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Metformin Hydrochloride 1000 mg Tablet, Film Coated, 500-count — NDC 71709-0112-06 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Metformin Hydrochloride 1000 mg Tablet, Film Coated, 500-count — NDC 71709-112-06 (Billing 71709-0112-06)

by Metcure Pharmaceuticals, Inc. · 500 TABLET, FILM COATED in 1 BOTTLE

This is a package of 500 tablets of Metformin Hydrochloride 1000 mg Tablet, Film Coated from Metcure Pharmaceuticals, Inc., marketed since Nov 2017 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 71709-0112-06
🏷️ FDA NDC (as labeled) 71709-112-06 billing pads the product segment with a zero
This package
Contains500-count Pack sizes2 compare ↓
Also priced by: Part D plans $0.0671/unit — full pricing hub ↓
Main listing for product 71709-112 · Also comes in: 1000 tablets 71709-112-07
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 71709-112-06
Product NDC 71709-112
11-digit billing NDC 71709011206
NCPDP billing unit EA — each (per item)
RxCUI 861004, 861007, 861010
UNII 786Z46389E
UPC 0371709110063, 0371709111060
Application # ANDA090564
SPL Set ID 5df6adc9-79fd-66ef-e053-2991aa0a75ce
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 2017-11-14
Route ORAL
Dosage form TABLET, FILM COATED
Substance METFORMIN HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 27250050000350
GPI class metFORMIN HCl
GCN Seq No 040974
GCN 10857
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 1,000 MG TABLET
FDB brand name Metformin Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 040974
  • GCN: 10857
  • GPI-14 (Medi-Span): 27250050000350
  • HICL (First Databank): 004763
  • AHFS class code: 68:20.04.00
  • RxCUI (RxNorm): 861004
Why two NDCs? The FDA registers this code as 71709-112-06 — 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 → 71709-0112-06. 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.

Clinical

Label name METFORMIN HCL 1,000 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.

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 $0.0671 $33.55 / 500 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
71709-0112-06 You're viewing this Main listing 500 TABLET, FILM COATED in 1 BOTTLE 2017-11-14 — Active
71709-0112-07 71709-112-07 1000 TABLET, FILM COATED in 1 BOTTLE 2017-11-14 — Active

