Home › NDC Lookup › Ingredients › Metformin Er 500 Mg › 82009-0117-10
Metformin ER 500 mg 500 mg Tablet, 1,000-count — NDC 82009-0117-10 package photo

Metformin ER 500 mg 500 mg Tablet, 1,000-count

by Quallent Pharmaceuticals Health LLC · 1000 TABLET in 1 BOTTLE (82009-117-10)
NDC 82009-0117-10
🏷️ FDA NDC (as labeled) 82009-117-10 billing pads the product segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

Past resolved recalls for this product (1)
Class II · Dec 30, 2024 · Terminated — Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg. (Granules Pharmaceuticals Inc.) · FDA recall D-0192-2025

🆔 Identity & classification

FDA NDC (as labeled) 82009-117-10
Product NDC 82009-117
11-digit billing NDC 82009011710
NCPDP billing unit EA — each (per item)
RxCUI 860975, 860981
UNII 786Z46389E
UPC 0382009117102, 0382009118017
Application # ANDA209313
SPL Set ID ff196435-14f4-8b9d-e053-6294a90a4ee8
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 2023-07-25
Route ORAL
Dosage form TABLET
Substance METFORMIN HYDROCHLORIDE
GPI-14 27250050007520
GCN Seq No 046754
GCN 89863
HICL code 004763
Ingredient (HICL) Metformin Hcl
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C4
Therapeutic class — intermediate (HIC2) Antihyperglycemics
HIC3 code C4L
Therapeutic class — specific (HIC3) Antihyperglycemic, Biguanide Type
AHFS code 68:20.04.00
AHFS class Biguanides
FDB label name METFORMIN HCL ER 500 MG TABLET
FDB brand name Metformin Hcl Er
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB1 · RLD · RS
Why two NDCs? The FDA registers this code as 82009-117-10 — 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 → 82009-0117-10. 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

LabelerQuallent Pharmaceuticals Health LLC
Application holderGRANULES INDIA LTD
FDA applicationANDA209313 (ANDA)
Labeler code82009
First marketedJul 2023
Product typeHuman Prescription Drug
Portfolio143 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 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 →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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
ImprintG8
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 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 FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.

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 eaPer package
Retail pharmacies payNADAC · weekly $0.028 $28.40 / 1000 tablets
Medicaid paysCMS SDUD · 12 mo $0.0733 $73.30 / 1000 tablets
Medicare drug plans payPart D · Q2 2026 $0.1129 $112.90 / 1000 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2023 Jan 2026 May 2026 Sep 2026 $0.033 $0.028
▼ Down 13% over the last 13 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

