Quick answers
- What is Gemfibrozil used for?
- The FDA-approved label (Lopid, Parke-Davis Div of Pfizer Inc, May 21, 2026) says: “LOPID (gemfibrozil tablets, USP) is indicated as adjunctive therapy to diet for: 1. Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Gemfibrozil have a boxed warning?
- The label we quote has no boxed warning, but 3 of 43 FDA labels for this medicine do. Check the label of your own product.
- Is there a shortage of Gemfibrozil?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated February 10, 2026). Ask your pharmacist about alternatives.
- Has Gemfibrozil been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Gemfibrozil?
- 27 companies list prescription products of Gemfibrozil in the FDA NDC Directory, including A-S Medication Solutions, Bryant Ranch Prepack and Aphena Pharma Solutions - Tennessee, LLC.
What Gemfibrozil is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
LOPID (gemfibrozil tablets, USP) is indicated as adjunctive therapy to diet for: 1. Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. …
— FDA label: Lopid, Parke-Davis Div of Pfizer Inc, effective May 21, 2026. Read the full label on DailyMed →
The FDA has 43 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
3 of 43 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet · Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 44 in the FDA NDC Directory |
| Brand names | Lopid |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| gemfibrozil 600 mg tablet | Generic | $0.1034 per tablet |
| gemfibrozil 600 mg tablet, film coated | Generic | $0.1034 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- A-S Medication Solutions6 products
- Bryant Ranch Prepack5 products
- Aphena Pharma Solutions - Tennessee, LLC4 products
- Remedyrepack Inc.3 products
- NuCare Pharmaceuticals, Inc.3 products
- Proficient Rx LP2 products
- Camber Pharmaceuticals, Inc.1 product
- PD-Rx Pharmaceuticals, Inc.1 product
- AvPAK1 product
- Zydus Pharmaceuticals USA Inc.1 product
- Cipla USA Inc.1 product
- Zydus Lifesciences Limited1 product
- XLCare Pharmaceuticals, Inc.1 product
- NCS HealthCare of KY, LLC dba Vangard Labs1 product
- Coupler LLC1 product
- Exelan Pharmaceuticals Inc.1 product
- Parke-Davis Div of Pfizer Inc1 product
- Viona Pharmaceuticals Inc1 product
- NorthStar RxLLC1 product
- Chartwell RX, LLC1 product
- Aurobindo Pharma Limited1 product
- Preferred Pharmaceuticals Inc.1 product
- NorthStar Rx LLC1 product
- Northwind Health Company, LLC1 product
- American Health Packaging1 product
- Cadila Pharmaceuticals Limited1 product
- Rising Pharma Holdings, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA018422 LOPID | Pfizer Pharms | December 21, 1981 | 43, latest December 10, 2020 2020: Labeling · 2018: Labeling · 2017: Labeling |
Generic approvals (8)
- ANDA074270Chartwell Molecules · September 27, 1993
- ANDA077836Invagen Pharms · July 27, 2006
- ANDA078012Epic Pharma LLC · March 26, 2007
- ANDA079072Northstar Hlthcare · September 13, 2010
- ANDA202726Aurobindo Pharma Ltd · September 16, 2015
- ANDA203266Cadila Pharms Ltd · June 17, 2016
- ANDA204189Cadila · August 28, 2018
- ANDA214603Ascent Pharms Inc · January 13, 2021
Shortage status
To be discontinued · updated February 10, 2026 · first posted February 10, 2026
| Product | Lopid, Tablet, 600 mg (NDC 0071-0737-20) |
|---|---|
| Company | Pfizer Inc. |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 205751, 310459 |
|---|---|
| SPL set ID of the quoted label | c48855b7-215e-453b-b3b1-a0f9dee7221f |
| FDA labels (SPL) | 43 |
| FDA applications | NDA018422, 8 ANDA |
| Active ingredients (FDA) | GEMFIBROZIL |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Lopid, Parke-Davis Div of Pfizer Inc, effective May 21, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →