Quick answers
- What is Cabergoline used for?
- The FDA-approved label (Cabergoline, Mylan Pharmaceuticals Inc., June 30, 2026) says: “CABERGOLINE is an ergot derivative indicated for the treatment of hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas in adults. Limitations of Use Avoid use of CABERGOLINE for the inhibition or suppression of postpartum physiologic lactation because of the risk of serious adverse reactions […]. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Cabergoline have a boxed warning?
- No. None of the 12 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Cabergoline?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Cabergoline been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started April 24, 2012 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Cabergoline?
- 9 companies list prescription products of Cabergoline in the FDA NDC Directory, including A-S Medication Solutions, SOLA Pharmaceuticals, LLC and Amneal Pharmaceuticals NY LLC.
What Cabergoline is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
CABERGOLINE is an ergot derivative indicated for the treatment of hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas in adults. Limitations of Use Avoid use of CABERGOLINE for the inhibition or suppression of postpartum physiologic lactation because of the risk of serious adverse reactions […]. …
— FDA label: Cabergoline, Mylan Pharmaceuticals Inc., effective June 30, 2026. Read the full label on DailyMed →
The FDA has 12 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.
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.
0 of 12 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet |
|---|---|
| Route | Oral |
| Prescription products | 12 in the FDA NDC Directory |
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 |
|---|---|---|
| cabergoline 0.5 mg tablet | Generic | $1.29 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 Solutions4 products
- SOLA Pharmaceuticals, LLC1 product
- Amneal Pharmaceuticals NY LLC1 product
- Somerset Therapeutics, LLC1 product
- Teva Pharmaceuticals USA, Inc.1 product
- Ingenus Pharmaceuticals, LLC1 product
- Mylan Pharmaceuticals Inc.1 product
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.1 product
- Cranbury Pharmaceuticals, LLC1 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 |
|---|---|---|---|
| NDA020664 DOSTINEX | Pfizer | December 23, 1996 | 14, latest April 21, 2025 2025: Labeling · 2019: Labeling · 2014: Manufacturing (CMC) |
Generic approvals (6)
- ANDA076310Strides Pharma Intl · December 29, 2005
- ANDA077750Ivax Sub Teva Pharms · March 7, 2007
- ANDA204735Ingenus Pharms LLC · August 1, 2018
- ANDA218618Amneal · June 25, 2024
- ANDA218109Somerset Theraps LLC · September 9, 2024
- ANDA220309Renata · June 15, 2026
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.
-
April 24, 2012 · Class III · Terminated · D-128-2013
Impurities/Degradation Products: This lot of product will not meet the impurity specification over shelf life
CABERGOLINE Tablets, 0.5 mg, RX only, 8 count bottles, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960 NDC 0093-5420-88 — Teva Pharmaceuticals USA, 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
| RxCUI (RxNorm) | 199703 |
|---|---|
| SPL set ID of the quoted label | e497366b-a124-4d7f-bd45-a883c392d4bb |
| FDA labels (SPL) | 12 |
| FDA applications | NDA020664, 6 ANDA |
| Active ingredients (FDA) | CABERGOLINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Cabergoline, Mylan Pharmaceuticals Inc., effective June 30, 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 →