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METFORMIN HYDROCHLORIDE ER 500 mg Tablet, Extended Release, 500-count

by Leading Pharma, LLC · 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (69315-410-05)

NDC 69315-0410-05

🏷️ FDA NDC (as labeled) 69315-410-05 billing pads the product segment with a zero

This package

Contains500-count Cost per ea$0.0288 NADAC Per package$14.40 / 500 tablets Pack sizes2 compare ↓

Also priced by: Medicaid pays $0.1796/unit · Part D plans $0.1129/unit — full pricing hub ↓

Also comes in: 100 tablets 69315-0410-01

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) 69315-410-05

Product NDC 69315-410

11-digit billing NDC 69315041005

NCPDP billing unit EA — each (per item)

RxCUI 860975

UNII 786Z46389E

UPC 0369315410011

Application # ANDA201991

SPL Set ID 3dca884d-ec44-496f-9eeb-31fd8fa3f574

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 2025-05-01

Route ORAL

Dosage form TABLET, EXTENDED RELEASE

Substance METFORMIN HYDROCHLORIDE

GPI-14 27250050007520

GCN Seq No 046754

GCN 89863

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 ER 500 MG TABLET

FDB brand name Metformin Hcl Er

Legend status F — Federal legend — prescription drug or device

TE code (Orange Book) AB1 · RLD · RS

Why two NDCs? The FDA registers this code as 69315-410-05 — 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 → 69315-0410-05. 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

LabelerLeading Pharma, LLC

Application holderINVENTIA HEALTHCARE LTD

FDA applicationANDA201991 (ANDA)

Labeler code69315

First marketedMay 2025

Product typeHuman Prescription Drug

Portfolio83 products on file

🔎 All NDCs from Leading Pharma, 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 ER 500 MG TABLET Ingredient Metformin Hcl

📖 What it is MedlinePlus · NLM

Metformin is used alone or with other medications, including insulin, to treat type 2 diabetes (condition in which the body does not use insulin normally and, therefore, cannot control the amount of sugar in the blood). Metformin is in a class of drugs called biguanides. Metformin helps to control the amount of glucose (sugar) in your blood. It decreases the amount of glucose you absorb from your food and the amount of glucose made by your liver. Metformin also increases your body's response to insulin, a natural substance that controls the amount of glucose in the blood. Metformin is not used...

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

No, and that's actually one of the things that makes metformin different. It doesn't force your pancreas to produce more insulin. Instead, it works in three ways: it tells your liv...
What exactly does metformin do — does it just push my pancreas to make more insulin?
Stomach upset, nausea, and diarrhea are really common at the start, and they can be significant for some people. The good news is they usually improve as your body adjusts. Always...
The stomach side effects sound rough — is there anything I can do about them?

📖 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

ShapeCapsule

ImprintIL001

Size18 mm

ScoringNot scored

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 K679OBS311
Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.

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

Where does this data come from?

Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price system	Per ea	Per package
Retail pharmacies payNADAC · weekly	$0.029	$14.40 / 500 tablets
Medicaid paysCMS SDUD · 12 mo	$0.1796	$89.80 / 500 tablets
Medicare drug plans payPart D · Q2 2026	$0.1129	$56.45 / 500 tablets

