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Metformin hydrochloride 500 mg Tablet, Extended Release, 90-count — NDC 71610-0554-60 package photo

Metformin hydrochloride 500 mg Tablet, Extended Release, 90-count

by Aphena Pharma Solutions - Tennessee, LLC · 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-554-60)
NDC 71610-0554-60
🏷️ FDA NDC (as labeled) 71610-554-60 billing pads the product segment with a zero
This package
Contains90-count Pack sizes7 compare ↓
Also priced by: Part D plans $0.1129/unit — full pricing hub ↓
Also comes in: 30 tablets 71610-0554-30 60 tablets 71610-0554-53 120 tablets 71610-0554-70 180 tablets 71610-0554-80 270 tablets 71610-0554-92 360 tablets 71610-0554-94
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

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

🆔 Identity & classification

FDA NDC (as labeled) 71610-554-60
Product NDC 71610-554
11-digit billing NDC 71610055460
NCPDP billing unit EA — each (per item)
RxCUI 860975
UNII 786Z46389E
Application # ANDA207427
SPL Set ID 5e5fb10b-b874-43c9-9424-9080b9e866c8
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 2018-07-17
Route ORAL
Dosage form TABLET, EXTENDED RELEASE
Substance METFORMIN HYDROCHLORIDE
GPI-14 27250050007520
GPI class metFORMIN HCl ER
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 71610-554-60 — 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 → 71610-0554-60. 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

LabelerAphena Pharma Solutions - Tennessee, LLC
Application holderREGCON HOLDINGS LLC
FDA applicationANDA207427 (ANDA)
Labeler code71610
First marketedJul 2018
Product typeHuman Prescription Drug
Portfolio795 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
  • No, and that's actually one of the things that makes metformin different. It doesn't force your pancreas to produce more insulin. Instead, it works in three ways: it tells your liv...
  • What exactly does metformin do — does it just push my pancreas to make more insulin?
  • Stomach upset, nausea, and diarrhea are really common at the start, and they can be significant for some people. The good news is they usually improve as your body adjusts. Always...
  • The stomach side effects sound rough — is there anything I can do about them?
📖 Read our full Metformin guide →
4
Nutrient depletion considerations

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

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

💊 What it looks like

Color white
ShapeRound
ImprintB115
Size13 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII K679OBS311
    Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
  • UNII 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 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 U725QWY32X
    Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.

