Home › NDC Lookup › Ingredients › Metformin Hydrochloride › 82804-0148-00
METFORMIN HYDROCHLORIDE EXTENDED RELEASE 750 mg Tablet, Extended Release, 100-count — NDC 82804-0148-00 package photo

METFORMIN HYDROCHLORIDE EXTENDED RELEASE 750 mg Tablet, Extended Release, 100-count

by Proficient Rx LP · 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82804-148-00)
NDC 82804-0148-00
🏷️ FDA NDC (as labeled) 82804-148-00 billing pads the product segment with a zero
This package
Contains100-count Pack sizes2 compare ↓
Also priced by: Part D plans $0.1129/unit — full pricing hub ↓
Also comes in: 30 tablets 82804-0148-30
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

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

🆔 Identity & classification

FDA NDC (as labeled) 82804-148-00
Product NDC 82804-148
11-digit billing NDC 82804014800
NCPDP billing unit EA — each (per item)
RxCUI 860981
UNII 786Z46389E
UPC 0382804148004
Application # ANDA090295
SPL Set ID f1530d4f-21d9-4a4f-a814-07b180828ecd
Established class (EPC) Biguanide
Chemical class Biguanides
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-05-12
Route ORAL
Dosage form TABLET, EXTENDED RELEASE
Substance METFORMIN HYDROCHLORIDE
GCN Seq No 052080
GCN 19578
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 750 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 82804-148-00 — 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 → 82804-0148-00. 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

LabelerProficient Rx LP
Application holderMARKSANS PHARMA LTD
FDA applicationANDA090295 (ANDA)
Labeler code82804
First marketedMay 2016
Product typeHuman Prescription Drug
Portfolio1,723 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name METFORMIN HCL ER 750 MG TABLET Ingredient Metformin Hcl
📖 What it is MedlinePlus · NLM

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

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

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

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

💊 What it looks like

Color white
ShapeCapsule
Imprint102
Size19 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 B1QE5P712K
    Hypromellose 2208 is a plant-derived thickening agent that dissolves in water. It's used as a binder to help hold tablet ingredients together and as a coating on pills to control how quickly the medicine releases in your body.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.

