Quick answers
- What is Pyridostigmine bromide used for?
- The FDA-approved label (Mestinon, Bausch Health US, LLC, December 2, 2020) says: “INDICATION: MESTINON is useful in the treatment of myasthenia gravis.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Pyridostigmine bromide have a boxed warning?
- The label we quote has no boxed warning, but 2 of 21 FDA labels for this medicine do. Check the label of your own product.
- Is there a shortage of Pyridostigmine bromide?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Pyridostigmine bromide been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started September 30, 2022 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Pyridostigmine bromide?
- 20 companies list prescription products of Pyridostigmine bromide in the FDA NDC Directory, including Bausch Health US, LLC, Method Pharmaceuticals, LLC and Amneal Pharmaceuticals of New York LLC.
What Pyridostigmine bromide is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
INDICATION: MESTINON is useful in the treatment of myasthenia gravis.
— FDA label: Mestinon, Bausch Health US, LLC, effective December 2, 2020. Read the full label on DailyMed →
The FDA has 21 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.
2 of 21 FDA labels for this medicine have a boxed warning.
Forms and how it is given
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 |
|---|---|---|
| pyridostigmine bromide 180 mg tablet | Generic | $3.87 per tablet |
| pyridostigmine bromide 180 mg tablet, extended release | Generic | $3.87 per tablet |
| pyridostigmine bromide 30 mg tablet | Generic | $6.94 per tablet |
| pyridostigmine bromide 60 mg tablet | Generic | $0.2379 per tablet |
| pyridostigmine bromide 60 mg/5 mL solution | Generic | $0.6554 per mL |
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.
- Bausch Health US, LLC3 products
- Method Pharmaceuticals, LLC2 products
- Amneal Pharmaceuticals of New York LLC2 products
- Rising Pharma Holdings, Inc.2 products
- Surgeon General-Department of the Army (TSG-DA)1 product
- Amneal Pharmaceuticals NY LLC1 product
- Alvogen Inc.1 product
- ANI Pharmaceuticals, Inc.1 product
- Zydus Lifesciences Limited1 product
- Zydus Pharmaceuticals USA Inc.1 product
- American Health Packaging1 product
- Golden State Medical Supply, Inc.1 product
- VistaPharm, LLC1 product
- Amneal Pharmaceuticals LLC1 product
- Sandoz Inc1 product
- Acella Pharmaceuticals, LLC1 product
- Novitium Pharma LLC1 product
- Novadoz Pharmaceuticals LLC1 product
- Major Pharmaceuticals1 product
- Apnar Pharma LP1 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 |
|---|---|---|---|
| NDA009829 MESTINON | Bausch | April 6, 1955 | 11, latest May 16, 2014 2014: Manufacturing (CMC) · 2014: Manufacturing (CMC) · 2001: Labeling |
| NDA011665 MESTINON | Bausch | January 12, 1959 | 13, latest July 25, 2014 2014: Manufacturing (CMC) · 2014: Manufacturing (CMC) · 2001: Manufacturing (CMC) |
| NDA015193 MESTINON | Bausch | January 25, 1965 | 11, latest October 29, 2019 2019: Labeling · 2015: Manufacturing (CMC) · 2014: Manufacturing (CMC) |
| NDA017398 REGONOL | Sandoz | August 14, 1973 | 18, latest April 5, 2021 2021: Labeling · 2016: Manufacturing (CMC) · 2013: Manufacturing (CMC) |
| NDA020414 PYRIDOSTIGMINE BROMIDE | Us Army | February 5, 2003 | 5, latest September 26, 2025 2025: Labeling · 2024: Manufacturing (CMC) · 2015: Manufacturing (CMC) |
| NDA217604 PYRIDOSTIGMINE BROMIDE | Amneal | October 4, 2024 | 1, latest May 12, 2026 2026: Labeling |
Generic approvals (11)
- ANDA040502Impax Labs · April 24, 2003
- ANDA040512Ani Pharms · October 8, 2003
- ANDA205650Zydus Pharms · June 22, 2015
- ANDA204737Alvogen · June 26, 2015
- ANDA205464Rising · August 15, 2017
- ANDA211181Mlv · July 20, 2018
- ANDA211694Novitium Pharma · March 8, 2019
- ANDA208797Rising · January 9, 2020
- ANDA212702Amneal · January 10, 2020
- ANDA212405Milla Pharms · April 19, 2022
- ANDA216512Msn · September 21, 2023
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.
-
September 30, 2022 · Class II · Terminated · D-0018-2023
cGMP Deviations: Out of specification for assay of one of the preservative ingredients.
Pyridostigmine Bromide Oral Solution, USP 60 mg/5 mL Delivers 5 mL, packaged in 5mL unit-dose cup, Rx only, Dist. by: VistaPharm, NDC 66689-406-01 — VistaPharm, 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) | 903841, 903843, 903845, 903847, 903849, 903851, 903855, 903857, 903859, 2695047 |
|---|---|
| SPL set ID of the quoted label | a851795e-b7a8-40c3-9922-5e79d3eb4d92 |
| FDA labels (SPL) | 21 |
| FDA applications | NDA009829, NDA011665, NDA015193, NDA017398, NDA020414, NDA217604, 11 ANDA |
| Active ingredients (FDA) | PYRIDOSTIGMINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Mestinon, Bausch Health US, LLC, effective December 2, 2020; 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 →