not undergo hepatic metabolism (no metabolites have been identified in humans) nor biliary excretion. Renal clearance (see Table 1 ) is approximately 3.5 times greater than creatinine clearance which indicates that tubular secretion is the major route of metformin elimination. Following oral administration, approximately 90% of the absorbed drug is eliminated via the renal route within the first 24 hours, with a plasma elimination half-life of approximately 6.2 hours.

In blood, the elimination half-life is approximately 17.6 hours, suggesting that the erythrocyte mass may be a compartment of distribution. Special Populations Patients with Type 2 Diabetes In the presence of normal renal function, there are no differences between single- or multiple-dose pharmacokinetics of metformin between patients with type 2 diabetes and normal subjects (see Table 1 ), nor is there any accumulation of metformin in either group at usual clinical doses. Renal Insufficiency In patients with decreased renal function (based on measured creatinine clearance), the plasma and blood half-life of metformin is prolonged and the renal clearance is decreased in proportion to the decrease in creatinine clearance ( see Tablet 1; also see WARNINGS ,).

Hepatic Insufficiency No pharmacokinetic studies of metformin have been conducted in patients with hepatic insufficiency. Geriatrics Limited data from controlled pharmacokinetic st…

🧬 Mechanism of Action 108 words ▾

Mechanism of Action Metformin is an antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose. Its pharmacologic mechanisms of action are different from other classes of oral antihyperglycemic agents. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.

Unlike sulfonylureas, metformin does not produce hypoglycemia in either patients with type 2 diabetes or normal subjects (except in special circumstances, see PRECAUTIONS ) and does not cause hyperinsulinemia. With metformin therapy, insulin secretion remains unchanged while fasting insulin levels and day-long plasma insulin response may actually decrease.

📦 How Supplied / Storage and Handling 147 words ▾

HOW SUPPLIED Metformin Hydrochloride Tablets USP, for oral administration, are available as: 500 mg: white to off-white, round, biconvex, beveled edge, film-coated tablets, debossed “ E ” over “213” on one side and plain on the other side and supplied as: NDC 24658-790-01 Bottles of 100 NDC 24658-790-10 Bottles of 1000 850 mg: white to off-white, round, biconvex, beveled edge, film-coated tablets, debossed “ E ” over “215” on one side and plain on the other side and supplied as: NDC 24658-791-05 Bottles of 500 1000 mg: white to off-white, oval, biconvex, film-coated tablets, debossed “ E 221” on one side and bisected on both sides and supplied as: NDC 24658-792-05 Bottles of 500 Store at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature].

Dispense contents in a tight, light-resistant containers as defined in the USP with a child-resistant closure, as required.

📋 Description 140 words ▾

DESCRIPTION Metformin hydrochloride is an oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin hydrochloride (N, N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown: Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5•HCl 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.

Each metformin hydrochloride tablet USP, intended for oral administration, contains 500 mg or 850 mg or 1000 mg metformin hydrochloride. In addition, each metformin hydrochloride tablet USP contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, polyethylene glycol and povidone. metformin-structural-formula.jpg

💬 Information for Patients 220 words ▾

Information for Patients Patients should be informed of the potential risks and benefits of metformin and of alternative modes of therapy. They should also be informed about the importance of adherence to dietary instructions, of a regular exercise program, and of regular testing of blood glucose, glycosylated hemoglobin, renal function and hematologic parameters. The risks of lactic acidosis, its symptoms, and conditions that predispose to its development, as noted in the WARNINGS and PRECAUTIONS sections should be explained to patients.

Patients should be advised to discontinue metformin immediately and to promptly notify their health practitioner if unexplained hyperventilation, myalgia, malaise, unusual somnolence or other nonspecific symptoms occur. Once a patient is stabilized on any dose level of metformin, gastrointestinal symptoms, which are common during initiation of therapy, are unlikely to be drug related. Later occurrence of gastrointestinal symptoms could be due to lactic acidosis or other serious disease.

Patients should be counselled against excessive alcohol intake, either acute or chronic, while receiving metformin. Metformin hydrochloride tablets alone do not usually cause hypoglycemia, although it may occur when metformin is used in conjunction with oral sulfonylureas and insulin. When initiating combination therapy, the risks of hypoglycemia, its symptoms and treatment, and conditions that predispose to its development should be explained to patients and responsible family members.

(See Patient Information printed below.)

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 24658-0783-10 · PURACAP 24658-0791-05 · PuraCap →
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.