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

▼ Down 3% over the last 9 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 500 mg 29300-0389-01	Unichem	100 tablets	$0.029	AB1	Availability likely	—
Metformin Hydrochloride 500 mg 42385-0977-01	Laurus	100 tablets	$0.029	AB1	Availability likely	—
Metformin Hydrochloride 500 mg 42806-0632-01	Epic	100 tablets	$0.029	AB1	Availability likely	—
Metformin Hydrochloride Extended Release 500 mg 49483-0623-01	TIME	100 tablets	$0.029	AB1	Availability likely	—
Metformin Hydrochloride 500 mg 50268-0550-15	AvPAK	1 tablet	$0.029	AB1	Availability likely	—
Metformin Hydrochloride 500 mg 67877-0159-01	Ascend	100 tablets	$0.029	AB1	Availability likely	—
Metformin Hydrochloride 500 mg 67877-0413-01	Ascend	100 tablets	$0.029	AB	Availability likely	—
Metformin Hydrochloride 500 mg 68094-0904-50	Precision	100 tablets	$0.029	AB1	Availability likely	—
Metformin 500 mg 68645-0595-59	Legacy	60 tablets	$0.029	AB1	Availability likely	—
Metformin Hydrochloride Er 500 mgthis 69315-0410-05	Leading	500 tablets	$0.029	AB1	Availability likely	—
Metformin 500 mg 70010-0491-01	Granules	100 tablets	$0.029	AB1	Availability likely	—
Metformin ER 500 mg 82009-0117-10	Quallent	1000 tablets	$0.029	AB1	Availability likely	—
Metformin Hydrochloride 500 mg 82009-0180-05	Quallent	500 tablets	$0.029	AB	Availability likely	—
Metformin Hydrochloride 500 mg 62756-0142-01	Sun	100 tablets	$0.029	—	FDA listed	+1%
Metformin hydrochloride 500 mg 33342-0239-11	Macleods	100 tablets	$0.031	AB1	FDA listed	+8%
Metformin Hydrochloride 500 mg 51224-0007-50	TAGI	100 tablets	$0.031	AB1	FDA listed	+8%
Metformin Hydrochloride 500 mg 69367-0412-60	Westminster	60 tablets	$0.138	AB2	Availability likely	+380%
Metformin hydrochloride 500 mg 27241-0188-60	Ajanta	60 tablets	$0.138	AB2	Availability likely	+380%
Metformin Hydrochloride 500 mg 59651-0042-60	Aurobindo	60 tablets	$0.138	AB2	Availability likely	+380%
Metformin Hydrochloride 500 mg 42571-0333-01	Micro	100 tablets	$0.262	AB3	Availability likely	+810%
Metformin Hydrochloride 500 mg 68180-0338-01	Lupin	100 tablets	$0.262	AB3	Availability likely	+810%
Metformin Hydrochloride 500 mg 70010-0496-01	Granules	100 tablets	$0.262	AB3	Availability likely	+810%
Metformin hydrochloride 500 mg 27241-0240-01	Ajanta	100 tablets	$0.262	AB3	Availability likely	+810%
Metformin Hydrochloride 500 mg 68462-0520-01	GLENMARK	100 tablets	$0.262	AB3	Availability likely	+810%
Metformin hydrochloride 500 mg 68682-0021-50	Oceanside	100 tablets	$0.402	—	FDA listed	+1296%
Glumetza 500 mg 68012-0004-50	Santarus,	100 tablets	$49.542	—	FDA listed	+171982%
Metformin Hydrochloride 500 mg 00615-8289-39	NCS	30 tablets	—	AB1	FDA listed	—
Metformin Hydrochloride 500 mg 10135-0823-05	Marlex	500 tablets	—	AB1	FDA listed	—
Metformin Hydrochloride Extended-Release 500mg 500 mg 17224-0311-28	Calvin	28 tablets	—	AB1	FDA listed	—