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

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

Inactive ingredient FAQ

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

💲 Pricing

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

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.1129 $10.16 / 90 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Metformin Hydrochloride 500 mg 29300-0389-01 Unichem 100 tablets $0.029 AB1 Availability likely —
Metformin Hydrochloride 500 mg 42385-0977-01 Laurus 100 tablets $0.029 AB1 Availability likely —
Metformin Hydrochloride 500 mg 42806-0632-01 Epic 100 tablets $0.029 AB1 Availability likely —
Metformin Hydrochloride Extended Release 500 mg 49483-0623-01 TIME 100 tablets $0.029 AB1 Availability likely —
Metformin Hydrochloride 500 mg 50268-0550-15 AvPAK 1 tablet $0.029 AB1 Availability likely —
Metformin Hydrochloride 500 mg 67877-0159-01 Ascend 100 tablets $0.029 AB1 Availability likely —
Metformin Hydrochloride 500 mg 67877-0413-01 Ascend 100 tablets $0.029 AB Availability likely —
Metformin Hydrochloride 500 mg 68094-0904-50 Precision 100 tablets $0.029 AB1 Availability likely —
Metformin 500 mg 68645-0595-59 Legacy 60 tablets $0.029 AB1 Availability likely —
Metformin Hydrochloride Er 500 mg 69315-0410-01 Leading 100 tablets $0.029 AB1 Availability likely —
Metformin 500 mg 70010-0491-01 Granules 100 tablets $0.029 AB1 Availability likely —
Metformin ER 500 mg 82009-0117-10 Quallent 1000 tablets $0.029 AB1 Availability likely —
Metformin Hydrochloride 500 mg 82009-0180-05 Quallent 500 tablets $0.029 AB Availability likely —
Metformin Hydrochloride 500 mg 62756-0142-01 Sun 100 tablets $0.029 — FDA listed —
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 42571-0333-01 Micro 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 70010-0496-01 Granules 100 tablets $0.262 AB3 Availability likely —
Metformin hydrochloride 500 mg 27241-0240-01 Ajanta 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 68682-0021-50 Oceanside 100 tablets $0.402 — FDA listed —
Glumetza 500 mg 68012-0004-50 Santarus, 100 tablets $49.542 — FDA listed —
Metformin Hydrochloride 500 mg 00615-8289-39 NCS 30 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 10135-0823-05 Marlex 500 tablets — AB1 FDA listed —
Metformin Hydrochloride Extended-Release 500mg 500 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 mgthis 71610-0554-60 Aphena 90 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 71610-0578-60 Aphena 90 tablets — AB FDA listed —
Metformin hydrochloride 500 mg 71610-0587-30 Aphena 30 tablets — AB1 FDA listed —
Metformin 500 mg 71610-0613-60 Aphena 90 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 71610-0652-30 Aphena 30 tablets — — FDA listed —
Metformin Hydrochloride 500 mg 71610-0837-30 Aphena 30 tablets — AB1 FDA listed —
Metformin hydrochloride 500 mg 71610-0858-30 Aphena 30 tablets — AB1 FDA listed —
Metformin 500 mg 72162-2424-00 Bryant 1000 tablets — AB1 FDA listed —
Metformin Hydrochloride Extended Release 500 mg 72189-0064-30 direct 30 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 72189-0150-30 direct 30 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 72578-0035-01 Viona 100 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 72664-0227-01 VGYAAN 100 tablets — — FDA listed —
Metformin Hydrochloride Extended Release 500 mg 72789-0009-30 PD-Rx 30 tablets — AB1 FDA listed —
Metformin hydrochloride 500 mg 72789-0105-01 PD-Rx 100 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 72789-0400-01 PD-Rx 100 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 72789-0454-60 PD-Rx 60 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 72789-0455-30 PD-Rx 30 tablets — AB1 FDA listed —
Metformin hydrochloride 500 mg 76385-0128-01 UNICHEM 100 tablets — AB1 FDA listed —
Metformin 500 mg 82804-0147-30 Proficient 30 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 82804-0195-60 Proficient 60 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 43547-0503-10 Solco 100 tablets — AB3 FDA listed —
Metformin Hydrochloride 500 mg 47335-0305-18 Sun 1000 tablets — — Discontinued —
Glumetza 500 mg 68012-0002-13 Santarus, 100 tablets — — FDA listed —
Metformin Hydrochloride 500 mg 68180-0336-01 Lupin 100 tablets — AB2 FDA listed —
Metformin Hydrochloride 500 mg 62207-0496-47 Granules 500 tablets — AB3 FDA listed —
Metformin hydrochloride 500 mg 68071-1419-02 NuCare 20 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 71335-3166-01 Bryant 60 tablets — AB1 FDA listed —
Metformin Hydrochloride 500 mg 67296-2305-09 Redpharm 90 tablets — AB1 FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2018
On the market since
Jul 2018
📍
2026
Currently FDA-listed
8 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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

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

🔬 Reported adverse events (FAERS)

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

Top reported reactions

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

Reporter sex

0 reports

Serious outcomes

Hospitalization33,199
Life-threatening6,855
Disabling2,592
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 8,466 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
71610-0554-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-554-30) 2021-05-12 Active
71610-0554-53 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-554-53) 2022-01-31 Active
71610-0554-60 You're viewing this 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-554-60) 2021-05-12 Active
71610-0554-70 120 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-554-70) 2021-06-09 Active
71610-0554-80 180 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-554-80) 2022-01-18 Active
71610-0554-92 270 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-554-92) 2021-06-18 Active
71610-0554-94 360 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-554-94) 2021-08-18 Active

