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Metformin hydrochloride 1000 mg Tablet, 60-count

by Legacy Pharmaceutical Packaging, LLC · 60 TABLET in 1 BOTTLE (68645-584-59)

NDC 68645-0584-59

🏷️ FDA NDC (as labeled) 68645-584-59 billing pads the product segment with a zero

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 Dr. Brian Staiger, PharmD

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) 68645-584-59

Product NDC 68645-584

11-digit billing NDC 68645058459

NCPDP billing unit EA — each (per item)

RxCUI 861004, 861007, 861010

UNII 786Z46389E

UPC 0368645582597, 0368645583594, 0368645584591

Application # ANDA090564

SPL Set ID b51da8d7-ab4a-4c40-97c9-88bd379366d1

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 2019-06-07

Route ORAL

Dosage form TABLET

Substance METFORMIN HYDROCHLORIDE

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

TE code (Orange Book) AB · RLD · RS

Why two NDCs? The FDA registers this code as 68645-584-59 — 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 → 68645-0584-59. 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

LabelerLegacy Pharmaceutical Packaging, LLC

Application holderGRANULES INDIA LTD

FDA applicationANDA090564 (ANDA)

Labeler code68645

First marketedJun 2019

Product typeHuman Prescription Drug

Portfolio38 products on file

🔎 All NDCs from Legacy Pharmaceutical Packaging, LLC

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 1,000 MG TABLET Ingredient Metformin Hcl

📗 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 →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Metformin Hydrochloride — tap one for details:

Activated CharcoalMajor Coffee CharcoalModerate European MandrakeModerate GlucomannanModerate Guar GumModerate Gum ArabicModerate Slippery ElmModerate TragacanthModerate

🌿 Every supplement checked against Metformin Hydrochloride (257 interactions) — ranked by severity →

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.

COENZYME Q10 Insignificant Depletion FOLIC ACID Moderate Depletion VITAMIN B12 Moderate Depletion THIAMINE Insufficient Evidence

🧪 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

ShapeOval

ImprintG;12

Size19 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.

Where does this data come from?

Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 system	Per ea	Per package
Retail pharmacies payNADAC · weekly	$0.023	$1.39 / 60 tablets
Medicaid paysCMS SDUD · 12 mo	$0.0840	$5.04 / 60 tablets
Medicare drug plans payPart D · Q2 2026	$0.0671	$4.03 / 60 tablets

NADAC price history (per ea) — tap or hover for the price & month

▼ Down 11% over the last 24 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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price 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 mgthis 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	+6%
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 mg 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

🏛️

2019

On the market since

Jun 2019

📍

2026

Currently FDA-listed

7 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 68645-0584-59, not the drug overall. Other pack sizes report separately.

💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.

📅 Q1 2025 – Q1 2026 · 5 quarters of data

ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.

Prescriptions last 4 qtrs

224.5K

Units reimbursed last 4 qtrs

26M

Gross reimbursed last 4 qtrs

$2.18M

Avg / prescription

$9.71

Avg / unit

$0.0840

Latest quarter Q1 2026

48.6KRx

Medicaid pays / ea

$0.0840

gross reimbursed

NADAC / ea

$0.0232

acquisition cost

Spread

+$0.0608

+262% vs cost

What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.

Fee-for-service vs managed care ⓘ

43% FFS 57% MCO

Fee-for-service · 97,470 Rx Managed care · 127,070 Rx

State Medicaid map

Units reimbursed · per 100k residents

1,45543,175

gray = no data reported ⓘ

Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.

Tap or hover a state

…for its Medicaid breakdown

🏆 Top states by units · per 100k residents

1 New Mexico 43,175 /100k

2 Arizona 21,750 /100k

3 Oklahoma 21,191 /100k

4 Nevada 18,738 /100k

5 West Virginia 18,252 /100k

6 Louisiana 16,501 /100k

7 California 15,598 /100k

8 Oregon 13,664 /100k

National units — by quarter

💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

🔬 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

Serious outcomes

Hospitalization33,199

Life-threatening6,855

Disabling2,592

Reports over time (by year) — tap or hover for the count & year

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 NDC	Description	Marketing start	Status
68645-0584-59 You're viewing this	60 TABLET in 1 BOTTLE (68645-584-59)	2019-06-07	Active

📄 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 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 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

🚨 Boxed Warning ~2 min read ▾

BOXED WARNING WARNING: 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 mcg/mL [see Warnings and Precautions (5.1) ].