Metformin Hydrochloride 500 mg 25000-0101-03	MARKSANS	30 tablets	—	AB1	FDA listed	—
Metformin hydrochloride 500 mg 42291-0825-10	AvKARE	1000 tablets	—	AB1	FDA listed	—
Metformin Hydrochloride 500 mg 42708-0201-60	QPharma	60 tablets	—	AB1	FDA listed	—
Metformin Hydrochloride 500 mg 50090-1494-00	A-S	60 tablets	—	AB1	FDA listed	—
Metformin Hydrochloride 500 mg 50090-5396-00	A-S	60 tablets	—	AB	FDA listed	—
Metformin Hydrochloride 500 mg 50090-5397-00	A-S	90 tablets	—	AB	FDA listed	—
Metformin 500 mg 50090-6515-00	A-S	60 tablets	—	AB1	FDA listed	—
Metformin 500 mg 50090-6516-00	A-S	90 tablets	—	AB1	FDA listed	—
Metformin Hydrochloride 500 mg 50090-7116-00	A-S	90 tablets	—	AB1	FDA listed	—
Metformin Hydrochloride 500 mg 50090-7576-00	A-S	60 tablets	—	AB1	FDA listed	—
Metformin Hydrochloride 500 mg 50090-7577-00	A-S	90 tablets	—	AB1	FDA listed	—
Metformin Hydrochloride 500 mg 50090-7579-00	A-S	90 tablets	—	AB1	FDA listed	—
Metformin Hydrochloride 500 mg 50090-7918-00	A-S	90 tablets	—	AB1	FDA listed	—
Metformin Hydrochloride Extended Release 500 mg 51655-0555-96	Northwind	180 tablets	—	AB1	FDA listed	—
Metformin Hydrochloride 500 mg 51655-0559-25	Northwind	60 tablets	—	AB1	FDA listed	—
Metformin Hydrochloride 500 mg 51655-0853-25	Northwind	60 tablets	—	AB	FDA listed	—
Metformin Hydrochloride 500 mg 59651-0548-25	Aurobindo	25000 tablets	—	AB1	FDA listed	—
Metformin ER 500 mg 62207-0491-31	Granules	5000 tablets	—	AB1	FDA listed	—
Metformin hydrochloride 500 mg 63187-0779-00	Proficient	100 tablets	—	AB1	FDA listed	—
Metformin Hydrochloride 500 mg 65162-0178-03	Amneal	30 tablets	—	—	FDA listed	—
Metformin Hydrochloride 500 mg 65841-0027-01	Zydus	100 tablets	—	AB1	Discontinued	—
Metformin Hydrochloride 500 mg 65841-0809-01	Zydus	100 tablets	—	AB	FDA listed	—
Metformin 500 mg 67046-0437-03	Coupler	30 tablets	—	AB1	FDA listed	—
Metformin Hydrochloride 500 mg 67296-1701-06	RedPharm	60 tablets	—	AB1	FDA listed	—
Metformin Hydrochloride Extended Release 500 mg 68071-3111-02	NuCare	120 tablets	—	AB1	FDA listed	—
Metformin Hydrochloride 500 mg 68788-8814-01	Preferred	100 tablets	—	AB1	FDA listed	—
Metformin Hydrochloride 500 mg 68788-8866-01	Preferred	100 tablets	—	AB1	FDA listed	—
Metformin Hydrochloride 500 mg 68788-8903-01	Preferred	100 tablets	—	AB1	FDA listed	—
Metformin Hydrochloride 500 mg 69238-2125-01	Amneal	100 tablets	—	—	FDA listed	—
Metformin 500 mg 70518-4370-00	REMEDYREPACK	30 tablets	—	AB1	FDA listed	—
Metformin Hydrochloride 500 mg 71205-0186-20	Proficient	20 tablets	—	AB1	FDA listed	—
Metformin Hydrochloride 500 mg 71205-0686-30	Proficient	30 tablets	—	AB	FDA listed	—
Metformin Hydrochloride Extended Release 500 mg 71335-0293-01	Bryant	60 tablets	—	AB1	FDA listed	—
Metformin Hydrochloride 500 mg 71335-0720-01	Bryant	60 tablets	—	AB1	FDA listed	—
Metformin Hydrochloride 500 mg 71335-0886-01	Bryant	60 tablets	—	AB1	FDA listed	—
