NDC 80425-0370-1 (80425-0370-01) — Zonisamide 100 mg Capsule, 30-count

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 80425-0370-1

Product NDC 80425-0370

11-digit billing NDC 80425037001

NCPDP billing unit EA — each (per item)

RxCUI 314285

UNII 459384H98V

Application # ANDA214492

SPL Set ID 0bc550a7-09a7-75e4-e063-6294a90a9fc1

Established class (EPC) Anti-epileptic Agent

Mechanism of action Carbonic Anhydrase Inhibitors; P-Glycoprotein Inhibitors

Physiologic effect Decreased Central Nervous System Disorganized Electrical Activity

Chemical class Sulfonamides

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2023-12-05

Route ORAL

Dosage form CAPSULE

Substance ZONISAMIDE

TE code (Orange Book) AB · RLD · RS

Quick answers

RxCUI (RxNorm): 314285

Why two NDCs? The FDA registers this code as 80425-0370-1 — 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 → 80425-0370-01. 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.

FDA openFDA NDC Directory · synced Oct 1, 2026
FDA label on DailyMed · label index refreshed Oct 1, 2026
RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
Medi-Span GPI (licensed)
First Databank (licensed) · refreshed Oct 1, 2026

RxNorm drug class

This medicine belongs to the Anti-epileptic Agent class.

Pharmacologic class Anti-epileptic Agent

Drug family (ATC) Other antiepileptics

How it works Carbonic Anhydrase Inhibitors, P-Glycoprotein 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.

RxClass (NLM) · catalog refreshed Oct 1, 2026

Clinical

📗 Our plain-language guide HelloPharmacist

It's added to your other medicines to help control partial seizures. The capsules (Zonegran and generic zonisamide) are for adults with epilepsy. Zonisade liquid is for adults and...
Take it by mouth once or twice a day, with or without food. Swallow capsules whole. If you use Zonisade liquid, shake it well and measure with the device your pharmacist gives you,...
Sleepiness, dizziness, poor balance, loss of appetite, irritability, headache, nausea and trouble with memory or focus are the most common. Many are dose-related, so tell your pres...
Call for any new rash, fever with swollen glands, eye pain or sudden vision changes, or mood changes and thoughts of self-harm. Also call for fast breathing, unusual tiredness, or...

📖 Read our full Zonisamide guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Zonisamide — tap one for details:

Activated CharcoalMajor Coffee CharcoalModerate European MandrakeModerate GlucomannanModerate Guar GumModerate Gum ArabicModerate Slippery ElmModerate TragacanthModerate

🌿 Every supplement checked against Zonisamide (206 interactions) — ranked by severity →

1

Nutrient depletion considerations

Zonisamide may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

VITAMIN K Insignificant Depletion

🧪 Full Zonisamide nutrient depletion report →

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.

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.

MedlinePlus (NLM) · refreshed Oct 1, 2026
FDA label on DailyMed · label index refreshed Oct 1, 2026

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 each	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
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	$0.1678	$5.03 / 30 capsules

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.

CMS NADAC weekly file
CMS ASP pricing files · refreshed Sep 20, 2026
CMS Medicaid State Drug Utilization Data · refreshed Oct 2, 2026
CMS Part D plan pricing files · refreshed Sep 24, 2026
VA National Acquisition Center price file

Packaging — all sizes for this product

Package NDC	Description	Marketing start	Marketing end	Status
80425-0370-01 You're viewing this Main listing	30 CAPSULE in 1 BOTTLE	2023-12-05	—	Active

Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Zonisamide 100 mg 29300-0430-01	Unichem	100 capsules	$0.106	AB	Availability likely	—
Zonisamide 100 mg 50268-0816-15	AvPAK	50 capsules	$0.106	AB	Availability likely	—
Zonisamide 100 mg 59651-0380-01	Aurobindo	100 capsules	$0.106	—	Availability likely	—
Zonisamide 100 mg 60687-0230-01	American	100 capsules	$0.106	AB	Availability likely	—
Zonisamide 100 mg 68001-0244-00	BluePoint	100 capsules	$0.106	AB	Availability likely	—
Zonisamide 100 mg 68462-0130-01	Glenmark	100 capsules	$0.106	AB	Availability likely	—
zonisamide 100 mg 69097-0861-07	Cipla	100 capsules	$0.106	AB	Availability likely	—
Zonisamide 100 mg 72578-0042-01	Viona	100 capsules	$0.106	AB	Availability likely	—
Zonisamide 100 mg 76282-0228-01	Exelan	100 capsules	$0.106	AB	Availability likely	—
zonisamide 100 mg 00615-8266-39	NCS	30 capsules	—	AB	FDA listed	—
Zonegran 100 mg 59212-0680-10	Advanz	100 capsules	—	AB	FDA listed	—
Zonisamide 100 mg 62756-0260-01	Sun	30 capsules	—	—	FDA listed	—
Zonisamide 100 mg 63187-0583-30	Proficient	30 capsules	—	AB	FDA listed	—
Zonisamide 100 mg 63187-0897-30	Proficient	30 capsules	—	—	FDA listed	—
Zonisamide 100 mg 63629-3293-01	Bryant	100 capsules	—	—	FDA listed	—
Zonisamide 100 mg 68788-4004-06	Preferred	60 capsules	—	AB	FDA listed	—
Zonisamide 100 mg 68788-7438-01	Preferred	100 capsules	—	—	FDA listed	—
Zonisamide 100 mg 70518-3224-00	REMEDYREPACK	100 capsules	—	AB	FDA listed	—
Zonisamide 100 mg 70518-3903-00	REMEDYREPACK	100 capsules	—	AB	FDA listed	—
Zonisamide 100 mg 70771-1144-00	Zydus	1000 capsules	—	AB	FDA listed	—
Zonisamide 100 mg 71205-0727-30	Proficient	30 capsules	—	AB	FDA listed	—
zonisamide 100 mg 71335-0486-01	Bryant	100 capsules	—	AB	FDA listed	—
Zonisamide 100 mg 71335-2797-01	Bryant	100 capsules	—	AB	FDA listed	—
Zonisamide 100 mg 71335-9679-01	Bryant	100 capsules	—	AB	FDA listed	—
Zonisamide 100 mgthis 80425-0370-01	Advanced	30 capsules	—	AB	FDA listed	—
Zonisamide 100 mg 80425-0392-01	Advanced	30 capsules	—	AB	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.

FDA openFDA NDC Directory · synced Oct 1, 2026
FDA Orange Book · refreshed Sep 3, 2026
CMS NADAC weekly file

Availability & generic status

🏛️

2023

On the market since

Dec 2023

📍

2026

Currently FDA-listed

3 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.

FDA Orange Book · refreshed Sep 3, 2026

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.

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.

FDA label on DailyMed · label index refreshed Oct 1, 2026
FDA openFDA NDC Directory · synced Oct 1, 2026

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

LabelerAdvanced Rx of Tennessee, LLC

Application holderUNICHEM LABORATORIES LTD

FDA applicationANDA214492 (ANDA)

Labeler code80425

First marketedDec 2023

Product typeHuman Prescription Drug

Portfolio280 products on file

🔎 All NDCs from Advanced Rx of Tennessee, LLC

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.

FDA openFDA NDC Directory · synced Oct 1, 2026
Drugs@FDA

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.

🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Medication Guide ⚠️ Precautions 📄 Package Label / Principal Display Panel

🎯 Indications and Usage 20 words ▾

INDICATIONS AND USAGE Zonisamide Capsules are indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.

⏱️ Dosage and Administration ~2 min read ▾

DOSAGE AND ADMINISTRATION Zonisamide Capsules are recommended as adjunctive therapy for the treatment of partial seizures in adults. Safety and efficacy in pediatric patients below the age of 16 have not been established. Zonisamide Capsules should be administered once or twice daily, using 25 mg, 50 mg or 100 mg capsules.

Zonisamide Capsules are given orally and can be taken with or without food. Capsules should be swallowed whole. Adults over Age 16: The prescriber should be aware that, because of the long half-life of zonisamide, up to two weeks may be required to achieve steady state levels upon reaching a stable dose or following dosage adjustment.

Although the regimen described below is one that has been shown to be tolerated, the prescriber may wish to prolong the duration of treatment at the lower doses in order to fully assess the effects of zonisamide at steady state, noting that many of the side effects of zonisamide are more frequent at doses of 300 mg per day and above. Although there is some evidence of greater response at doses above 100-200 mg/day, the increase appears small and formal dose-response studies have not been conducted. The initial dose of Zonisamide Capsules should be 100 mg daily.

After two weeks, the dose may be increased to 200 mg/day for at least two weeks. It can be increased to 300 mg/day and 400 mg/day, with the dose stable for at least two weeks to achieve steady state at each level. Evidence from controlled trials suggests that Zonisamide Capsules doses of 100–600 mg/day are effective, but there is no suggestion of increasing response above 400 mg/day (see CLINICAL PHARMACOLOGY, Clinical Studies subsection).

There is little experience with doses greater than 600 mg/day. Patients with Renal or Hepatic Disease: Because zonisamide is metabolized in the liver and excreted by the kidneys, patients with renal or hepatic disease should be treated with caution, and might require slower titration and more frequent monitoring (see CLINICAL PHARMACOLOGY and PRECAUTIONS ).

⛔ Contraindications 15 words ▾

CONTRAINDICATIONS Zonisamide Capsules are contraindicated in patients who have demonstrated hypersensitivity to sulfonamides or zonisamide.

⚠️ Warnings ~3 min read ▾

WARNINGS Potentially Fatal Reactions to Sulfonamides: Fatalities have occurred, although rarely, as a result of severe reactions to sulfonamides (zonisamide is a sulfonamide) including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias. Such reactions may occur when a sulfonamide is readministered irrespective of the route of administration. If signs of hypersensitivity or other serious reactions occur, discontinue zonisamide immediately.