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 (2.3), (2.7), Contraindications (4), Warnings and Precautions (5.1) ].

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 Warnings and Precautions (5.1) ]. WARNING: LACTIC ACIDOSIS See full prescribing information for complete boxed warning. • Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias.

Symptoms included malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Laboratory abnormalities included elevated blood lactate levels, anion gap acidosis, increased lactate/pyruvate ratio; and metformin plasma levels generally >5 mcg/mL. (5.1) • Risk factors include renal impairment, concomitant use of certain drugs, age >65 years old, radiological studies with contrast, surgery and other procedures, hypoxic states, 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 in the Full Prescribing Information. (5.1) • If lactic acidosis is suspected, discontinue metformin hydrochloride tablets and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended.

(5.1)

🎯 Indications and Usage 70 words ▾

1 INDICATIONS AND USAGE Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. Metformin hydrochloride tablets are biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. (1)

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Adult Dosage for metformin hydrochloride Tablets: • Starting dose: 500 mg orally twice a day or 850 mg once a day, with meals (2.1) • Increase the dose in increments of 500 mg weekly or 850 mg every 2 weeks, up to a maximum dose of 2550 mg per day, given in divided doses (2.1) • Doses above 2000 mg may be better tolerated given 3 times a day with meals (2.1) Pediatric Dosage for metformin hydrochloride Tablets: • Starting dose: 500 mg orally twice a day, with meals (2.2) • Increase dosage in increments of 500 mg weekly up to a maximum of 2000 mg per day, given in divided doses twice daily (2.2) Renal Impairment: • Prior to initiation, assess renal function with estimated glomerular filtration rate (eGFR) (2.3) o Do not use in patients with eGFR below 30 mL/minute/1.73 m2 (2.3) o Initiation is not recommended in patients with eGFR between 30 to 45 mL/minute/1.73 m2 (2.3) o Assess risk/benefit of continuing if eGFR falls below 45 mL/minute/1.73 m2 (2.3) o Discontinue if eGFR falls below 30 mL/minute/1.73 m2 (2.3)

2.1Adult Dosage Metformin Hydrochloride Tablets • The recommended starting dose of metformin hydrochloride tablets are 500 mg orally twice a day or 850 mg once a day, given with meals. • Increase the dose in increments of 500 mg weekly or 850 mg every 2 weeks on the basis of glycemic control and tolerability, up to a maximum dose of 2550 mg per day, given in divided doses. • Doses above 2000 mg may be better tolerated given 3 times a day with meals.

2.2Pediatric Dosage for Metformin Hydrochloride Tablets • The recommended starting dose of metformin hydrochloride tablets for pediatric patients 10 years of age and older is 500 mg orally twice a day, given with meals. • Increase dosage in increments of 500 mg weekly on the basis of glycemic control and tolerability, up to a maximum of 2000 mg per day, given in divided doses twice daily.

2.3Recommendations 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 m 2 . • Initiation of metformin hydrochloride tablets in patients with an eGFR between 30 to 45 mL/minute/ 1.73 m 2 is not recommended. • In patients taking metformin hydrochloride tablets whose eGFR later falls below 45 mL/min/1.73 m 2 , assess the benefit risk of continuing therapy. • Discontinue metformin hydrochloride tablets if the patient’s eGFR later falls below 30 mL/ minute/ 1.73 m 2 [see Warnings and Precautions (5.1) ].

2.4Discontinuation for Iodinated Contrast Imaging Procedures Discontinue 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 m 2 ; in patients with a history of liver disease, alcoholism, or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after the imaging procedure; restart metformin hydrochloride tablets if renal function is stable.

