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Metformin Hydrochloride Extended-Release 500mg 500 mg Tablet, Extended Release, 28-count — NDC 17224-0311-28 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Metformin Hydrochloride Extended-Release 500mg 500 mg Tablet, Extended Release, 28-count — NDC 17224-311-28 (Billing 17224-0311-28)

by Calvin Scott & Co., Inc. · 28 TABLET, EXTENDED RELEASE in 1 BOTTLE

This is a package of 28 tablets of Metformin Hydrochloride Extended-Release 500mg 500 mg Tablet, Extended Release from Calvin Scott & Co., Inc., marketed since Jun 2017 and currently FDA-listed. It is this product's only package size.

NDC 17224-0311-28
🏷️ FDA NDC (as labeled) 17224-311-28 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 17224-311-28 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
17224 labeler · 311 product · 28 package
Package marketed since
Jun 8, 2017
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 1722431128 8
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Metformin Hydrochloride (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 13, 2025 — CGMP Deviations (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0328-2025
Class II · Feb 25, 2025 — Presence of Foreign Tablets/Capsules. (A-S Medication Solutions LLC) · FDA recall D-0292-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 17224-311-28
Product NDC 17224-311
11-digit billing NDC 17224031128
RxCUI 860975
UNII 786Z46389E
Application # ANDA078321
SPL Set ID e9cd0d23-56eb-40dd-abf4-9e681ec220f5
Established class (EPC) Biguanide
Chemical class Biguanides
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-06-08
Route ORAL
Dosage form TABLET, EXTENDED RELEASE
Substance METFORMIN HYDROCHLORIDE
TE code (Orange Book) AB1 · RLD · RS
Quick answers
  • RxCUI (RxNorm): 860975
Why two NDCs? The FDA registers this code as 17224-311-28 — 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 → 17224-0311-28. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Biguanide class.

Pharmacologic class Biguanide
Drug family (ATC) Biguanides
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📖 What it is MedlinePlus · NLM

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

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

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

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

Pricing

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

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

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
17224-0311-28 You're viewing this Main listing 28 TABLET, EXTENDED RELEASE in 1 BOTTLE 2017-06-08 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Metformin Hydrochloride 500 mg 29300-0389-01 Unichem 100 tablets $0.028 AB1 Availability likely —
Metformin Hydrochloride 500 mg 42385-0977-01 Laurus 100 tablets $0.028 AB1 Availability likely —
Metformin Hydrochloride 500 mg 42806-0632-01 Epic 100 tablets $0.028 AB1 Availability likely —
Metformin Hydrochloride Extended Release 500 mg 49483-0623-01 TIME 100 tablets $0.028 AB1 Availability likely —
Metformin Hydrochloride 500 mg 50268-0550-15 AvPAK 1 tablet $0.028 AB1 Availability likely —
Metformin Hydrochloride 500 mg 67877-0159-01 Ascend 100 tablets $0.028 AB1 Availability likely —
Metformin Hydrochloride 500 mg 67877-0413-01 Ascend 100 tablets $0.028 AB1 Availability likely —
Metformin Hydrochloride 500 mg 68094-0904-50 Precision 100 tablets $0.028 AB1 Availability likely —
Metformin 500 mg 68645-0595-59 Legacy 60 tablets $0.028 AB1 Availability likely —
Metformin Hydrochloride Er 500 mg 69315-0410-01 Leading 100 tablets $0.028 AB1 Availability likely —
Metformin 500 mg 70010-0491-01 Granules 100 tablets $0.028 AB1 Availability likely —
Metformin ER 500 mg 82009-0117-10 Quallent 1000 tablets $0.028 AB1 Availability likely —
Metformin Hydrochloride 500 mg 82009-0180-05 Quallent 500 tablets $0.028 AB1 Availability likely —
Metformin Hydrochloride 500 mg 62756-0142-01 Sun 100 tablets $0.029 — FDA listed —
Metformin hydrochloride 500 mg 33342-0239-11 Macleods 100 tablets $0.031 AB1 FDA listed —
Metformin Hydrochloride 500 mg 51224-0007-50 TAGI 100 tablets $0.031 AB1 FDA listed —
Metformin Hydrochloride 500 mg 69367-0412-60 Westminster 60 tablets $0.164 AB2 Availability likely —
Metformin hydrochloride 500 mg 27241-0188-60 Ajanta 60 tablets $0.164 AB2 Availability likely —
Metformin Hydrochloride 500 mg 59651-0042-60 Aurobindo 60 tablets $0.164 AB2 Availability likely —
Metformin Hydrochloride 500 mg 42571-0333-01 Micro 100 tablets $0.271 AB3 Availability likely —
Metformin Hydrochloride 500 mg 68180-0338-01 Lupin 100 tablets $0.271 AB3 Availability likely —
Metformin Hydrochloride 500 mg 70010-0496-01 Granules 100 tablets $0.271 AB3 Availability likely —
Metformin hydrochloride 500 mg 27241-0240-01 Ajanta 100 tablets $0.271 AB3 Availability likely —
Metformin Hydrochloride 500 mg 68462-0520-01 GLENMARK 100 tablets $0.271 AB3 Availability likely —
Metformin hydrochloride 500 mg 68682-0021-50 Oceanside 100 tablets $0.402 — FDA listed —
Glumetza 500 mg 68012-0004-50 Santarus, 100 tablets $49.542 — FDA listed —
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 mgthis 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 — AB1 FDA listed —
Metformin Hydrochloride 500 mg 50090-5397-00 A-S 90 tablets — AB1 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 — AB1 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 — AB1 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 — AB1 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 —
Metformin Hydrochloride 500 mg 70518-4639-00 REMEDYREPACK 1 tablet — 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

🏛️
2017
On the market since
Jun 2017
📍
2026
Currently FDA-listed
9 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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

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

What it looks like

Color white
ShapeOval
ImprintOE;584
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.