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

Pack size FAQ

What quantity is in this package?
This is a 500-count package — 500 tablet, film coated in 1 bottle.
How does this package differ from NDC 71709-0112-07?
Both are Metformin Hydrochloride 1000 mg Tablet, Film Coated — the drug itself is identical. This page's package is the 500-count one, while NDC 71709-0112-07 is the 1000 tablets package.
What NDC number is used to bill for this package of Metformin Hydrochloride 1000 mg Tablet, Film Coated?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Metformin Hydrochloride 1000 mg 00378-7187-05 Mylan 500 tablets $0.023 AB Availability likely —
Metformin Hydrochloride 1000 mg 00904-7164-61 Major 100 tablets $0.023 AB Availability likely —
Metformin Hydrochloride 1000 mg 23155-0843-01 Heritage 100 tablets $0.023 AB Availability likely —
Metformin Hydrochloride 1000 mg 42385-0949-01 Laurus 100 tablets $0.023 AB Availability likely —
Metformin HCl 1000 mg 49483-0620-01 TIME 100 tablets $0.023 AB Availability likely —
Metformin Hydrochloride 1000 mg 60687-0162-01 American 1 tablet $0.023 AB Availability likely —
Metformin Hydrochloride 1000 mg 62135-0684-05 Chartwell 500 tablets $0.023 AB Availability likely —
Metformin Hydrochloride 1000 mg 65862-0010-01 Aurobindo 100 tablets $0.023 AB Availability likely —
Metformin HCl 1000 mg 67877-0563-01 Ascend 100 tablets $0.023 AB Availability likely —
Metformin Hydrochloride 1000 mg 68094-0480-60 Precision 500 tablets $0.023 AB Availability likely —
Metformin Hydrochloride 1000 mg 68382-0760-01 Zydus 100 tablets $0.023 AB Availability likely —
Metformin hydrochloride 1000 mg 68645-0584-59 Legacy 60 tablets $0.023 AB Availability likely —
Metformin Hydrochloride 1000 mg 69367-0182-01 Westminster 100 tablets $0.023 AB Availability likely —
Metformin Hydrochloride 1000 mg 69367-0383-01 Westminster 100 tablets $0.023 AB Availability likely —
Metformin Hydrochloride 1000 mg 70010-0065-01 Granules 100 tablets $0.023 AB Availability likely —
Metformin Hydrochloride 1000 mg 82009-0047-10 Quallent 1000 tablets $0.023 AB Availability likely —
Metformin Hydrochloride 1000 mg 82009-0175-10 Quallent 1000 tablets $0.023 AB Availability likely —
Metformin Hydrochloride 1000 mg 83301-0010-01 Mullan 100 tablets $0.023 AB Availability likely —
Metformin Hydrochloride 1000 mg 71093-0134-04 ACI 100 tablets $0.025 AB Availability likely —
Metformin Hydrochloride 1000 mg 00615-8578-05 NCS 15 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 24658-0792-05 PuraCap 500 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 25000-0132-03 MARKSANS 30 tablets — AB FDA listed —
Metformin hydrochloride 1000 mg 33342-0143-10 Macleods 90 tablets — — FDA listed —
Metformin HCl 1000 mg 42708-0018-30 QPharma, 30 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 42708-0202-30 QPharma 30 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 42806-0315-01 Epic 100 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 43063-0544-30 PD-Rx 30 tablets — — FDA listed —
Metformin Hydrochloride 1000 mg 43353-0987-30 Aphena 30 tablets — AB FDA listed —
Metformin HCl 1000 mg 50090-3579-00 A-S 60 tablets — AB FDA listed —
Metformin HCl 1000 mg 50090-4892-00 A-S 90 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 50090-5052-00 A-S 90 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 50090-6507-00 A-S 60 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 50090-6508-00 A-S 90 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 50090-6856-00 A-S 60 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 50090-6857-00 A-S 90 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 50090-7454-00 A-S 60 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 50090-7455-00 A-S 90 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 50090-7578-00 A-S 90 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 50090-7586-00 A-S 60 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 50090-7587-00 A-S 90 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 50090-7588-00 A-S 90 tablets — AB FDA listed —
Metformin HCl 1000 mg 50090-7750-00 A-S 90 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 50090-7866-00 A-S 90 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 50090-7868-00 A-S 90 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 50090-7877-00 A-S 60 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 50090-7878-00 A-S 90 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 50228-0107-00 ScieGen 100 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 51655-0566-25 Northwind 60 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 51655-0644-26 Northwind 90 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 51655-0649-26 Northwind 90 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 53746-0220-01 Amneal 100 tablets — — FDA listed —
Metformin HCl 1000 mg 55700-0669-30 Quality 30 tablets — AB Discontinued —
Metformin Hydrochloride 1000 mg 59651-0856-23 Aurobindo 2000 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 60429-0113-01 Golden 100 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 62207-0442-43 Granules 100 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 63187-0239-90 Proficient 90 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 63629-8503-01 Bryant 500 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 63629-8504-01 Bryant 100 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 65841-0811-01 Zydus 100 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 67046-1516-03 Coupler 30 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 67046-1554-03 Coupler, 30 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 67877-0221-01 Ascend 100 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 67877-0932-01 Ascend 100 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 68071-3526-01 NuCare 100 tablets — AB FDA listed —
Metformin HCl 1000 mg 68071-3697-01 NuCare 100 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 68071-3976-06 NuCare 60 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 68788-8430-01 Preferred 100 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 68788-8560-01 Preferred 100 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 68788-8600-01 Preferred 100 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 70518-3101-00 REMEDYREPACK 30 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 70518-3130-00 REMEDYREPACK 30 tablets — AB Discontinued —
Metformin Hydrochloride 1000 mg 70518-4262-00 REMEDYREPACK 180 tablets — AB FDA listed —
Metformin HCl 1000 mg 71205-0548-00 Proficient 100 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 71205-0555-00 Proficient 100 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 71205-0783-30 Proficient 30 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 71205-0884-00 Proficient 100 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 71335-1833-00 Bryant 1000 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 71335-2533-00 Bryant 1000 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 71610-0672-30 Aphena 30 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 71610-0673-30 Aphena 30 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 71610-0937-60 Aphena 90 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 71610-0941-60 Aphena 90 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mgthis 71709-0112-06 Metcure 500 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 72162-1523-01 Bryant 100 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 72189-0220-30 direct 30 tablets — AB FDA listed —
Metformin HCL 1000 mg 72189-0635-82 Direct_Rx 180 tablets — AB FDA listed —
Metformin HCl 1000 mg 72789-0189-21 PD-Rx 21 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 72789-0551-30 PD-Rx 30 tablets — AB FDA listed —
Metformin HCl 1000 mg 80425-0435-01 Advanced 30 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 87441-0054-01 Unit 30 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 80425-0591-01 Advanced 30 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 68071-5313-09 NuCare 90 tablets — AB FDA listed —
Metformin Hydrochloride 1000 mg 68788-4185-01 Preferred 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

🏛️
2017
On the market since
Nov 2017
📍
2026
Currently FDA-listed
9 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.