2.3…

💊 Dosage Forms and Strengths 112 words ▾

3 DOSAGE FORMS AND STRENGTHS Metformin Hydrochloride Tablets, USP are available as: • Tablets: 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. • Tablets: 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. • Tablets: 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.

Metformin Hydrochloride Tablets : 500 mg, 850 mg, and 1000 mg (3)

⛔ Contraindications 74 words ▾

4 CONTRAINDICATIONS Metformin hydrochloride tablets are contraindicated in patients with: • Severe renal impairment (eGFR below 30 mL/min/1.73 m2) [see Warnings and Precautions (5.1) ]. • Hypersensitivity to metformin. • Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. • Severe renal impairment (eGFR below 30 mL/min/1.73 m 2 ) (4, 5.1) • Hypersensitivity to metformin (4) • Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. (4)

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Lactic Acidosis: See boxed warning. ( 5.1) • Vitamin B 12 Deficiency: Metformin may lower vitamin B 12 levels. Measure hematological parameters annually and vitamin B 12 at 2 to 3 year intervals and manage any abnormalities.

(5.2) • Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues: Increased risk of hypoglycemia when used in combination with insulin and/or an insulin secretagogue. Lower dose of insulin or insulin secretagogue may be required (5.3)

5.1Lactic 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 mcg/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 (2.1), Clinical Pharmacology (12.3) ]: o Before initiating metformin hydrochloride tablets, obtain an estimated glomerular filtration rate (eGFR). o Metformin hydrochloride tablets are contraindicated in patients with an eGFR less than 30 mL/ min/1.73 m 2 [see Contraindications (4) ]. o Initiation of metformin hydrochloride tablets is not recommended in patients with eGFR between 30 to 45 mL/min/1.73 m 2 . o Obtain an eGFR at least annually in all patients taking metformin hydrochloride tablets. o 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 m 2 , 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 pati…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are also discussed elsewhere in the labeling: • Lactic Acidosis [see Boxed Warning and Warnings and Precautions (5.1) ] • Vitamin B 12 Deficiency [see Warnings and Precautions (5.2) ] • Hypoglycemia [see Warnings and Precautions (5.3) ] For metformin hydrochloride tablets, the most common adverse reactions (>5.0%) are diarrhea, nausea/vomiting, flatulence, asthenia, indigestion, abdominal discomfort, and headache. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Granules Pharmaceuticals Inc. at 1-877-770-3183 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.1Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Metformin Hydrochloride Tablets In a U.S. clinical trial of metformin hydrochloride tablets in patients with type 2 diabetes mellitus, a total of 141 patients received metformin hydrochloride tablets up to 2550 mg per day. Adverse reactions reported in greater than 5% of metformin hydrochloride tablets treated patients and that were more common than in placebo-treated patients, are listed in Table 1.

Table 1: Adverse Reactions from a Clinical Trial of Metformin Hydrochloride Tablets Occurring >5% and More Common than Placebo in Patients with Type 2 Diabetes Mellitus Diarrhea led to discontinuation of metformin hydrochloride tablets in 6% of patients. Additionally, the following adverse reactions were reported in ≥ 1% to ≤ 5% of metformin hydrochloride tablets treated 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.

In metformin hydrochloride tablets clinical trials of 29-week duration, a decrease to subnormal levels of previously normal serum vitamin B 12 levels was observed in approximately 7% of patients. Pediatric Patients In clinical trials with metformin hydrochloride tablets in pediatric patients with type 2 diabetes mellitus, the profile of adverse reactions was similar to that observed in adults. Table 1

6.2Postmarketing Experience The following adverse reactions have been identified during post approval use of metformin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cholestatic, hepatocellular, and mixed hepatocellular liver injury have been reported with postmarketing use of metformin.

🔄 Drug Interactions 87 words ▾

7 DRUG INTERACTIONS Table 3 presents clinically significant drug interactions with metformin hydrochloride tablets. Table 3: Clinically Significant Drug Interactions with Metformin Hydrochloride Tablets • Carbonic anhydrase inhibitors may increase risk of lactic acidosis. Consider more frequent monitoring (7) • Drugs that reduce metformin clearance (such as ranolazine, vandetanib, dolutegravir, and cimetidine) may increase the accumulation of metformin.

