Home › NDC Lookup › Ingredients › Metformin Hydrochloride › 68012-0002-13
Glumetza metformin hydrochloride 500 mg Tablet, Film Coated, Extended Release, 100-count — NDC 68012-0002-13 package photo

Glumetza metformin hydrochloride 500 mg Tablet, Film Coated, Extended Release, 100-count

by Santarus, Inc. · 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68012-002-13)
NDC 68012-0002-13
🏷️ FDA NDC (as labeled) 68012-002-13 billing pads the product segment with a zero
Rx only Brand On market Non-controlled
🗂️ Data synced Sep 17, 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) 68012-002-13
Product NDC 68012-002
11-digit billing NDC 68012000213
NCPDP billing unit EA — each (per item)
RxCUI 861015, 861018, 1807888, 1807915
UNII 786Z46389E
UPC 0368012003168, 0368012004509
Application # NDA021748
SPL Set ID fb832474-88d9-4e29-95cd-fbc446944cc4
Established class (EPC) Biguanide
Chemical class Biguanides
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2006-08-01
Route ORAL
Dosage form TABLET, FILM COATED, EXTENDED RELEASE
Substance METFORMIN HYDROCHLORIDE
GCN Seq No 061267
GCN 97061
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 GLUMETZA ER 500 MG TABLET
FDB brand name Glumetza
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 68012-002-13 — 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 → 68012-0002-13. 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

LabelerSantarus, Inc.
Application holderSANTARUS INC
FDA applicationNDA021748 (NDA)
Labeler code68012
First marketedAug 2006
Product typeHuman Prescription Drug
Portfolio3 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name GLUMETZA 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
  • 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 blue / white
ShapeOval
ImprintM500
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 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.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.

4 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 · 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Metformin Hydrochloride 500 mg 42806-0632-01 Epic 100 tablets $0.029 AB1 Availability likely —
Metformin Hydrochloride 500 mg 67877-0159-01 Ascend 100 tablets $0.029 AB1 Availability likely —
Metformin Hydrochloride Er 500 mg 69315-0410-01 Leading 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 42385-0977-01 Laurus 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 67877-0413-01 Ascend 100 tablets $0.029 AB Availability likely —
Metformin Hydrochloride 500 mg 68094-0904-50 Precision 100 tablets $0.029 AB1 Availability likely —
Metformin Hydrochloride 500 mg 82009-0180-05 Quallent 500 tablets $0.029 AB Availability likely —
Metformin Hydrochloride 500 mg 29300-0389-01 Unichem 100 tablets $0.029 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 $0.138 AB2 Availability likely —
Metformin hydrochloride 500 mg 27241-0188-60 Ajanta 60 tablets $0.138 AB2 Availability likely —
Metformin Hydrochloride 500 mg 59651-0042-60 Aurobindo 60 tablets $0.138 AB2 Availability likely —
Metformin hydrochloride 500 mg 27241-0240-01 Ajanta 100 tablets $0.262 AB3 Availability likely —
Metformin Hydrochloride 500 mg 42571-0333-01 Micro 100 tablets $0.262 AB3 Availability likely —
Metformin Hydrochloride 500 mg 50228-0445-01 ScieGen 100 tablets $0.262 AB3 Availability likely —
Metformin Hydrochloride 500 mg 68180-0338-01 Lupin 100 tablets $0.262 AB3 Availability likely —
Metformin Hydrochloride 500 mg 68462-0520-01 GLENMARK 100 tablets $0.262 AB3 Availability likely —
Metformin Hydrochloride 500 mg 70010-0496-01 Granules 100 tablets $0.262 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 43547-0503-10 Solco 100 tablets — AB3 FDA listed —
Metformin Hydrochloride 500 mg 47335-0305-18 Sun 1000 tablets — — Discontinued —
Metformin Hydrochloride 500 mg 62207-0496-47 Granules 500 tablets — AB3 FDA listed —
Glumetza 500 mgthis 68012-0002-13 Santarus, 100 tablets — — 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 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 Hydrochloride 500 mg 71610-0652-30 Aphena 30 tablets — — FDA listed —
Metformin Hydrochloride Extended-Release 500mg 500 mg 17224-0311-28 Calvin 28 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 Hydrochloride 500 mg 71335-9683-01 Bryant 60 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 72664-0227-01 VGYAAN 100 tablets — — FDA listed —
Metformin Hydrochloride 500 mg 00615-8289-39 NCS 30 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 65841-0027-01 Zydus 100 tablets — AB1 Discontinued —
Metformin Hydrochloride 500 mg 82804-0195-60 Proficient 60 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 10135-0823-05 Marlex 500 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 50090-7918-00 A-S 90 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 65162-0178-03 Amneal 30 tablets — — FDA listed —
Metformin Hydrochloride Extended Release 500 mg 68071-3111-02 NuCare 120 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 71610-0837-30 Aphena 30 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 72578-0035-01 Viona 100 tablets — AB1 FDA listed —
Metformin hydrochloride 500 mg 72789-0105-01 PD-Rx 100 tablets — AB1 FDA listed —
Metformin hydrochloride 500 mg 76385-0128-01 UNICHEM 100 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 67296-1701-06 RedPharm 60 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 68180-0336-01 Lupin 100 tablets — AB2 FDA listed —
Metformin Hydrochloride 500 mg 69238-2125-01 Amneal 100 tablets — — FDA listed —
Metformin Hydrochloride 500 mg 72789-0455-30 PD-Rx 30 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 71335-0886-01 Bryant 60 tablets — AB1 FDA listed —
Metformin hydrochloride 500 mg 71610-0858-30 Aphena 30 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 72789-0400-01 PD-Rx 100 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 50090-7579-00 A-S 90 tablets — AB1 FDA listed —
Metformin hydrochloride 500 mg 63187-0779-00 Proficient 100 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 25000-0101-03 MARKSANS 30 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 50090-7576-00 A-S 60 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 59651-0548-25 Aurobindo 25000 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 68788-8814-01 Preferred 100 tablets — AB1 FDA listed —
Metformin hydrochloride 500 mg 42291-0825-10 AvKARE 1000 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 50090-1494-00 A-S 60 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 50090-7116-00 A-S 90 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 Extended Release 500 mg 72189-0064-30 direct 30 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 72789-0454-60 PD-Rx 60 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 50090-7577-00 A-S 90 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 71335-2568-01 Bryant 60 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 42708-0201-60 QPharma 60 tablets — AB1 FDA listed —
Metformin Hydrochloride Extended Release 500 mg 51655-0555-96 Northwind 180 tablets — AB1 FDA listed —
Metformin hydrochloride 500 mg 68071-1419-02 NuCare 20 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 72189-0150-30 direct 30 tablets — AB1 FDA listed —
Metformin Hydrochloride Extended Release 500 mg 72789-0009-30 PD-Rx 30 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 the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
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

🏛️
2006
On the market since
Aug 2006
📍
2026
Currently FDA-listed
20 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Glumetza — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Glumetza. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$89.8K
Claims incl. refills
20
Beneficiaries
13
Spend / beneficiary
$6,910.12
Spend / claim
$4,491.58
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 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 Glumetza (this brand).

Top reported reactions

Lactic Acidosis4,414
Diarrhoea4,413
Nausea3,585
Fatigue3,163
Acute Kidney Injury3,156
Vomiting2,659
Dyspnoea2,652

Age at onset

Neonate149
Infant16
Child18
Adolescent80
Adult6,349
Elderly6,783

Reporter sex

58,368 reports
Male · 45%
Female · 55%
Unknown · 0%

Serious outcomes

Hospitalization22,845
Death5,636
Life-threatening5,042
Disabling1,707
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 6,432 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
68012-0002-13 You're viewing this 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68012-002-13) 2006-08-01 Active

🧭 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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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 68012-002-13, 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: 68012-0002-13, written without dashes as 68012000213. 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 68012-0002-13, the first segment (68012) is the labeler code FDA assigned to Santarus, Inc.; the middle segment (0002) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (13) 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 Santarus, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Santarus, 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.

📄 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 study 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 in the full prescribing information [see Dosage and Administration ( 2.2 ), Contraindications ( 4 ), Warnings and Precautions ( 5.1 ), and Drug Interactions ( 7 )] .

If metformin-associated lactic acidosis is suspected, immediately discontinue GLUMETZA and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended [see Warnings and Precautions ( 5.1 )]. WARNING: LACTIC ACIDOSIS See full prescribing information for complete boxed warning. • Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias.

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

( 5.1 )

🎯 Indications and Usage 49 words ▾

1 INDICATIONS AND USAGE GLUMETZA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. GLUMETZA is 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 ~2 min read ▾

2 DOSAGE AND ADMINISTRATION • Starting dose: 500 mg orally once daily with the evening meal ( 2.1 ) • Increase the dose in increments of 500 mg every 1 to 2 weeks, up to a maximum of 2,000 mg once daily with the evening meal. ( 2.1 ) • Patients receiving metformin hydrochloride (HCl) tablets may be switched to GLUMETZA once daily at the same total daily dose, up to 2,000 mg once daily. ( 2.1 ) • Swallow GLUMETZA tablets whole and never crush, cut or chew.

( 2.1 ) Renal Impairment: • Prior to initiation, assess renal function with estimated glomerular filtration rate (eGFR). ( 2.2 ) o Do not use in patients with eGFR below 30 mL/minute/1.73 m 2 . o Initiation is not recommended in patients with eGFR between 30 to 45 mL/minute/1.73 m 2 . o Assess risk/benefit of continuing GLUMETZA if eGFR falls below 45 mL/minute/1.73 m 2 . o Discontinue if eGFR falls below 30 mL/minute/1.73 m 2 . Discontinuation for Iodinated Contrast Imaging Procedures: • GLUMETZA may need to be discontinued at time of, or prior to, iodinated contrast imaging procedures.

( 2.3 )

2.1Adult Dosage and Administration • The recommended starting dose of GLUMETZA is 500 mg orally once daily with the evening meal. • Increase the dose in increments of 500 mg every 1 to 2 weeks on the basis of glycemic control and tolerability, up to a maximum of 2,000 mg once daily with the evening meal. • Patients receiving metformin hydrochloride (HCl) may be switched to GLUMETZA once daily at the same total daily dose, up to 2,000 mg once daily. • Swallow GLUMETZA whole and never crush, cut or chew. • If a dose of GLUMETZA is missed, instruct patients not to take two doses the same day and to resume their usual dose of GLUMETZA with the next schedule dose.

2.2Recommendations for Use in Renal Impairment • Assess renal function prior to initiation of GLUMETZA and periodically thereafter. • GLUMETZA is contraindicated in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/minute/1.73 m 2 . • Initiation of GLUMETZA in patients with an eGFR between 30 to 45 mL/minute/1.73 m 2 is not recommended. • In patients taking GLUMETZA whose eGFR later falls below 45 mL/minute/1.73 m 2 , assess the benefit risk of continuing therapy. • Discontinue GLUMETZA if the patient’s eGFR later falls below 30 mL/minute/1.73 m 2 [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )].

2.3Discontinuation for Iodinated Contrast Imaging Procedures Discontinue GLUMETZA at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR between 30 and 60 mL/minute/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 GLUMETZA if renal function is stable [see Warnings and Precautions ( 5.1 )].

