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Metformin Hydrochloride 850 mg Tablet, Film Coated, 1,000-count — NDC 65841-0810-10 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Metformin Hydrochloride 850 mg Tablet, Film Coated, 1,000-count — NDC 65841-810-10 (Billing 65841-0810-10)

by Zydus Lifesciences Limited · 1000 TABLET, FILM COATED in 1 BOTTLE

This is a package of 1,000 tablets of Metformin Hydrochloride 850 mg Tablet, Film Coated from Zydus Lifesciences Limited, marketed since Dec 2014 and currently FDA-listed.

NDC 65841-0810-10
🏷️ FDA NDC (as labeled) 65841-810-10 billing pads the product segment with a zero
This package
Contains1,000-count Pack sizes5 compare ↓
Also priced by: Part D plans $0.1129/unit — full pricing hub ↓
Product page 65841-0810-01 Also comes in: 1 tablet 65841-810-77 90 tablets 65841-810-16 100 tablets 65841-810-01 500 tablets 65841-810-05
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 65841-810-10 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
65841 labeler · 810 product · 10 package
Package marketed since
Dec 9, 2014
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0368382760012
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Metformin Hydrochloride (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Feb 25, 2025 — Presence of Foreign Tablets/Capsules. (A-S Medication Solutions LLC) · FDA recall D-0292-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 65841-810-10
Product NDC 65841-810
11-digit billing NDC 65841081010
RxCUI 860975, 861004, 861010
UNII 786Z46389E
UPC 0368382760012
Application # ANDA203686
SPL Set ID 5043d03e-3c9d-4c96-b48d-187f02a1d27c
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 2014-12-09
Route ORAL
Dosage form TABLET, FILM COATED
Substance METFORMIN HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 860975
Why two NDCs? The FDA registers this code as 65841-810-10 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 65841-0810-10. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Biguanide class.

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

Clinical

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

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

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

Pricing

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

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.1129 $112.90 / 1000 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
65841-0810-01 65841-810-01 Main listing 100 TABLET, FILM COATED in 1 BOTTLE 2014-12-09 — Active
65841-0810-05 65841-810-05 500 TABLET, FILM COATED in 1 BOTTLE 2014-12-09 — Active
65841-0810-10 You're viewing this 1000 TABLET, FILM COATED in 1 BOTTLE 2014-12-09 — Active
65841-0810-16 65841-810-16 90 TABLET, FILM COATED in 1 BOTTLE 2014-12-09 — Active
65841-0810-77 65841-810-77 100 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED in 1 BLISTER PACK 2014-12-09 — Active