Consider the benefits and risks of concomitant use (7) • Alcohol can potentiate the effect of metformin on lactate metabolism. Warn patients against excessive alcohol intake (7) Table 3

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS • Females and Males of Reproductive Potential: Advise premenopausal females of the potential for an unintended pregnancy. (8.3) • Geriatric Use: Assess renal function more frequently. (8.5) • Hepatic Impairment: Avoid use in patients with hepatic impairment. (8.7) See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling

8.1Pregnancy Risk Summary Limited data with metformin hydrochloride tablets in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. Published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk [see Data ]. There are risks to the mother and fetus associated with poorly controlled diabetes mellitus in pregnancy [see Clinical Considerations ].

No adverse developmental effects were observed when metformin was administered to pregnant Sprague Dawley rats and rabbits during the period of organogenesis at doses up to 2- and 5-times, respectively, a 2550 mg clinical dose, based on body surface area [see Data ]. The estimated background risk of major birth defects is 6 to 10% in women with pre-gestational diabetes mellitus with an HbA1C >7 and has been reported to be as high as 20 to 25% in women with a HbA1C > 10. The estimated background risk of miscarriage for the indicated population is unknown.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Poorly-controlled diabetes mellitus in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, stillbirth and delivery complications. Poorly controlled diabetes mellitus increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity.

Data Human Data Published data from post-marketing studies have not reported a clear association with metformin and major birth defects, miscarriage, or adverse maternal or fetal outcomes when metformin was used during pregnancy. However, these studies cannot definitely establish the absence of any metformin-associated risk because of methodological limitations, including small sample size and inconsistent comparator groups. Animal Data Metformin hydrochloride did not adversely affect development outcomes when administered to pregnant rats and rabbits at doses up to 600 mg/kg/day.

This represents an exposure of about 2 and 5 times a 2550 mg clinical dose based on body surface area comparisons for rats and rabbits, respectively. Determination of fetal concentrations demonstrated a partial placental barrier to metformin.

8.2Lactation Risk Summary Limited published studies report that metformin is present in human milk [see Data ]. However, there is insufficient information to determine the effects of metformin on the breastfed infant and no available information on the effects of metformin on milk production. Therefore, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for metformin hydrochloride tablets and any potential adverse effects on the breastfed child from metformin hydrochloride tablets or from the underlying maternal condition.

Data Published clinical lactation studies report that metformin is present in human milk which resulted in infant doses approximately 0.11 % to 1% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 0.13 and 1. However, the studies were not designed to definitely establish the risk of use of metformin during lactation because of small sample size and limited adverse event data collected in infants.

8.3Females and Males of Reproductive Potential Discuss the potential for unintended pregnancy with premenopausal women as therapy with met…

🤰 Pregnancy ~2 min read ▾

🧒 Pediatric Use 158 words ▾

8.4Pediatric Use Metformin Hydrochloride Tablets The safety and effectiveness of metformin hydrochloride tablets for the treatment of type 2 diabetes mellitus have been established in pediatric patients 10 to 16 years old. Safety and effectiveness of metformin hydrochloride tablets have not been established in pediatric patients less than 10 years old. Use of metformin hydrochloride tablets in pediatric patients 10 to 16 years old for the treatment of type 2 diabetes mellitus 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 10 to 16 years old with type 2 diabetes mellitus, which demonstrated a similar response in glycemic control to that seen in adults [see Clinical Studies (14.1) ].

In this study, adverse reactions were similar to those described in adults. A maximum daily dose of 2000 mg of metformin hydrochloride tablets is recommended. [see Dosage and Administration (2.2). ]

🧓 Geriatric Use 88 words ▾

8.5Geriatric 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. 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 Warnings and Precautions (5.1) ].

🆘 Overdosage 84 words ▾

10 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 has been established. Lactic acidosis has been reported in approximately 32% of metformin overdose cases [see Warnings and Precautions (5.1) ].