What it looks like

Color white
ShapeRound
ImprintG;10
Size11 mm
ScoringNot scored
FlavorBlackberry
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 0WZ8WG20P6
    Hypromellose 2910 is a plant-based cellulose derivative that acts as a thickener, binder, and film-coating agent. It helps control how quickly the medicine dissolves and protects the tablet or capsule from moisture and light.
  • 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 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
  • UNII B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII U725QWY32X
    Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
  • UNII RDH86HJV5Z
    Povidone K90 is a synthetic polymer made from a chemical called vinyl pyrrolidone. It acts as a binder to hold pill ingredients together and as a dispersant to help the medicine break down and dissolve properly in your body.
  • 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 XHX3C3X673
    Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.

8 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.

Manufacturer & labeler

LabelerMetcure Pharmaceuticals, Inc.
Application holderGRANULES INDIA LTD
FDA applicationANDA090564 (ANDA)
Labeler code71709
First marketedNov 2017
Product typeHuman Prescription Drug
Portfolio3 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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Patient Medication Information ⚠️ Precautions 🍼 Nursing Mothers 🧬 Pharmacokinetics 🔬 Clinical Studies 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 185 words ▾

WARNINGS WARNINGS: LACTIC ACIDOSIS: Postmarketing 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 μg/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, and hepatic impairment. Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided (see DOSAGE AND ADMINISTRATION , CONTRAINDICATIONS , and PRECAUTIONS ).

If metformin-associated lactic acidosis is suspected, immediately discontinue metformin hydrochloride tablets and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended (see PRECAUTIONS ).

🎯 Indications and Usage 28 words ▾

INDICATIONS AND USAGE Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children 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 hydrochloride tablets or any other pharmacologic agent. Dosage of metformin hydrochloride tablets must be individualized on the basis of both effectiveness and tolerance, while not exceeding the maximum recommended daily doses. 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 hydrochloride tablets should be given in divided doses with meals. Metformin hydrochloride tablets 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 hydrochloride tablets 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 hydrochloride tablets may be sufficient during periods of transient loss of control in patients usually well-controlled on diet alone. Recommended Dosing Schedule Adults – The usual starting dose of metformin hydrochloride tablets USP is 500 mg twice a day or 850 mg once a day, given with meals. In general, clinically significant responses are not seen at doses below 1500 mg per day.

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. The dosage of metformin hydrochloride tablets must be individualized on the basis of both effectiveness and tolerability. 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 hydrochloride tablets may be given to a maximum daily dose of 2550 mg per day. Doses above 2000 mg may be better tolerated given 3 times a day with meals. Pediatrics – The usual starting dose of metformin hydrochloride 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. The dosage of metformin hydrochloride tablets must be individualized on the basis of both effectiveness and tolerability. Recommendations for Use in Renal Impairment Assess renal function prior to initiation of metformin hydrochloride tablets and periodically thereafter.

Metformin hydrochloride tablets are contraindicated in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/minute/1.73 m2. Initiation of metformin hydrochloride tablets in patients with an eGFR between 30 to 45 mL/min/1.73 m2 is not recommended. In patients taking metformin hydrochloride tablets whose eGFR later falls below 45 mL/min/1.73 m2, assess the benefit risk of continuing therapy.

Discontinue metformin hydrochloride tablets if the patient's eGFR later falls below 30 mL/min/1.73 m2 (See WARNINGS and PRECAUTIONS ). Discontinuation for Iodinated Contrast Imaging Procedures Discontinue metformin hydrochloride tablets at the time of, or prior to, an iodinated co… [Excerpted — this section continues on DailyMed.]

⛔ Contraindications 47 words ▾

CONTRAINDICATIONS A Metformin hydrochloride tablets are contraindicated in patients with: Severe renal impairment (eGFR below 30 mL/min/1.73 m2) (see WARNINGS and PRECAUTIONS ). Known hypersensitivity to metformin hydrochloride. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin.

🤒 Adverse Reactions 179 words ▾

ADVERSE REACTIONS In a US double-blind clinical study of metformin hydrochloride tablets in patients with type 2 diabetes, a total of 141 patients received metformin hydrochloride tablets therapy (up to 2550 mg per day) and 145 patients received placebo. Adverse reactions reported in greater than 5% of the metformin hydrochloride tablets patients, and that were more common in metformin hydrochloride tablets - than placebo-treated patients, are listed in Table 11. Diarrhea led to discontinuation of study medication in 6% of patients treated with metformin hydrochloride tablets.