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 AB 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 mgthis 82009-0117-10 Quallent 1000 tablets $0.028 AB1 Availability likely —
Metformin Hydrochloride 500 mg 82009-0180-05 Quallent 500 tablets $0.028 AB Availability likely —
Metformin Hydrochloride 500 mg 62756-0142-01 Sun 100 tablets $0.029 — FDA listed +2%
Metformin hydrochloride 500 mg 33342-0239-11 Macleods 100 tablets $0.031 AB1 FDA listed +10%
Metformin Hydrochloride 500 mg 51224-0007-50 TAGI 100 tablets $0.031 AB1 FDA listed +10%
Metformin Hydrochloride 500 mg 00615-8289-39 NCS 30 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 10135-0823-05 Marlex 500 tablets — AB1 FDA listed —
Metformin Hydrochloride Extended-Release 500mg 500 mg 17224-0311-28 Calvin 28 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 25000-0101-03 MARKSANS 30 tablets — AB1 FDA listed —
Metformin hydrochloride 500 mg 42291-0825-10 AvKARE 1000 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 42708-0201-60 QPharma 60 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 50090-1494-00 A-S 60 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 50090-5396-00 A-S 60 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 50090-5397-00 A-S 90 tablets — AB FDA listed —
Metformin 500 mg 50090-6515-00 A-S 60 tablets — AB1 FDA listed —
Metformin 500 mg 50090-6516-00 A-S 90 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 50090-7116-00 A-S 90 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 50090-7576-00 A-S 60 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 50090-7577-00 A-S 90 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 50090-7579-00 A-S 90 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 50090-7918-00 A-S 90 tablets — AB1 FDA listed —
Metformin Hydrochloride Extended Release 500 mg 51655-0555-96 Northwind 180 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 51655-0559-25 Northwind 60 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 51655-0853-25 Northwind 60 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 59651-0548-25 Aurobindo 25000 tablets — AB1 FDA listed —
Metformin ER 500 mg 62207-0491-31 Granules 5000 tablets — AB1 FDA listed —
Metformin hydrochloride 500 mg 63187-0779-00 Proficient 100 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 65162-0178-03 Amneal 30 tablets — — FDA listed —
Metformin Hydrochloride 500 mg 65841-0027-01 Zydus 100 tablets — AB1 Discontinued —
Metformin Hydrochloride 500 mg 65841-0809-01 Zydus 100 tablets — AB FDA listed —
Metformin 500 mg 67046-0437-03 Coupler 30 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 67296-1701-06 RedPharm 60 tablets — AB1 FDA listed —
Metformin Hydrochloride Extended Release 500 mg 68071-3111-02 NuCare 120 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 68788-8814-01 Preferred 100 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 68788-8866-01 Preferred 100 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 68788-8903-01 Preferred 100 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 69238-2125-01 Amneal 100 tablets — — FDA listed —
Metformin 500 mg 70518-4370-00 REMEDYREPACK 30 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 71205-0186-20 Proficient 20 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 71205-0686-30 Proficient 30 tablets — AB FDA listed —
Metformin Hydrochloride Extended Release 500 mg 71335-0293-01 Bryant 60 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 71335-0720-01 Bryant 60 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 71335-0886-01 Bryant 60 tablets — AB1 FDA listed —
Metformin 500 mg 71335-2354-01 Bryant 60 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 71335-2568-01 Bryant 60 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 71335-9683-01 Bryant 60 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 71610-0447-30 Aphena 30 tablets — — FDA listed —
Metformin Hydrochloride Extended Release 500 mg 71610-0454-30 Aphena 30 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 71610-0533-30 Aphena 30 tablets — AB1 FDA listed —
Metformin hydrochloride 500 mg 71610-0554-30 Aphena 30 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 71610-0578-60 Aphena 90 tablets — AB FDA listed —
Metformin hydrochloride 500 mg 71610-0587-30 Aphena 30 tablets — AB1 FDA listed —
Metformin 500 mg 71610-0613-60 Aphena 90 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 71610-0652-30 Aphena 30 tablets — — FDA listed —
Metformin Hydrochloride 500 mg 71610-0837-30 Aphena 30 tablets — AB1 FDA listed —
Metformin hydrochloride 500 mg 71610-0858-30 Aphena 30 tablets — AB1 FDA listed —
Metformin 500 mg 72162-2424-00 Bryant 1000 tablets — AB1 FDA listed —
Metformin Hydrochloride Extended Release 500 mg 72189-0064-30 direct 30 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 72189-0150-30 direct 30 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 72578-0035-01 Viona 100 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 72664-0227-01 VGYAAN 100 tablets — — FDA listed —
Metformin Hydrochloride Extended Release 500 mg 72789-0009-30 PD-Rx 30 tablets — AB1 FDA listed —
Metformin hydrochloride 500 mg 72789-0105-01 PD-Rx 100 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 72789-0400-01 PD-Rx 100 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 72789-0454-60 PD-Rx 60 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 72789-0455-30 PD-Rx 30 tablets — AB1 FDA listed —
Metformin hydrochloride 500 mg 76385-0128-01 UNICHEM 100 tablets — AB1 FDA listed —
Metformin 500 mg 82804-0147-30 Proficient 30 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 82804-0195-60 Proficient 60 tablets — AB1 FDA listed —
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

🏛️
2023
On the market since
Jul 2023
📍
2026
Currently FDA-listed
3 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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

