Prescription medicine
Copper Brand names: Paragard, Miudella; first approved as Paragard T 380A
Copper (Paragard) is a prescription medicine with an FDA approval on record since 1984. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the copper FDA label on DailyMed (effective June 9, 2024, CooperSurgical, Inc.); the NDA 18680 record on Drugs@FDA; every copper label on DailyMed.
Highlights of the record
FDA label of June 9, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageParagard is indicated for prevention of pregnancy in females of reproductive potential for up to 10 years.
Forms and strengths
- 313.4 mg
Intrauterine device.
On the market
- Earliest approval on file
- November 15, 1984 Paragard T 380A, Coopersurgical; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- January 23, 2037 Miudella system; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 0 since 2012 0 Class I among all firms' recalls; 5 more by firms not listed as its makers
- FAERS reports
- 42,854 through July 30, 2026
What is copper used for?
From the label: indications and usageParagard is indicated for prevention of pregnancy in females of reproductive potential for up to 10 years. Paragard is a copper-containing intrauterine system (IUS) indicated for prevention of pregnancy in females of reproductive potential for up to 10 years.
Conditions named in the indications of copper's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Copper-containing Intrauterine Device.
Source: FDA drug label (ParaGard T 380A), CooperSurgical, Inc., effective June 9, 2024 (SPL set 3c420b53-c95e-46af-aebd-73741be58391), via openFDA; the full label on DailyMed
Is there a generic for copper (Paragard)?
No generic copper is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists no patent for Paragard T 380A system; a patent listed only for Miudella system runs to January 23, 2037. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1984 earliest approval on file
- 2037 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has copper been recalled?
The FDA's Enforcement Report lists 5 recalls naming copper since 2012: 0 Class I (the most serious), 5 Class II, 0 Class III; 0 still ongoing. 5 of them are by firms that FDA's NDC Directory does not list as a maker of copper and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| June 19, 2019 | Class II | RXQ Compounding LLC not a listed maker | Lack of Assurance of Sterility |
| June 2, 2015 | Class II | The Compounding Pharmacy of America not a listed maker | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility |
| October 6, 2014 | Class II | Oregon Compounding Centers, Inc. dba Creative Compounds not a listed maker | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control … |
| July 26, 2013 | Class II | Beacon Hill Medical Pharmacy, P.C. not a listed maker | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance |
| May 25, 2012 | Class II | Franck's Lab Inc., d.b.a. Franck's Compounding Lab not a listed maker | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for copper?
The FDA Adverse Event Reporting System holds 42,854 reports that list copper among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 56 are coded as a death and 749 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Copper side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other