Additionally, the following adverse reactions were reported in ≥1.0 to ≤5.0% of metformin hydrochloride tablets patients and were more commonly reported with metformin hydrochloride tablets 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 hydrochloride tablets in pediatric patients with type 2 diabetes, the profile of adverse reactions was similar to that observed in adults.

To report SUSPECTED ADVERSE REACTIONS, please call Metcure Pharmaceuticals, Inc at 1-833-755-8327 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

👥 Use in Specific Populations 122 words ▾

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 TABLE 1; also see CONTRAINDICATIONS , WARNINGS , PRECAUTIONS and DOSAGE AND ADMINISTRATION).

DOSAGE AND ADMINISTRATION Hepatic Insufficiency No pharmacokinetic studies of metformin have been conducted in patients with hepatic insufficiency (see PRECAUTIONS ).

🤰 Pregnancy 138 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 hydrochloride tablets should not be used during pregnancy unless clearly needed.

There are no adequate and well-controlled studies in pregnant women with metformin hydrochloride tablets. 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 195 words ▾

Pediatrics After administration of a single oral metformin hydrochloride 500 mg tablet with food, geometric mean metformin Cmax and AUC differed less than 5% between pediatric type 2 diabetic patients (12 to 16 years of age) and gender- and weight-matched healthy adults (20 to 45 years of age), all with normal renal function.

Pediatric Use The safety and effectiveness of metformin hydrochloride tablets for the treatment of type 2 diabetes have been established in pediatric patient's ages 10 to 16 years (studies have not been conducted in pediatric patients below the age of 10 years). Use of metformin hydrochloride tablets in this age group is supported by evidence from adequate and well-controlled studies of metformin hydrochloride tablets 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 AND ADMINISTRATION : Recommended Dosing Schedule: Pediatrics)

🧓 Geriatric Use 181 words ▾

Geriatrics Limited data from controlled pharmacokinetic studies of metformin hydrochloride tablets in healthy elderly subjects suggest that total plasma clearance of metformin is decreased, the half-life is prolonged, and Cmax is increased, compared to healthy young subjects. From these data, it appears that the change in metformin pharmacokinetics with aging is primarily accounted for by a change in renal function (see TABLE 1; also see WARNINGS , PRECAUTIONS and DOSAGE AND ADMINISTRATION). DOSAGE AND ADMINISTRATION

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. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy and the higher risk of lactic acidosis.

Assess renal function more frequently in elderly patients (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 The 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 hydrochloride 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 (Cmax), a 25% lower area under the plasma concentration versus time curve (AUC), and a 35-minute prolongation of time to peak plasma concentration (Tmax) 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 metformin hydrochloride tablets 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 mcg/mL. During controlled clinical trials of metformin hydrochloride tablets, maximum metformin plasma levels did not exceed 5 mcg/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 TABLE 1; also see CONTRAINDICATIONS , WARNINGS , PRECAUTIONS and DOSAGE AND ADMINISTRATION).

DOSAGE AND ADMINISTRATION Hepatic Insufficiency No pharmacokinetic studies of m… [Excerpted — this section continues on DailyMed.]

🧬 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 158 words ▾

HOW SUPPLIED Metformin Hydrochloride Tablets, USP 500 mg - White to off-white, round, biconvex, film coated tablets debossed with G over 10 on one side and plain on the other side. Bottles of 500 NDC 71709-110-06 850 mg - White to off-white, round, biconvex, film coated tablets debossed with G over 11 on one side and plain on the other side. Bottles of 500 NDC 71709-111-06 1000 mg - White to off-white, oval, biconvex, scored, film coated tablets debossed with G and 12 on either side of the scoreline on one side and plain on the other side.

