What this pack is
DILANTIN is the brand name in this record; extended phenytoin sodium capsules is the generic name. Read both together with the dosage form (multiple oral forms (tablets, oral liquid and chewable tablets)).
PACK CHECK · MARKET FIRST
DILANTINGeneric nameextended phenytoin sodium capsules
How this medicine works
Phenytoin limits repetitive neuronal firing through effects on voltage-dependent sodium channels. Metabolism can become saturated within the therapeutic range, so dose and blood concentration are not simply linear; pack strength, body weight or one level cannot independently generate a personal regimen.
Read source: United States ↗Current regulatory record · reviewed 2026-09-05More about its action and precautions →Check the market, names, dosage form and route together
A medicine may use different brand names across markets. Keep the market, brand, generic name, dosage form and route together; one matching field does not prove that two packs are the same or interchangeable.
Open the complete product-identity record
Use these fields when the pack, market name or package image needs closer checking. They are evidence boundaries, not substitution instructions.
- International brand name
- DILANTIN
- Source-scoped market brand names
- DILANTIN · United StatesCurrent regulator record ↗Current brand label; not proof of live stock, price or individual suitability.
The evidence status and note below apply only to the stated market and source. They do not prove that packs in different markets can be substituted.
- Generic name
- extended phenytoin sodium capsules
- Dosage-form class
- This dossier covers only DILANTIN extended phenytoin sodium capsules. Oral suspension, chewable tablets, prompt-release capsules, fosphenytoin injection and other manufacturers' products are not the same exact product. Formulation or brand changes require professional monitoring and cannot be self-substituted by a shared ingredient or total milligrams.
- Route
- Oral
- Package-image status
- A source-linked public label image is available below
No source-verifiable mainland-China trade-name cue has been established for this record. This does not establish whether the medicine exists, is approved or is available in mainland China. Check pack text and current CDE/NMPA records item by item.
FOR EVERYDAY QUESTIONS
After the leaflet, continue with the question you still need to check
What this page can show
This is a source-traceable public record. It helps you read the product identity and its listed source documents; each market still needs its own current record check.
What to bring to the next conversation
Bring the actual pack, the label or prescription, and a complete medicine list when you speak with a pharmacist or clinician.
NEXT SAFE STEP
Choose the next safe check
A question about changing, combining or splitting?Put the exact packs on one list before a pharmacist or prescriber checks the full context.Open the family medicine list →A question about cost, reimbursement or availability?First lock the market, exact presentation and date. Use local official reimbursement, hospital or pharmacy channels for a current answer rather than a web estimate.Open regulator and market-record entry points →Unsure about a pack or a cross-border product?Photo reading can return possible record matches only. Check the actual product against the current regulator record for its market.Identify pack text locally →Saw a recall, approval or procurement headline?Open the original publisher, then match its product, market and date. Do not make a stop or switch decision from a headline.Read primary-source news →
PRODUCT PRESENTATION IDENTITY
Strength, pack and device identity
Package strength is not an individual dose. These fields help identify the exact labelled product; they do not calculate how much, how often, a missed-use action, splitting, switching or conversion.
2 source-backed strength, pack or device records — open the full list
First match the market, dosage form and labelled amount on the pack in hand. The number of tablets, sachets or devices in a pack is not a personal dose or schedule.
United States label · Current U.S. DailyMed brand label (revised August 2023)
Phenytoin sodium 30 mg per capsule; 100-capsule bottle
- Product code
- NDC 58151-118-01
- Form and route
- DILANTIN extended phenytoin sodium capsule · oral
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-09-05; actual marketing, stock and availability are not established.
- phenytoin sodium
- 30 mglabelled amount per capsule; not an individual's capsule count, frequency, course or switching conversion
- Package
- 100 capsules per bottle
- Labelled appearance
- white opaque body with pale-pink cap · size 4 hard capsule · imprint VLE / DILANTIN 30 mg
United States label · Current U.S. DailyMed brand label (revised August 2023)
Phenytoin sodium 100 mg per capsule; 100-capsule bottle
- Product code
- NDC 58151-110-01
- Form and route
- DILANTIN extended phenytoin sodium capsule · oral
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-09-05; actual marketing, stock and availability are not established.
- phenytoin sodium
- 100 mglabelled amount per capsule; not an individual's capsule count, frequency, course or switching conversion
- Package
- 100 capsules per bottle
- Labelled appearance
- white opaque body with medium-orange cap · size 3 hard capsule · imprint VLE / DILANTIN / 100 mg
PUBLIC LABEL IMAGE
Appearance and package-text clues
This current public-label package panel helps check the brand, generic name, strength and dosage-form clues only. It does not authenticate a product in hand or establish originator status, availability, sale eligibility, another package or another market.
Open the public label source ↗LABEL READING · NOT A PRESCRIPTION
DILANTIN enlarged label: per-capsule amount, no abrupt withdrawal, levels and polypharmacy review
Reading level: drug-specific label reading. This record has been expanded around its dosage form or a higher-risk reading question; the current target-market label and professional review still apply.
The 30 mg or 100 mg figure is the amount per capsule and 100 Capsules is the bottle count. Pack numbers do not determine an individual's capsule count, frequency, course or switching conversion. Abrupt antiepileptic withdrawal may precipitate status epilepticus; changes require professional planning.
- Do not abruptly stop, double after a missed dose, rotate brands or replace extended capsules with another form. Brand or dosage-form changes may alter absorption and require professionally planned phenytoin-level and clinical monitoring.