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 ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Metformin is an antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes mellitus, lowering both basal and postprandial plasma glucose. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. With metformin therapy, insulin secretion remains unchanged while fasting insulin levels and day-long plasma insulin response may decrease.

12.3Pharmacokinetics Absorption The absolute bioavailability of a metformin hydrochloride tablets 500 mg given under fasting conditions is approximately 50% to 60%. Studies using single oral doses of metformin hydrochloride tablets 500 to 1500 mg and 850 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. 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.

Following a single oral dose of metformin hydrochloride extended-release tablets, C max is achieved with a median value of 7 hours and a range of 4 to 8 hours. Peak plasma levels are approximately 20% lower compared to the same dose of metformin hydrochloride tablets, however, the extent of absorption (as measured by AUC) is comparable to metformin hydrochloride tablets. At steady state, the AUC and C max are less than dose proportional for metformin hydrochloride extended-release tablets within the range of 500 to 2000 mg administered once daily.

Peak plasma levels are approximately 0.6, 1.1, 1.4 and 1.8 mcg/mL for 500, 1000, 1500, and 2000 mg once-daily doses, respectively. The extent of metformin absorption (as measured by AUC) from metformin hydrochloride extended-release tablets at a 2000 mg once-daily dose is similar to the same total daily dose administered as metformin hydrochloride tablets 1000 mg twice daily. After repeated administration of metformin hydrochloride extended-release tablets, metformin did not accumulate in plasma.

Effect of food: Food decreases the extent of absorption and slightly delays the absorption of metformin, as shown by approximately a 40% lower mean peak plasma concentration (C max ), a 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 hydrochloride tablets with food, compared to the same tablet strength administered fasting. 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. Metformin partitions into erythrocytes, most likely as a function of time. Metabolism 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.

Elimination Renal clearance (see Table 4) 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.

Specific Populations Renal Impairment In patients with decreased renal function the plasma and blood half-life of metformin is prolonged and the renal clearance is decreased (see Table 3) [see Dosage and Administration (2.3), Contraindications (4), Warnings…

🧬 Mechanism of Action 66 words ▾

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED

16.1How 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. Unit of Use Bottles of 60 - 500mg - NDC 68645-582-59 850 mg - White to off-white, round, biconvex, film coated tablets debossed with G over 11 on one side and plain on the other side. Unit of Use Bottles of 60 - 850mg - NDC 68645-583-59 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.

Unit of Use Bottles of 60 - 1000mg - NDC 68645-584-59

16.2Storage Store at 20° to 25° C (68° to 77° F); excursions permitted to 15° to 30° C (59° to 86° F). [See USP Controlled Room Temperature.] Dispense in tight, light-resistant containers with child-resistant closure.

Unit of Use Bottles of 60 - 1000mg - NDC 68645-584-59

📦 Storage and Handling 36 words ▾

📋 Description 151 words ▾

11 DESCRIPTION Metformin hydrochloride tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below: Metformin hydrochloride, USP is a white to off-white crystalline compound with a molecular formula of C H N • HCl and a molecular weight of 165.63.

Metformin hydrochloride is freely soluble in water, slightly 4 11 5 soluble in alcohol, practically insoluble in acetone and in methylene chloride. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68.

Metformin hydrochloride tablets, USP 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, macrogol and titanium dioxide.

Formula

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Lactic Acidosis: Explain the risks of lactic acidosis, its symptoms, and conditions that predispose to its development. Advise patients to discontinue metformin hydrochloride tablets immediately and to promptly notify their healthcare provider if unexplained hyperventilation, myalgias, malaise, unusual somnolence or other nonspecific symptoms occur.

Counsel patients against excessive alcohol intake and inform patients about importance of regular testing of renal function while receiving metformin hydrochloride tablets. Instruct patients to inform their doctor that they are taking metformin hydrochloride tablets prior to any surgical or radiological procedure, as temporary discontinuation may be required [see Warnings and Precautions (5.1) ]. Hypoglycemia Inform patients that hypoglycemia may occur when metformin hydrochloride tablets are coadministered with oral sulfonylureas and insulin.