Metformin 500 mg 71335-2354-01	Bryant	60 tablets	—	AB1	FDA listed	—
Metformin Hydrochloride 500 mg 71335-2568-01	Bryant	60 tablets	—	AB1	FDA listed	—
Metformin Hydrochloride 500 mg 71335-9683-01	Bryant	60 tablets	—	AB1	FDA listed	—
Metformin Hydrochloride 500 mg 71610-0447-30	Aphena	30 tablets	—	—	FDA listed	—
Metformin Hydrochloride Extended Release 500 mg 71610-0454-30	Aphena	30 tablets	—	AB1	FDA listed	—
Metformin Hydrochloride 500 mg 71610-0533-30	Aphena	30 tablets	—	AB1	FDA listed	—
Metformin hydrochloride 500 mg 71610-0554-30	Aphena	30 tablets	—	AB1	FDA listed	—
Metformin Hydrochloride 500 mg 71610-0578-60	Aphena	90 tablets	—	AB	FDA listed	—
Metformin hydrochloride 500 mg 71610-0587-30	Aphena	30 tablets	—	AB1	FDA listed	—
Metformin 500 mg 71610-0613-60	Aphena	90 tablets	—	AB1	FDA listed	—
Metformin Hydrochloride 500 mg 71610-0652-30	Aphena	30 tablets	—	—	FDA listed	—
Metformin Hydrochloride 500 mg 71610-0837-30	Aphena	30 tablets	—	AB1	FDA listed	—
Metformin hydrochloride 500 mg 71610-0858-30	Aphena	30 tablets	—	AB1	FDA listed	—
Metformin 500 mg 72162-2424-00	Bryant	1000 tablets	—	AB1	FDA listed	—
Metformin Hydrochloride Extended Release 500 mg 72189-0064-30	direct	30 tablets	—	AB1	FDA listed	—
Metformin Hydrochloride 500 mg 72189-0150-30	direct	30 tablets	—	AB1	FDA listed	—
Metformin Hydrochloride 500 mg 72578-0035-01	Viona	100 tablets	—	AB1	FDA listed	—
Metformin Hydrochloride 500 mg 72664-0227-01	VGYAAN	100 tablets	—	—	FDA listed	—
Metformin Hydrochloride Extended Release 500 mg 72789-0009-30	PD-Rx	30 tablets	—	AB1	FDA listed	—
Metformin hydrochloride 500 mg 72789-0105-01	PD-Rx	100 tablets	—	AB1	FDA listed	—
Metformin Hydrochloride 500 mg 72789-0400-01	PD-Rx	100 tablets	—	AB1	FDA listed	—
Metformin Hydrochloride 500 mg 72789-0454-60	PD-Rx	60 tablets	—	AB1	FDA listed	—
Metformin Hydrochloride 500 mg 72789-0455-30	PD-Rx	30 tablets	—	AB1	FDA listed	—
Metformin hydrochloride 500 mg 76385-0128-01	UNICHEM	100 tablets	—	AB1	FDA listed	—
Metformin 500 mg 82804-0147-30	Proficient	30 tablets	—	AB1	FDA listed	—
Metformin Hydrochloride 500 mg 82804-0195-60	Proficient	60 tablets	—	AB1	FDA listed	—
Metformin Hydrochloride 500 mg 43547-0503-10	Solco	100 tablets	—	AB3	FDA listed	—
Metformin Hydrochloride 500 mg 47335-0305-18	Sun	1000 tablets	—	—	Discontinued	—
Glumetza 500 mg 68012-0002-13	Santarus,	100 tablets	—	—	FDA listed	—
Metformin Hydrochloride 500 mg 68180-0336-01	Lupin	100 tablets	—	AB2	FDA listed	—
Metformin Hydrochloride 500 mg 62207-0496-47	Granules	500 tablets	—	AB3	FDA listed	—
Metformin hydrochloride 500 mg 68071-1419-02	NuCare	20 tablets	—	AB1	FDA listed	—
Metformin Hydrochloride 500 mg 71335-3166-01	Bryant	60 tablets	—	AB1	FDA listed	—
Metformin Hydrochloride 500 mg 67296-2305-09	Redpharm	90 tablets	—	AB1	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

