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Pyridostigmine Bromide 60 mg/5mL Solution, 473 mL — NDC 69238-1731-02 package photo

Pyridostigmine Bromide 60 mg/5mL Solution, 473 mL

by Amneal Pharmaceuticals NY LLC · 473 mL in 1 BOTTLE (69238-1731-2)
NDC 69238-1731-02
🏷️ FDA NDC (as labeled) 69238-1731-2 billing pads the package segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 69238-1731-2
Product NDC 69238-1731
11-digit billing NDC 69238173102
NCPDP billing unit ML — per mL (volume)
RxCUI 903843
UNII KVI301NA53
Application # ANDA212702
SPL Set ID 9c3a5abf-e217-4292-a305-5afd12b99e95
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 2020-01-17
Route ORAL
Dosage form SOLUTION
Substance PYRIDOSTIGMINE BROMIDE
GPI-14 76000050102060
GPI class Pyridostigmine Bromide
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
TE code (Orange Book) AA · RLD · RS
Why two NDCs? The FDA registers this code as 69238-1731-2 — a 5-4-1 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 package segment → 69238-1731-02. 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.

🏭 Manufacturer & labeler

LabelerAmneal Pharmaceuticals NY LLC
Application holderAMNEAL PHARMACEUTICALS LLC
FDA applicationANDA212702 (ANDA)
Labeler code69238
First marketedJan 2020
Product typeHuman Prescription Drug
Portfolio372 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.

🩺 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
  • Think of it as a protective shield you put up before a threat arrives. Pyridostigmine temporarily occupies key spots on an enzyme in your body that soman would otherwise permanentl...
  • What exactly is pyridostigmine supposed to do for me — does it actually stop soman from hurting me?
  • Timing is everything with this medication. It needs to be started at least several hours before any anticipated exposure — not when an alarm goes off. If you take it immediately be...
  • Does it matter when I take it? Can I just take it right before a threat?
📖 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.

💊 What it looks like

Color pink
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 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.

9 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 DailyMedingredient 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.

💲 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 $0.508 $240.28 / 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
NADAC price history (per mL) — tap or hover for the price & month
Dec 2025 Feb 2026 May 2026 Aug 2026 $0.610 $0.457
▼ Down 14% over the last 9 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Pryidostigmine Bromide 60 mg/5mL 16571-0833-16 Rising 473 ml $0.508 AA Availability likely
Pyridostigmine Bromide 60 mg/5mL 42192-0626-16 Acella 473 ml $0.508 AA Availability likely
Pyridostigmine Bromide 60 mg/5mLthis 69238-1731-02 Amneal 473 ml $0.508 AA Availability likely
Pyridostigmine 60 mg/5mL 70954-0148-10 Novitium 473 ml $0.508 AA Availability likely
Pyridostigmine Bromide 60 mg/5mL 72205-0098-72 Novadoz 473 ml $0.508 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 FDA listed
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

🏛️
2020
On the market since
Jan 2020
📍
2026
Currently FDA-listed
6 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 69238-1731-02, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
1.2K
Units reimbursed last 4 qtrs
328.2K
Gross reimbursed last 4 qtrs
$308.1K
Avg / prescription
$263.79
Avg / unit
$0.9388
Latest quarter Q4 2025
265Rx
Medicaid pays / mL
$0.9388
gross reimbursed
vs
NADAC / mL
$0.5080
acquisition cost
=
Spread
+$0.4308
+85% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
23% FFS 77% MCO
Fee-for-service · 270 Rx Managed care · 898 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 21,794 units · 279 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 5,820 units · 101 per 100k residents MN Wisconsin: no data reported WI Michigan: 4,110 units · 40.9 per 100k residents MI New York: 42,837 units · 219 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 3,974 units · 31.7 per 100k residents IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: 48,741 units · 376 per 100k residents PA New Jersey: 10,741 units · 116 per 100k residents NJ Massachusetts: no data reported MA California: 41,579 units · 107 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: 8,121 units · 93.2 per 100k residents VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: 13,380 units · 123 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 81,798 units · 268 per 100k residents TX Florida: 45,318 units · 200 per 100k residents FL
Units reimbursed · per 100k residents
31.7376
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Pennsylvania 376 /100k
2 Washington 279 /100k
3 Texas 268 /100k
4 New York 219 /100k
5 Florida 200 /100k
6 North Carolina 123 /100k
7 New Jersey 116 /100k
8 California 107 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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

Medicare Part D (outpatient prescription) spending for Pyridostigmine Bromide — 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. 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 PYRIDOSTIGMINE BROMIDE — the ingredient across all brands.

Top reported reactions

Myasthenia Gravis1,221
Fatigue915
Asthenia742
Diarrhoea681
Dyspnoea633
Headache620
Nausea587

Age at onset

Neonate14
Infant8
Child20
Adolescent21
Adult736
Elderly718

Reporter sex

10,644 reports
Male · 40%
Female · 60%
Unknown · 0%

Serious outcomes

Hospitalization3,762
Death806
Life-threatening611
Disabling242
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 781 0
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
69238-1731-02 You're viewing this 473 mL in 1 BOTTLE (69238-1731-2) 2020-01-17 Active

📄 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 13 words

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

⏱️ Dosage and Administration 147 words

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 41 words

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 ~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 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 124 words

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 54 words

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 68 words

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 80 words

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

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