You're viewing one of 7 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 71610-0554-60?
NDC 71610-0554-60 is a 90-count package — 90 tablet, extended release in 1 bottle, plastic.
What is the difference between NDC 71610-0554-60 and NDC 71610-0554-30?
Both are Metformin hydrochloride 500 mg Tablet, Extended Release — the drug itself is identical. NDC 71610-0554-60 is the 90-count package, while NDC 71610-0554-30 is the 30 tablets package.
What NDC number is used to bill for this package of Metformin hydrochloride 500 mg Tablet, Extended Release?
Bill NDC 71610-0554-60 — the 11-digit billing format is 71610055460. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

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

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 71610-554-60, 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: 71610-0554-60, written without dashes as 71610055460. 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 71610-0554-60, the first segment (71610) is the labeler code FDA assigned to Aphena Pharma Solutions - Tennessee, LLC; the middle segment (0554) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (60) 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 Aphena Pharma Solutions - Tennessee, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 6 other package presentations of this same product, including 30 tablets (71610-0554-30), 60 tablets (71610-0554-53), 120 tablets (71610-0554-70). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Aphena Pharma Solutions - Tennessee, LLC 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 ⛔ Contraindications 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🚨 Boxed Warning ~3 min read ▾

WARNINGS Lactic Acidosis: Lactic acidosis is a rare, but serious, metabolic complication that can occur due to metformin accumulation during treatment with Metformin Hydrochloride; when it occurs, it is fatal in approximately 50% of cases. Lactic acidosis may also occur in association with a number of pathophysiologic conditions, including diabetes mellitus, and whenever there is significant tissue hypoperfusion and hypoxemia. Lactic acidosis is characterized by elevated blood lactate levels (>5 mmol/L), decreased blood pH, electrolyte disturbances with an increased anion gap, and an increased lactate/pyruvate ratio.

When metformin is implicated as the cause of lactic acidosis, metformin plasma levels >5 μg/mL are generally found. The reported incidence of lactic acidosis in patients receiving metformin Hydrochloride is very low (approximately 0.03 cases/1000 patient-years, with approximately 0.015 fatal cases/1000 patientyears). In more than 20,000 patient-years exposure to metformin in clinical trials, there were no reports of lactic acidosis.

Reported cases have occurred primarily in diabetic patients with significant renal insufficiency, including both intrinsic renal disease and renal hypoperfusion, often in the setting of multiple concomitant medical/surgical problems and multiple concomitant medications. Patients with congestive heart failure requiring pharmacologic management, in particular those with unstable or acute congestive heart failure who are at risk of hypoperfusion and hypoxemia, are at increased risk of lactic acidosis. The risk of lactic acidosis increases with the degree of renal dysfunction and the patient's age.

The risk of lactic acidosis may, therefore, be significantly decreased by regular monitoring of renal function in patients taking Metformin Hydrochloride by use of the minimum effective dose of Metformin Hydrochloride. In particular, treatment of the elderly should be accompanied by careful monitoring of renal function. Metformin Hydrochloride treatment should not be initiated in patients ≥80 years of age unless measurement of creatinine clearance demonstrates that renal function is not reduced, as these patients are more susceptible to developing lactic acidosis.

In addition, Metformin Hydrochloride should be promptly withheld in the presence of any condition associated with hypoxemia, dehydration, or sepsis. Because impaired hepatic function may significantly limit the ability to clear lactate, Metformin Hydrochloride should generally be avoided in patients with clinical or laboratory evidence of hepatic disease. Patients should be cautioned against excessive alcohol intake, either acute or chronic, when taking Metformin Hydrochloride, since alcohol potentiates the effects of metformin Hydrochloride on lactate metabolism.

In addition, Metformin Hydrochloride should be temporarily discontinued prior to any intravascular radiocontrast study and for any surgical procedure (see also PRECAUTIONS ). The onset of lactic acidosis often is subtle, and accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress. There may be associated hypothermia, hypotension, and resistant bradyarrhythmias with more marked acidosis.