💊 Dosage Forms and Strengths 48 words ▾

3 DOSAGE FORMS AND STRENGTHS GLUMETZA is available as: • Extended-release tablets: 500 mg white, film-coated, oval-shaped tablets with “M500” on one side. • Extended-release tablets: 1,000 mg white, film-coated, oval-shaped tablets with “M1000” on one side. GLUMETZA Extended-Release Tablets: 500 mg and 1,000 mg ( 3 )

⛔ Contraindications 85 words ▾

4 CONTRAINDICATIONS GLUMETZA is contraindicated in patients with: • Severe renal impairment (eGFR below 30 mL/minute/1.73 m 2 ) [see Warnings and Precautions ( 5.1 )] . • Known hypersensitivity to metformin. • Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. • Severe renal impairment: (eGFR below 30 mL/minute/1.73 m 2 ) ( 4 , 5.1 ) • Known hypersensitivity to metformin ( 4 ) • Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Lactic Acidosis: See boxed warning. ( 5.1 ) • Vitamin B 12 Deficiency: Metformin may lower vitamin B 12 levels. Monitor 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, hypothermia, hypotension and resistant bradyarrhythmias have occurred with severe acidosis. Metformin-associated lactic acidosis was characterized by elevated blood lactate concentrations (>5 mmol/Liter), 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 GLUMETZA. In GLUMETZA-treated patients with a diagnosis or strong suspicion of lactic acidosis, prompt hemodialysis is recommended to correct the acidosis and remove accumulated metformin (metformin HCl is dialyzable, with a clearance of up to 170 mL/minute 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 GLUMETZA 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 ) and Clinical Pharmacology ( 12.3 ) ]: • Before initiating GLUMETZA, obtain an estimated glomerular filtration rate (eGFR). • GLUMETZA is contraindicated in patients with an eGFR less than 30 mL/minute/1.73 m 2 [see Contraindications ( 4 )]. • Initiation of GLUMETZA is not recommended in patients with eGFR between 30 to 45 mL/minute/1.73 m 2 . • Obtain an eGFR at least annually in all patients taking GLUMETZA.

In patients at increased risk for the development of renal impairment (e.g., the elderly), renal function should be assessed more frequently. • In patients taking GLUMETZA whose eGFR later falls below 45 mL/minute/1.73 m 2 , assess the benefit and risk of continuing therapy. • Drug Interactions: The concomitant use of GLUMETZA 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 [see Drug Interactions ( 7 )].

Therefore, consider more frequent monitoring of patients. • Age 65 or Greater: The risk of metformin-associated lactic acidosis increases with the patient’s age because elderly patients have a greater likelihood of having hepatic, renal, or cardiac impairment than younger patients. Assess renal functi…

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS Adverse reactions occurring >5% in GLUMETZA clinical trials: hypoglycemia, diarrhea, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience The following adverse reactions are discussed in more detail in other sections of 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 )] 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.

In clinical trials conducted in the U.S., over 1,000 patients with type 2 diabetes mellitus have been treated with GLUMETZA 1,500 to 2,000 mg/day in active-controlled and placebo-controlled studies with the 500 mg dosage form. In the add-on to sulfonylurea study, patients receiving background glyburide therapy were randomized to receive add-on treatment of either one of three different regimens of GLUMETZA or placebo. In total, 431 patients received GLUMETZA and glyburide and 144 patients received placebo and glyburide.

Adverse reactions reported in greater than 5% of patients treated with GLUMETZA that were more common in the combined GLUMETZA and glyburide group than in the placebo and glyburide group are shown in Table 1. In 0.7% of patients treated with GLUMETZA and glyburide, diarrhea was responsible for discontinuation of study medication compared to no patients in the placebo and glyburide group. Table 1: Adverse Reactions Reported by >5% Adverse reactions that were more common in the GLUMETZA-treated than in the placebo-treated patients. of Patients for the Combined GLUMETZA Groups Versus Placebo Group Adverse Reaction GLUMETZA + Glyburide (n=431) Placebo + Glyburide (n=144) Hypoglycemia 14% 5% Diarrhea 13% 6% Nausea 7% 4% Laboratory Tests Vitamin B 12 Concentrations In clinical trials of 29-week duration with metformin HCl tablets, a decrease to subnormal levels of previously normal serum vitamin B12 levels was observed in approximately 7% of patients.

6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of GLUMETZA. 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 GLUMETZA. Table 2: Clinically Significant Drug Interactions with GLUMETZA 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 GLUMETZA may increase the risk for lactic acidosis.

