Quick answers
- What is Penicillamine used for?
- The FDA-approved label (Cuprimine, Bausch Health US, LLC, January 26, 2026) says: “INDICATIONS CUPRIMINE is indicated in the treatment of Wilson’s disease, cystinuria, and in patients with severe, active rheumatoid arthritis who have failed to respond to an adequate trial of conventional therapy. Available evidence suggests that CUPRIMINE is not of value in ankylosing spondylitis. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Penicillamine have a boxed warning?
- Yes. The FDA label for Cuprimine has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Penicillamine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Penicillamine been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started November 22, 2023 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Penicillamine?
- 11 companies list prescription products of Penicillamine in the FDA NDC Directory, including Par Health USA, LLC, Actavis Pharma, Inc. and Lupin Pharmaceuticals, Inc..
What Penicillamine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
INDICATIONS CUPRIMINE is indicated in the treatment of Wilson’s disease, cystinuria, and in patients with severe, active rheumatoid arthritis who have failed to respond to an adequate trial of conventional therapy. Available evidence suggests that CUPRIMINE is not of value in ankylosing spondylitis. …
— FDA label: Cuprimine, Bausch Health US, LLC, effective January 26, 2026. Read the full label on DailyMed →
The FDA has 11 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.
This label has a boxed warning. Read it on the full label →
9 of 11 FDA labels for this medicine have a boxed warning.
Forms and how it is given
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.
- Par Health USA, LLC2 products
- Actavis Pharma, Inc.1 product
- Lupin Pharmaceuticals, Inc.1 product
- Dr. Reddy's Laboratories Inc.1 product
- Proficient Rx LP1 product
- Cycle Pharmaceuticals Ltd1 product
- Viatris Specialty LLC1 product
- Navinta LLC1 product
- Bausch Health US, LLC1 product
- Breckenridge Pharmaceutical, Inc.1 product
- Granules Pharmaceuticals 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 |
|---|---|---|---|
| NDA019853 CUPRIMINE | Valeant Pharms Intl | December 4, 1970 | 12, latest October 26, 2004 2004: Labeling · 2004: Labeling · 2003: Labeling |
| NDA019854 DEPEN | Mylan Speciality LP | November 8, 1978 | 5, latest August 17, 1994 1994: Manufacturing (CMC) · 1993: Manufacturing (CMC) · 1990: Manufacturing (CMC) |
Generic approvals (9)
- ANDA210976Watson Labs Inc · June 24, 2019
- ANDA211196Ph Health · December 23, 2019
- ANDA211231Ph Health · December 23, 2019
- ANDA211867DR Reddys · August 4, 2020
- ANDA212933Lupin · November 30, 2020
- ANDA211735Granules · December 2, 2020
- ANDA213293Invagen Pharms · August 19, 2021
- ANDA215409Breckenridge · August 23, 2021
- ANDA214363Navinta LLC · October 8, 2021
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
November 22, 2023 · Class II · Terminated · D-0148-2024
Failed Dissolution Specifications
Penicillamine Tablets USP 250 mg, 100-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 Manufactured by: Lupin Limited, Nagpur-441 108, India, NDC# 70748-153-01 — Lupin Pharmaceuticals Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Cuprimine, Bausch Health US, LLC, effective January 26, 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 →