The patient and the patient's physician must be aware of the possible importance of such symptoms and the patient should be instructed to notify the physician immediately if they occur (see also PRECAUTIONS ). Metformin Hydrochloride should be withdrawn until the situation is clarified. Serum electrolytes, ketones, blood glucose, and if indicated, blood pH, lactate levels, and even blood metformin levels may be useful.

Once a patient is stabilized on any dose level of Metformin Hydrochloride, gastrointestinal symptoms, which are common during initiation of therapy, are unlikely to be drug related. Later occurrence of gastrointestinal symptoms could be due to lactic acidosis or other serious disease. Lev…

🎯 Indications and Usage 27 words ▾

INDICATIONS AND USAGE Metformin Hydrochloride Extended-release Tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

⏱️ Dosage and Administration ~1 min read ▾

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

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

Thereafter, glycosylated hemoglobin should be measured at intervals of approximately 3 months. The therapeutic goal should be to decrease both fasting plasma glucose and glycosylated hemoglobin levels to normal or near normal by using the lowest effective dose of Metformin Hydrochloride Extended-release Tablets either when used as monotherapy or in combination with sulfonylurea or insulin. Monitoring of blood glucose and glycosylated hemoglobin will also permit detection of primary failure, i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication, and secondary failure, i.e., loss of an adequate blood glucose lowering response after an initial period of effectiveness.

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

(See Patient Information printed below.)

⛔ Contraindications 110 words ▾

CONTRAINDICATIONS Metformin Hydrochloride is contraindicated in patients with: Renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels ≥1.5 mg/dL [males], ≥1.4 mg/dL [females] or abnormal creatinine clearance) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia (see WARNINGS and PRECAUTIONS ). Known hypersensitivity to Metformin Hydrochloride. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.

Diabetic ketoacidosis should be treated with insulin. Metformin Hydrochloride should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function. (See also PRECAUTIONS. )

🤒 Adverse Reactions ~2 min read ▾

ADVERSE REACTIONS In a US double-blind clinical study of Metformin Hydrochloride Tablets in patients with type 2 diabetes, a total of 141patients received Metformin Hydrochloride Tablets therapy (up to 2550 mg per day) and 145 patients received placebo.Adverse reactions reported in greater than 5% of the Metformin Hydrochloride Tablets patients, and that were more common in Metformin Hydrochloride Tablets - than placebo-treated patients, are listed in Table 11. . Table 11: Most Common Adverse Reactions (>5.0 Percent) in Placebo-Controlled Studies of Metformin Hydrochloride Tablets Monotherapy Reactions that were more common in metformin Hydrochloride Extended-release Tablets - than placebo-treated patients.

Metformin Hydrochloride Extended-release Tablets Monotherapy n=141) Placebo (n=145) Adverse Reaction % of Patients Diarrhea 53.2

11.7Nausea/Vomiting 25.5

8.3Flatulance 12.1

5.5Asthenia 9.2

5.5Indigestion 7.1

4.1Abdominal Discomfort 6.4

4.8Headache 5.7

4.8Diarrhea led to discontinuation of study medication in 6% of patients treated with Metformin Hydrochloride Tablets. Additionally, the following adverse reactions were reported in ≥1.0% to ≤5.0% of Metformin Hydrochloride Tablets patients and were more commonly reported with Metformin Hydrochloride Tablets than placebo: abnormal stools, hypoglycemia, myalgia, lightheaded, dyspnea, nail disorder, rash, sweating increased, taste disorder,chest discomfort, chills, flu syndrome, flushing, palpitation. In worldwide clinical trials over 900 patients with type 2 diabetes have been treated with Metformin Hydrochloride Extended-release Tablets in placebo- and active-controlled studies.

