Pyridostigmine Bromide 60 mg/5mL Solution, 473 mL — NDC 69238-1731-2 (Billing 69238-1731-02)
This is a package of 473 mL of Pyridostigmine Bromide 60 mg/5mL Solution from Amneal Pharmaceuticals NY LLC, marketed since Jan 2020 and currently FDA-listed; retail pharmacies pay about $0.5648 per mL (NADAC). It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 69238-1731-2 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 69238 labeler · 1731 product · 2 package
- Package marketed since
- Jan 17, 2020
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Billing quantity
- 473 mL per package
- Barcode (UPC-A, from the NDC)
- 3 6923817312 3
- Medicaid fills, this package
- 1,168 prescriptions in the last four reported quarters
- FDA record last changed
- Oct 8, 2026
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): 004763
- GCN: 18520
- GPI-14 (Medi-Span): 76000050102060
- HICL (First Databank): 001990
- AHFS class code: 12:04.00.00
- RxCUI (RxNorm): 903843
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 8, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Cholinesterase Inhibitor class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 8, 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 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 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 mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.565 | $267.15 / 473 ml |
| Medicaid paysCMS SDUD · 12 mo | $0.9388 | $444.05 / 473 ml |
| Medicare drug plans payPart D · Q2 2026 | $1.24 | $587.28 / 473 ml |
Where does this data come from?
- CMS NADAC weekly file · file of Oct 7, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q4 2025
- 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 |
|---|---|---|---|---|
| 69238-1731-02 You're viewing this Main listing | 473 mL in 1 BOTTLE | 2020-01-17 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Pryidostigmine Bromide 60 mg/5mL 16571-0833-16 | Rising | 473 ml | $0.565 | AA | Availability likely | — |
| Pyridostigmine Bromide 60 mg/5mL 42192-0626-16 | Acella | 473 ml | $0.565 | AA | Availability likely | — |
| Pyridostigmine Bromide 60 mg/5mLthis 69238-1731-02 | Amneal | 473 ml | $0.565 | AA | Availability likely | — |
| Pyridostigmine 60 mg/5mL 70954-0148-10 | Novitium | 473 ml | $0.565 | AA | Availability likely | — |
| Pyridostigmine Bromide 60 mg/5mL 72205-0098-72 | Novadoz | 473 ml | $0.565 | AA | Availability likely | — |
| Mestinon 60 mg/5mL 00187-3012-20 | Bausch | 473 ml | — | AA | FDA listed | — |
| Pryidostigmine Bromide 60 mg/5mL 24689-0104-01 | Apnar | 473 ml | — | AA | FDA listed | — |
| Pyridostigmine Bromide 60 mg/5mL 66689-0406-10 | VistaPharm, | 10 cups | — | AA | FDA listed | — |
| pyridostigmine bromide 60 mg/5mL 68682-0307-05 | Oceanside | 473 ml | — | AA | Discontinued | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Oct 7, 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 Oct 3, 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.
🧪 Avoiding an ingredient? See Pyridostigmine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 3K9958V90M
A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
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UNII H3R47K3TBD
FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
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UNII WZB9127XOA
A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
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UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
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UNII 33X04XA5AT
Lactic acid is a naturally occurring organic acid derived from milk or plant sources. It lowers and maintains pH in formulations, helps preserve the product, and can enhance ingredient stability and absorption.
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UNII OJ245FE5EU
Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
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UNII 506T60A25R
Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
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UNII C151H8M554
A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
9 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 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 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
More NDCs from Amneal Pharmaceuticals NY LLC labeler code 69238
- fluphenazine hydrochloride 2.5 mg Tablet, Film Coated NDC 69238-1679-1
- fluphenazine hydrochloride 5 mg Tablet, Film Coated NDC 69238-1680-1
- fluphenazine hydrochloride 10 mg Tablet, Film Coated NDC 69238-1681-1
- Norethindrone Acetate and Ethinyl Estradiol, and Ferrous Fumarate Kit NDC 69238-1686-3
- Enalapril Maleate 1 mg/mL Solution NDC 69238-1729-7
- Naproxen 25 mg/mL Suspension NDC 69238-1730-2
- Clobetasol Propionate .05 g/100mL Shampoo NDC 69238-1732-8
- Doxepin Hydrochloride 50 mg/g Cream NDC 69238-1733-6
- Pilocarpine Hydrochloride 10 mg/mL Solution/ Drops NDC 69238-1745-8
- Pilocarpine Hydrochloride 20 mg/mL Solution/ Drops NDC 69238-1746-8
- Pilocarpine Hydrochloride 40 mg/mL Solution/ Drops NDC 69238-1747-8
- Abiraterone Acetate 500 mg Tablet NDC 69238-1754-6
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS Pyridostigmine bromide oral solution is useful in the treatment of myasthenia gravis.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Pyridostigmine bromide oral solution is available as follows: Oral Solution- Raspberry-flavored, containing 60 mg pyridostigmine bromide per teaspoonful (5 mL). This form permits accurate dosage adjustment for children and "brittle" myasthenic patients who require fractions of 60 mg doses. It is more easily swallowed, especially in the morning, by patients with bulbar involvement.
Dosage: The size and frequency of the dosage must be adjusted to the needs of the individual patient. Oral Solution - The average dose is ten 5 mL teaspoonfuls daily, spaced to provide maximum relief when maximum strength is needed. In severe cases as many as 25 teaspoonfuls a day may be required, while in mild cases one to six teaspoonfuls 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 is 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™ (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 Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🧬 Clinical Pharmacology ▾
ACTIONS 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™), 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 oral solution, USP 60 mg/5 mL is available as a clear, pink to red colored raspberry flavored solution. It is supplied as follows: One 473 mL bottle: NDC 69238-1731-2 Store pyridostigmine bromide oral solution, USP at 20° to 25°C (68° to 77°F); excursions permitted between 15°to 30°C (59°to 86°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant containers as defined by the USP.
📋 Description ▾
DESCRIPTION Pyridostigmine bromide, USP is an orally active cholinesterase inhibitor. Chemically, pyridostigmine bromide, USP is 3-hydroxy-1-methylpyridinium bromide dimethylcarbamate. Its structural formula is: Pyridostigmine bromide, USP is available as a clear, pink to red colored raspberry flavored oral solution containing 60 mg pyridostigmine bromide, USP per 5 mL (1 teaspoonful) in a vehicle containing 5% alcohol, FD&C Red # 40, FD&C Blue # 1, glycerin, lactic acid, sodium benzoate, sorbitol solution, sucrose, artificial juicy raspberry flavor and purified water.
Structural Formula
⚠️ 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
📚 References ▾
REFERENCES Osserman KE, Genkins G. Studies in myasthenia gravis: Reduction in mortality rate after crisis. JAMA.
Jan 1963; 183:97-101. Osserman KE, Genkins G. Studies in myasthenia gravis.
NY State J Med. June 1961; 61:2076-2085. Grob D.
Myasthenia gravis. A review of pathogenesis and treatment. Arch Intern Med.
Oct 1961; 108:615-638. Schwab RS. Management of myasthenia gravis.
New Eng J Med . Mar 1963; 268:596-597. Schwab RS.
Management of myasthenia gravis. New Eng J Med . Mar 1963; 268:717-719.
Cronnelly R, Stanski DR, Miller RD, Sheiner LB. Pyridostigmine kinetics with and without renal function. Clin Pharmacol Ther.
1980; 28:No. 1, 78-81. 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.
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. Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 04-2019-00
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL Bottle Label