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Gemfibrozil 600 mg Tablet, Film Coated, 30-count — NDC 70518-4764-00 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Gemfibrozil 600 mg Tablet, Film Coated, 30-count — NDC 70518-4764-0 (Billing 70518-4764-00)

by REMEDYREPACK INC. · 30 TABLET, FILM COATED in 1 BLISTER PACK

This is a package of 30 tablets of Gemfibrozil 600 mg Tablet, Film Coated from REMEDYREPACK INC., marketed since Sep 2026 and currently FDA-listed. It is this product's only package size.

NDC 70518-4764-00
🏷️ FDA NDC (as labeled) 70518-4764-0 billing pads the package segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 2, 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70518-4764-0
Product NDC 70518-4764
11-digit billing NDC 70518476400
Application # ANDA202726
SPL Set ID cf32b795-bf42-4861-b273-06d27de3f21d
Established class (EPC) Peroxisome Proliferator Receptor alpha Agonist
Mechanism of action Peroxisome Proliferator-activated Receptor alpha Agonists
Chemical class Fibric Acids
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-09-24
Route ORAL
Dosage form TABLET, FILM COATED
Substance GEMFIBROZIL
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 70518-4764-0 — 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 → 70518-4764-00. 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.

Clinical

📗 Our plain-language guide HelloPharmacist
  • It's used with diet to treat very high triglycerides, especially when they raise your risk of pancreatitis. It's also used in a narrow group of people to lower the risk of coronary...
  • Take it by mouth twice a day, 30 minutes before breakfast and dinner. Follow your prescriber's directions and your label.
  • Stomach issues like indigestion, belly pain, diarrhea and nausea are the most common. Fatigue, rash, vertigo and headache can also occur. Let me know if they bother you.
  • Call promptly for muscle pain, tenderness or weakness, ongoing or severe belly pain, yellow skin or eyes, or signs of allergic reaction like swelling or trouble breathing.
📖 Read our full Gemfibrozil guide →
1
Nutrient depletion considerations