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

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 82009-0117-10, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
98
Units reimbursed last 4 qtrs
20.8K
Gross reimbursed last 4 qtrs
$1.5K
Avg / prescription
$15.55
Avg / unit
$0.0733
Latest quarter Q1 2026
0Rx
Medicaid pays / ea
$0.0733
gross reimbursed
vs
NADAC / ea
$0.0284
acquisition cost
=
Spread
+$0.0449
+158% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
100% MCO
Fee-for-service · 0 Rx Managed care · 98 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 4,830 units · 84.2 per 100k residents MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 10,272 units · 81.9 per 100k residents IL Indiana: 5,670 units · 82.6 per 100k residents IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
81.984.2
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Minnesota 84.2 /100k
2 Indiana 82.6 /100k
3 Illinois 81.9 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
82009-0117-10 You're viewing this 1000 TABLET in 1 BOTTLE (82009-117-10) 2023-07-25 Active

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🚨 Boxed Warning ~2 min read ▾

BOXED WARNING WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin­-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin­-associated lactic acidosis was characterized by elevated blood lactate levels (>5 mmol/Liter), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio; and metformin plasma levels generally >5 mcg/mL [see Warnings and Precautions (5.1)].

Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g. carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, and hepatic impairment. Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided [see Dosage and Administration (2.3) , (2.7) , Contraindications (4), Warnings and Precautions (5.1)].

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

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

Steps to reduce the risk of and manage metformin­ associated lactic acidosis in these high risk groups are provided in the Full Prescribing Information. (5.1) • If lactic acidosis is suspected, discontinue metformin hydrochloride extended-release tablets and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended.

(5.1)

🎯 Indications and Usage 56 words ▾

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

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Adult Dosage for Metformin Hydrochloride Extended-Release Tablets : • Swallow metformin hydrochloride extended-release tablets whole and never crush, cut or chew ( 2.1 ) • Starting dose: 500 mg orally once daily with the evening meal ( 2.1 ) • Increase the dose in increments of 500 mg weekly, up to a maximum of 2000 mg once daily with the evening meals ( 2.1 ) • Patients receiving metformin hydrochloride tablets may be switched to metformin hydrochloride extended-release tablets once daily at the same total daily dose, up to 2000 mg once daily ( 2.1 ) Renal Impairment : • Prior to initiation, assess renal function with estimated glomerular filtration rate (eGFR) ( 2.3 ) o Do not use in patients with eGFR below 30 mL/minute/1.73 m 2 ( 2.3 ) o Initiation is not recommended in patients with eGFR between 30 to 45 mL/minute/1.73 m 2 ( 2.3 ) o Assess risk/benefit of continuing if eGFR falls below 45 mL/minute/1.73 m 2 ( 2.3 ) o Discontinue if eGFR falls below 30 mL/minute/1.73 m 2 ( 2.3 ) Discontinuation for Iodinated Contrast Imaging Procedures : • Metformin hydrochloride extended-release tablets may need to be discontinued at time of, or prior to, iodinated contrast imaging procedures ( 2.4 )

2.1Adult Dosage Metformin Hydrochloride Extended-Release Tablets • Swallow metformin hydrochloride extended-release tablets whole and never crush, cut or chew. • The recommended starting dose of metformin hydrochloride extended-release tablets are 500 mg orally once daily with the evening meal. • Increase the dose in increments of 500 mg weekly on the basis of glycemic control and tolerability, up to a maximum of 2000 mg once daily with the evening meal. • If glycemic control is not achieved with metformin hydrochloride extended-release tablets 2000 mg once daily, consider a trial of metformin hydrochloride extended-release tablets 1000 mg twice daily.

If higher doses are required, switch to metformin hydrochloride tablets at total daily doses up to 2550 mg administered in divided daily doses, as described above. • Patients receiving metformin hydrochloride tablets may be switched to metformin hydrochloride extended-release tablets once daily at the same total daily dose, up to 2000 mg once daily.

