Pyridostigmine Bromide 60 mg Tablet, 100-count — NDC 62559-470-01 (Billing 62559-0470-01)
NDC 62559-470-01 (billing 62559-0470-01) is a package of 100 tablets of Pyridostigmine Bromide 60 mg Tablet from ANI Pharmaceuticals, Inc., marketed since Jan 2024 and currently FDA-listed; retail pharmacies pay about $0.2487 per tablet (NADAC). It is this product's only package size.
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 004764
- GCN: 18530
- GPI-14 (Medi-Span): 76000050100305
- HICL (First Databank): 001990
- AHFS class code: 12:04.00.00
- RxCUI (RxNorm): 903857
- 11-digit billing NDC: 62559047001
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Sep 24, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Cholinesterase Inhibitor class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Sep 24, 2026
Clinical
Pyridostigmine is used to treat myasthenia gravis. Pyridostigmine is in a class called cholinergic agents. It works by increasing the amount of certain natural substances in the body to improve nerve and muscle activity.
Read the full MedlinePlus article ↗- It depends on the product. Mestinon and the oral solution treat myasthenia gravis. Regonol is a hospital injection that reverses muscle relaxants. Other tablets are for military us...
- Take it exactly as prescribed. Oral products are swallowed, and doses are adjusted to your needs and spaced through the day. The military extended-release tablet must be taken with...
- Stomach upset is most common, including diarrhea, cramps and nausea. Some people notice twitching, sweating or drooling. These come from extra acetylcholine activity, so tell your...
- Get help right away for trouble breathing, severe dizziness, fainting, or growing muscle weakness. These can be signs of a serious reaction or too much medicine.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Pyridostigmine Bromide — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.249 | $24.87 / 100 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.3322 | $33.22 / 100 tablets |
| Medicare drug plans payPart D · Q2 2026 | $0.3682 | $36.82 / 100 tablets |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 62559-0470-01 62559-470-01 You're viewing this Main listing | 100 TABLET in 1 BOTTLE (62559-470-01) | 2024-01-16 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Pyridostigmine Bromide 60 mg 68682-0302-10 | Oceanside | 100 tablets | $0.197 | AB | Discontinued | save 21% |
| Pyridostigmine Bromide 60 mg 00115-3511-01 | Amneal | 100 tablets | $0.249 | AB | Availability likely | — |
| pyridostigmine bromide 60 mg 00904-6622-61 | Major | 100 tablets | $0.249 | AB | Availability likely | — |
| Pyridostigmine Bromide 60 mgthis 62559-0470-01 | ANI | 100 tablets | $0.249 | AB | Availability likely | — |
| Pyridostigmine Bromide 60 mg 68084-0494-01 | American | 100 tablets | $0.249 | AB | Availability likely | — |
| Mestinon 60 mg 00187-3010-30 | Bausch | 100 tablets | — | AB | FDA listed | — |
| pyridostigmine bromide 60 mg 51407-0590-30 | Golden | 30 tablets | — | AB | FDA listed | — |
| Pyridostigmine Bromide 60 mg 58657-0811-01 | Method | 100 tablets | — | AB | FDA listed | — |
| pyridostigmine bromide 60 mg 65841-0819-01 | Zydus | 100 tablets | — | AB | FDA listed | — |
| pyridostigmine bromide 60 mg 68382-0659-01 | Zydus | 100 tablets | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Sep 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 3SY5LH9PMK
Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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UNII 4ELV7Z65AP
Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
3 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Pyridostigmine Bromide Tablets USP are useful in the treatment of myasthenia gravis.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Each Pyridostigmine Bromide Tablet contains 60 mg pyridostigmine bromide. Dosage The size and frequency of the dosage must be adjusted to the needs of the individual patient. The average dose is ten 60 mg tablets daily, spaced to provide maximum relief when maximum strength is needed.
In severe cases as many as twenty-five tablets a day may be required, while in mild cases one to six tablets a day may suffice. NOTE: For information on a diagnostic test for myasthenia gravis, and for the evaluation and stabilization of therapy, please see product literature on Tensilon (edrophonium chloride).
⛔ Contraindications ▾
CONTRAINDICATIONS Pyridostigmine bromide tablets are contraindicated in mechanical intestinal or urinary obstruction, and particular caution should be used in its administration to patients with bronchial asthma. Care should be observed in the use of atropine for counteracting side effects, as discussed below.
⚠️ Warnings ▾
WARNINGS Although failure of patients to show clinical improvement may reflect underdosage, it can also be indicative of overdosage. As is true of all cholinergic drugs, overdosage of pyridostigmine bromide may result in cholinergic crisis, a state characterized by increasing muscle weakness which, through involvement of the muscles of respiration, may lead to death. Myasthenic crisis due to an increase in the severity of the disease is also accompanied by extreme muscle weakness, and thus may be difficult to distinguish from cholinergic crisis on a symptomatic basis.
Such differentiation is extremely important, since increases in doses of pyridostigmine bromide or other drugs of this class in the presence of cholinergic crisis or of a refractory or "insensitive" state could have grave consequences. Osserman and Genkins 1 indicate that the differential diagnosis of the two types of crisis may require the use of Tensilon TM (edrophonium chloride) as well as clinical judgment. The treatment of the two conditions obviously differs radically.