In placebo-controlled trials, 781 patients were administered Metformin Hydrochloride Extended-release Tablets and 195 patients received placebo. 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 12. Table 12: Most Common Adverse Reactions (>5.0 Percent) in Placebo-Controlled Studies of Metformin Hydrochloride Extended-release Tablets Reactions that were more common in metformin Hydrochloride Extended-release Tablets - than placebo-treated patients.

Metformin Hydrochloride Extended-release Tablets n=781) Placebo (n=195) Adverse Reaction % of Patients Diarrhea 9.6

2.6Nausea/Vomiting 6.5

1.5Diarrhea led to discontinuation of study medication in 0.6% of patients treated with Metformin Hydrochloride Extended-release Tablets. 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.

Liver function test abnormalities or hepatitis, resolving upon metformin discontinuation, have been reported very rarely.

🔄 Drug Interactions ~2 min read ▾

Drug Interactions (Clinical Evaluation of Drug Interactions Conducted with Metformin Hydrochloride Tablets) Glyburide - In a single-dose interaction study in type 2 diabetes patients, coadministration of metformin and glyburide did not result in any changes in either metformin pharmacokinetics or pharmacodynamics. Decreases in glyburide AUC and C max were observed, but were highly variable. The single-dose nature of this study and the lack of correlation between glyburide blood levels and pharmacodynamic effects, makes the clinical significance of this interaction uncertain (see DOSAGE AND ADMINISTRATION: Concomitant Metformin Hydrochloride and Oral Sulfonylurea Therapy in Adult Patients ).

Furosemide - A single-dose, metformin-furosemide drug interaction study in healthy subjects demonstrated that pharmacokinetic parameters of both compounds were affected by coadministration. Furosemide increased the metformin plasma and blood C max by 22% and blood AUC by 15%, without any significant change in metformin renal clearance. When administered with metformin, the C max and AUC of furosemide were 31% and 12% smaller, respectively, than when administered alone, and the terminal half-life was decreased by 32%, without any significant change in furosemide renal clearance.

No information is available about the interaction of metformin and furosemide when coadministered chronically. Nifedipine - A single-dose, metformin-nifedipine drug interaction study in normal healthy volunteers demonstrated that coadministration of nifedipine increased plasma metformin C max and AUC by 20% and 9%, respectively, and increased the amount excreted in the urine. T max and half-life were unaffected.

Nifedipine appears to enhance the absorption of metformin. Metformin had minimal effects on nifedipine. Cationic drugs - Cationic drugs (e.g., amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, or vancomycin) that are eliminated by renal tubular secretion theoretically have the potential for interaction with metformin by competing for common renal tubular transport systems.

Such interaction between metformin and oral cimetidine has been observed in normal healthy volunteers in both single- and multiple-dose, metformin-cimetidine drug interaction studies, with a 60% increase in peak metformin plasma and whole blood concentrations and a 40% increase in plasma and whole blood metformin AUC. There was no change in elimination half-life in the single-dose study. Metformin had no effect on cimetidine pharmacokinetics.

Although such interactions remain theoretical (except for cimetidine), careful patient monitoring and dose adjustment of metformin hydrochloride and/or the interfering drug is recommended in patients who are taking cationic medications that are excreted via the proximal renal tubular secretory system. Other - Certain drugs tend to produce hyperglycemia and may lead to loss of glycemic control. These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid.

When such drugs are administered to a patient receiving metformin hydrochloride, the patient should be closely observed for loss of blood glucose control. When such drugs are withdrawn from a patient receiving metformin hydrochloride, the patient should be observed closely for hypoglycemia. In healthy volunteers, the pharmacokinetics of metformin and propranolol, and metformin and ibuprofen were not affected when coadministered in single-dose interaction studies.

Metformin is negligibly bound to plasma proteins and is, therefore, less likely to interact with highly protein-bound drugs such as salicylates, sulfonamides, chloramphenicol, and probenecid, as compared to the sulfonylureas, which are extensively bound to serum proteins.