🏛️

2025

On the market since

May 2025

📍

2026

Currently FDA-listed

1 year 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 69315-0410-05, 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.

📅 Q3 2025 – Q4 2025 · 2 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

2.1K

Units reimbursed last 4 qtrs

152.1K

Gross reimbursed last 4 qtrs

$27.3K

Avg / prescription

$12.78

Avg / unit

$0.1796

Latest quarter Q4 2025

1.9KRx

Medicaid pays / ea

$0.1796

gross reimbursed

NADAC / ea

$0.0288

acquisition cost

Spread

+$0.1508

+524% 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 ⓘ

21% FFS 79% MCO

Fee-for-service · 444 Rx Managed care · 1,694 Rx

State Medicaid map

Units reimbursed · per 100k residents

6.01,990

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 Louisiana 1,990 /100k

2 Mississippi 513 /100k

3 Oklahoma 440 /100k

4 Missouri 257 /100k

5 Arkansas 69.4 /100k

6 New Mexico 47.1 /100k

7 Kentucky 31.4 /100k

8 Alabama 23.9 /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.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.

500 tablets this page69315-0410-05 2,138 Rx · $27,315

100 tablets69315-0410-01 71 Rx · $886

Drug total (last 4 qtrs): 2,209 Rx · 157,395 units · $28,201 gross reimbursed

Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

🔬 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 ER (this brand).

Top reported reactions

Lactic Acidosis4,521

Diarrhoea4,263

Nausea3,480

Acute Kidney Injury3,203

Fatigue3,057

Dyspnoea2,603

Vomiting2,596

Age at onset

Neonate159

Infant22

Child20

Adolescent80

Adult6,228

Elderly6,736

Reporter sex

Male · 45%

Female · 55%

Unknown · 0%

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	Per unit	Per pack	Marketing start	Status
69315-0410-01	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (69315-410-01)	$0.0288 / ea	$2.88	2025-05-01	Active
69315-0410-05 You're viewing this	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (69315-410-05)	$0.0288 / ea	$14.40	2025-05-01	Active

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

This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($0.0288 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 97% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 69315-0410-05?

NDC 69315-0410-05 is a 500-count package — 500 tablet, extended release in 1 bottle.

What is the difference between NDC 69315-0410-05 and NDC 69315-0410-01?

Both are METFORMIN HYDROCHLORIDE ER 500 mg Tablet, Extended Release — the drug itself is identical. NDC 69315-0410-05 is the 500-count package, while NDC 69315-0410-01 is the 100 tablets package.

What NDC number is used to bill for this package of METFORMIN HYDROCHLORIDE ER 500 mg Tablet, Extended Release?

Bill NDC 69315-0410-05 — the 11-digit billing format is 69315041005. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 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 📋 Description 💬 Information for Patients

🚨 Boxed Warning ~2 min read ▾

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 s tudy with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, hepatic impairment, and mitochondrial diseases [see Warnings and Precautions ( 5.1 )] . 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 ), Contraindications ( 4 ), Warnings and Precautions ( 5.1 )].

If metformin-associated lactic acidosis is suspected, immediately discontinue metformin hydrochloride extended-release 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/m L. ( 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, hepatic impairment and mitochondrial diseases. 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 extended-release tablets and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended.( 5.1 )

🎯 Indications and Usage 57 words ▾

1 INDICATIONS AND USAGE Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Metformin hydrochloride extended-release tablets are a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION . Recommended Dosage in Adults : Swallow metformin hydrochloride extended-release tablets whole and never crush, cut or chew ( 2.2 ) Starting dosage: 500 mg orally once daily with the evening meal ( 2.2 ) Increase the dosage in increments of 500 mg weekly, up to a maximum of 2000 mg once daily with the evening meal ( 2.2 ) Patients receiving metformin hydrochloride immediate-release tablets may be switched to metformin hydrochloride extended-release tablets once daily at the same total daily dosage, up to 2000 mg once daily ( 2.3 ) Recommended Dosage in Patients with Renal Impairment: Prior to initiation, assess renal function with estimated glomerular filtration rate (e GFR) ( 2.4 ) Do not use in patients with e GFR below 30 mL/minute/1.73 m 2 ( 2.4 ) Initiation is not recommended in patients with e GFR between 30 to 45 mL/minute/1.73 m 2 ( 2.4 ) Assess risk/benefit of continuing if e GFR falls below 45 mL/ minute/1.73 m 2 ( 2.4 ) Discontinue if e GFR falls below 30 mL/minute/1.73 m 2 ( 2.4 ) Discontinuation for Iodinated Contrast Imaging Procedures: Metformin hydrochloride extended-release tablets may need to be discontinued at time of, or prior to, iodinated contrast imaging procedures ( 2.5 )

2.2Recommended Dosage for Metformin Hydrochloride Extended-Release Tablets in Adults With Type 2 Diabetes Mellitus Swallow metformin hydrochloride extended-release tablets whole and never crush, cut or chew. The recommended starting dosage of metformin hydrochloride extended-release is 500 mg orally once daily with the evening meal. Increase the dosage in increments of 500 mg weekly on the basis of glycemic control and tolerability, up to a maximum of 2000 mg once daily with the evening meal.

