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Pryidostigmine Bromide Pyridostigmine 60 mg/5mL Solution, 473 mL — NDC 16571-0833-16 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Pryidostigmine Bromide Pyridostigmine 60 mg/5mL Solution, 473 mL — NDC 16571-833-16 (Billing 16571-0833-16)

by Rising Pharma Holdings, Inc. · 473 mL in 1 BOTTLE, PLASTIC

This is a package of 473 mL of Pryidostigmine Bromide Pyridostigmine 60 mg/5mL Solution from Rising Pharma Holdings, Inc., marketed since Sep 2022 and currently FDA-listed; retail pharmacies pay about $0.5648 per mL (NADAC). It is this product's only package size.

NDC 16571-0833-16
🏷️ FDA NDC (as labeled) 16571-833-16 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 16571-833-16
Product NDC 16571-833
11-digit billing NDC 16571083316
NCPDP billing unit ML — per mL (volume)
RxCUI 903843
UNII KVI301NA53
UPC 0316571833160
Application # ANDA208797
SPL Set ID beda905e-005a-439d-ac74-92db4e269780
Established class (EPC) Cholinesterase Inhibitor
Mechanism of action Cholinesterase Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-09-15
Route ORAL
Dosage form SOLUTION
Substance PYRIDOSTIGMINE BROMIDE
TE code (Orange Book) AA · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 76000050102060
GCN Seq No 004763
GCN 18520
HICL code 001990
Ingredient (HICL) Pyridostigmine Bromide
HIC1 code J
Therapeutic class — broad (HIC1) Autonomic Nervous System
HIC2 code J1
Therapeutic class — intermediate (HIC2) Cholinergics
HIC3 code J1B
Therapeutic class — specific (HIC3) Cholinesterase Inhibitors
AHFS code 12:04.00.00
AHFS class Parasympathomimetic (Cholinergic Agents)
FDB label name PYRIDOSTIGMINE 60 MG/5 ML SOLN
FDB brand name Pyridostigmine Bromide
Legend status F — Federal legend — prescription drug or device
Quick answers
  • 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
Why two NDCs? The FDA registers this code as 16571-833-16 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 16571-0833-16. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Cholinesterase Inhibitor class.

Pharmacologic class Cholinesterase Inhibitor
Drug family (ATC) Anticholinesterases
How it works Cholinesterase Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name PYRIDOSTIGMINE 60 MG/5 ML SOLN Ingredient Pyridostigmine Bromide
📖 What it is MedlinePlus · NLM

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 ↗
📗 Our plain-language guide HelloPharmacist
  • 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.
📖 Read our full Pyridostigmine guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 systemPer mLPer package
Retail pharmacies payNADAC · weekly $0.565 $267.15 / 473 ml
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per mL) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $0.610 $0.457
▼ Down 4% over the last 10 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
16571-0833-16 You're viewing this Main listing 473 mL in 1 BOTTLE, PLASTIC 2022-09-15 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Pryidostigmine Bromide 60 mg/5mLthis 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/5mL 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 —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2022
On the market since
Sep 2022
📍
2026
Currently FDA-listed
4 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color purple
FlavorRaspberry
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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.

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • UNII 4N14V5R27W
    A natural flavoring derived from raspberry fruit that gives medicines a pleasant taste. It helps mask bitter or unpleasant flavors to make medications easier to swallow.
  • 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.
  • 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.
  • 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.
  • 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.

10 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerRising Pharma Holdings, Inc.
Application holderRISING PHARMA HOLDING INC
FDA applicationANDA208797 (ANDA)
Labeler code16571
First marketedSep 2022
Product typeHuman Prescription Drug
Portfolio525 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📚 References 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 14 words ▾

INDICATION Pyridostigmine bromide oral solution USP is useful in the treatment of myasthenia gravis.

⏱️ Dosage and Administration 150 words ▾

Dosage and Administration Pyridostigmine bromide oral solution is available in the following dosage form: 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 TM (edrophonium chloride).

⛔ Contraindications 43 words ▾

Contraindications Pyridostigmine bromide oral solution 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 ~1 min read ▾

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 oral solution 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 oral solution 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 oral solution during pregnancy or lactation in humans has not been established. Therefore, use of pyridostigmine bromide oral solution in women who may become pregnant requires weighing the drug's potential benefits against its possible hazards to mother and child.

🤒 Adverse Reactions 128 words ▾

Adverse Reactions The side effects of pyridostigmine bromide oral solution 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 Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🧬 Mechanism of Action 58 words ▾

ACTIONS Pyridostigmine bromide oral solution 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 (Prostigmine 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 47 words ▾

How Supplied Oral Solution, 60 mg pyridostigmine bromide per teaspoonful (5 mL) and 5% alcohol — bottles of 16 fluid ounces (1 pint) (NDC 16571-833-16). Store pyridostigmine bromide oral solution USP at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). Brands mentioned are trademarks of their respective owners.

📋 Description 69 words ▾

Description Pyridostigmine bromide oral solution USP is an orally active cholinesterase inhibitor. Chemically, pyridostigmine bromide is 3-hydroxy-1-methylpyridinium bromide dimethylcarbamate. Its structural formula is: Pyridostigmine bromide oral solution USP is available in the following form: Oral Solution containing 60 mg pyridostigmine bromide per teaspoonful in a vehicle containing 5% alcohol, glycerin, lactic acid, sodium benzoate, sorbitol, sucrose, FD&C Red No.

40, FD&C Blue No. 1, raspberry flavor and water. structure

⚠️ Precautions 46 words ▾

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 178 words ▾

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 patho-genesis 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.

Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Iss. 03/2022

📄 Package Label / Principal Display Panel 6 words ▾

Pyridostigmine Bromide Syrup 60mg/5mL Bottle pyridostigmine-label01

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Pyridostigmine Bromide (matched by generic name) — the program that covers self-administered drugs. 9 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Pyridostigmine Bromide. CMS lists 4 products for this generic; we show the highest-spend one. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$5.53M
Claims incl. refills
71.4K
Beneficiaries
45.1K
Spend / beneficiary
$122.42
Spend / claim
$77.39
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for PRYIDOSTIGMINE BROMIDE (this brand).

Top reported reactions

Myasthenia Gravis186
Fatigue158
Dyspnoea140
Asthenia117
Headache108
Diarrhoea105
Malaise89

Age at onset

Neonate3
Infant1
Child2
Adolescent4
Adult127
Elderly133

Reporter sex

0 reports

Serious outcomes

Hospitalization622
Death173
Life-threatening81
Disabling47
Reports over time (by year) — tap or hover for the count & year
2024 2025 2026 240 90
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
← 16571-0832-01 · Rising 16571-0834-01 · Rising →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.