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Pyridostigmine Bromide 60 mg Tablet, 100-count — NDC 68682-0302-10 package photo

Pyridostigmine Bromide 60 mg Tablet, 100-count

by Oceanside Pharmaceuticals · 100 TABLET in 1 BOTTLE (68682-302-10)
NDC 68682-0302-10
🏷️ FDA NDC (as labeled) 68682-302-10 billing pads the product segment with a zero
Rx only Brand 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) 68682-302-10
Product NDC 68682-302
11-digit billing NDC 68682030210
NCPDP billing unit EA — each (per item)
RxCUI 903857
UNII KVI301NA53
UPC 0368682302103
Application # NDA009829
SPL Set ID 7e51c874-78f9-4f95-997a-4d09272a8890
Established class (EPC) Cholinesterase Inhibitor
Mechanism of action Cholinesterase Inhibitors
DEA schedule Non-controlled
Marketing category NDA AUTHORIZED GENERIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2007-10-30
Route ORAL
Dosage form TABLET
Substance PYRIDOSTIGMINE BROMIDE
GPI-14 76000050100305
GPI class Pyridostigmine Bromide
GCN Seq No 004764
GCN 18530
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 BR 60 MG TABLET
FDB brand name Pyridostigmine Bromide
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 68682-302-10 — 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 → 68682-0302-10. 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

LabelerOceanside Pharmaceuticals
Application holderBAUSCH HEALTH US LLC
FDA applicationNDA009829 (NDA AUTHORIZED GENERIC)
Labeler code68682
First marketedOct 2007
Product typeHuman Prescription Drug
Portfolio87 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 BR 60 MG TABLET Ingredient 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?
📖 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.

🧪 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 J2B2A4N98G
    Lactose is a natural sugar derived from milk. In medications, it serves as a filler and binder to add bulk and help hold tablet or capsule ingredients together during manufacturing.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.

3 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 eaPer package
Retail pharmacies payNADAC · weekly $0.197 $19.73 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.3175 $31.75 / 100 tablets
Medicare drug plans payPart D · Q2 2026 $0.3682 $36.82 / 100 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Apr 2022 Sep 2022 Feb 2024 $0.314 $0.197
▼ Down 17% 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Pyridostigmine Bromide 60 mgthis 68682-0302-10 Oceanside 100 tablets $0.197 AB FDA listed
Pyridostigmine Bromide 60 mg 00115-3511-01 Amneal 100 tablets $0.265 AB Availability likely +34%
pyridostigmine bromide 60 mg 00904-6622-61 Major 100 tablets $0.265 AB Availability likely +34%
Pyridostigmine Bromide 60 mg 62559-0470-01 ANI 100 tablets $0.265 Availability likely +34%
Pyridostigmine Bromide 60 mg 68084-0494-01 American 100 tablets $0.265 AB Availability likely +34%
Mestinon 60 mg 00187-3010-30 Bausch 100 tablets AB FDA listed
pyridostigmine bromide 60 mg 51407-0590-30 Golden 30 tablets AB FDA listed
Pyridostigmine Bromide 60 mg 58657-0811-01 Method 100 tablets AB FDA listed
pyridostigmine bromide 60 mg 65841-0819-01 Zydus 100 tablets AB FDA listed
pyridostigmine bromide 60 mg 68382-0659-01 Zydus 100 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

🏛️
2007
On the market since
Oct 2007
📍
2026
Currently FDA-listed
19 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.

🗺️ 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 68682-0302-10, 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 – Q3 2025 · 3 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
107
Units reimbursed last 4 qtrs
15.7K
Gross reimbursed last 4 qtrs
$5K
Avg / prescription
$46.70
Avg / unit
$0.3175
Latest quarter Q3 2025
30Rx
Medicaid pays / ea
$0.3175
gross reimbursed
vs
NADAC / ea
$0.1973
acquisition cost
=
Spread
+$0.1202
+61% 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
100% FFS
Fee-for-service · 107 Rx Managed care · 0 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 15,740 units · 80.4 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: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported 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: no data reported 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: no data reported 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: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
80.480.4
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 New York 80.4 /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

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
68682-0302-10 You're viewing this 100 TABLET in 1 BOTTLE (68682-302-10) 2007-10-30 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.
⏱️ Dosage and Administration 100 words

DOSAGE AND ADMINISTRATION Pyridostigmine Bromide Tablets contain 60 mg pyridostigmine bromide each. Dosage The size and frequency of the dosage must be adjusted to the needs of the individual patient. The average dose is ten 60 mg tablets daily spaced to provide maximum relief when maximum strength is needed.

In severe cases as many as 25 tablets a day may be required, while in mild cases one to six tablets 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 42 words

CONTRAINDICATIONS Pyridostigmine Bromide 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 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 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 Tablets during pregnancy or lactation in humans has not been established. Therefore, use of Pyridostigmine Bromide Tablets in women who may become pregnant requires weighing the drug’s potential benefits against its possible hazards to mother and child.

🤒 Adverse Reactions 125 words

ADVERSE REACTIONS The side effects of Pyridostigmine Bromide 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.

🤰 Pregnancy 45 words

Usage in Pregnancy The safety of Pyridostigmine Bromide Tablets during pregnancy or lactation in humans has not been established. Therefore, use of Pyridostigmine Bromide Tablets in women who may become pregnant requires weighing the drug’s potential benefits against its possible hazards to mother and child.

🧒 Pediatric Use 12 words

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

📦 How Supplied / Storage and Handling 65 words

HOW SUPPLIED Pyridostigmine Bromide Tablets, USP are available containing 60 mg of pyridostigmine bromide each in bottles of 100 (NDC 68682-302-10). Each tablet is cross-scored on one side and engraved "OCEANSIDE 302" on the other side. Store Pyridostigmine Bromide Tablets at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Keep Pyridostigmine Bromide Tablets in a dry place with the silica gel enclosed.

📋 Description 45 words

DESCRIPTION Pyridostigmine Bromide Tablets, USP is an orally active cholinesterase inhibitor. Chemically, pyridostigmine bromide is 3-hydroxy-1-methylpyridinium bromide dimethylcarbamate. Its structural formula is: Pyridostigmine bromide is available as tablets containing 60 mg pyridostigmine bromide; each tablet also contains lactose, silicon dioxide and stearic acid. Chemical Structure

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.