🧪 Avoiding an ingredient? See Metformin inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 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 D9C330MD8B
    Copovidone is a synthetic polymer made by combining two types of plastic-like molecules. It acts as a binder and film-former to help hold tablet ingredients together and improve how the medicine dissolves in your body.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.

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

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

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerCalvin Scott & Co., Inc.
Application holderCSPC OUYI PHARMACEUTICAL CO LTD
FDA applicationANDA078321 (ANDA)
Labeler code17224
First marketedJun 2017
Product typeHuman Prescription Drug
Portfolio20 products on file

More NDCs from Calvin Scott & Co., Inc. labeler code 17224

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⚠️ Warnings 🔄 Drug Interactions 🆘 Overdosage ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 97 words ▾

USES: Metformin is used with a proper diet and exercise program and possibly with other medications to control high blood sugar. It is used in patients with type 2 diabetes (non-insulin-dependent diabetes). Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems.

Proper control of diabetes may also lessen your risk of a heart attack or stroke. Metformin works by helping to restore your body's proper response to the insulin you naturally produce. It also decreases the amount of sugar that your liver makes and that your stomach/intestines absorb.

⚠️ Warnings 181 words ▾

WARNING: Metformin can rarely cause a serious (sometimes fatal) condition called lactic acidosis. Stop taking metformin and get medical help right away if you develop any of the following symptoms of lactic acidosis: unusual tiredness, dizziness, severe drowsiness, chills, blue/cold skin, muscle pain, fast/difficult breathing, slow/irregular heartbeat, stomach pain with nausea, vomiting, or diarrhea. Lactic acidosis is more likely to occur in patients who have certain medical conditions, including kidney or liver disease, recent surgery, a serious infection, conditions that may cause a low level of oxygen in the blood or poor circulation (such as congestive heart failure, recent heart attack, recent stroke), heavy alcohol use, a severe loss of body fluids (dehydration), or X-ray or scanning procedures that require an injectable iodinated contrast drug.

Tell your doctor immediately if any of these conditions occur or if you notice a big change in your overall health. You may need to stop taking this medication temporarily. The elderly are also at higher risk, especially those older than 80 years who have not had kidney tests.

(See also Side Effects and Precautions sections.)

🔄 Drug Interactions 150 words ▾

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist.

Do not start, stop, or change the dosage of any medicines without your doctor's approval. Many drugs can affect your blood sugar levels, making it more difficult to control your blood sugar. Before you start, stop, or change any medication, talk with your doctor or pharmacist about how the medication may affect your blood sugar.

Check your blood sugar levels regularly as directed by your doctor. Tell your doctor about the results and of any symptoms of high or low blood sugar. (See also Side Effects section.) Your doctor may need to adjust your anti-diabetic medication, exercise program, or diet.

🆘 Overdosage 52 words ▾

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Overdose can cause lactic acidosis. Symptoms of overdose may include: severe drowsiness, severe nausea/vomiting/diarrhea, rapid breathing, slow/irregular heartbeat.

⚠️ Precautions ~2 min read ▾

PRECAUTIONS: See also Warning section. Before taking this medication, tell your doctor or pharmacist if you are allergic to metformin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems.

Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: severe breathing problems (such as obstructive lung disease, severe asthma), metabolic acidosis (such as diabetic ketoacidosis), blood problems (such as anemia, vitamin B12 deficiency), kidney disease, liver disease. Before having surgery or any X-ray/scanning procedure using injectable iodinated contrast material, tell your doctor that you are taking this medication.

You will need to temporarily stop this medication before the time of your surgery/procedure. Consult your doctor for further instructions. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar levels. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcohol while using this medication because it can increase your risk of lactic acidosis and developing low blood sugar.

High fever, "water pills" (diuretics such as hydrochlorothiazide), too much sweating, diarrhea, or vomiting may cause loss of too much body water (dehydration) and increase your risk of lactic acidosis. Stop taking this medication and tell your doctor right away if you have prolonged diarrhea or vomiting. Be sure to drink enough fluids to prevent dehydration unless your doctor directs you otherwise.

It may be harder to control your blood sugar when your body is stressed (such as due to fever, infection, injury, or surgery). Consult your doctor because increased stress may require a change in your treatment plan, medications, or blood sugar testing. Older adults may be a greater risk for side effects such as low blood sugar or lactic acidosis.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Your doctor may direct you to use insulin instead of this product during your pregnancy.

Follow your doctor's instructions carefully. Metformin can cause changes in the menstrual cycle (promote ovulation) and increase the risk of becoming pregnant. Consult your doctor or pharmacist about the use of reliable birth control while using this medication.

Metformin passes into breast milk in small amounts. Consult your doctor before breast-feeding.

📄 Package Label / Principal Display Panel 3 words ▾

Package Labeling: Label0

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

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

Serious outcomes

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.

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Calvin Scott & Co., Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Calvin Scott & Co., Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 17224-0185-21 · Calvin 17224-0502-30 · Calvin →
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.