Home › NDC Lookup › Ingredients › Metformin Hydrochloride › 68071-5323-06
Metformin Hydrochloride 500 mg Tablet, Film Coated, 60-count — NDC 68071-5323-06 package photo

Metformin Hydrochloride 500 mg Tablet, Film Coated, 60-count

by NuCare Pharmaceuticals, Inc. · 60 TABLET, FILM COATED in 1 BOTTLE (68071-5323-6)
NDC 68071-5323-06
🏷️ FDA NDC (as labeled) 68071-5323-6 billing pads the package segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Sep 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
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) 68071-5323-6
Product NDC 68071-5323
11-digit billing NDC 68071532306
Application # ANDA077095
SPL Set ID 5ba1c159-5e1d-68ab-e063-6294a90a9139
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 2024-03-29
Route ORAL
Dosage form TABLET, FILM COATED
Substance METFORMIN HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 68071-5323-6 — 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 → 68071-5323-06. 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.

🏭 Manufacturer & labeler

LabelerNuCare Pharmaceuticals, Inc.
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA077095 (ANDA)
Labeler code68071
First marketedMar 2024
Product typeHuman Prescription Drug
Portfolio365 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

📗 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.

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
ImprintM4
Size11 mm
ScoringNot scored
FlavorBlackberry
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 0WZ8WG20P6
    Hypromellose 2910 is a plant-based cellulose derivative that acts as a thickener, binder, and film-coating agent. It helps control how quickly the medicine dissolves and protects the tablet or capsule from moisture and light.
  • 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 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 B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII 30IQX730WE
    Polyethylene glycol 6000 is a synthetic polymer made from ethylene glycol units. It acts as a binder, filler, and solubilizer in medicines to help hold ingredients together, add bulk, and improve how well active drugs dissolve and absorb.
  • UNII RDH86HJV5Z
    Povidone K90 is a synthetic polymer made from a chemical called vinyl pyrrolidone. It acts as a binder to hold pill ingredients together and as a dispersant to help the medicine break down and dissolve properly in your body.
  • UNII XHX3C3X673
    Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.

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.