Specific experience with sulfonamide-type adverse reaction to zonisamide is described below. Serious Skin Reactions: Consideration should be given to discontinuing Zonisamide Capsules in patients who develop an otherwise unexplained rash. If the drug is not discontinued, patients should be observed frequently.

Seven deaths from severe rash [i.e., Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)] were reported in the first 11 years of marketing in Japan. All of the patients were receiving other drugs in addition to zonisamide. In post-marketing experience from Japan, a total of 49 cases of SJS or TEN have been reported, a reporting rate of 46 per million patient-years of exposure.

Although this rate is greater than background, it is probably an underestimate of the true incidence because of under-reporting. There were no confirmed cases of SJS or TEN in the US, European, or Japanese development programs. In the US and European randomized controlled trials, 6 of 269 (2.2%) zonisamide patients discontinued treatment because of rash compared to none on placebo.

Across all trials during the US and European development, rash that led to discontinuation of zonisamide was reported in 1.4% of patients (12.0 events per 1000 patient-years of exposure). During Japanese development, serious rash or rash that led to study drug discontinuation was reported in 2.0% of patients (27.8 events per 1000 patient-years). Rash usually occurred early in treatment, with 85% reported within 16 weeks in the US and European studies and 90% reported within two weeks in the Japanese studies.

There was no apparent relationship of dose to the occurrence of rash. Serious Hematologic Events: Two confirmed cases of aplastic anemia and one confirmed case of agranulocytosis were reported in the first 11 years of marketing in Japan, rates greater than generally accepted background rates. There were no cases of aplastic anemia and two confirmed cases of agranulocytosis in the US, European, or Japanese development programs.

There is inadequate information to assess the relationship, if any, between dose and duration of treatment and these events. Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multi-Organ Hypersensitivity: Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multi-organ hypersensitivity, has occurred with Zonisamide Capsules. Some of these events have been fatal or life-threatening.

DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy and/or facial swelling, in association with other organ system involvement, such as hepatitis, nephritis, hematologic abnormalities, myocarditis, or myositis, sometimes resembling an acute viral infection. Eosinophilia is often present. This disorder is variable in its expression, and other organ systems not noted here may be involved.

It is important to note that early manifestations of hypersensitivity (e.g., fever, lymphadenopathy) may be present even though rash is not evident. If such signs or symptoms are present, the patient should be evaluated immediately. Zonisamide Capsules should be discontinued if an alternative etiology for the signs or symptoms cannot be established.

Oligohidrosis and Hyperthermia in Pediatric Patients: Oligohidrosis, sometimes resulting in heat stroke and hospitalization, is seen in association with zonisamide in pediatric patients. During the pre-approval development program… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

ADVERSE REACTIONS The most common adverse reactions with Zonisamide Capsules (an incidence at least 4% greater than placebo) in controlled clinical trials and shown in descending order of frequency were somnolence, anorexia, dizziness, ataxia, agitation/irritability, and difficulty with memory and/or concentration. In controlled clinical trials, 12% of patients receiving Zonisamide Capsules as adjunctive therapy discontinued due to an adverse reaction compared to 6% receiving placebo. Approximately 21% of the 1,336 patients with epilepsy who received Zonisamide Capsules in clinical studies discontinued treatment because of an adverse reaction.

The most common adverse reactions leading to discontinuation were somnolence, fatigue and/or ataxia (6%), anorexia (3%), difficulty concentrating (2%), difficulty with memory, mental slowing, nausea/vomiting (2%), and weight loss (1%). Many of these adverse reactions were dose-related (see WARNINGS and PRECAUTIONS ). Adverse Reaction Incidence in Controlled Clinical Trials: Table 4 lists adverse reactions that occurred in at least 2% of patients treated with Zonisamide Capsules in controlled clinical trials that were numerically more common in the Zonisamide Capsules group.

In these studies, either Zonisamide Capsules or placebo was added to the patient's current AED therapy. Table 4. Adverse Reactions in Placebo-Controlled, Add-On Trials (Events that occurred in at least 2% of Zonisamide Capsules-treated patients and occurred more frequently in Zonisamide Capsules-treated than placebo-treated patients) BODY SYSTEM/PREFERRED TERM Zonisamide Capsules (n=269) % PLACEBO (n=230) % BODY AS A WHOLE Headache 10 8 Abdominal Pain 6 3 Flu Syndrome 4 3 DIGESTIVE Anorexia 13 6 Nausea 9 6 Diarrhea 5 2 Dyspepsia 3 1 Constipation 2 1 Dry Mouth 2 1 HEMATOLOGIS AND LYMPHATIC Ecchymosis 2 1 METABOLIC AND NUTRITIONAL Weight Loss 3 2 NERVOUS SYSTEM Dizziness 13 7 Ataxia 6 1 Nystagmus 4 2 Paresthesia 4 1 NEUROPSYCHIATRIC AND COGNITIVE DYSFUNCTION-ALTERED COGNITIVE FUNCTION Confusion 6 3 Difficulty Concentrating 6 2 Difficulty with Memory 6 2 Mental Slowing 4 2 NEUROPSYCHIATRIC AND COGNITIVE DYSFUNCTION-BEHAVIORAL ABNORMALITIES(NON-PSYCHOSIS-RELATED) Agitation/Irritability 9 4 Depression 6 3 Insomnia 6 3 Anxiety 3 2 Nervousness 2 1 NEUROPSYCHIATRIC AND COGNITIVE DYSFUNCTION-BEHAVIORAL ABNORMALITIES (PSYCHOSIS-RELATED) Schizophrenic/Schizophreniform Behavior 2 0 NEUROPSYCHIATRIC AND COGNITIVE DYSFUNCTION-CNS DEPRESSION Somnolence 17 7 Fatigue 8 6 Tiredness 7 5 NEUROPSYCHIATRIC AND COGNITIVE DYSFUNCTION-SPEECH AND LANGUAGE ABNORMALITIES Speech Abnormalities 5 2 Difficulties in Verbal Expression 2 <1 RESPIRATORY Rhinitis 2 1 SKIN AND APPENDAGES Rash 3 2 SPECIAL SENSES Diplopia 6 3 Taste Perversion 2 0 Other Adverse Reactions in Clinical Trials: Zonisamide Capsules have been administered to 1,598 individuals during all clinical trials, only some of which were placebo-controlled.

The frequencies represent the proportion of the 1,598 individuals exposed to Zonisamide Capsules who experienced an event on at least one occasion. All events are included except those already listed in the previous table or discussed in WARNINGS or PRECAUTIONS , trivial events, those too general to be informative, and those not reasonably associated with Zonisamide Capsules. Events are further classified within each category and listed in order of decreasing frequency as follows: frequent occurring in at least 1:100 patients; infrequent occurring in 1:100 to 1:1000 patients; rare occurring in fewer than 1:1000 patients.

Body as a Whole : Frequent: Accidental injury, asthenia. Infrequent: Chest pain, flank pain, malaise, allergic reaction, face edema, neck rigidity. Rare: Lupus erythematosus.

Cardiovascular : Infrequent: Palpitation, tachycardia, vascular insufficiency, hypotension, hypertension, thrombophlebitis, syncope, bradycardia. Rare: Atrial fibrillation, heart failure, pulmonary embolus, ventricular extrasystoles. Digestive : Freq… [Excerpted — this section continues on DailyMed.]

🆘 Overdosage 177 words ▾

OVERDOSAGE Human Experience: Experience with Zonisamide Capsules daily doses over 800 mg/day is limited. During Zonisamide Capsules clinical development, three patients ingested unknown amounts of Zonisamide Capsules as suicide attempts, and all three were hospitalized with CNS symptoms. One patient became comatose and developed bradycardia, hypotension, and respiratory depression; the zonisamide plasma level was 100.1 mcg/mL measured 31 hours post-ingestion.

Zonisamide plasma levels fell with a half-life of 57 hours, and the patient became alert five days later. Management: No specific antidotes for Zonisamide Capsules overdosage are available. Following a suspected recent overdose, emesis should be induced or gastric lavage performed with the usual precautions to protect the airway.

General supportive care is indicated, including frequent monitoring of vital signs and close observation. Zonisamide has a long half-life (see CLINICAL PHARMACOLOGY section). Due to the low protein binding of zonisamide (40%), renal dialysis may be effective.

The effectiveness of renal dialysis as a treatment of overdose has not been formally studied. A poison control center should be contacted for information on the management of Zonisamide Capsules overdosage.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Mechanism of Action: The precise mechanism(s) by which zonisamide exerts its antiseizure effect is unknown. Zonisamide demonstrated anticonvulsant activity in several experimental models. In animals, zonisamide was effective against tonic extension seizures induced by maximal electroshock but ineffective against clonic seizures induced by subcutaneous pentylenetetrazol.

Zonisamide raised the threshold for generalized seizures in the kindled rat model and reduced the duration of cortical focal seizures induced by electrical stimulation of the visual cortex in cats. Furthermore, zonisamide suppressed both interictal spikes and the secondarily generalized seizures produced by cortical application of tungstic acid gel in rats or by cortical freezing in cats. The relevance of these models to human epilepsy is unknown.

Zonisamide may produce these effects through action at sodium and calcium channels. In vitro pharmacological studies suggest that zonisamide blocks sodium channels and reduces voltage-dependent, transient inward currents (T-type Ca 2+ currents), consequently stabilizing neuronal membranes and suppressing neuronal hypersynchronization. In vitro binding studies have demonstrated that zonisamide binds to the GABA/benzodiazepine receptor ionophore complex in an allosteric fashion which does not produce changes in chloride flux.

Other in vitro studies have demonstrated that zonisamide (10–30 mcg/mL) suppresses synaptically- driven electrical activity without affecting postsynaptic GABA or glutamate responses (cultured mouse spinal cord neurons) or neuronal or glial uptake of [ 3 H]-GABA (rat hippocampal slices). Thus, zonisamide does not appear to potentiate the synaptic activity of GABA. In vivo microdialysis studies demonstrated that zonisamide facilitates both dopaminergic and serotonergic neurotransmission.

Zonisamide is a carbonic anhydrase inhibitor. The contribution of this pharmacological action to the therapeutic effects of zonisamide is unknown. However, as a carbonic anhydrase inhibitor, zonisamide may cause metabolic acidosis (see WARNINGS, Metabolic Acidosis subsection).

Pharmacokinetics: Absorption Following a 200-400 mg oral zonisamide dose, peak plasma concentrations (range: 2-5 mcg/mL) in normal volunteers occur within 2-6 hours. In the presence of food, the time to maximum concentration is delayed; occurring at 4-6 hours, but food has no effect on the bioavailability of zonisamide. Zonisamide absorption is dose-proportional in the range of 200-400 mg.

Cmax and AUC, however, increase disproportionately at 800 mg, possibly due to saturable binding of zonisamide to red blood cells. Once a stable dose is reached, steady state is achieved within 14 days. Distribution The apparent volume of distribution (V/F) of zonisamide is about

1.45L/kg following a 400 mg oral dose. Zonisamide, at concentrations of 1.0-7.0 mcg/mL, is approximately 40% bound to human plasma proteins. Zonisamide extensively binds to erythrocytes, resulting in an eight-fold higher concentration of zonisamide in red blood cells than in plasma.

Protein binding of zonisamide is unaffected in the presence of therapeutic concentrations of phenytoin, phenobarbital or carbamazepine. Metabolism and Elimination Following oral administration of 14 C-zonisamide to healthy volunteers, only zonisamide was detected in plasma. Zonisamide is excreted primarily in urine as parent drug and as the glucuronide of a metabolite.

Following multiple dosing, 62% of the radiolabeled dose was recovered in the urine, with 3% in the feces by day 10. Zonisamide undergoes acetylation by N-acetyl-transferases to form N-acetyl zonisamide and reduction to form the open ring metabolite, 2–sulfamoylacetyl phenol (SMAP). Of the excreted dose, 35% was recovered as zonisamide, 15% as N-acetyl zonisamide, and 50% as the glucuronide of SMAP.

Reduction of zonisamide to SMAP is mediated by cytochrome P450 isozyme 3A4 (CYP3A4). Zonisamide does not induce its own m… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 121 words ▾

HOW SUPPLIED Zonisamide Capsules USP, for oral administration, are available as 100 mg Hard gelatin capsules of size "1" with light red opaque cap and white to off white opaque body imprinted "Ú" on cap and "430" on body with black ink, containing white to off white granular powder and supplied as: Bottles of 30 Capsules NDC: 80425-0370-01 Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature], in a dry place and protected from light. Additional Medication Guide can be obtained by calling Unichem at 1-866-562-4616 Manufactured by UNICHEM LABORATORIES LTD.

Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India. Manufactured for: East Brunswick, NJ 08816 02-R-07/2020 Distributed by Advanced Rx Pharmacy of Tennessee, LLC Image

📋 Description 155 words ▾

DESCRIPTION Zonisamide Capsules USP, are an antiseizure drug chemically classified as a sulfonamide and unrelated to other antiseizure agents. The active ingredient is zonisamide, 1,2 -benzisoxazole-3-methanesulfonamide. The empirical formula is C 8 H 8 N 2 O 3 S with a molecular weight of 212.23.

Zonisamide is a white to off white powder, pKa = 10.6, and is freely soluble in dimethyl formamide, soluble in methanol. The chemical structure is: Zonisamide Capsules USP, are supplied for oral administration as capsules containing 25 mg, 50 mg or 100 mg zonisamide. Each capsule contains the labeled amount of zonisamide plus the following inactive ingredients: hydrogenated vegetable oil, microcrystalline cellulose, colloidal silicon dioxide, sodium lauryl sulfate, gelatin and titanium dioxide.

Additionally the 50 mg contains D&C Red No. 28 and FD&C Blue No. 1 and the 100 mg contains FD&C Red No.

40. The black imprinting ink contains shellac, propylene glycol, black iron oxide and potassium hydroxide. Image

💬 Medication Guide ~3 min read ▾

SPL MEDGUIDE MEDICATION GUIDE Zonisamide (zoe nis' a mide) Capsules What is the most important information I should know about Zonisamide Capsules? Zonisamide Capsules may cause serious side effects, including: Serious skin rash that can cause death. Serious allergic reactions that may affect different parts of the body.