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 systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.1129 $11.29 / 100 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Metformin Hydrochloride 750 mg 29300-0399-01 Unichem 100 tablets $0.054 AB1 Availability likely —
Metformin Hydrochloride 750 mg 42385-0978-01 Laurus 100 tablets $0.054 AB1 Availability likely —
Metformin Hydrochloride 750 mg 42806-0633-01 Epic 100 tablets $0.054 AB1 Availability likely —
Metformin Hydrochloride Extended Release 750 mg 49483-0624-01 TIME 100 tablets $0.054 AB1 Availability likely —
Metformin Hydrochloride 750 mg 50268-0551-15 AvPAK 1 tablet $0.054 AB1 Availability likely —
Metformin Hydrochloride 750 mg 62756-0143-01 Sun 100 tablets $0.054 — Discontinued —
Metformin Hydrochloride 750 mg 67877-0414-01 Ascend 100 tablets $0.054 AB Availability likely —
Metformin Hydrochloride 750 mg 68094-0804-50 Precision 100 tablets $0.054 AB1 Availability likely —
Metformin 750 mg 70010-0492-01 Granules 100 tablets $0.054 AB1 Availability likely —
Metformin Hydrochloride 750 mg 72578-0036-01 Viona 100 tablets $0.054 AB Availability likely —
Metformin hydrochloride ER 750 mg 76385-0129-01 UNICHEM 100 tablets $0.054 AB1 Availability likely —
Metformin ER 750 mg 82009-0118-01 Quallent 100 tablets $0.054 AB1 Availability likely —
Metformin Hydrochloride 750 mg 82009-0181-01 Quallent 100 tablets $0.054 AB Availability likely —
Metformin hydrochloride 750 mg 33342-0240-11 Macleods 100 tablets $0.067 AB1 FDA listed —
Metformin Hydrochloride 750 mg 51224-0107-50 TAGI 100 tablets $0.067 AB1 FDA listed —
Metformin Hydrochloride 750 mg 10135-0824-05 Marlex 500 tablets — AB1 FDA listed —
Metformin Hydrochloride 750 mg 25000-0102-03 MARKSANS 30 tablets — AB1 FDA listed —
Metformin hydrochloride ER 750 mg 42291-0824-10 AvKARE 1000 tablets — AB1 FDA listed —
Metformin Hydrochloride Extended Release 750 mg 43063-0902-30 PD-Rx 30 tablets — AB1 FDA listed —
Metformin Hydrochloride 750 mg 50090-5246-00 A-S 90 tablets — AB FDA listed —
Metformin Hydrochloride 750 mg 50090-6839-00 A-S 90 tablets — AB FDA listed —
Metformin 750 mg 50090-7372-00 A-S 90 tablets — AB1 FDA listed —
Metformin 750 mg 50090-7373-00 A-S 90 tablets — AB1 FDA listed —
Metformin Hydrochloride 750 mg 50090-7534-00 A-S 90 tablets — AB1 FDA listed —
Metformin Hydrochloride 750 mg 50090-7535-00 A-S 90 tablets — AB1 FDA listed —
Metformin Hydrochloride 750 mg 51655-0077-26 Northwind 90 tablets — AB FDA listed —
Metformin Hydrochloride 750 mg 51655-0368-52 Northwind 30 tablets — AB1 FDA listed —
Metformin Hydrochloride 750 mg 59651-0549-01 Aurobindo 100 tablets — AB1 FDA listed —
Metformin ER 750 mg 62207-0492-40 Granules 3500 tablets — AB1 FDA listed —
Metformin Hydrochloride 750 mg 63629-9147-01 Bryant 100 tablets — AB1 FDA listed —
Metformin Hydrochloride 750 mg 65162-0179-03 Amneal 30 tablets — — FDA listed —
Metformin Hydrochloride 750 mg 65841-0039-01 Zydus 100 tablets — AB Discontinued —
Metformin Hydrochloride 750 mg 67046-1556-03 Coupler 30 tablets — AB1 FDA listed —
Metformin Hydrochloride 750 mg 68788-7205-01 Preferred 100 tablets — AB1 FDA listed —
Metformin Hydrochloride 750 mg 69238-2126-01 Amneal 100 tablets — — FDA listed —
Metformin Hydrochloride 750 mg 70518-2709-00 REMEDYREPACK 30 tablets — AB1 Discontinued —
Metformin Hydrochloride 750 mg 70518-4163-00 REMEDYREPACK 30 tablets — AB1 FDA listed —
Metformin Hydrochloride 750 mg 71205-0141-00 Proficient 100 tablets — AB1 FDA listed —
Metformin Hydrochloride 750 mg 71335-0776-01 Bryant 30 tablets — AB1 FDA listed —
Metformin Hydrochloride Extended Release 750 mg 71335-0889-01 Bryant 30 tablets — AB1 Discontinued —
Metformin Hydrochloride 750 mg 71335-2504-01 Bryant 30 tablets — AB1 FDA listed —
Metformin 750 mg 71335-2524-01 Bryant 30 tablets — AB1 FDA listed —
Metformin Hydrochloride 750 mg 71335-9752-01 Bryant 30 tablets — AB FDA listed —
Metformin hydrochloride ER 750 mg 71610-0666-60 Aphena 90 tablets — AB1 FDA listed —
Metformin Hydrochloride 750 mg 71610-0740-53 Aphena 60 tablets — — FDA listed —
Metformin hydrochloride ER 750 mg 71610-0867-53 Aphena 60 tablets — AB1 FDA listed —
Metformin Hydrochloride 750 mg 72162-1293-01 Bryant 100 tablets — AB1 FDA listed —
Metformin hydrochloride ER 750 mg 72789-0106-01 PD-Rx 100 tablets — AB1 FDA listed —
Metformin Hydrochloride 750 mg 72789-0451-30 PD-Rx 30 tablets — AB1 FDA listed —
Metformin Hydrochloride 750 mg 72789-0472-01 PD-Rx 100 tablets — AB FDA listed —
Metformin Hydrochloride 750 mg 72789-0548-93 PD-Rx 180 tablets — AB1 FDA listed —
Metformin Hydrochloride Extended Release 750 mgthis 82804-0148-00 Proficient 100 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

🏛️
2016
On the market since
May 2016
📍
2026
Currently FDA-listed
10 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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

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

🔬 Reported adverse events (FAERS)

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

Top reported reactions

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

Reporter sex

90,664 reports
Male · 47%
Female · 53%
Unknown · 0%

Serious outcomes

Death8,296
Disabling2,592
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 8,466 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
82804-0148-00 You're viewing this 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82804-148-00) 2024-09-20 Active
82804-0148-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82804-148-30) 2025-02-20 Active