Gemfibrozil may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Gemfibrozil 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 · 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
70518-4764-00 You're viewing this Main listing 30 TABLET, FILM COATED in 1 BLISTER PACK 2026-09-24 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Gemfibrozil 600 mg 75834-0131-05 Nivagen 500 tablets $0.103 AB Discontinued —
Gemfibrozil 600 mg 31722-0128-05 Camber 500 tablets $0.104 AB Availability likely —
Gemfibrozil 600 mg 69097-0821-03 Cipla 60 tablets $0.104 AB Availability likely —
Gemfibrozil 600 mg 76282-0225-05 Exelan 500 tablets $0.104 AB Availability likely —
Gemfibrozil 600 mg 60687-0224-01 American 100 tablets $0.104 AB Availability likely —
Gemfibrozil 600 mg 50268-0350-15 AvPAK 50 tablets $0.104 AB Availability likely —
Gemfibrozil 600 mg 16571-0784-06 Rising 60 tablets $0.104 AB Availability likely —
Gemfibrozil 600 mg 65862-0624-05 Aurobindo 500 tablets $0.104 AB Availability likely —
Gemfibrozil 600 mg 72603-0206-01 NorthStar 60 tablets $0.104 AB Availability likely —
Gemfibrozil 600 mg 16714-0101-02 Northstar 60 tablets $0.104 AB Availability likely —
Gemfibrozil 600 mg 00615-8354-39 NCS 30 tablets — AB FDA listed —
Gemfibrozil 600 mg 63187-0772-30 Proficient 30 tablets — AB FDA listed —
Gemfibrozil 600 mg 71610-0107-53 Aphena 60 tablets — AB FDA listed —
Gemfibrozil 600 mg 71610-0200-60 Aphena 90 tablets — AB FDA listed —
Gemfibrozil 600 mg 71610-0601-53 Aphena 60 tablets — AB FDA listed —
Gemfibrozil 600 mg 72865-0186-05 XLCare 500 tablets — AB FDA listed —
Gemfibrozil 600 mg 50090-6913-00 A-S 60 tablets — AB FDA listed —
Gemfibrozil 600 mg 50090-6939-00 A-S 90 tablets — AB FDA listed —
Gemfibrozil 600 mg 70771-1431-00 Zydus 1000 tablets — — FDA listed —
Gemfibrozil 600 mg 71209-0008-03 Cadila 60 tablets — AB FDA listed —
Gemfibrozil 600 mg 71335-1902-01 Bryant 60 tablets — AB FDA listed —
Gemfibrozil 600 mg 72162-2119-06 Bryant 60 tablets — AB FDA listed —
Gemfibrozil 600 mg 72578-0066-01 Viona 100 tablets — — FDA listed —
Gemfibrozil 600 mg 70518-4305-00 REMEDYREPACK 180 tablets — AB FDA listed —
Lopid 600 mg 00071-0737-20 Parke-Davis 60 tablets — AB FDA listed —
Gemfibrozil 600 mg 50090-5808-00 A-S 60 tablets — AB FDA listed —
Gemfibrozil 600 mg 68788-7964-03 Preferred 30 tablets — AB FDA listed —
Gemfibrozil 600 mg 82804-0221-90 Proficient 90 tablets — AB FDA listed —
Gemfibrozil 600 mg 68071-2387-03 NuCare 30 tablets — AB FDA listed —
Gemfibrozil 600 mg 70518-1563-00 REMEDYREPACK 45 tablets — AB Discontinued —
Gemfibrozil 600 mg 71335-0051-01 Bryant 60 tablets — AB FDA listed —
Gemfibrozil 600 mg 71335-0971-01 Bryant 60 tablets — AB Discontinued —
Gemfibrozil 600 mg 51655-0143-26 Northwind 90 tablets — AB FDA listed —
Gemfibrozil 600 mg 68071-1733-06 NuCare 60 tablets — AB FDA listed —
Gemfibrozil 600 mg 68382-0553-01 Zydus 100 tablets — — FDA listed —
Gemfibrozil 600 mg 71335-2025-01 Bryant 60 tablets — AB FDA listed —
Gemfibrozil 600 mg 50090-7234-00 A-S 90 tablets — AB FDA listed —
Gemfibrozil 600 mg 50090-7233-00 A-S 60 tablets — AB FDA listed —
Gemfibrozil 600 mg 71335-1996-01 Bryant 60 tablets — AB FDA listed —
Gemfibrozil 600 mg 62135-0160-31 Chartwell 300 tablets — AB FDA listed —
Gemfibrozil 600 mg 71610-0824-30 Aphena 30 tablets — AB FDA listed —
Gemfibrozil 600 mg 66267-0436-30 NuCare 30 tablets — AB FDA listed —
Gemfibrozil 600 mg 67046-0233-03 Coupler 30 tablets — AB FDA listed —
Gemfibrozil 600 mg 43063-0745-60 PD-Rx 60 tablets — AB FDA listed —
Gemfibrozil 600 mg 50090-7809-00 A-S 90 tablets — AB FDA listed —
Gemfibrozil 600 mgthis 70518-4764-00 REMEDYREPACK 30 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

🏛️
2026
On the market since
Sep 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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
ImprintE;82
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 776XM7047L
    Calcium stearate is a white powder derived from stearic acid and calcium. It works as a lubricant and glidant to help the medicine flow smoothly during manufacturing and prevent ingredients from sticking to equipment.
  • UNII RFW2ET671P
    Hydroxypropyl cellulose is a plant-derived thickening agent made from cellulose. It acts as a binder to hold tablet ingredients together and as a film-former to coat tablets or control how fast the medicine releases.
  • 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 2165RE0K14
    A plant-based thickener made from cellulose that helps control how quickly the medicine dissolves and releases its active ingredient. It also binds ingredients together and improves the tablet's texture and handling during manufacturing.
  • 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 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 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • 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 O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

10 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

LabelerREMEDYREPACK INC.
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA202726 (ANDA)
Labeler code70518
First marketedSep 2026
Product typeHuman Prescription Drug
Portfolio1,527 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.

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
📄 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 ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Gemfibrozil — the program that covers self-administered drugs. 10 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Gemfibrozil. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$3.19M
Claims incl. refills
159.6K
Beneficiaries
119.4K
Spend / beneficiary
$26.71
Spend / claim
$19.98
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

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 REMEDYREPACK INC.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
REMEDYREPACK 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.
← 70518-4763-00 · REMEDYREPACK 70518-4765-01 · REMEDYREPACK →
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.