Less sweating and increase in your body temperature (fever). Serious eye problems Suicidal thoughts or actions in some people. Increased level of acid in your blood (metabolic acidosis).

Problems with your concentration, attention, memory, thinking, speech, or language. Blood cell changes such as reduced red and white blood cell counts. These serious side effects are described below.

1. Zonisamide Capsules may cause a serious skin rash that can cause death. These serious skin reactions are more likely to happen when you begin taking zonisamide within the first 4 months of treatment but may occur at later times.

2. Zonisamide Capsules can cause other types of allergic reactions or serious problems that may affect different parts of the body such as your liver, kidneys, heart, or blood cells. You may or may not have a rash with these types of reactions.

These reactions can be very serious and can cause death. Call your health care provider right away if you have: fever severe muscle pain rash swollen lymph glands swelling of your face unusual bruising or bleeding weakness, fatigue yellowing of your skin or the white part of your eyes 3. Zonisamide Capsules may cause you to sweat less and to increase your body temperature (fever).

You may need to be hospitalized for this. You should watch for decreased sweating and fever, especially when it is hot and especially in children taking Zonisamide Capsules. Call your health care provider right away if you have: high fever, recurring fever, or long lasting fever less sweat than normal 4.

Zonisamide Capsules may cause eye problems. Serious eye problems include: sudden decrease in vision with or without eye pain and redness a blockage of fluid in the eye causing increased pressure in the eye (secondary angle closure glaucoma) These eye problems can lead to permanent loss of vision if not treated. Call your healthcare provider right away if you have any new eye symptoms, including any eye pain or redness or any new problems with your vision.

5. Like other antiepileptic drugs, Zonisamide Capsules may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying attempt to commit suicide new or worse depression new or worse anxiety feeling agitated or restless panic attacks trouble sleeping (insomnia) new or worse irritability acting aggressive, being angry, or violent acting on dangerous impulses an extreme increase in activity and talking (mania) other unusual changes in behavior or mood Suicidal thoughts or actions can be caused by things other than medicines.

If you have suicidal thoughts or actions, your healthcare provider may check for other causes. How can I watch for early symptoms of suicidal thoughts and actions? Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.

Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you are worried about symptoms. Do not stop Zonisamide Capsules without first talking to a healthcare provider.

Stopping Zonisamide Capsules suddenly can cause serious problems. Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus). 6.

Zonisamide Capsules can increase the level of acid in your blood (metabolic acidosis). If left untreated, metabolic acidosis can cause brittle or soft bones (osteoporosis, osteomalacia, osteopenia), kidney stones and can slow the rate of growth… [Excerpted — this section continues on DailyMed.]

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General: Somnolence is commonly reported, especially at higher doses of Zonisamide Capsules (see WARNINGS: Cognitive/ Neuropsychiatric Adverse Events subsection). Zonisamide is metabolized by the liver and eliminated by the kidneys; caution should therefore be exercised when administering Zonisamide Capsules to patients with hepatic and renal dysfunction (see CLINICAL PHARMACOLOGY, Specific Populations subsection). Kidney Stones: Among 991 patients treated during the development of Zonisamide Capsules, 40 patients (4.0%) with epilepsy receiving Zonisamide Capsules developed clinically possible or confirmed kidney stones (e.g., clinical symptomatology, sonography, etc.), a rate of 34 per 1000 patient-years of exposure (40 patients with 1168 years of exposure).

Of these, 12 were symptomatic, and 28 were described as possible kidney stones based on sonographic detection. In nine patients, the diagnosis was confirmed by a passage of a stone or by a definitive sonographic finding. The rate of occurrence of kidney stones was 28.7 per 1000 patient-years of exposure in the first six months, 62.6 per 1000 patient-years of exposure between 6 and 12 months, and 24.3 per 1000 patient-years of exposure after 12 months of use.

There are no normative sonographic data available for either the general population or patients with epilepsy. Although the clinical significance of the sonographic findings may not be certain, the development of nephrolithiasis may be related to metabolic acidosis (see WARNINGS, Metabolic Acidosis subsection). The analyzed stones were composed of calcium or urate salts.

In general, increasing fluid intake and urine output can help reduce the risk of stone formation, particularly in those with predisposing risk factors. It is unknown, however, whether these measures will reduce the risk of stone formation in patients treated with Zonisamide Capsules. Although not approved in pediatric patients, sonographic findings consistent with nephrolithiasis were also detected in 8 % of a subset of Zonisamide Capsules treated pediatric patients who had at least one renal ultrasound prospectively performed in a clinical development program investigating open-label treatment.

The incidence of kidney stone as an adverse event was 3 % (see WARNINGS, Metabolic Acidosis subsection). Effect on Renal Function: In several clinical studies, zonisamide was associated with a statistically significant 8% mean increase from baseline of serum creatinine and blood urea nitrogen (BUN) compared to essentially no change in the placebo patients. The increase appeared to persist over time but was not progressive; this has been interpreted as an effect on glomerular filtration rate (GFR).

There were no episodes of unexplained acute renal failure in clinical development in the US, Europe, or Japan. The decrease in GFR appeared within the first 4 weeks of treatment. In a 30-day study, the GFR returned to baseline within 2–3 weeks of drug discontinuation.

There is no information about reversibility, after drug discontinuation, of the effects on GFR after long-term use. Zonisamide Capsules should be discontinued in patients who develop acute renal failure or a clinically significant sustained increase in the creatinine/BUN concentration. Zonisamide Capsules should not be used in patients with renal failure (estimated GFR < 50 mL/min) as there has been insufficient experience concerning drug dosing and toxicity.

Status Epilepticus: Estimates of the incidence of treatment emergent status epilepticus in Zonisamide Capsules-treated patients are difficult because a standard definition was not employed. Nonetheless, in controlled trials, 1.1% of patients treated with Zonisamide Capsules had an event labeled as status epilepticus compared to none of the patients treated with placebo. Among patients treated with Zonisamide Capsules across all epilepsy studies (controlled and uncontrolled), 1.0% of patients had an event reported as status epilepticus.… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 8 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Zonisamide 100mg Capsules #30

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.

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

in vivo: In a living person or animal rather than in a laboratory dish.

serotonergic: Acting on serotonin, a chemical messenger involved in mood, sleep, and digestion.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

Active ingredient: The part of a medicine that produces its intended effect on the body.

adjunctive therapy: A medicine added alongside a main treatment to help it work better.

adverse event: Any unwanted medical problem that happens during treatment, whether or not the medicine actually caused it.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

agitation: A state of feeling restless and upset and being unable to relax, sometimes with pacing or fidgeting.

agranulocytosis: A severe drop in a certain type of infection-fighting white blood cell, greatly raising the risk of serious infections.

anemia: A low level of red blood cells or the oxygen-carrying protein inside them, which can cause tiredness, weakness, and paleness.

anorexia: Loss of appetite, or not feeling hungry (on a drug label this means reduced appetite, not the eating disorder).

anxiety: A feeling of worry, nervousness, or unease, sometimes along with a racing heart or restlessness.

aplastic anemia: A serious condition where the bone marrow stops making enough new blood cells.

asthenia: Unusual weakness or lack of physical strength and energy.

ataxia: Loss of muscle coordination that makes walking, balance, and controlled movements clumsy or unsteady.

atrial fibrillation: An irregular, often fast heart rhythm coming from the heart's upper chambers, which can raise the risk of blood clots.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

baseline: A person's starting condition, measured before treatment begins, used to see how much they change later on.

Bioavailability: The share of a dose that actually reaches the bloodstream and is able to have an effect.

bradycardia: A slower-than-normal heart rate, usually under 60 beats per minute.

BUN: Blood urea nitrogen, a waste product measured in a blood test that helps show how well the kidneys are working.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

Cmax: The highest level a medicine reaches in the blood after a dose is taken.

CNS depression: A slowing of brain and nervous-system activity that can cause drowsiness, slowed breathing, or reduced alertness.

constipation: Having bowel movements less often than usual, or passing stools that are hard, dry, and difficult to move.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

CYP3A4: One of the most important liver and gut enzymes, responsible for breaking down a large share of all medicines.

cytochrome P450: A large family of enzymes, mostly in the liver, that break down many medicines so the body can remove them.

depression: A lasting low mood with loss of interest that affects everyday life.

diarrhea: Loose, watery bowel movements that happen more often than normal.

diplopia: Double vision, or seeing two images of a single object.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

dose-response: The relationship between the size of a dose and the strength of the body's reaction to it.

dyspepsia: Discomfort, fullness, or a burning feeling in the upper belly, commonly called indigestion.

ecchymosis: A bruise; a flat blue or purple mark on the skin where blood has leaked underneath.

edema: Swelling caused by extra fluid trapped in the body's tissues.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

emesis: The medical word for vomiting, or bringing up the contents of the stomach through the mouth.

eosinophilia: A higher-than-normal level of eosinophils, a type of white blood cell often linked to allergies or drug reactions.

GFR: A measure (glomerular filtration rate) of how well the kidneys filter the blood; lower numbers mean weaker kidney function.

glaucoma: An eye condition, often linked to high pressure inside the eye, that can slowly damage vision.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

heart failure: A condition in which the heart cannot pump blood as well as it should, causing tiredness, breathlessness, and swelling.

hepatitis: Inflammation of the liver, which can be caused by infections, alcohol, or certain medicines.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

inhibitor: A substance that blocks an enzyme or transporter, which can raise the levels of drugs it normally handles.

insomnia: Trouble falling asleep, staying asleep, or getting restful sleep.

irritability: Getting annoyed, frustrated, or angry more easily than usual.

lymphadenopathy: Swollen or enlarged lymph nodes, often felt as lumps in the neck, armpits, or groin.

malaise: A general feeling of being unwell, uneasy, or low on energy, without one clear symptom.