If glycemic control is not achieved with metformin hydrochloride extended-release tablets 2000 mg once daily, consider a trial of metformin hydrochloride extended-release tablets 1000 mg twice daily. If a dose of metformin hydrochloride extended-release tablets is missed, instruct patients not to take two doses the same day and to resume their usual dose of metformin hydrochloride extended-release tablets with the next schedule dose.

2.3Switching Between Metformin Hydrochloride Immediate-Release Tablets and Metformin Hydrochloride Extended-Release Tablets Patients may switch between metformin hydrochloride immediate-release tablets and metformin hydrochloride extended-release tablets at the same total daily dosage. Patients receiving metformin hydrochloride extended-release tablets who require dosages higher than 2,000 mg daily may switch to metformin hydrochloride immediate-release tablets and titrate to the maximum total daily dosage of 2,550 mg.

2.4Recommended Dosage in Patients With Renal Impairment Assess renal function prior to initiation of metformin hydrochloride extended-release tablets and periodically thereafter. Metformin hydrochloride extended-release tablets are contraindicated in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/minute/1.73 m 2 Initiation of metformin hydrochloride extended-release tablets in patients with an eGFR between 30 to 45 mL/minute/1.73 m 2 is not recommended. In patients taking metformin hydrochloride extended-release tablets whose eGFR later falls below 45 mL/min/1.73 m 2 , assess the benefit risk of continuing therapy.

Discontinue metformin hydrochloride extended-release tablets if the patient's eGFR later falls below 30 mL/minute/1.73 m 2 [ see Warnings and Precautions ( 5.1 ) ].

2.5Discontinuation for Iodinated Contrast Imaging Procedures Discontinue metformin hydrochloride extended-release 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 hy…

💊 Dosage Forms and Strengths 53 words ▾

3 DOSAGE FORMS AND STRENGTHS Metformin hydrochloride extended-release tablets USP, 500 mg are available as: White to off white capsule shaped, biconvex, beveled edge tablet, with occasionally mottled appearance, debossed with " " 001" on one side and plain on other side. Metformin Hydrochloride Extended-Release Tablets, USP: 500 mg ( 3 ) Image

⛔ Contraindications 82 words ▾

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

Severe renal impairment (e GFR 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 ~2 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 extended-release tablets. In metformin hydrochloride extended-release 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 extended-release 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 ( 2.2 ) , Clinical Pharmacology ( 12.3 ) ]: Before initiating metformin hydrochloride extended-release tablets, obtain an estimated glomerular filtration rate (eGFR). Metformin hydrochloride extended-release tablets are contraindicated in patients with an eGFR less than 30 mL/min/1.73 m 2 [see Contraindications ( 4 )] .

Initiation of metformin hydrochloride extended-release tablets are not recommended in patients with eGFR between 30 to 45 mL/min/1.73 m 2 . Obtain an eGFR at least annually in all patients taking metformin hydrochloride extended-release 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 extended-release 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 extended-release 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 frequen…

🤒 Adverse Reactions ~2 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 extended-release 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 Leading Pharma, LLC at 1-844-740-7500 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 Extended-Release Tablets: In placebo-controlled trials, in adults with type 2 diabetes mellitus, 781 patients were administered metformin hydrochloride extended-release tablets. Adverse reactions reported in greater than 5% of the metformin hydrochloride extended-release tablets patients, and that were more common in metformin hydrochloride extended-release tablets- than placebo-treated patients, are listed in Table 1.

Table 1: Adverse Reactions from Clinical Trials of Metformin Hydrochloride Extended-Release Tablets Occurring >5% and More Common than Placebo in Adults with Type 2 Diabetes Mellitus Metformin Hydrochloride Extended-Release Tablets (n=781) Placebo (n=195) Diarrhea 10% 3% Nausea/Vomiting 7% 2% Diarrhea led to discontinuation of metformin hydrochloride extended-release tablets in 0.6% of patients. Additionally, the following adverse reactions were reported in ≥1.0% to ≤5.0% of metformin hydrochloride extended-release tablets patients and were more commonly reported with metformin hydrochloride extended-release tablets than placebo: abdominal pain, constipation, distention abdomen, dyspepsia/heartburn, flatulence, dizziness, headache, upper respiratory infection, taste disturbance.

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 ~2 min read ▾

7 DRUG INTERACTIONS Table 2 presents clinically significant drug interactions with metformin hydrochloride extended-release tablets. Table 2: Clinically Significant Drug Interactions with metformin hydrochloride extended-release tablets Carbonic Anhydrase Inhibitors Clinical Impact: Carbonic anhydrase inhibitors frequently cause a decrease in serum bicarbonate and induce non-anion gap, hyperchloremic metabolic acidosis. Concomitant use of these drugs with metformin hydrochloride extended- release tablets may increase the risk for lactic acidosis.

Intervention: Consider more frequent monitoring of these patients. Examples: Topiramate, zonisamide, acetazolamide or dichlorphenamide. Drugs that Reduce Metformin Hydrochloride Extended-Release Tablets Clearance Clinical Impact: Concomitant use of drugs that interfere with common renal tubular transport systems involved in the renal elimination of metformin (e.g., organic cationic transporter-2 [OCT2] / multidrug and toxin extrusion [MATE] inhibitors) could increase systemic exposure to metformin and may increase the risk for lactic acidosis [see Clinical Pharmacology (12.3)].

Intervention: Consider the benefits and risks of concomitant use with metformin hydrochloride extended-release tablets. Examples: Ranolazine, vandetanib, dolutegravir, and cimetidine. Alcohol Clinical Impact: Alcohol is known to potentiate the effect of metformin on lactate metabolism.

Intervention: Warn patients against excessive alcohol intake while receiving metformin hydrochloride extended-release tablets. Insulin Secretagogues or Insulin Clinical Impact: Coadministration of metformin hydrochloride extended-release tablets with an insulin secretagogue (e.g., sulfonylurea) or insulin may increase the risk of hypoglycemia. Intervention: Patients receiving an insulin secretagogue or insulin may require lower doses of the insulin secretagogue or insulin.

Drugs Affecting Glycemic Control Clinical Impact: Certain drugs tend to produce hyperglycemia and may lead to loss of glycemic control. Intervention: When such drugs are administered to a patient receiving metformin hydrochloride extended-release tablets, observe the patient closely for loss of blood glucose control. When such drugs are withdrawn from a patient receiving metformin hydrochloride extended-release tablets, observe the patient closely for hypoglycemia.

Examples: Thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blockers, and isoniazid. 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 )

👥 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 ) He patic Impairment: Avoid use in patients with hepatic impairment. ( 8 )

8.1Pregnancy Risk Summary Limited data with metformin hydrochloride extended-release 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 extended-release tablets and any potential adverse effects on the breastfed child from metformin hydrochloride extended-release 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 metformin hydrochloride extended…

🤰 Pregnancy ~2 min read ▾

🧒 Pediatric Use 18 words ▾

8.4Pediatric Use Safety and effectiveness of metformin hydrochloride extended-release tablets in pediatric patients have not been established.

🧓 Geriatric Use 92 words ▾

8.5Geriatric Use Controlled clinical studies of metformin hydrochloride extended-release 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 112 words ▾

10 OVERDOSAGE In the event of an overdose with metformin hydrochloride extended-release tablets, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations. 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 extended-release 500 mg tablet given under fasting conditions is approximately 50% to 60%. Studies using single oral doses of metformin hydrochloride extended-release 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 extended-release 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 (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 of metformin hydrochloride extended-release tablets with food, compared to the same tablet strength administered fasting. Although the extent of metformin absorption (as measured by AUC) from the metformin hydrochloride extended-release tablets increased by approximately 50% when given with food, there was no effect of food on Cmax and Tmax of metformin.

Both high and low fat meals had the same effect on the pharmacokinetics of metformin hydrochloride extended-release tablets. 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 approx…

🧬 Mechanism of Action 66 words ▾

📦 How Supplied / Storage and Handling 151 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Table 8: Metformin Hydrochloride Extended-Release Tablets, USP Available Strengths, Units, and appearance Metformin Hydrochloride Extended-Release Tablets, USP 500 mg Bottles of 100 NDC 69315-410-01 White to off white capsule shaped, biconvex, beveled edge tablet, with occasionally mottled appearance, debossed with " 001" on one side and plain on other side. Bottles of 500 NDC 69315-410-05 Image

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 light-resistant containers.

