Legend statusF — Federal legend — prescription drug or device
TE code (Orange Book)AB · RLD · RS
Why two NDCs?
The FDA registers this code as 47781-335-30 — 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 → 47781-0335-30. 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 classCholinesterase Inhibitor
Drug family (ATC)Anticholinesterases
How it worksCholinesterase 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.
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 ER 180 MG TABIngredient Pyridostigmine Bromide
📗 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?
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.
💬 Questions about Pyridostigmine Bromide?
Ask a licensed pharmacist directly — free, answered by our team.
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.
Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.
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 system
Per ea
Per package
Retail pharmacies payNADAC · weekly
$4.294
$128.83 / 30 tablets
Medicaid paysCMS SDUD · 12 mo
$5.31
$159.38 / 30 tablets
Medicare drug plans payPart D · Q2 2026
$6.20
$186.11 / 30 tablets
NADAC price history (per ea) — tap or hover for the price & month
▼ Down 26% over the last 24 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.
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
🏛️
2015
On the market since
Jun 2015
📍
2026
Currently FDA-listed
11 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 47781-0335-30, 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
1.9K
Units reimbursed last 4 qtrs
104K
Gross reimbursed last 4 qtrs
$552.4K
Avg / prescription
$296.99
Avg / unit
$5.3126
Latest quarter Q4 2025
668Rx
Medicaid pays / ea
$5.3126
gross reimbursed
vs
NADAC / ea
$4.2944
acquisition cost
=
Spread
+$1.0182
+24% vs cost
What Medicaid paid per ea (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 ⓘ
44% FFS56% MCO
Fee-for-service · 813 Rx Managed care · 1,047 Rx
State Medicaid map
Units reimbursed · per 100k residents
5.3111
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
Prescriptions—
Units—
Reimbursed—
🏆 Top states by units · per 100k residents
1New Hampshire111 /100k
2California86.8 /100k
3New York80.0 /100k
4Alabama67.5 /100k
5Maryland58.7 /100k
6Louisiana51.8 /100k
7Pennsylvania44.1 /100k
8North Carolina35.4 /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
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
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 NDC
Description
Marketing start
Status
47781-0335-30 You're viewing this
30 TABLET, EXTENDED RELEASE in 1 BOTTLE (47781-335-30)
2015-06-29
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.
INDICATION Pyridostigmine Bromide Extended-release Tablets is useful in the treatment of myasthenia gravis.
⏱️Dosage and Administration188 words▾
DOSAGE AND ADMINISTRATION Each Pyridostigmine Bromide Extended-release Tablet contains 180 mg pyridostigmine bromide, USP. This form provides uniformly slow release, hence prolonged duration of drug action; it facilitates control of myasthenic symptoms with fewer individual doses daily. The immediate effect of a 180 mg Pyridostigmine Bromide Extended-release Tablet is about equal to that of a 60 mg pyridostigmine bromide tablet; however, its duration of effectiveness, although varying in individual patients, averages 2½ times that of a 60 mg dose.
Dosage The size and frequency of the dosage must be adjusted to the needs of the individual patient. One to three Pyridostigmine Bromide Extended-release Tablets, 180 mg, once or twice daily, will usually be sufficient to control symptoms; however, the needs of certain individuals may vary markedly from this average. The interval between doses should be at least 6 hours.
For optimum control, it may be necessary to use the more rapidly acting tablets or syrup in conjunction with Pyridostigmine Bromide Extended-release Tablets therapy. Note: For information on a diagnostic test for myasthenia gravis, and for the evaluation and stabilization of therapy, please see product literature on edrophonium chloride.
⛔Contraindications43 words▾
CONTRAINDICATIONS Pyridostigmine Bromide Extended-release Tablets 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 Extended-release Tablets 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 Extended-release Tablets 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 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 Extended-release Tablets during pregnancy or lactation in humans has not been established. Therefore, use of Pyridostigmine Bromide Extended-release Tablets in women who may become pregnant requires weighing the drug's potential benefits against its possible hazards to mother and child.
🤒Adverse Reactions127 words▾
ADVERSE REACTIONS The side effects of Pyridostigmine Bromide Extended-release Tablets 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 Alvogen, Inc. at 1-866-770-3024 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🧒Pediatric Use12 words▾
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
📦How Supplied / Storage and Handling104 words▾
HOW SUPPLIED Pyridostigmine Bromide Extended-release Tablets, 180 mg, are supplied in bottles of 30 tablets, NDC 47781-335-30. Pyridostigmine Bromide Extended-release Tablets are available as a cream to yellow, capsule-shaped tablet, containing 180 mg pyridostigmine bromide, USP, debossed “335” on one side and has functional scoring on the other side. Storage Store Pyridostigmine Bromide Extended-release Tablets at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].
Keep Pyridostigmine Bromide Extended-release Tablets in a dry place with the silica gel (desiccant) enclosed. Note: Because of the hygroscopic nature of the Pyridostigmine Bromide Extended-release Tablets, mottling may occur. This does not affect their efficacy.
📦Storage and Handling55 words▾
Storage Store Pyridostigmine Bromide Extended-release Tablets at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature]. Keep Pyridostigmine Bromide Extended-release Tablets in a dry place with the silica gel (desiccant) enclosed. Note: Because of the hygroscopic nature of the Pyridostigmine Bromide Extended-release Tablets, mottling may occur. This does not affect their efficacy.
No label section mentions that — try another word, or open the full label on DailyMed below.
Glossary — plain-language definitions of medical terms used in this label:
contraindicated: Should not be used in that situation, because the risk is considered too high.
Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.
Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.
diaphoresis: Heavy or excessive sweating.
diarrhea: Loose, watery bowel movements that happen more often than normal.
Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.
efficacy: How well a treatment works under the controlled conditions of a clinical study.
extended-release: A pill or capsule made to release its medicine slowly over many hours, so it can be taken less often; often labeled ER or XR.
lactation: The making and release of milk from a mother's breasts after giving birth.
myasthenia gravis: A long-term condition where muscles tire and grow weak easily, often affecting the eyes, face, and swallowing.
NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.
Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.
refractory: Describing a disease that does not respond to, or improve with, treatment.
withdrawal: Uncomfortable physical or mental symptoms that appear when a medicine the body has gotten used to is reduced or stopped.
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.