Intervention: Consider more frequent monitoring of these patients. Examples: Topiramate, zonisamide, acetazolamide or dichlorphenamide. Drugs that Reduce GLUMETZA 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 GLUMETZA. 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 GLUMETZA. Insulin Secretagogues or Insulin Clinical Impact: Coadministration of GLUMETZA 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 GLUMETZA, observe the patient closely for loss of blood glucose control. When such drugs are withdrawn from a patient receiving GLUMETZA, 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 ) • Hepatic Impairment: Avoid use in patients with hepatic impairment. ( 8.7 )

8.1Pregnancy Risk Summary Limited data with GLUMETZA 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 3 and 1 times, respectively, a 2,000 mg clinical dose, based on body surface area [see Data]. The estimated background risk of major birth defects is 6–10% in women with pregestational diabetes mellitus with an HbA1c >7 and has been reported to be as high as 20–25% in women with an 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 2–4% and 15–20%, 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 postmarketing 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 HCl was not teratogenic or embyrolethal when administered to rats prior to pregnancy through the period of organogenesis at doses up to 900 mg/kg, or when administered to rabbits during the period of organogenesis at doses up to 90 mg/kg.

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 GLUMETZA and any potential adverse effects on the breastfed child from GLUMETZA 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 GLUMETZA may result in ovulation in some anovulatory women.

8.4Pediatric Use Safety and effectiveness of GLUMETZA in pediatric patients have not been established.

8.5Geriatric Use Clinical studies of GLUMETZA did not include sufficient numbers of subjects aged 65 and over to determine whether they r…

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary Limited data with GLUMETZA 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 3 and 1 times, respectively, a 2,000 mg clinical dose, based on body surface area [see Data]. The estimated background risk of major birth defects is 6–10% in women with pregestational diabetes mellitus with an HbA1c >7 and has been reported to be as high as 20–25% in women with an 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 2–4% and 15–20%, 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 postmarketing 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 HCl was not teratogenic or embyrolethal when administered to rats prior to pregnancy through the period of organogenesis at doses up to 900 mg/kg, or when administered to rabbits during the period of organogenesis at doses up to 90 mg/kg.

🧒 Pediatric Use 15 words ▾

8.4Pediatric Use Safety and effectiveness of GLUMETZA in pediatric patients have not been established.

🧓 Geriatric Use 96 words ▾

8.5Geriatric Use Clinical studies of GLUMETZA did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. 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 Dosage and Administration ( 2.2 ) and Warnings and Precautions ( 5.1 )].

🆘 Overdosage 86 words ▾

10 OVERDOSAGE Overdose of metformin HCl 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/minute 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 a biguanide that improves glucose tolerance in patients with type 2 diabetes, 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 Following a single oral dose of 1,000 mg (2x500 mg tablets) GLUMETZA after a meal, the time to reach maximum plasma metformin concentration (Tmax) is achieved at approximately 7-8 hours. In both single- and multiple-dose studies in healthy subjects, once daily 1,000 mg (2x500 mg tablets) dosing provides equivalent systemic exposure, as measured by area under the curve (AUC), and up to 35% higher Cmax, of metformin relative to the immediate-release given as 500 mg twice daily. At usual clinical doses and dosing schedules of metformin, steady state plasma concentrations of metformin are reached within 24-48 hours and are generally <1 mcg/mL.

Single oral doses of GLUMETZA from 500 mg to 2,500 mg resulted in less than proportional increase in both AUC and C max . Effect of food: Low-fat and high-fat meals increased the systemic exposure (as measured by AUC) from GLUMETZA tablets by about 38% and 73%, respectively, relative to fasting. Both meals prolonged metformin T max by approximately 3 hours but C max was not affected.

In a two-way, single-dose, crossover study in healthy volunteers, the 1,000 mg tablet was found to be similar to two 500 mg tablets under fed conditions based on equivalent C max and AUCs for the two formulations. Distribution The apparent volume of distribution (V/F) of metformin following single oral doses of 850 mg metformin HCl 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 healthy 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. Excretion Renal clearance is approximately 3.5 times greater than creatinine clearance, which indicates that tubular secretion is the major route of metformin elimination.