2.3Recommendations for Use in Renal Impairment • Assess renal function prior to initiation of metformin hydrochloride extended-release tablets and periodically thereafter. • Metformin hydrochloride extended-release tablets are contraindicated in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/minute/1.73 m 2 . • Initiation of metformin hydrochloride extended-release tablets in patients with an eGFR between 30 to 45 mL/minute/ 1.73 m 2 is not recommended. • In patients taking metformin hydrochloride extended-release tablets whose eGFR later falls below 45 mL/min/1.73 m 2 , assess the benefit risk of continuing therapy. • Discontinue metformin hydrochloride extended- release tablets if the patient's eGFR later falls below 30 mL/minute/1.73 m 2 [see Warnings and Precautions (5.1) ].

2.4Discontinuation for Iodinated Contrast Imaging Procedure Discontinue metformin hydrochloride extended-release tablets at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR between 30 and 60 mL/min/1.73 m 2 ; in patients with a history of liver disease, alcoholism, or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after the imaging procedure; restart metformin hydrochloride extended-release tablets if renal function is stable.

💊 Dosage Forms and Strengths 73 words ▾

3 DOSAGE FORMS AND STRENGTHS Metformin hydrochloride extended-release tablets are available as: • Extended-release tablets: 500 mg White to off-white uncoated, modified capsule shaped tablets debossed with "G7" on one side and plain on other side. • Extended-release tablets: 750 mg White to off white uncoated, modified capsule shaped tablets debossed with "G8" on one side and plain on other side. Metformin Hydrochloride Extended-Release Tablets: 500 mg and 750 mg ( 3 )

⛔ Contraindications 75 words ▾

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

( 4 )

⚠️ Warnings and Cautions ~1 min read ▾

5. WARNINGS AND PRECAUTIONS • Lactic Acidosis : See boxed warning. (5.1) • Vitamin B 12 Deficiency : Metformin may lower vitamin B 12 levels.

Measure hematological parameters annually and vitamin B 12 at 2 to 3 year intervals and manage any abnormalities. (5.2) • Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues : Increased risk of hypoglycemia when used in combination with insulin and/or an insulin secretagogue. Lower dose of insulin or insulin secretagogue may be required (5.3)

5.1 Lactic Acidosis

5.2Vitamin B 12 Deficiency In metformin hydrochloride tablets clinical trials of 29-week duration, a decrease to subnormal levels of previously normal serum vitamin B 12 levels was observed in approximately 7% of patients. Such decrease, possibly due to interference with B 12 absorption from the B 12 -intrinsic factor complex, may be associated with anemia but appears to be rapidly reversible with discontinuation of metformin hydrochloride tablets or vitamin B 12 supplementation. Certain individuals (those with inadequate vitamin B 12 or calcium intake or absorption) appear to be predisposed to developing subnormal vitamin B 12 levels.

Measure hematologic parameters on an annual basis and vitamin B 12 at 2 to 3 year intervals in patients on metformin hydrochloride extended-release tablets and manage any abnormalities [see Adverse Reactions (6.1) .

5.3Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues Insulin and insulin secretagogues (e.g., sulfonylurea) are known to cause hypoglycemia. Metformin hydrochloride extended-release tablets may increase the risk of hypoglycemia when combined with insulin and/or an insulin secretagogue. Therefore, a lower dose of insulin or insulin secretagogue may be required to minimize the risk of hypoglycemia when used in combination with metformin hydrochloride extended-release tablets [see Drug Interactions (7) ].

5.4Macrovascular Outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with metformin hydrochloride extended-release tablets.

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are also discussed elsewhere in the labeling: Lactic Acidosis [see Boxed Warning and Warnings and Precautions (5.1) ] Vitamin B 12 Deficiency [see Warnings and Precautions (5.2) ] Hypoglycemia [see Warnings and Precautions (5.3) ] For metformin hydrochloride extended-release tablets, the most common adverse reactions (>5.0%) are diarrhea, nausea/vomiting, flatulence, asthenia, indigestion, abdominal discomfort, and headache. (6.1) To report SUSPECTED ADVERSE REACTIONS, Quallent Pharmaceuticals Health LLC at 1-877-605-7243 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.1Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Metformin Hydrochloride Extended-Release Tablets In placebo-controlled trials, 781 patients were administered metformin hydrochloride extended-release tablets. Adverse reactions reported in greater than 5% of the metformin hydrochloride extended release tablets patients, and that were more common in metformin hydrochloride extended-release tablets-than placebo-treated patients, are listed in Table 2.

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

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

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Table 3 presents clinically significant drug interactions with metformin hydrochloride extended-release tablets. Table 3: Clinically Significant Drug Interactions with Metformin Hydrochloride Extended-Release Tablets Carbonic Anhydrase Inhibitors Clinical Impact: Carbonic anhydrase inhibitors frequently cause a decrease in serum bicarbonate and induce non-anion gap, hyperchloremic metabolic acidosis. Concomitant use of these drugs with metformin hydrochloride extended-release tablets may increase the risk for lactic acidosis.

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

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

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

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

Examples: Thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blockers, and isoniazid. • Carbonic anhydrase inhibitors may increase risk of lactic acidosis. Consider more frequent monitoring (7) • Drugs that reduce metformin clearance (such as ranolazine, vandetanib, dolutegravir, and cimetidine) may increase the accumulation of metformin. Consider the benefits and risks of concomitant use (7) • Alcohol can potentiate the effect of metformin on lactate metabolism.

Warn patients against excessive alcohol intake ( 7 )

👥 Use in Specific Populations ~3 min read ▾

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

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

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

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

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

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

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

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

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

🤰 Pregnancy ~2 min read ▾

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

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

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

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

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

🧒 Pediatric Use 22 words ▾

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

🧓 Geriatric Use 89 words ▾

8.5Geriatric Use Controlled clinical studies of metformin hydrochloride extended-release tablets did not include sufficient numbers of elderly patients to determine whether they respond differently from younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy and the higher risk of lactic acidosis. Assess renal function more frequently in elderly patients [see Warnings and Precautions (5.1) ].

🆘 Overdosage 84 words ▾

10 OVERDOSAGE Overdose of metformin hydrochloride has occurred, including ingestion of amounts greater than 50 grams. Hypoglycemia was reported in approximately 10% of cases, but no causal association with metformin has been established. Lactic acidosis has been reported in approximately 32% of metformin overdose cases [see Warnings and Precautions (5.1)] .

Metformin is dialyzable with a clearance of up to 170 mL/min under good hemodynamic conditions. Therefore, hemodialysis may be useful for removal of accumulated drug from patients in whom metformin overdosage is suspected.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

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

12.3Pharmacokinetics Absorption Following a single oral dose of metformin hydrochloride extended-release tablets, C max is achieved with a median value of 7 hours and a range of 4 to 8 hours. Peak plasma levels are approximately 20% lower compared to the same dose of metformin hydrochloride tablets, however, the extent of absorption (as measured by AUC) is comparable to metformin hydrochloride tablets. At steady state, the AUC and C max are less than dose proportional for metformin hydrochloride extended-release tablets within the range of 500 to 2000 mg administered once daily.

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

Effect of food : Food decreases the extent of absorption and slightly delays the absorption of metformin, as shown by approximately a 40% lower mean peak plasma concentration (C max ), a 25% lower area under the plasma concentration versus time curve (AUC), and a 35-minute prolongation of time to peak plasma concentration (T max ) following administration of a single 850 mg tablet of metformin hydrochloride tablets with food, compared to the same tablet strength administered fasting. Although the extent of metformin absorption (as measured by AUC) from the metformin hydrochloride extended-release tablet increased by approximately 50% when given with food, there was no effect of food on C max and T max of metformin.

Both high and low fat meals had the same effect on the pharmacokinetics of metformin hydrochloride extended-release tablets. Distribution The apparent volume of distribution (V/F) of metformin following single oral doses of metformin hydrochloride tablets 850 mg averaged 654 ± 358 L. Metformin is negligibly bound to plasma proteins.

