Quick answers
- What is Bromocriptine mesylate used for?
- The FDA-approved label (Cycloset, Avvisto Therapeutics LLC, January 12, 2026) says: “CYCLOSET is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. CYCLOSET is an ergot derivative indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use: Should not be used to treat type 1 diabetes or diabetic ketoacidosis. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Bromocriptine mesylate have a boxed warning?
- No. None of the 9 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Bromocriptine mesylate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Bromocriptine mesylate been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started October 23, 2025 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Bromocriptine mesylate?
- 9 companies list prescription products of Bromocriptine mesylate in the FDA NDC Directory, including ANI Pharmaceuticals, Inc., Mylan Pharmaceuticals Inc. and Padagis US LLC.
What Bromocriptine mesylate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
CYCLOSET is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. CYCLOSET is an ergot derivative indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use: Should not be used to treat type 1 diabetes or diabetic ketoacidosis. …
— FDA label: Cycloset, Avvisto Therapeutics LLC, effective January 12, 2026. Read the full label on DailyMed →
The FDA has 9 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.
0 of 9 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet · Capsule |
|---|---|
| Route | Oral |
| Prescription products | 10 in the FDA NDC Directory |
| Brand names | Cycloset |
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 |
|---|---|---|
| bromocriptine mesylate 0.8 mg tablet | Brand: Cycloset | $5.25 per tablet |
| bromocriptine mesylate 2.5 mg tablet | Generic | $1.63 per tablet |
| bromocriptine mesylate 5 mg capsule | Generic | $4.12 per capsule |
NADAC list of November 4, 2026; these prices took effect between June 17, 2026 and 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.
- ANI Pharmaceuticals, Inc.2 products
- Mylan Pharmaceuticals Inc.1 product
- Padagis US LLC1 product
- Avvisto Therapeutics LLC1 product
- Sandoz Inc1 product
- Zydus Lifesciences Limited1 product
- Zydus Pharmaceuticals USA Inc.1 product
- Remedyrepack Inc.1 product
- American Health Packaging1 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 |
|---|---|---|---|
| NDA017962 PARLODEL | Esjay Pharma | June 28, 1978 | 68, latest June 30, 2026 2026: Labeling · 2026: Labeling · 2021: Labeling |
| NDA020866 CYCLOSET | Veroscience | May 5, 2009 | 9, latest August 17, 2020 2020: Labeling · 2020: Labeling · 2017: Labeling |
Generic approvals (4)
- ANDA074631Sandoz · January 13, 1998
- ANDA077226Mylan · April 4, 2005
- ANDA078899Zydus Pharms USA Inc · July 30, 2008
- ANDA077646Padagis Us · October 1, 2008
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.
-
October 23, 2025 · Class II · Ongoing · D-0159-2026
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only. Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India. Distributed by: Zydus Pharmaceuticals, Pennington, NJ 08534. NDC 68382-110-06 — Zydus Pharmaceuticals (USA) Inc
-
May 9, 2016 · Class II · Terminated · D-1491-2016
Failed impurities/degradation specifications: Out of specification results noticed in related substance test during analysis of 24 months long term (25 degree Celsius /65% RH) stability samples of two batches.
Bromocriptine Mesylate Capsules USP, 5 mg, 30-count bottles, Rx only, Manufactured by: Cadila Healthcare ltd., Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-110-06 — Zydus 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) | 197411, 197412, 859077, 859081 |
|---|---|
| SPL set ID of the quoted label | e42ba916-16b9-4d1c-8d09-9d2fbb1b6c20 |
| FDA labels (SPL) | 9 |
| FDA applications | NDA017962, NDA020866, 4 ANDA |
| Active ingredients (FDA) | BROMOCRIPTINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Cycloset, Avvisto Therapeutics LLC, effective January 12, 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 →