🤰 Pregnancy 133 words ▾

Pregnancy Teratogenic Effects Recent information strongly suggests that abnormal blood glucose levels during pregnancy are associated with a higher incidence of congenital abnormalities. Most experts recommend that insulin be used during pregnancy to maintain blood glucose levels as close to normal as possible. Because animal reproduction studies are not always predictive of human response, metformin hydrochloride should not be used during pregnancy unless clearly needed.

There are no adequate and well-controlled studies in pregnant women with metformin hydrochloride. Metformin was not teratogenic in rats and rabbits at doses up to 600 mg/kg/day. This represents an exposure of about two and six times the maximum recommended human daily dose of 2000 mg based on body surface area comparisons for rats and rabbits, respectively.

Determination of fetal concentrations demonstrated a partial placental barrier to metformin.

🧒 Pediatric Use 159 words ▾

Pediatric Use The safety and effectiveness of Metformin Hydrochloride Tablets for the treatment of type 2 diabetes have been established in pediatric patients ages 10 to 16 years (studies have not been conducted in pediatric patients below the age of 10 years). Use of Metformin Hydrochloride Tablets in this age group is supported by evidence from adequate and well-controlled studies of Metformin Hydrochloride Tablets in adults with additional data from a controlled clinical study in pediatric patients ages 10 to 16 years with type 2 diabetes, which demonstrated a similar response in glycemic control to that seen in adults.

(See CLINICAL PHARMACOLOGY: Pediatric Clinical Studies .) In this study, adverse effects were similar to those described in adults. (See ADVERSE REACTIONS: Pediatric Patients .) A maximum daily dose of 2000 mg is recommended. (See DOSAGE AND ADMINISTRATION: Recommended Dosing Schedule: Pediatrics .) Safety and effectiveness of Metformin Hydrochloride Extended - Release Tablets in pediatric patients have not been established.

🧓 Geriatric Use 153 words ▾

Geriatric Use Controlled clinical studies of metformin hydrochloride did not include sufficient numbers of elderly patients to determine whether they respond differently from younger patients, although other reported clinical experience has not identified differences in responses between the elderly and younger patients. Metformin is known to be substantially excreted by the kidney and because the risk of serious adverse reactions to the drug is greater in patients with impaired renal function, metformin hydrochloride should only be used in patients with normal renal function (see CONTRAINDICATIONS, WARNINGS , and CLINICAL PHARMACOLOGY: Pharmacokinetics ).

Because aging is associated with reduced renal function, metformin Hydrochloride Extended-release Tablets should be used with caution as age increases. Care should be taken in dose selection and should be based on careful and regular monitoring of renal function. Generally, elderly patients should not be titrated to the maximum dose of metformin hydrochloride (see also WARNINGS and DOSAGE AND ADMINISTRATION ).

🆘 Overdosage 81 words ▾

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 Hydrochloride has been established. Lactic acidosis has been reported in approximately 32% of metformin overdose cases (see WARNINGS ).

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 110 words ▾

CLINICAL PHARMACOLOGY Mechanism of Action Metformin is an antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose. Its pharmacologic mechanisms of action are different from other classes of oral antihyperglycemic agents. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.

Unlike sulfonylureas, metformin does not produce hypoglycemia in either patients with type 2 diabetes or normal subjects (except in special circumstances, see PRECAUTIONS ) and does not cause hyperinsulinemia. With metformin therapy, insulin secretion remains unchanged while fasting insulin levels and day-long plasma insulin response may actually decrease.

🧬 Mechanism of Action 108 words ▾

Mechanism of Action Metformin is an antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose. Its pharmacologic mechanisms of action are different from other classes of oral antihyperglycemic agents. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.

Unlike sulfonylureas, metformin does not produce hypoglycemia in either patients with type 2 diabetes or normal subjects (except in special circumstances, see PRECAUTIONS ) and does not cause hyperinsulinemia. With metformin therapy, insulin secretion remains unchanged while fasting insulin levels and day-long plasma insulin response may actually decrease.

📦 How Supplied / Storage and Handling 131 words ▾

HOW SUPPLIED Metformin Hydrochloride Extended-release TabletsUSP are available as follows: 500 mg Bottles of 90 NDC 72789-105-90 500 mg Bottles of 100 NDC 72789-105-01 500 mg Bottles of 180 NDC 72789-105-93 500 mg Bottles of 500 NDC 72789-105-82 500 mg Bottles of 1000 NDC 72789-105-95 750 mg Bottles of 90 NDC 72789-106-90 750 mg Bottles of 100 NDC 72789-106-01 750 mg Bottles of 180 NDC 72789-106-93 750 mg Bottles of 500 NDC 72789-106-82 750 mg Bottles of 1000 NDC 72789-106-95 Metformin Hydrochloride Extended-release Tablets USP, 500 mg are white to off-white color, round, biconvex tablet, having B115 on one side and plain on the other.

Metformin Hydrochloride Extended-release Tablets USP, 750 mg are white to off-white color, capsule shape, biconvex tablet, having B116 on one side and plain on the other.

📦 Storage and Handling 31 words ▾

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

📋 Description ~1 min read ▾

DESCRIPTION Metformin Hydrochloride Extended-release Tablets USP are oral antihyperglycemic drugs used in the management of type 2 diabetes. Metformin Hydrochloride (N,N-dimethylimidodicarbonimidic diamide Hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown: Metformin Hydrochloride is a white to off-white crystalline compound with a molecular formula of C 4 H 11 N 5 • HCl and a molecular weight of 165.63.

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

Metformin Hydrochloride Extended-release Tablets USP contain 500 mg or 750 mg of Metformin Hydrochloride USP as the active ingredient. Metformin Hydrochloride Extended-release Tablets USP 500 mg and 750 mg contain the inactive ingredients microcrystalline cellulose, hypromellose, povidone, sodium carboxymethyl cellulose, and magnesium stearate. System Components and Performance- Metformin Hydrochloride Extended-release Tablets USP comprises a duel hydrophilic polymer matrix system.

Metformin hydrochloride is combined with a drug release controlling polymers to form a monophasic matrix system. After administration, fluid from the gastrointestinal (GI) tract enters the tablet, causing the polymers to hydrate and swell. Drug is released slowly from the dosage form by a process of diffusion through the gel matrix that is essentially independent of pH.

The hydrated polymer system is not rigid and is expected to be broken up by normal peristalsis in the GI tract. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass. The USP Dissolution Test is pending. structure

💬 Information for Patients ~1 min read ▾

Information for Patients Patients should be informed of the potential risks and benefits of metformin hydrochloride and of alternative modes of therapy. They should also be informed about the importance of adherence to dietary instructions, of a regular exercise program, and of regular testing of blood glucose, glycosylated hemoglobin, renal function, and hematologic parameters. The risks of lactic acidosis, its symptoms, and conditions that predispose to its development, as noted in the WARNINGS and PRECAUTIONS sections, should be explained to patients.

Patients should be advised to discontinue metformin hydrochloride immediately and to promptly notify their health practitioner if unexplained hyperventilation, myalgia, malaise, unusual somnolence, or other nonspecific symptoms occur. Once a patient is stabilized on any dose level of metformin hydrochloride, gastrointestinal symptoms, which are common during initiation of metformin therapy, are unlikely to be drug related. Later occurrence of gastrointestinal symptoms could be due to lactic acidosis or other serious disease.

Patients should be counselled against excessive alcohol intake, either acute or chronic, while receiving metformin hydrochloride. Metformin hydrochloride alone does not usually cause hypoglycemia, although it may occur when metformin hydrochloride are used in conjunction with oral sulfonylureas and insulin. When initiating combination therapy, the risks of hypoglycemia, its symptoms and treatment, and conditions that predispose to its development should be explained to patients and responsible family members.

(See Patient Information printed below.) Patients should be informed that metformin Hydrochloride Extended-release Tablets must be swallowed whole and not crushed or chewed, and that the inactive ingredients may occasionally be eliminated in the feces as a soft mass that may resemble the original tablet.

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