💲 Pricing

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

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

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Metformin Hydrochloride 500 mg 71093-0132-04 ACI 100 tablets $0.014 AB Availability likely —
Metformin Hydrochloride 500 mg 82009-0174-10 Quallent 1000 tablets $0.015 AB Availability likely —
Metformin Hydrochloride 500 mg 23155-0841-01 Heritage 100 tablets $0.015 AB Availability likely —
Metformin Hydrochloride 500 mg 42385-0947-01 Laurus 100 tablets $0.015 AB Availability likely —
Metformin Hydrochloride 500 mg 60687-0155-01 American 1 tablet $0.015 AB Availability likely —
Metformin Hydrochloride 500 mg 68094-0688-60 Precision 500 tablets $0.015 AB Availability likely —
Metformin Hydrochloride 500 mg 68382-0758-01 Zydus 100 tablets $0.015 AB Availability likely —
Metformin Hydrochloride 500 mg 69367-0180-01 Westminster 100 tablets $0.015 AB Availability likely —
Metformin Hydrochloride 500 mg 65862-0008-01 Aurobindo 100 tablets $0.015 AB Availability likely —
Metformin Hydrochloride 500 mg 83301-0008-01 Mullan 100 tablets $0.015 AB Availability likely —
Metformin Hydrochloride 500 mg 62135-0680-05 Chartwell 500 tablets $0.015 AB Availability likely —
Metformin Hydrochloride 500 mg 69367-0381-01 Westminster 100 tablets $0.015 AB Availability likely —
Metformin Hydrochloride 500 mg 59651-0854-01 Aurobindo 100 tablets $0.015 AB Availability likely —
Metformin Hydrochloride 500 mg 70010-0063-01 Granules 100 tablets $0.015 AB Availability likely —
Metformin Hydrochloride 500 mg 00904-7162-61 Major 100 tablets $0.015 AB Availability likely —
Metformin Hydrochloride 500 mg 00378-7185-05 Mylan 500 tablets $0.015 AB Availability likely —
Metformin Hydrochloride 500 mg 67877-0930-01 Ascend 100 tablets $0.015 AB Availability likely —
Metformin hydrochloride 500 mg 68645-0582-59 Legacy 60 tablets $0.015 AB Availability likely —
Metformin Hydrochloride 500 mg 24658-0790-01 PuraCap 100 tablets $0.017 AB FDA listed —
Metformin Hydrochloride 500 mg 42806-0313-01 Epic 100 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 71205-0622-30 Proficient 30 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 71205-0882-00 Proficient 100 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 71709-0110-06 Metcure 500 tablets — AB FDA listed —
Metformin hydrochloride 500 mg 33342-0141-10 Macleods 90 tablets — — FDA listed —
Metformin Hydrochloride 500 mg 50090-7013-00 A-S 100 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 50228-0105-00 ScieGen 9000 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 60429-0111-01 Golden 100 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 63187-0238-90 Proficient 90 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 63629-8501-01 Bryant 500 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 63629-8502-01 Bryant 100 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 50090-7595-00 A-S 60 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 67046-1594-03 Coupler 30 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 68071-3900-06 NuCare 60 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 71335-1834-00 Bryant 25 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 71610-0917-30 Aphena 30 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 50090-6858-00 A-S 60 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 53746-0218-01 Amneal 100 tablets — — FDA listed —
Metformin Hydrochloride 500 mg 55154-4172-00 Cardinal 10 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 70518-2833-00 REMEDYREPACK 30 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 71205-0784-30 Proficient 30 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 71610-0929-30 Aphena 30 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 72162-1522-01 Bryant 100 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 50090-2081-00 A-S 60 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 50090-6859-00 A-S 90 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 50090-7011-00 A-S 100 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 68788-4076-01 Preferred 100 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 68788-8564-01 Preferred 100 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 70518-1149-01 REMEDYREPACK 1 tablet — AB Discontinued —
Metformin Hydrochloride 500 mg 71335-2224-00 Bryant 25 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 71610-0920-53 Aphena 60 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 68071-3739-01 NuCare 100 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 43353-0982-30 Aphena 30 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 50090-7010-00 A-S 60 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 65841-0809-01 Zydus 100 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 68788-8652-01 Preferred 100 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 72189-0219-30 direct 30 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 00615-8629-05 NCS 15 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 50090-7597-00 A-S 90 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 71335-2466-00 Bryant 25 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 72789-0561-20 PD-Rx 20 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 43063-0527-14 PD-Rx 14 tablets — — FDA listed —
Metformin Hydrochloride 500 mg 50090-7278-00 A-S 60 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 50090-7280-00 A-S 90 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 51655-0556-25 Northwind 60 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 68788-8498-01 Preferred 100 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 70518-1951-01 REMEDYREPACK 30 tablets — AB Discontinued —
Metformin Hydrochloride 500 mg 71335-3132-00 Bryant 25 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 50090-6485-00 A-S 90 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 67046-0298-03 Coupler 30 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 68071-3518-08 NuCare 180 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 00615-8015-05 NCS 15 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 25000-0134-03 MARKSANS 30 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 67877-0217-01 Ascend 100 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 70518-4698-00 REMEDYREPACK 30 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 68071-5306-08 NuCare 180 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 82804-0309-78 Proficient 180 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 42708-0203-60 QPharma,Inc. 60 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 50090-8041-00 A-S 60 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 50090-8043-00 A-S 90 tablets — AB FDA listed —
Metformin Hydrochloride 500 mgthis 68071-5323-06 NuCare 60 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

🏛️
2024
On the market since
Mar 2024
📍
2026
Currently FDA-listed
2 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
68071-5323-06 You're viewing this 60 TABLET, FILM COATED in 1 BOTTLE (68071-5323-6) 2026-09-16 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ 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 68071-5323-6, 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: 68071-5323-06, written without dashes as 68071532306. 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 68071-5323-06, the first segment (68071) is the labeler code FDA assigned to NuCare Pharmaceuticals, Inc.; the middle segment (5323) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (06) 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 NuCare Pharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
NuCare Pharmaceuticals, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

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