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pyridostigmine bromide 180 mg Tablet, Extended Release, 30-count — NDC 68682-0301-30 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

pyridostigmine bromide 180 mg Tablet, Extended Release, 30-count — NDC 68682-301-30 (Billing 68682-0301-30)

by Oceanside Pharmaceuticals · 30 TABLET, EXTENDED RELEASE in 1 BOTTLE

This is a package of 30 tablets of pyridostigmine bromide 180 mg Tablet, Extended Release from Oceanside Pharmaceuticals, no longer marketed (first marketed Jan 1959), no longer in the FDA NDC Directory, this package's marketing ended Sep 2026; retail pharmacies pay about $3.79 per tablet (NADAC). It is this product's only package size.

NDC 68682-0301-30
🏷️ FDA NDC (as labeled) 68682-301-30 billing pads the product segment with a zero
Rx only Brand Discontinued Non-controlled ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 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

NDC database record

One package, one record: these facts belong to NDC 68682-301-30 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
68682 labeler · 301 product · 30 package
Package marketed since
Jan 12, 1959
Package marketing ended
Sep 30, 2026
Sample package
No — commercial package
Billing quantity
30 EA per package
Barcode (UPC-A, from the NDC)
3 6868230130 4
FDA record last changed
Oct 1, 2026
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Sep 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68682-301-30
Product NDC 68682-301
11-digit billing NDC 68682030130
NCPDP billing unit EA — each (per item)
Application # NDA011665
SPL Set ID 7cf12f6c-4c6c-474b-895a-93151d657ca6
Established class (EPC) Cholinesterase Inhibitor
Mechanism of action Cholinesterase Inhibitors
DEA schedule Non-controlled
Marketing category NDA AUTHORIZED GENERIC
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Sep 2026)
Marketing start 1959-01-12
Marketing end 2026-09-30
Route ORAL
Dosage form TABLET, EXTENDED RELEASE
Substance PYRIDOSTIGMINE BROMIDE
TE code (Orange Book) AB · RLD · RS

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

GCN Seq No 004765
GCN 18540
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 ER 180 MG TAB
FDB brand name Pyridostigmine Bromide Er
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 004765
  • GCN: 18540
  • HICL (First Databank): 001990
  • AHFS class code: 12:04.00.00
Why two NDCs? The FDA registers this code as 68682-301-30 — 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 → 68682-0301-30. 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.

Clinical

Label name PYRIDOSTIGMINE ER 180 MG TAB 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 eaPer package
Retail pharmacies payNADAC · weekly $3.789 $113.66 / 30 tablets
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 · Q2 2026 $6.20 $186.11 / 30 tablets
NADAC price history (per ea) — tap or hover for the price & month
Nov 2021 Apr 2022 Sep 2022 Feb 2024 $6.311 $3.789
▼ Down 35% over the last 15 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
68682-0301-30 You're viewing this Main listing 30 TABLET, EXTENDED RELEASE in 1 BOTTLE 1959-01-12 Sep 30, 2026 Discontinued by firm

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
pyridostigmine bromide 180 mgthis 68682-0301-30 Oceanside 30 tablets $3.789 AB Discontinued —
Pyridostigmine Bromide 180 mg 47781-0335-30 Alvogen, 30 tablets $3.996 AB Availability likely +5%
Pyridostigmine Bromide 180 mg 64980-0220-03 Rising 30 tablets $3.996 AB Availability likely +5%
Mestinon 180 mg 00187-3013-30 Bausch 30 tablets — AB FDA listed —
About this product: this is an authorized generic — the brand-name product marketed without its brand name. 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

🏛️
1959
On the market since
Jan 1959
📍
2026
Currently FDA-listed
67 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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.

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.

We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
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.

Manufacturer & labeler

LabelerOceanside Pharmaceuticals
Application holderBAUSCH HEALTH US LLC
FDA applicationNDA011665 (NDA AUTHORIZED GENERIC)
Labeler code68682
First marketedJan 1959
Product typeHuman Prescription Drug
Portfolio87 products on file

More NDCs from Oceanside Pharmaceuticals labeler code 68682

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 🧒 Pediatric Use 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📚 References 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 13 words ▾

INDICATION Pyridostigmine Bromide Extended-release Tablets are useful in the treatment of myasthenia gravis.

⏱️ Dosage and Administration 185 words ▾

DOSAGE AND ADMINISTRATION Pyridostigmine Bromide Extended-release Tablets each contain 180 mg pyridostigmine bromide. 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 180 mg tablets, 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 regular tablets or oral solution in conjunction with 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 Tensilon (edrophonium chloride).

⛔ Contraindications 43 words ▾

CONTRAINDICATIONS Pyridostigmine Bromide Extended-release 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 ~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 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 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 Reactions 126 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 Oceanside Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🧒 Pediatric Use 12 words ▾

Pediatric Use Safety and effectiveness in pediatric patients have not been established.

📦 How Supplied / Storage and Handling 89 words ▾

HOW SUPPLIED Pyridostigmine Bromide Extended-release Tablets are available as light straw-colored, capsule-shaped tablets containing 180 mg pyridostigmine bromide in bottles of 30 (NDC 68682-301-30). Each tablet is engraved “MES V 180” on one side and is single-scored on the other. Note: Because of the hygroscopic nature of the Extended-release Tablets, mottling may occur.

This does not affect their efficacy. Store Pyridostigmine Extended-release Tablets at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Keep Pyridostigmine Bromide Extended-release Tablets in a dry place with the silica gel enclosed.

📋 Description 49 words ▾

DESCRIPTION Pyridostigmine Bromide is an orally active cholinesterase inhibitor. Chemically, pyridostigmine bromide is 3-hydroxy-1-methylpyridinium bromide dimethylcarbamate. Its structural formula is: Pyridostigmine Bromide Extended-release Tablets contain 180 mg pyridostigmine bromide; each tablet also contains carnauba wax, corn-derived proteins, isopropyl alcohol, magnesium stearate, silica gel, tribasic calcium phosphate and water. Structure

⚠️ Precautions 46 words ▾

PRECAUTION 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 202 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 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.

Distributed by: Oceanside Pharmaceuticals, a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA Manufactured by: Bausch Health Companies Inc. Laval, Quebec H7L 4A8, Canada © 2020 Bausch Health Companies Inc. or its affiliates Rev. September 2020 9472403 20001104D

📄 Package Label / Principal Display Panel 40 words ▾

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 180 mg tablets NDC 68682-301-30 Rx only PYRIDOSTIGMINE BROMIDE EXTENDED- RELEASE TABLETS, 180 mg Each extended-release tablet contains 180 mg pyridostigmine bromide in a specially constructed tablet for sustained release 30 Tablets OCEANSIDE PHARMACEUTICALS label

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 — 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.

About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) ✓ Available
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Who lists this product with the FDA?
Oceanside Pharmaceuticals is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 68682-0300-30 · Oceanside 68682-0302-10 · Oceanside →
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.