Following oral administration, approximately 90% of the absorbed drug is eliminated via the renal route within the first 24 hours, with a plasma elimination half-life of approximately 6.2 hours. In blood, the elimination half-life is approximately 17.6 hours, suggesting that the erythrocyte mass may be a compartment of distribution. Special Populations Renal Impairment Following a single-dose administration of GLUMETZA 500 mg in subjects with mild and moderate renal impairment, the oral and renal clearance of metformin were decreased by 33% and 50% and 16% and 53%, respectively .

Metformin peak and systemic exposure was 27% and 61% greater, respectively in subjects with mild renal impairment and 74% and 2.36-fold greater in subjects with moderate renal impairment as compared to healthy subjects [see Dosage and Administration ( 2.2 ), Contraindications ( 4 ), and Warnings and Precautions ( 5.1 )]. Hepatic Impairment No pharmacokinetic studies of GLUMETZA have been conducted in subjects with hepatic impairment [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.7 )]. Geriatrics Limited data from controlled pharmacokinetic studies of metformin HCl in healthy elderly subjects suggest that total plasma clearance of metformin is decreased by 35%, the half-life is prolonged by 64% and C max is increased by 76%, compared to healthy young subjects.

From these data, it appears that the change in metformin pharmacokinetics with aging is primarily accounted for by a change in renal function […

🧬 Mechanism of Action 64 words ▾

12.1Mechanism of Action Metformin is a biguanide that improves glucose tolerance in patients with type 2 diabetes, 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.

📦 How Supplied / Storage and Handling 65 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING GLUMETZA is supplied as: 500 mg Bottles of 100 NDC 68012-004-50 white, film-coated, oval-shaped, extended-release tablets with “M500” on one side. 1,000 mg Bottles of 90 NDC 68012-003-16 white, film-coated, oval-shaped, extended-release tablets with “M1000” on one side. 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].

📋 Description 150 words ▾

11 DESCRIPTION GLUMETZA contains the biguanide antihyperglycemic agent metformin in the form of monohydrochloride salt. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown: Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5•HCl and a molecular weight of 165.63.

Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68.

GLUMETZA tablets contain 500 mg or 1,000 mg of metformin hydrochloride, which is equivalent to 389.93 mg or 779.86 mg metformin, respectively. Each 500 mg tablet contains coloring, hypromellose, magnesium stearate, microcrystalline cellulose and polyethylene oxide. Each 1,000 mg tablet contains colloidal silicon dioxide, polyvinyl alcohol, crospovidone, glyceryl dibehenate, polyacrylate dispersion, hypromellose, talc, polyethylene glycol, titanium dioxide, simethicone emulsion, polysorbate and coloring.

Chemical Structure-Glumetza

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Lactic Acidosis: Explain the risks of lactic acidosis, its symptoms, and conditions that predispose to its development. Advise patients to discontinue GLUMETZA 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 GLUMETZA. Instruct patients to inform their doctor that they are taking GLUMETZA 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 GLUMETZA is 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 B12 Deficiency: Inform patients about importance of regular hematological parameters while receiving GLUMETZA [see Warnings and Precautions ( 5.2 )]. Females of Reproductive Age: Inform females that treatment with GLUMETZA may result in ovulation in some premenopausal anovulatory women which may lead to unintended pregnancy [see Use in Specific Populations ( 8.3 )].

Administration Information: Inform patients that GLUMETZA 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. Distributed by: Salix Pharmaceuticals, a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA Manufactured by: Bausch Health Companies Inc. Steinbach, MB R5G 1Z7, Canada GLUMETZA is a registered trademark of Salix Pharmaceuticals, Inc. or its affiliates. © 2026 Salix Pharmaceuticals, Inc. or its affiliates 9618906 A black text on a white background AI-generated content may be incorrect.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 68007-0403-01 · GUILIN 68012-0003-16 · Santarus, →
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.