Pack size FAQ

What quantity is in this package?
This is a 1,000-count package — 1000 tablet, film coated in 1 bottle.
How does this package differ from NDC 65841-0810-16?
Both are Metformin Hydrochloride 850 mg Tablet, Film Coated — the drug itself is identical. This page's package is the 1,000-count one, while NDC 65841-0810-16 is the 90 tablets package.
What NDC number is used to bill for this package of Metformin Hydrochloride 850 mg Tablet, Film Coated?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Metformin Hydrochloride 850 mg 00378-7186-05 Mylan 500 tablets $0.024 AB Availability likely —
Metformin Hydrochloride 850 mg 00904-7163-61 Major 100 tablets $0.024 AB Availability likely —
Metformin Hydrochloride 850 mg 23155-0842-01 Heritage 100 tablets $0.024 AB Availability likely —
Metformin Hydrochloride 850 mg 42385-0948-01 Laurus 100 tablets $0.024 AB Availability likely —
Metformin HCl 850 mg 49483-0621-01 TIME 100 tablets $0.024 AB Availability likely —
Metformin Hydrochloride 850 mg 59651-0855-01 Aurobindo 100 tablets $0.024 AB Availability likely —
Metformin Hydrochloride 850 mg 60687-0143-01 American 1 tablet $0.024 AB Availability likely —
Metformin Hydrochloride 850 mg 65862-0009-01 Aurobindo 100 tablets $0.024 AB Availability likely —
Metformin HCl 850 mg 67877-0562-01 Ascend 100 tablets $0.024 AB Availability likely —
Metformin Hydrochloride 850 mg 67877-0931-01 Ascend 100 tablets $0.024 AB Availability likely —
Metformin Hydrochloride 850 mg 68094-0580-60 Precision 500 tablets $0.024 AB Availability likely —
Metformin Hydrochloride 850 mg 68382-0759-01 Zydus 100 tablets $0.024 AB Availability likely —
Metformin hydrochloride 850 mg 68645-0583-59 Legacy 60 tablets $0.024 AB Availability likely —
Metformin Hydrochloride 850 mg 69367-0181-01 Westminster 100 tablets $0.024 AB Availability likely —
Metformin Hydrochloride 850 mg 69367-0382-01 Westminster 100 tablets $0.024 AB Availability likely —
Metformin Hydrochloride 850 mg 70010-0064-01 Granules 100 tablets $0.024 — Availability likely —
Metformin Hydrochloride 850 mg 83301-0009-01 Mullan 100 tablets $0.024 AB Availability likely —
Metformin Hydrochloride 850 mg 71093-0133-04 ACI 100 tablets $0.025 AB Availability likely —
Metformin Hydrochloride 850 mg 42806-0314-01 Epic 100 tablets $0.027 AB FDA listed —
Metformin Hydrochloride 850 mg 00615-8577-39 NCS 30 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 24658-0791-05 PuraCap 500 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 25000-0131-03 MARKSANS 30 tablets — AB FDA listed —
Metformin hydrochloride 850 mg 33342-0142-10 Macleods 90 tablets — — FDA listed —
Metformin HCl 850 mg 50090-3050-00 A-S 60 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 50090-6753-00 A-S 60 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 50090-6754-00 A-S 90 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 50090-7106-00 A-S 60 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 50090-7107-00 A-S 90 tablets — AB FDA listed —
Metformin HCl 850 mg 50090-7465-00 A-S 90 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 50228-0106-00 ScieGen 4200 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 53746-0219-01 Amneal 100 tablets — — FDA listed —
Metformin Hydrochloride 850 mg 60429-0112-01 Golden 100 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 62135-0683-05 Chartwell 500 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 62207-0441-43 Granules 100 tablets — AB FDA listed —
Metformin Hydrochloride 850 mgthis 65841-0810-10 Zydus 1000 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 67046-0804-03 Coupler 30 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 67877-0218-01 Ascend 100 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 68071-3495-08 NuCare 180 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 68071-3531-01 NuCare 100 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 68071-3575-08 NuCare 180 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 68071-3833-08 NuCare 180 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 68788-8528-01 Preferred 100 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 68788-8603-01 Preferred 100 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 68788-8756-01 Preferred 100 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 70518-3084-00 REMEDYREPACK 30 tablets — AB Discontinued —
Metformin HCl 850 mg 70518-4479-00 REMEDYREPACK 90 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 70882-0125-30 Cambridge 30 tablets — AB Discontinued —
Metformin HCl 850 mg 71205-0567-00 Proficient 100 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 71205-0883-00 Proficient 100 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 71335-1785-01 Bryant 60 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 71335-1835-01 Bryant 60 tablets — AB FDA listed —
Metformin HCl 850 mg 71335-1983-01 Bryant 60 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 71335-2245-01 Bryant 60 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 71335-2593-01 Bryant 60 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 71610-0918-60 Aphena 90 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 71610-0923-30 Aphena 30 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 71709-0111-06 Metcure 500 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 72189-0221-90 direct 90 tablets — AB FDA listed —
Metformin Hydrochloride 850 mg 72789-0409-90 PD-Rx 90 tablets — AB 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

🏛️
2014
On the market since
Dec 2014
📍
2026
Currently FDA-listed
12 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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

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

What it looks like

Color White
ShapeOval
ImprintZ;71
Size19 mm
ScoringScored — splits in 2
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

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

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

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

  • UNII 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 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • 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 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.

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

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

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerZydus Lifesciences Limited
Application holderZYDUS HEALTHCARE USA LLC
FDA applicationANDA203686 (ANDA)
Labeler code65841
First marketedDec 2014
Product typeHuman Prescription Drug
Portfolio720 products on file

More NDCs from Zydus Lifesciences Limited labeler code 65841

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

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
📄 Package Label / Principal Display Panel
📄 Package Label / Principal Display Panel 58 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-809-01 in bottle of 100 tablets Metformin Hydrochloride Tablets USP, 500 mg Rx only 100 tablets NDC 65841-810-01 in bottle of 100 tablets Metformin Hydrochloride Tablets USP, 850 mg Rx only 100 tablets NDC 65841-811-01 in bottle of 100 tablets Metformin Hydrochloride Tablets USP, 1000 mg Rx only 100 tablets Image Image Image

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

About this NDC listing & data coverage

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

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Zydus Lifesciences Limited. 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 4 other package presentations of this same product, including 1 tablet (65841-0810-77), 90 tablets (65841-0810-16), 100 tablets (65841-0810-01). 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?
Zydus Lifesciences Limited 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.
← 65841-0809-01 · Zydus 65841-0811-01 · Zydus →
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.