Bottles of 500 NDC 71709-112-06 Storage Store at 20°–25° C (68°–77° F); excursions permitted to 15°–30° C (59°–86° F). [See USP Controlled Room Temperature.] Dispense in tight, light-resistant containers with child-resistant closure. Distributed By: Metcure Pharmaceuticals, Inc 18 Campus Blvd., Suite 100 Newtown Square, PA 19073 Manufactured by: Granules India Limited Hyderabad-500081, INDIA MADE IN INDIA Jul 2017 M.L.No.: 37/RR/AP/2003/F/R

📦 Storage and Handling 55 words ▾

Storage Store at 20°–25° C (68°–77° F); excursions permitted to 15°–30° C (59°–86° F). [See USP Controlled Room Temperature.] Dispense in tight, light-resistant containers with child-resistant closure. Distributed By: Metcure Pharmaceuticals, Inc 18 Campus Blvd., Suite 100 Newtown Square, PA 19073 Manufactured by: Granules India Limited Hyderabad-500081, INDIA MADE IN INDIA Jul 2017 M.L.No.: 37/RR/AP/2003/F/R

📋 Description 146 words ▾

DESCRIPTION ​ Metformin Hydrochloride Tablets USP are oral antihyperglycemic drugs 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, USP 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.

Metformin hydrochloride tablets contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride. Each tablet contains the inactive ingredients povidone (K-30), povidone (K-90), pregelatinized starch, and magnesium stearate. In addition, the coating for the tablets contains artificial blackberry flavor, hypromellose and polyethylene glycol.

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💬 Information for Patients ~1 min read ▾

Information for Patients Patients should be informed of the potential risks and benefits of metformin hydrochloride tablets 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 hydrochloride tablets 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 hydrochloride tablets, gastrointestinal symptoms, which are common during initiation of Metformin 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 counseled against excessive alcohol intake, either acute or chronic, while receiving metformin hydrochloride tablets. Metformin hydrochloride tablets alone does not usually cause hypoglycemia, although it may occur when metformin hydrochloride tablets are 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.)

💬 Patient Medication Information ~3 min read ▾

PATIENT INFORMATION Metformin Hydrochloride Tablets, USP Read this information carefully before you start taking this medicine and each time you refill your prescription. There may be new information. This information does not take the place of your doctor's advice.

Ask your doctor or pharmacist if you do not understand some of this information or if you want to know more about this medicine. What are metformin hydrochloride tablets? Metformin hydrochloride tablets are used to treat type 2 diabetes.

This is also known as non-insulin-dependent diabetes mellitus. People with type 2 diabetes are not able to make enough insulin or respond normally to the insulin their bodies make. When this happens, sugar (glucose) builds up in the blood.

This can lead to serious medical problems including kidney damage, amputations, and blindness. Diabetes is also closely linked to heart disease. The main goal of treating diabetes is to lower your blood sugar to a normal level.

High blood sugar can be lowered by diet and exercise, by a number of medicines taken by mouth, and by insulin shots. Before you take metformin hydrochloride tablets, try to control your diabetes by exercise and weight loss. While you take your diabetes medicine, continue to exercise and follow the diet advised for your diabetes.

No matter what your recommended diabetes management plan is, studies have shown that maintaining good blood sugar control can prevent or delay complications of diabetes, such as blindness. The medicine can help control your blood sugar in a number of ways. These include helping your body respond better to the insulin it makes naturally, decreasing the amount of sugar your liver makes, and decreasing the amount of sugar your intestines absorb.

Metformin hydrochloride tablets do not cause your body to make more insulin. Because of this, when taken alone, it rarely cause hypoglycemia (low blood sugar), and usually do not cause weight gain. However, when they are taken with a sulfonylurea or with insulin, hypoglycemia is more likely to occur, as is weight gain.

Tell your doctor if you are pregnant or plan to become pregnant. Metformin hydrochloride tablets may not be right for you. Talk with your doctor about your choices.

You should also discuss your choices with your doctor if you are nursing a child. Can metformin hydrochloride tablets be used in children? Metformin hydrochloride tablets has been shown to effectively lower glucose levels in children (ages 10 to 16 years) with type 2 diabetes.

Metformin hydrochloride tablets has not been studied in children younger than 10 years old. Metformin hydrochloride tablets have not been studied in combination with other oral glucose-control medicines or insulin in children. If you have any questions about the use of metformin hydrochloride tablets in children, talk with your doctor or other healthcare provider.

How should I take metformin hydrochloride tablets? Your doctor will tell you how much medicine to take and when to take it. You will probably start out with a low dose of the medicine.

Your doctor may slowly increase your dose until your blood sugar is better controlled. You should take metformin hydrochloride tablets with meals. Your doctor may have you take other medicines along with metformin hydrochloride tablets to control your blood sugar.

These medicines may include insulin shots. Taking metformin hydrochloride tablets with insulin may help you better control your blood sugar while reducing the insulin dose. Continue your exercise and diet program and test your blood sugar regularly while taking metformin hydrochloride tablets.