📋 Description 147 words ▾

11 DESCRIPTION Metformin hydrochloride extended-release 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 is a white to off-white crystalline compound with a molecular formula of C 4 H 11 N 5 .

HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pK a of metformin is 12.4.

The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride extended-release tablets, USP contains 500 mg of metformin hydrochloride, which is equivalent to 389.93 mg metformin base. Metformin hydrochloride extended-release tablets USP, 500 mg contain the inactive ingredients carboxymethylcellulose sodium, hypromellose and magnesium stearate.

Metformin Hydrochloride Extended-Release Tablets, USP meets USP Dissolution Test 3. Image

💬 Information for Patients ~3 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 extended-release 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 extended-release tablets. Instruct patients to inform their doctor that they are taking metformin hydrochloride extended-release 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 extended-release 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 extended-release tablets [see Warnings and Precautions ( 5.2 )] . Females of Reproductive Age: Inform females that treatment with metformin hydrochloride extended-release tablets may result in ovulation in some premenopausal anovulatory women which may lead to unintended pregnancy [see Use in Specific Populations ( 8.6 )].

Metformin Hydrochloride Extended-Release Tablets Administration Information: Inform patients that metformin hydrochloride extended-release tablets must be swallowed whole and not crushed, cut, or chewed, and that the inactive ingredients may occasionally be eliminated in the feces as a soft mass that may resemble the original tablet. Manufactured By: Inventia Healthcare Limited F1-F1/1-F75/1, Additional Ambernath M.I.D.C., Ambernath (East), Thane 421506, Maharashtra State, India Manufactured for: Leading Pharma, LLC Fairfield, NJ 07004, USA PATIENT INFORMATION Metformin hydrochloride (met-FOR-min HYE-droe-KLOR-ide) Extended-Release Tablets Read the Patient Information that comes with metformin hydrochloride extended-release tablets before you start taking it and each time you get a refill.

There may be new information. This leaflet does not take the place of talking with your healthcare provider about your medical condition or treatment. What is the most important information I should know about metformin hydrochloride extended- release tablets?

Serious side effects can happen in people taking metformin hydrochloride e x t e nd e d - r e l e a s e tablets, including: Lactic Acidosis. Metformin hydrochloride, the medicine in metformin hydrochloride extended-release tablets, can cause a rare, but serious, side effect called lactic acidosis (a build-up of lactic acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in a hospital.

Stop taking metformin hydrochloride extended-release tablets and call your healthcare provider right away if you get any of the following symptoms of lactic acidosis: feel very weak and tired have unusual (not normal) muscle pain have trouble breathing have unusual sleepiness or sleep longer than usual have unexplained stomach or intestinal problems with nausea and vomiting, or diarrhea feel cold, especially in your arms and legs feel dizzy or lightheaded have a slow or irregular heartbeat You have a higher chance of getting lactic acidosis if you: have kidney problems.

People whose kidneys are not working properly should not take metformin hydrochloride extended-release tablets. have liver problems. have congestive heart failure that requires treatm…

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.

Cmax: The highest level a medicine reaches in the blood after a dose is taken.

constipation: Having bowel movements less often than usual, or passing stools that are hard, dry, and difficult to move.

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.

dyspepsia: Discomfort, fullness, or a burning feeling in the upper belly, commonly called indigestion.

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.

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

GFR: A measure (glomerular filtration rate) of how well the kidneys filter the blood; lower numbers mean weaker kidney function.

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.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hyperglycemia: High blood sugar, meaning there is more glucose (sugar) in the blood than normal.

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.

immediate-release: A standard pill or capsule that releases all of its medicine soon after it is swallowed.

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.

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.

placebo-controlled: Describes a study that compares people taking the real medicine against people taking a dummy pill with no active ingredient.

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.

Tmax: The time after a dose when a medicine reaches its highest level in the blood.

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

transporter: A protein that moves drugs across cell membranes, carrying them either into or out of cells.

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 ↗

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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.

METFORMIN HYDROCHLORIDE ER 500 mg Tablet, Extended Release, 500-count

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