Explain to patients receiving concomitant therapy the risks of hypoglycemia, its symptoms and treatment, and conditions that predispose to its development [see Warnings and Precautions (5.3) ]. Vitamin B 12 Deficiency: Inform patients about importance of regular hematological parameters while receiving metformin hydrochloride tablets [see Warnings and Precautions (5.2) ]. Females of Reproductive Age: Inform females that treatment with metformin hydrochloride tablets may result in ovulation in some premenopausal anovulatory women which may lead to unintended pregnancy [see Use in Specific Populations (8.3) ].

Manufactured by: Granules India Limited Hyderabad-500 081, India MADE IN INDIA Manufactured for: Granules Pharmaceuticals Inc. Chantilly, VA 20151 Distributed by: Wal-Mart Bentonville, AR 72716 Packaged by: Legacy Pharmaceutical Packaging, LLC Earth City, MO 63045 Revision date: 08/2023

Glossary — plain-language definitions of medical terms used in this label:

antihyperglycemic: Describes a medicine that lowers blood sugar.

contraindicated: Should not be used in that situation, because the risk is considered too high.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

accumulation: A buildup of a medicine in the body when new doses are taken before earlier ones are fully removed.

adverse event: Any unwanted medical problem that happens during treatment, whether or not the medicine actually caused it.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

asthenia: Unusual weakness or lack of physical strength and energy.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

Bioavailability: The share of a dose that actually reaches the bloodstream and is able to have an effect.

Boxed Warning: The strongest safety warning the FDA can require, set inside a bold black border because the risk it describes can be very serious.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

creatinine clearance: An estimate of how fast the kidneys filter waste from the blood, often used to choose the right medicine dose.

diabetic ketoacidosis: A serious condition, mainly in people with diabetes, where the blood turns acidic because the body burns fat instead of sugar for energy.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

dyspnea: The medical word for shortness of breath, or the feeling that you cannot get enough air.

eGFR: Estimated glomerular filtration rate, a blood-test-based estimate of how well the kidneys filter; lower numbers mean weaker function.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.

extended-release: A pill or capsule made to release its medicine slowly over many hours, so it can be taken less often; often labeled ER or XR.

flatulence: Passing gas from the bowel; feeling bloated or gassy.

flushing: Temporary redness and warmth of the skin, often on the face and neck, from widening of small blood vessels.

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

HbA1c: A blood test showing average blood sugar over the past two to three months; also called A1C or glycated hemoglobin.

heart failure: A condition in which the heart cannot pump blood as well as it should, causing tiredness, breathlessness, and swelling.

hemodialysis: A treatment that uses a machine to filter waste and extra fluid from the blood when the kidneys cannot.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

hepatic metabolism: The breakdown of a medicine by the liver into other substances the body can use or remove.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypoglycemia: Low blood sugar, when the amount of glucose (sugar) in the blood drops below the normal range.

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

lactation: The making and release of milk from a mother's breasts after giving birth.

lactic acidosis: A buildup of a waste product called lactic acid in the blood, which makes the blood too acidic.

malaise: A general feeling of being unwell, uneasy, or low on energy, without one clear symptom.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

metabolic acidosis: A condition where too much acid builds up in the body's blood and fluids.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

myalgia: Muscle pain or aching.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

plasma concentration: The amount of medicine measured in the liquid part of the blood at a given time.

potentiate: To make the effect of one medicine stronger by taking another substance along with it.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

reproductive potential: The ability to have children, meaning a person who could become pregnant or could father a child.

somnolence: Feeling very sleepy or drowsy, with trouble staying awake during the day.

steady state: The point where the amount of medicine going in equals the amount leaving, so blood levels stay fairly even.

stillbirth: The death of a baby in the womb late in pregnancy or during birth.

tolerance: When the body gets used to a medicine over time, so a larger dose is needed to get the same effect.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

volume of distribution: A calculated value showing how widely a medicine spreads into body tissues versus staying in the blood.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

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

← 68645-0583-59 · Legacy 68645-0590-90 · Legacy →

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.

Metformin hydrochloride 1000 mg Tablet, 60-count

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