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METFORMIN HYDROCHLORIDE 500 mg Tablet, Extended Release, 180-count — NDC 71335-9683-08 package photo

METFORMIN HYDROCHLORIDE 500 mg Tablet, Extended Release, 180-count

by Bryant Ranch Prepack · 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9683-8)
NDC 71335-9683-08
🏷️ FDA NDC (as labeled) 71335-9683-8 billing pads the package segment with a zero
This package
Contains180-count Pack sizes9 compare ↓
Also priced by: Part D plans $0.1129/unit — full pricing hub ↓
Also comes in: 15 tablets 71335-9683-06 20 tablets 71335-9683-09 30 tablets 71335-9683-02 45 tablets 71335-9683-07 60 tablets 71335-9683-01 90 tablets 71335-9683-04 100 tablets 71335-9683-03 120 tablets 71335-9683-05
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) 71335-9683-8
Product NDC 71335-9683
11-digit billing NDC 71335968308
RxCUI 860975
UNII 786Z46389E
Application # ANDA076756
SPL Set ID 86627ff4-da1c-429d-991b-88e97f6967d6
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 2020-08-06
Route ORAL
Dosage form TABLET, EXTENDED RELEASE
Substance METFORMIN HYDROCHLORIDE
TE code (Orange Book) AB1 · RLD · RS
Why two NDCs? The FDA registers this code as 71335-9683-8 — a 5-4-1 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 package segment → 71335-9683-08. 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

LabelerBryant Ranch Prepack
Application holderNOSTRUM PHARMACEUTICALS LLC
FDA applicationANDA076756 (ANDA)
Labeler code71335
First marketedAug 2020
Product typeHuman Prescription Drug
Portfolio4,434 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

📖 What it is MedlinePlus · NLM

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

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

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

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

💊 What it looks like

Color White
ShapeCapsule
ImprintNM5
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 VM7F0B23ZI
    Hypromellose 2208 is a plant-derived thickening agent that forms a protective coating on tablets and capsules. It slows down how quickly the medicine dissolves, controlling drug release into your body.
  • UNII 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
  • 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 ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

6 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 $20.32 / 180 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 mgthis 71335-9683-08 Bryant 180 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 —
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

🏛️
2020
On the market since
Aug 2020
📍
2026
Currently FDA-listed
6 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
71335-9683-01 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9683-1) 2023-04-11 Active
71335-9683-02 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9683-2) 2023-04-11 Active
71335-9683-03 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9683-3) 2023-04-11 Active
71335-9683-04 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9683-4) 2023-04-11 Active
71335-9683-05 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9683-5) 2023-04-11 Active
71335-9683-06 15 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9683-6) 2023-04-11 Active
71335-9683-07 45 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9683-7) 2023-04-11 Active
71335-9683-08 You're viewing this 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9683-8) 2023-04-11 Active
71335-9683-09 20 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9683-9) 2023-04-11 Active

You're viewing the largest of 9 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 71335-9683-08?
NDC 71335-9683-08 is a 180-count package — 180 tablet, extended release in 1 bottle.
What is the difference between NDC 71335-9683-08 and NDC 71335-9683-06?
Both are METFORMIN HYDROCHLORIDE 500 mg Tablet, Extended Release — the drug itself is identical. NDC 71335-9683-08 is the 180-count package, while NDC 71335-9683-06 is the 15 tablets package.
What NDC number is used to bill for this package of METFORMIN HYDROCHLORIDE 500 mg Tablet, Extended Release?
Bill NDC 71335-9683-08 — the 11-digit billing format is 71335968308. 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 71335-9683-8, 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: 71335-9683-08, written without dashes as 71335968308. 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 71335-9683-08, the first segment (71335) is the labeler code FDA assigned to Bryant Ranch Prepack; the middle segment (9683) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (08) 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 Bryant Ranch Prepack. 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 8 other package presentations of this same product, including 15 tablets (71335-9683-06), 20 tablets (71335-9683-09), 30 tablets (71335-9683-02). 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?
Bryant Ranch Prepack is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

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

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

Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g., carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, 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 ), 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 54 words ▾

1 INDICATIONS AND USAGE Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults 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 meal (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) Do not use in patients with eGFR below 30 mL/minute/1.73 m 2 (2.3) Initiation is not recommended in patients with eGFR between 30-45 mL/minute/1.73 m 2 (2.3) Assess risk/benefit of continuing if eGFR falls below 45 mL/minute/1.73 m 2 (2.3) 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 is 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 is 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 – 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 Procedures 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.

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 is 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…

💊 Dosage Forms and Strengths 50 words ▾

3 DOSAGE FORMS AND STRENGTHS Metformin hydrochloride extended-release tablets: 500 mg and 750 mg (3) Metformin hydrochloride extended-release tablets, USP are available as: • Extended-release tablets: 500 mg which are white, uncoated, oblong tablets, debossed with “NM5”. • Extended-release tablets: 750 mg which are white, uncoated, oblong tablets, debossed with”NM7”.

⛔ Contraindications 75 words ▾

4 CONTRAINDICATIONS 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) Metformin hydrochloride extended-release tablets are contraindicated in patients with: Severe renal impairment (eGFR below 30 mL/min/1.73 m 2 ) [see Warnings and Precautions ( 5.1 )]. Hypersensitivity to metformin.

Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.

⚠️ Warnings and Cautions ~2 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)

5.1Lactic Acidosis There have been postmarketing cases of metformin-associated lactic acidosis, including fatal cases. These cases had a subtle onset and were accompanied by nonspecific symptoms such as malaise, myalgias, abdominal pain, respiratory distress, or increased somnolence; however, hypotension and resistant bradyarrhythmias have occurred with severe acidosis. Metformin-associated lactic acidosis was characterized by elevated blood lactate concentrations (>5 mmol/L), anion gap acidosis (without evidence of ketonuria or ketonemia), and an increased lactate: pyruvate ratio; metformin plasma levels were generally >5 mcg/mL.

Metformin decreases liver uptake of lactate increasing lactate blood levels which may increase the risk of lactic acidosis, especially in patients at risk. If metformin-associated lactic acidosis is suspected, general supportive measures should be instituted promptly in a hospital setting, along with immediate discontinuation of Metformin hydrochloride extended-release tablets. In Metformin hydrochloride extended-release tablets treated patients with a diagnosis or strong suspicion of lactic acidosis, prompt hemodialysis is recommended to correct the acidosis and remove accumulated metformin (metformin hydrochloride is dialyzable with a clearance of up to 170 mL/min under good hemodynamic conditions).

Hemodialysis has often resulted in reversal of symptoms and recovery. Educate patients and their families about the symptoms of lactic acidosis and, if these symptoms occur, instruct them to discontinue Metformin hydrochloride extended-release tablets and report these symptoms to their healthcare provider. For each of the known and possible risk factors for metformin-associated lactic acidosis, recommendations to reduce the risk of and manage metformin-associated lactic acidosis are provided below: Renal impairment —The postmarketing metformin-associated lactic acidosis cases primarily occurred in patients with significant renal impairment.

The risk of metformin accumulation and metformin-associated lactic acidosis increases with the severity of renal impairment because metformin is substantially excreted by the kidney. Clinical recommendations based upon the patient’s renal function include [see Dosage and Administration (2.1) and Clinical Pharmacology (12.3) ] Before initiating Metformin hydrochloride extended-release tablets, obtain an estimated glomerular filtration rate (eGFR). Metformin hydrochloride extended-release tablets is contraindicated in patients with an eGFR less than 30 mL/min/1.73 m 2 [see Contraindications (4) ] Initiation of Metformin hydrochloride extended-release tablets is not recommended in patients with eGFR between 30-45 mL/min/1.73 m 2 .

Obtain an eGFR at least annually in all patients taking Metformin hydrochloride extended-release tablets. In patients at risk for the development of renal impairment (e.g., the elderly), renal function should be assessed more frequently. In patients taking Metformin hydrochloride extended-release tablets whose eGFR falls below 45 mL/min/1.73 m 2 , assess the benefit and risk ofcontinuing therapy.

Drug interactions — The concomitant use of Metformin hydrochloride extended-release tablets with specific drugs may increase the risk of metformin-associated lactic acidosis: those that impair renal function, result in significant hemodynamic change, interfere with acid-base balance, or increase metformin accumulation. Consider more frequent monitoring of pat…

🤒 Adverse Reactions 44 words ▾

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, contact Nostrum Laboratories, Inc at [email protected] or call 1-877-770-1288 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

🔄 Drug Interactions 58 words ▾

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 6–10% in women with pre-gestational diabetes mellitus with an HbA1C >7 and has been reported to be as high as 20–25% 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 2–4% and 15–20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Poorly-controlled diabetes mellitus in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, stillbirth and delivery complications. Poorly controlled diabetes mellitus increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity.

Data Human Data Published data from 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 extended-release tablet…

🆘 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, Cmax 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 tablets 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…

📦 How Supplied / Storage and Handling 68 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING NDC: 71335-9683-1: 60 Tablets in a BOTTLE NDC: 71335-9683-2: 30 Tablets in a BOTTLE NDC: 71335-9683-3: 100 Tablets in a BOTTLE NDC: 71335-9683-4: 90 Tablets in a BOTTLE NDC: 71335-9683-5: 120 Tablets in a BOTTLE NDC: 71335-9683-6: 15 Tablets in a BOTTLE NDC: 71335-9683-7: 45 Tablets in a BOTTLE NDC: 71335-9683-8: 180 Tablets in a BOTTLE NDC: 71335-9683-9: 20 Tablets in a BOTTLE

📋 Description 138 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 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.

It 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 as the active ingredient. Each tablet contains the inactive ingredients hypromellose, silicified microcrystalline cellulose, xanthan gum, maltodextrin, colloidal silicon dioxide and stearic acid.

💬 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 is coadministered with oral sulfonylureas and insulin.

Explain to patients receiving concomitant therapy the risks of hypoglycemia, its symptoms and treatment, and conditions that predispose to its development [see Warnings and Precautions ( 5.3 )]. Vitamin B 12 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. Manufactured by: Nostrum Laboratories Inc. 1800 N Topping Avenue Kansas City, MO 64120 Rev.

August 2019

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 71335-9682-01 · Bryant 71335-9684-00 · Bryant →
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.