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

Pack size FAQ

What quantity is in NDC 82804-0148-00?
NDC 82804-0148-00 is a 100-count package — 100 tablet, extended release in 1 bottle, plastic.
What is the difference between NDC 82804-0148-00 and NDC 82804-0148-30?
Both are METFORMIN HYDROCHLORIDE EXTENDED RELEASE 750 mg Tablet, Extended Release — the drug itself is identical. NDC 82804-0148-00 is the 100-count package, while NDC 82804-0148-30 is the 30 tablets package.
What NDC number is used to bill for this package of METFORMIN HYDROCHLORIDE EXTENDED RELEASE 750 mg Tablet, Extended Release?
Bill NDC 82804-0148-00 — the 11-digit billing format is 82804014800. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 82804-148-00, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 82804-0148-00, written without dashes as 82804014800. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 82804-0148-00, the first segment (82804) is the labeler code FDA assigned to Proficient Rx LP; the middle segment (0148) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (00) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Proficient Rx LP. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 30 tablets (82804-0148-30). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Proficient Rx LP is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 How Supplied / Storage and Handling
🎯 Indications and Usage 25 words ▾

Metformin Hydrochloride Extended-Release Tablets, USP is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

⏱️ Dosage and Administration ~2 min read ▾

There is no fixed dosage regimen for the management of hyperglycemia in patients with type 2 diabetes with metformin hydrochloride extended-release tablets or any other pharmacologic agent. Dosage of metformin hydrochloride extended-release tablets must be individualized on the basis of both effectiveness and tolerance, while not exceeding the maximum recommended daily doses. The maximum recommended daily dose of metformin hydrochloride extended-release tablets in adults is 2000 mg.

Metformin hydrochloride extended-release tablets should generally be given once daily with the evening meal. Metformin hydrochloride extended-release tablets should be started at a low dose, with gradual dose escalation, both to reduce gastrointestinal side effects and to permit identification of the minimum dose required for adequate glycemic control of the patient. During treatment initiation and dose titration (see Recommended Dosing Schedule), fasting plasma glucose should be used to determine the therapeutic response to metformin hydrochloride extended-release tablets and identify the minimum effective dose for the patient.

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

Short-term administration of metformin hydrochloride extended-release tablets may be sufficient during periods of transient loss of control in patients usually well-controlled on diet alone. Metformin hydrochloride extended-release tablets must be swallowed whole and never crushed or chewed. Occasionally, the inactive ingredients of metformin hydrochloride extended-release tablets will be eliminated in the feces as a soft, hydrated mass.

(See Patient information printed below.) Recommended Dosing Schedule Adults - In general, clinically significant responses are not seen at doses below 1500 mg per day. However, a lower recommended starting dose and gradually increased dosage is advised to minimize gastrointestinal symptoms. The usual starting dose of metformin hydrochloride extended-release tablet is 500 mg once daily with the evening meal.

Dosage increases should be made in increments of 500 mg weekly, up to a maximum of 2000 mg once daily with the evening meal. If glycemic control is not achieved on metformin hydrochloride extended-release tablets 2000 mg once daily, a trial of metformin hydrochloride extended-release tablets 1000 mg twice daily should be considered. In a randomized trial, patients currently treated with metformin hydrochloride tablets were switched to metformin hydrochloride extended-release tablets.

Results of this trial suggest that patients receiving metformin hydrochloride tablets treatment may be safely switched to metformin hydrochloride extended-release tablets once daily at the same total daily dose, up to 2000 mg once daily. Following a switch from metformin hydrochloride tablets to metformin hydrochloride extended-release tablets, glycemic control should be closely monitored and dosage adjustments made accordingly Pediatrics – Safety and effectiveness of metformin hydrochloride extended-release tablets in pediatric patients have not been established.

Transfer From Other Antidiabetic Therapy When transferring patients from standard oral hypoglycemic agents other than chlorpropamide to metformin hydrochloride extended-release tablets, no transition period generally is necessary. When transferring…

⚠️ Warnings 176 words ▾

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 PRECAUTIONS).

Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g. carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, and hepatic impairment. Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided (see DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, and PRECAUTIONS).

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

📦 How Supplied / Storage and Handling 37 words ▾

HOW SUPPLIED METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS ARE SUPPLIED: in bottles of 30 and 100 750 mg - White to Off-White capsule shaped no score imprint code 102 Bottles of 30 NDC 82804-148-30 Bottles of 100 NDC 82804-148-00

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 82804-0147-30 · Proficient 82804-0149-30 · Proficient →
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.