Metformin partitions into erythrocytes, most likely as a function of time. Metabolism Intravenous single-dose studies in normal subjects demonstrate that metformin is excreted unchanged in the urine and does not undergo hepatic metabolism (no metabolites have been identified in humans) nor biliary excretion. Elimination Renal clearance (see Table 4) is approximately 3.5 times greater than creatinine clearance, which indicates that tubular secretion is the major route of metformin elimination.

Following oral administration, approximately 90% of the absorbed drug is eliminated via the renal route within the first 24 hours, with a plasma elimination half-life of approximately 6.2 hours. In blood, the elimination half-life is approximately 17.6 hours, suggesting that the erythrocyte mass may be a compartment of distribution. Specific Populations Renal Impairment In patients with decreased renal function the plasma and blood half-life of metformin is prolonged and the renal clearance is decreased (see Table 3) [see Dosage and Administration (2.3), Contraindications (4) , Warnings and Precautions (5.1) and Use in Specific Populations (8.6)].

Hepatic Impairment No pharmacokinetic studies of metformin have been conducted in patients with hepatic impairment [see Warnings and Precautions (5.1) and U…

🧬 Mechanism of Action 66 words ▾

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

📦 How Supplied / Storage and Handling 107 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Table 13: Metformin Hydrochloride Extended-Release Tablets, USP Available Strengths, Units, and Appearance Metformin Hydrochloride Extended-Release Tablets, USP 500 mg Bottles of 1000 NDC 82009-117-10 White to off white uncoated, modified capsule shaped tablets debossed with “G7” on one side and plain on other side. 750 mg Bottles of 100 NDC 82009-118-01 White to off white uncoated modified capsule shaped tablets dedossed with “G8” on one side and plain on other side.

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

📋 Description 172 words ▾

11 DESCRIPTION Metformin hydrochloride extended-release tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N -dimethylimidodicarbonimidic diamide hydrochloride . The structural formula is as shown below: Metformin hydrochloride, USP is a white to off-white crystalline compound with a molecular formula of C 4 H 11 N 5 .HCl and a molecular weight of 165.62.

Metformin hydrochloride is freely soluble in water, slightly soluble in ethanol, practically insoluble in acetone and in methylene chloride. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.35.

Metformin hydrochloride extended-release tablets, USP contains 500 mg or 750 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 584.90 mg metformin base, respectively. Metformin hydrochloride extended-release tablets USP, 500 mg tablets contain the inactive ingredients hypromellose, magnesium stearate, and polyvinyl pyrrolidone Metformin hydrochloride extended-release tablets USP, 750 mg tablets contain the inactive ingredients hypromellose, magnesium stearate, and polyvinyl pyrrolidone Meets USP Dissolution Test 10 metfor-structure

💬 Information for Patients ~1 min read ▾

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

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

Explain to patients receiving concomitant therapy the risks of hypoglycemia, its symptoms and treatment, and conditions that predispose to its development [see Warnings and Precautions (5.3) ]. Vitamin B12 Deficiency: Inform patients about importance of regular hematological parameters while receiving metformin hydrochloride extended-release tablets [see Warnings and Precautions (5.2) ]. Females of Reproductive Age: Inform females that treatment with metformin hydrochloride extended-release tablets may result in ovulation in some premenopausal anovulatory women which may lead to unintended pregnancy [see Use in Specific Populations (8.3) ].

Metformin Hydrochloride Extended-Release Tablets Administration Information: Inform patients that metformin hydrochloride extended-release tablets must be swallowed whole and not crushed, cut, or chewed, and that the inactive ingredients may occasionally be eliminated in the feces as a soft mass that may resemble the original tablet. Dispense with Patient Information is also available at: https://www.quallentpharmaceuticals.com Manufactured by: Granules India Limited Hyderabad-500 081, India MADE IN INDIA Manufactured for: Quallent Pharmaceuticals Health LLC Grand Cayman, Cayman Islands Revision date: 03/2023

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 82009-0116-05 · Quallent 82009-0118-01 · Quallent →
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.