Whereas the presence of myasthenic crisis suggests the need for more intensive anticholinesterase therapy, the diagnosis of cholinergic crisis, according to Osserman and Genkins 1 calls for the prompt withdrawal of all drugs of this type. The immediate use of atropine in cholinergic crisis is also recommended. Atropine may also be used to abolish or obtund gastrointestinal side effects or other muscarinic reactions; but such use, by masking signs of overdosage, can lead to inadvertent induction of cholinergic crisis.
For detailed information on the management of patients with myasthenia gravis, the physician is referred to one of the excellent reviews such as those by Osserman and Genkins 2 , Grob 3 or Schwab 4,5 . Usage in Pregnancy The safety of pyridostigmine bromide during pregnancy or lactation in humans has not been established. Therefore, use of pyridostigmine bromide in women who may become pregnant requires weighing the drug's potential benefits against its possible hazards to mother and child.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The side effects of pyridostigmine bromide are most commonly related to overdosage and generally are of two varieties, muscarinic and nicotinic. Among those in the former group are nausea, vomiting, diarrhea, abdominal cramps, increased peristalsis, increased salivation, increased bronchial secretions, miosis and diaphoresis. Nicotinic side effects are comprised chiefly of muscle cramps, fasciculation and weakness.
Muscarinic side effects can usually be counteracted by atropine, but for reasons shown in the preceding section the expedient is not without danger. As with any compound containing the bromide radical, a skin rash may be seen in an occasional patient. Such reactions usually subside promptly upon discontinuance of the medication.
To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc. at 1-855-204-1431 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🤰 Pregnancy ▾
Usage in Pregnancy The safety of pyridostigmine bromide during pregnancy or lactation in humans has not been established. Therefore, use of pyridostigmine bromide in women who may become pregnant requires weighing the drug's potential benefits against its possible hazards to mother and child.
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Pyridostigmine bromide inhibits the destruction of acetylcholine by cholinesterase and thereby permits freer transmission of nerve impulses across the neuromuscular junction. Pyridostigmine is an analog of neostigmine (Prostigmin TM ), but differs from it in certain clinically significant respects; for example, pyridostigmine is characterized by a longer duration of action and fewer gastrointestinal side effects.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Pyridostigmine Bromide Tablets USP, 60 mg are white, round, flat-faced, beveled edge tablets with a quadrisect functional score on one side and debossed with ‘ANI’ over ‘470’ on the other and are supplied in bottles of 100 (NDC 62559-470-01). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in original container. Keep Pyridostigmine Bromide Tablets USP in a dry place with the silica gel enclosed.
📋 Description ▾
DESCRIPTION Pyridostigmine bromide is an orally active cholinesterase inhibitor. Chemically, pyridostigmine bromide is 3-hydroxy-1-methylpyridinium bromide dimethylcarbamate. Its structural formula is: Each Pyridostigmine Bromide Tablet USP intended for oral administration contains 60 mg of pyridostigmine bromide USP.
In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide and stearic acid. structure
⚠️ Precautions ▾
PRECAUTIONS Pyridostigmine is mainly excreted unchanged by the kidney 6,7,8 . Therefore, lower doses may be required in patients with renal disease, and treatment should be based on titration of drug dosage to effect 6,7 . Pediatric Use Safety and effectiveness in pediatric patients have not been established.
📚 References ▾
REFERENCES 1. Osserman KE, Genkins G. Studies in myasthenia gravis: Reduction in mortality rate after crisis.
JAMA . Jan 1963; 183:97-101. 2.
Osserman KE, Genkins G. Studies in myasthenia gravis. NY State J Med.
June 1961; 61:2076-2085. 3. Grob D.
Myasthenia gravis. A review of pathogenesis and treatment. Arch Intern Med.
Oct 1961; 108:615-638. 4. Schwab RS.
Management of myasthenia gravis. New Eng J Med. Mar 1963; 268:596-597.
5. Schwab RS. Management of myasthenia gravis.
New Eng J Med. Mar 1963; 268:717-719. 6.
Cronnelly R, Stanski DR, Miller RD, Sheiner LB. Pyridostigmine kinetics with and without renal function. Clin Pharmacol Ther.
1980; 28:No. 1, 78-81. 7.
Miller RD. Pharmacodynamics and pharmacokinetics of anticholinesterase. In: Ruegheimer E, Zindler M, ed.
Anaesthesiology. (Hamburg, Germany: Congress; Sep 14-21, 1980; 222-223.) (Int Congr. No.
538), Amsterdam, Netherlands: Excerpta Medica; 1981. 8. Breyer-Pfaff U, Maier U, Brinkmann AM, Schumm F.
Pyridostigmine kinetics in healthy subjects and patients with myasthenia gravis. Clin Pharmacol Ther. 1985;5:495-501.
All brand names listed are the trademarks of their respective owners and are not trademarks of ANI Pharmaceuticals, Inc. Distributed by: ANI Pharmaceuticals, Inc. Baudette, MN 56623 9894 Rev 03/25 ani-logo
📄 Package Label / Principal Display Panel ▾
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Pyridostigmine Bromide Tablets USP, 60 mg NDC 62559- 470 -01 Unit-of-Use CAUTION: Extremely moisture sensitive. Do not remove desiccant. Close tightly. Rx only 100 Tablets 60mg_label