Your doctor will monitor your diabetes and may perform blood tests on you from time to time to make sure your kidneys and your liver are functioning normally. There is no evidence that metformin hydrochloride tablets causes harm to the liver or kidneys. Tell your doctor if you: Have an illness that causes severe vomiting, diarrhea or fever, or if you drink a much lower a… [Excerpted — this section continues on DailyMed.]

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General Lactic Acidosis—There have been postmarketing cases of metformin-associated lactic acidosis, including fatal cases. These cases had a subtle onset and were accompanied by nonspecific symptoms such as malaise, myalgias, abdominal pain, respiratory distress, or increased somnolence; however, hypotension and resistant bradyarrhythmias have occurred with severe acidosis. Metformin-associated lactic acidosis was characterized by elevated blood lactate concentrations (>5 mmol/L), anion gap acidosis (without evidence of ketonuria or ketonemia), and an increased lactate: pyruvate ratio; metformin plasma levels were generally >5 μg/mL.

Metformin decreases liver uptake of lactate increasing lactate blood levels which may increase the risk of lactic acidosis, especially in patients at risk. If metformin-associated lactic acidosis is suspected, general supportive measures should be instituted promptly in a hospital setting, along with immediate discontinuation of metformin hydrochloride tablets. In metformin hydrochloride tablets treated patients with a diagnosis or strong suspicion of lactic acidosis, prompt hemodialysis is recommended to correct the acidosis and remove accumulated metformin (metformin hydrochloride is dialyzable with a clearance of up to 170 mL/min under good hemodynamic conditions).

Hemodialysis has often resulted in reversal of symptoms and recovery. Educate patients and their families about the symptoms of lactic acidosis and, if these symptoms occur, instruct them to discontinue metformin hydrochloride tablets and report these symptoms to their healthcare provider. For each of the known and possible risk factors for metformin-associated lactic acidosis, recommendations to reduce the risk of and manage metformin-associated lactic acidosis are provided below: Renal Impairment —The postmarketing metformin-associated lactic acidosis cases primarily occurred in patients with significant renal impairment.

The risk of metformin accumulation and metformin-associated lactic acidosis increases with the severity of renal impairment because metformin is substantially excreted by the kidney. Clinical recommendations based upon the patient's renal function include (see DOSAGE AND ADMINISTRATION , CLINICAL PHARMACOLOGY ) Before initiating metformin hydrochloride tablets, obtain an estimated glomerular filtration rate (eGFR) Metformin hydrochloride tablets are contraindicated in patients with an eGFR less than 30 mL/min/1.73 m2(see CONTRAINDICATIONS ).

Initiation of metformin hydrochloride tablets is not recommended in patients with eGFR between 30 to 45 mL/min/1.73 m2. Obtain an eGFR at least annually in all patients taking metformin hydrochloride tablets. In patients at risk for the development of renal impairment (e.g., the elderly), renal function should be assessed more frequently.

In patients taking metformin hydrochloride tablets whose eGFR falls below 45 mL/min/1.73 m2, assess the benefit and risk of continuing therapy. Drug Interactions—The concomitant use of metformin hydrochloride tablets with specific drugs may increase the risk of metformin-associated lactic acidosis: those that impair renal function, result in significant hemodynamic change, interfere with acid-base balance, or increase metformin accumulation. Consider more frequent monitoring of patients.

Age 65 or Greater—The risk of metformin-associated lactic acidosis increases with the patient's age because elderly patients have a greater likelihood of having hepatic, renal, or cardiac impairment than younger patients. Assess renal function more frequently in elderly patients. Radiologic Studies with Contrast—Administration of intravascular iodinated contrast agents in metformin-treated patients has led to an acute decrease in renal function and the occurrence of lactic acidosis.

Stop metformin hydrochloride tablets, at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR between 30 and 60 mL/min/1.73 m2;… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 86 words ▾

Nursing Mothers Studies in lactating rats show that metformin is excreted into milk and reaches levels comparable to those in plasma. Similar studies have not been conducted in nursing mothers. Because the potential for hypoglycemia in nursing infants may exist, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

If metformin hydrochloride tablets are discontinued, and if diet alone is inadequate for controlling blood glucose, insulin therapy should be considered.

🧬 Pharmacokinetics ~2 min read ▾

Pharmacokinetics Absorption and Bioavailability The 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 hydrochloride 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 (Cmax), a 25% lower area under the plasma concentration versus time curve (AUC), and a 35-minute prolongation of time to peak plasma concentration (Tmax) 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 metformin hydrochloride tablets 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 mcg/mL. During controlled clinical trials of metformin hydrochloride tablets, maximum metformin plasma levels did not exceed 5 mcg/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.