mania: A period of unusually high energy, racing thoughts, and an excited or irritable mood that is more extreme than normal.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Medication Guide: An FDA-approved handout written for patients that explains important safety information about certain medicines in plain language.

metabolic acidosis: A condition where too much acid builds up in the body's blood and fluids.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

metabolite: A new substance formed when the body breaks a medicine down.

myositis: Swelling and irritation of muscle tissue that can cause pain, tenderness, or weakness.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

nephrolithiasis: Kidney stones; hard mineral deposits that form in the kidneys.

nystagmus: Rapid, involuntary back-and-forth movements of the eyes that a person cannot control.

open-label: A study in which both the patients and their doctors know which treatment each person is receiving.

osteomalacia: Softening of the bones, often from low vitamin D, that can cause bone pain and weakness.

osteopenia: Bones that are thinner and weaker than normal, but not as severe as osteoporosis.

osteoporosis: A condition where bones become thin and weak, making them more likely to break.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

paresthesia: A tingling, prickling, or "pins and needles" feeling in the skin, often in the hands or feet.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

placebo-controlled: Describes a study that compares people taking the real medicine against people taking a dummy pill with no active ingredient.

potentiate: To make the effect of one medicine stronger by taking another substance along with it.

protein binding: How much of a medicine sticks to proteins in the blood instead of moving freely through the body.

psychosis: A state of losing touch with reality, such as seeing or hearing things that are not there or holding false beliefs.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

receptor: A special docking spot on a cell that a medicine or natural body chemical attaches to in order to trigger an effect.

respiratory depression: Breathing that becomes too slow or too shallow to move enough air, so the body may not get enough oxygen.

seizure: A sudden burst of abnormal electrical activity in the brain that can cause shaking, staring, confusion, or loss of awareness.

serum creatinine: A waste product measured in a blood test; higher levels can mean the kidneys are not filtering as well as normal.

somnolence: Feeling very sleepy or drowsy, with trouble staying awake during the day.

statistically significant: A result unlikely to be due to chance alone, suggesting a real difference between the groups being compared.

status epilepticus: A seizure that lasts a long time, or repeated seizures without recovery in between, which is a medical emergency.

steady state: The point where the amount of medicine going in equals the amount leaving, so blood levels stay fairly even.

Stevens-Johnson syndrome: A rare, serious reaction causing painful blistering and peeling of the skin and the moist linings of the mouth, eyes, and other areas.

subcutaneous: An injection placed into the fatty layer just under the skin; often written as subcut or SC.

syncope: The medical term for fainting, a brief loss of consciousness from a temporary drop in blood flow to the brain.

tachycardia: A faster-than-normal heart rate, usually over 100 beats per minute.

titration: Slowly adjusting a medicine's dose up or down in small steps to find the amount that works best with the fewest side effects.

toxic epidermal necrolysis: A rare, life-threatening reaction in which large areas of the top layer of skin blister and peel away, like a severe burn.

volume of distribution: A calculated value showing how widely a medicine spreads into body tissues versus staying in the blood.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

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 Zonisamide — the program that covers self-administered drugs. 8 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 Zonisamide. 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

$3.8M

Claims incl. refills

108.9K

Beneficiaries

58.3K

Spend / beneficiary

$65.25

Spend / claim

$34.92

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 ZONISAMIDE — the ingredient across all brands.

Top reported reactions

Seizure1,194

Fatigue496

Somnolence467

Dizziness397

Nausea383

Fall367

Headache361

Age at onset

Neonate100

Infant74

Child159

Adolescent72

Adult614

Elderly223

Reporter sex

Male · 40%

Female · 60%

Unknown · 0%

Serious outcomes

Hospitalization3,247

Death677

Life-threatening482

Disabling225

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.

FDA Adverse Event Reporting System (FAERS)

About this NDC listing & data coverage

Finished prescription product

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	— Not published for this NDC No photo available yet for this listing.
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)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
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

Why is there no price listed?

The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.

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.

Is this package still being marketed?

Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Advanced Rx of Tennessee, LLC. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

Advanced Rx of Tennessee, LLC 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.

Related NDC lookups

🧪 All Zonisamide NDCsSame ingredient 🏭 All Advanced labeler NDCsLabeler code 80425 📚 All Anti-epileptic Agent NDCsDrug class 📖 Read the Zonisamide drug informationUses, warnings & side effects

Zonisamide 100 mg Capsule, 30-count — NDC 80425-0370-1 (Billing 80425-0370-01)

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

RxNorm drug class

Clinical

Patient education

Supplement & herbal interactions

Pricing

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Therapeutic equivalents

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Inactive Ingredients / Excipients

Inactive ingredient FAQ

Manufacturer & labeler

Full prescribing information FDA SPL

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

Reported adverse events (FAERS)

Top reported reactions

Age at onset

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Serious outcomes

About this NDC listing & data coverage

Questions about this listing

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