🔬 Clinical Studies ~3 min read ▾

Clinical Studies METFORMIN HYDROCHLORIDE TABLETS In a double-blind, placebo-controlled, multicenter U.S. clinical trial involving obese patients with type 2 diabetes whose hyperglycemia was not adequately controlled with dietary management alone (baseline fasting plasma glucose [FPG] of approximately 240 mg/dL), treatment with metformin hydrochloride tablets (up to 2550 mg/day) for 29 weeks resulted in significant mean net reductions in fasting and postprandial plasma glucose (PPG) and hemoglobin A1c (HbA1c) of 59 mg/dL, 83 mg/dL, and 1.8%, respectively, compared to the placebo group (see Table 2).

Table 2: Metformin Hydrochloride Tablets vs Placebo Summary of Mean Changes from Baseline* in Fasting Plasma Glucose, HbA1c, and Body Weight, at Final Visit (29-week study) *All patients on diet therapy at Baseline **Not statistically significant Metformin Hydrochloride Tablets (n=141) Placebo (n=145) p–Value FPG (mg/dL) Baseline 241.5 237.7 NS** Change at FINAL VISIT -53.0 6.3 0.001 Hemoglobin A 1c (%) Baseline 8.4

8.2NS** Change at FINAL VISIT -1.4 0.4 0.001 Body Weight (lbs) Baseline 201.0 206.0 NS** Change at FINAL VISIT -1.4 -2.4 NS** A 29-week, double-blind, placebo-controlled study of metformin hydrochloride tablets and glyburide, alone and in combination, was conducted in obese patients with type 2 diabetes who had failed to achieve adequate glycemic control while on maximum doses of glyburide (baseline FPG of approximately 250 mg/dL) (see Table 3). Patients randomized to the combination arm started therapy with metformin hydrochloride tablets 500 mg and glyburide 20 mg.

At the end of each week of the first four weeks of the trial, these patients had their dosages of metformin hydrochloride tablets increased by 500 mg if they had failed to reach target fasting plasma glucose. After week four, such dosage adjustments were made monthly, although no patient was allowed to exceed metformin hydrochloride tablets 2500 mg. Patients in the metformin hydrochloride tablets only arm (metformin plus placebo) followed the same titration schedule.

At the end of the trial, approximately 70% of the patients in the combination group were taking metformin hydrochloride tablets 2000 mg/glyburide 20 mg or metformin hydrochloride tablets 2500 mg/glyburide 20 mg. Patients randomized to continue on glyburide experienced worsening of glycemic control, with mean increases in FPG, PPG, and HbA1c of 14 mg/dL, 3 mg/dL, and 0.2%, respectively. In contrast, those randomized to metformin hydrochloride tablets (up to 2500 mg/day) experienced a slight improvement, with mean reductions in FPG, PPG, and HbA1c of 1 mg/dL, 6 mg/dL, and 0.4%, respectively.

The combination of metformin hydrochloride tablets and glyburide was effective in reducing FPG, PPG, and HbA1c levels by 63 mg/dL, 65 mg/dL, and 1.7%, respectively. Compared to results of glyburide treatment alone, the net differences with combination treatment were -77 mg/dL, - 68 mg/dL, and -1.9%, respectively (see Table 3). Table 3: Combined Metformin Hydrochloride Tablets/Glyburide (Comb) vs Glyburide (Glyb) or Metformin Hydrochloride Tablets (MET) Monotherapy: Summary of Mean Changes from Baseline* in Fasting Plasma Glucose, HbA1c, and Body Weight, at Final Visit (29-week study) *All patients on glyburide, 20 mg/day, at Baseline **Not statistically significant p-values Comb (n=213) Glyb (n=209) MET (n=210) Glyb vs Comb MET vs Comb MET vs Glyb Fasting Plasma Glucose (mg/dL) Baseline 250.5 247.5 253.9 NS** NS** NS** Change at FINAL VISIT -63.5 13.7 -0.9 0.001 0.001 0.025 Hemoglobin A 1c (%) Baseline 8.8 8.5

8.9NS** NS** 0.007 Change at FINAL VISIT -1.7 0.2 -0.4 0.001 0.001 0.001 Body Weight (lbs) Baseline 202.2 203.0 204.0 NS** NS** NS** Change at FINAL VISIT 0.9 -0.7 -8.4 0.011 0.001 0.001 The magnitude of the decline in fasting blood glucose concentration following the institution of metformin hydrochloride tablets therapy was proportional to the level of fasting hyperglycemia. Patients with type 2 diab… [Excerpted — this section continues on DailyMed.]

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 182 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term carcinogenicity studies have been performed in rats (dosing duration of 104 weeks) and mice (dosing duration of 91 weeks) at doses up to and including 900 mg/kg/day and 1500 mg/kg/day, respectively. These doses are both approximately four times the maximum recommended human daily dose of 2000 mg based on body surface area comparisons. No evidence of carcinogenicity with metformin was found in either male or female mice.

Similarly, there was no tumorigenic potential observed with metformin in male rats. There was, however, an increased incidence of benign stromal uterine polyps in female rats treated with 900 mg/kg/day. There was no evidence of a mutagenic potential of metformin in the following in vitro tests: Ames test (S. typhimurium), gene mutation test (mouse lymphoma cells), or chromosomal aberrations test (human lymphocytes).

Results in the in vivo mouse micronucleus test were also negative. Fertility of male or female rats was unaffected by metformin when administered at doses as high as 600 mg/kg/day, which is approximately three times the maximum recommended human daily dose based on body surface area comparisons.

📄 Package Label / Principal Display Panel ~1 min read ▾

PRINCIPAL DISPLAY PANEL - 500 MG, BOTTLES OF 500 Metcure Pharmaceuticals, Inc NDC 71709-110-06 METFORMIN HYDROCHLORIDE Tablets, USP 500 mg Rx Only 500 Tablets 717091106 PRINCIPAL DISPLAY PANEL - 850 MG, BOTTLES OF 500 Metcure Pharmaceuticals, Inc NDC 71709-111-06 METFORMIN HYDROCHLORIDE Tablets, USP 850 mg Rx Only 500 Tablets 717091106 PRINCIPAL DISPLAY PANEL - 1000 MG, BOTTLES OF 500 Metcure Pharmaceuticals, Inc NDC 71709-112-06 METFORMIN HYDROCHLORIDE Tablets, USP 1000 mg Rx Only 500 Tablets 7170911206 PRINCIPAL DISPLAY PANEL - 500 MG, BOTTLES OF 1000 Metcure Pharmaceuticals, Inc NDC 71709-110-07 METFORMIN HYDROCHLORIDE Tablets, USP 500 mg Rx Only 1000 Tablets 7170911007 PRINCIPAL DISPLAY PANEL - 850 MG, BOTTLES OF 1000 Metcure Pharmaceuticals, Inc NDC 71709-111-07 METFORMIN HYDROCHLORIDE Tablets, USP 850 mg Rx Only 1000 Tablets 7170911107 PRINCIPAL DISPLAY PANEL - 1000 MG, BOTTLES OF 1000 Metcure Pharmaceuticals, Inc NDC 71709-112-07 METFORMIN HYDROCHLORIDE Tablets, USP 1000 mg Rx Only 1000 Tablets 7170911207

PRINCIPAL DISPLAY PANEL - 850 MG, BOTTLES OF 500 Metcure Pharmaceuticals, Inc NDC 71709-111-06 METFORMIN HYDROCHLORIDE Tablets, USP 850 mg Rx Only 500 Tablets 717091106

PRINCIPAL DISPLAY PANEL - 1000 MG, BOTTLES OF 500 Metcure Pharmaceuticals, Inc NDC 71709-112-06 METFORMIN HYDROCHLORIDE Tablets, USP 1000 mg Rx Only 500 Tablets 7170911206

PRINCIPAL DISPLAY PANEL - 500 MG, BOTTLES OF 1000 Metcure Pharmaceuticals, Inc NDC 71709-110-07 METFORMIN HYDROCHLORIDE Tablets, USP 500 mg Rx Only 1000 Tablets 7170911007

PRINCIPAL DISPLAY PANEL - 850 MG, BOTTLES OF 1000 Metcure Pharmaceuticals, Inc NDC 71709-111-07 METFORMIN HYDROCHLORIDE Tablets, USP 850 mg Rx Only 1000 Tablets 7170911107

PRINCIPAL DISPLAY PANEL - 1000 MG, BOTTLES OF 1000 Metcure Pharmaceuticals, Inc NDC 71709-112-07 METFORMIN HYDROCHLORIDE Tablets, USP 1000 mg Rx Only 1000 Tablets 7170911207

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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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 Metcure Pharmaceuticals, Inc.. 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 1 other package presentation of this same product, including 1000 tablets (71709-0112-07). 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?
Metcure Pharmaceuticals, Inc. 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.
← 71709-0111-06 · Metcure 71713-0091-30 · Thirty →
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.