- Nystagmus, unsteady walking, slurred speech, drowsiness or mental-status change may signal neurologic toxicity. Do not self-adjust from a webpage; contact a healthcare professional promptly.
- Severe rash, blistering, mucosal injury, swelling of the face/lips/tongue/throat, or fever with rash or lymph-node enlargement may involve severe skin reactions, DRESS or angioedema and needs urgent medical assessment.
- Phenytoin has many interactions. Prescriptions, OTC medicines, herbs, supplements, alcohol use and nutrition support should be reviewed together by a doctor or pharmacist; simply spacing doses is insufficient.
- Clearance may decrease in older adults. With renal/hepatic impairment or hypoalbuminemia, total concentration can mislead and a professional may consider unbound phenytoin. Do not self-reduce by age.
- Genetic factors such as CYP2C9 are only part of severe-skin-reaction and metabolism assessment. The label does not support whole-genome screening for everyone, and webpage genetic results must not determine self-dosing.
PHARMACOVIGILANCE · OFFICIAL ROUTES
Check safety information in the right market
Start with the public label or product record linked to this dossier, then use the official safety routes below for the market that applies to the medicine in hand.
Match five details before using a safety record
- Brand and generic nameBoth must match the medicine named by the record.
- Dosage form and strengthTablet, capsule, injection, inhaler, patch and eye drop are not interchangeable.
- Market and notice dateA record applies only to the country or region and date it names.
- Lot, pack and manufacturerRecord these only when the official notice specifically names them.
- Current product informationA historical record may have been superseded by the current label.
This checklist only helps organise the right question. It does not create a personal conclusion about stopping, switching, dose, combination or suitability.
This dossier’s product-level source checkU.S. National Library of Medicine DailyMed · United States · Public medicine label · 2026-09-05
This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk.
Markets actually represented by the reviewed product documents
- United States · 1
This is a document-coverage summary, not a claim that the medicine is authorised, supplied, interchangeable or actively monitored in every listed market today.
This record’s label or product-record routeDailyMed (NLM): current U.S. DILANTIN extended phenytoin sodium capsule brand label (30 mg and 100 mg; revised Aug 2023) ↗Current regulatory record · reviewed 2026-09-05
This is not a conclusion that the medicine has no risk, warning, recall or newer notice in another market. Start with the checked product-level label above, then use the official market gateways below for the product in hand.
See the reviewed safety-record directory →Global official safety gateways
- NMPA Centre for Drug Reevaluation · Mainland ChinaPrimary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item.Drug-vigilance bulletins and safety notices ↗reviewed 2026-08-22
- FDA · United StatesPrimary FDA pages for important new safety issues, labelling changes and risk communications.Drug Safety Communications ↗reviewed 2026-08-22
- FDA MedWatch · United StatesU.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality.Safety information and serious-problem reporting ↗reviewed 2026-08-22
- EMA · European Union / European Economic AreaOfficial EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment.Pharmacovigilance overview and EudraVigilance ↗reviewed 2026-08-22
- MHRA · United KingdomPrimary UK MHRA medicine-safety updates for professionals and the public.Drug Safety Update ↗reviewed 2026-08-22
- PMDA · JapanPMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents.Medicine safety information ↗reviewed 2026-08-22
- MFDS · Republic of KoreaMFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case.Medicine safety letters ↗reviewed 2026-08-22
- HSA · SingaporeHSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information.Adverse-event reporting and medicine-safety information ↗reviewed 2026-08-22
- Health Canada · CanadaHealth Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item.MedEffect Canada: advisories, warnings and recalls ↗reviewed 2026-08-22
- TGA · AustraliaPrimary Australian TGA safety alerts, advisories and monitoring information for therapeutic products.Medicine safety alerts ↗reviewed 2026-08-22
- Swissmedic · SwitzerlandOfficial Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality.Pharmacovigilance and suspected adverse-reaction reporting ↗reviewed 2026-08-22
- Medsafe · New ZealandNew Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information.Medicine safety communications ↗reviewed 2026-08-22
- SAHPRA · South AfricaSAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information.Medicine safety information, alerts and pharmacovigilance ↗reviewed 2026-08-22
- WHO · GlobalWHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market.Medicine and vaccine safety-alert archive ↗reviewed 2026-08-22
- Anvisa · BrazilAnvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item.Pharmacovigilance, alerts and VigiMed ↗reviewed 2026-08-22
This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline.
For severe or rapidly worsening symptoms, suspected overdose, a severe allergic reaction, loss of consciousness or another emergency, use local emergency services. Do not wait for an online alert search or change a medicine from this page.
PRIVATE FAMILY LIST
Bring this record into a local medicine list
Only the brand, generic name, dosage form and route are added, and they stay in this browser. Copy strength, label directions, start/stop history and any concern from the actual pack; this tool does not calculate a dose or decide combination, switching or stopping.
Add to the family medicine list →PACK · LABEL · MEDICINE LIST
Six checks for this medicine pack
Use this card to organise questions about DILANTIN (extended phenytoin sodium capsules). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
DILANTIN is the brand in this record and extended phenytoin sodium capsules is the active-ingredient name. Check both with the dosage form (This dossier covers only DILANTIN extended phenytoin sodium capsules. Oral suspension, chewable tablets, prompt-release capsules, fosphenytoin injection and other manufacturers' products are not the same exact product. Formulation or brand changes require professional monitoring and cannot be self-substituted by a shared ingredient or total milligrams.) and the market on the actual pack.
Read the labelled strength in context
mg, mcg, mg/mL or a percentage describes the labelled amount in one tablet, capsule, measured volume, spray or other unit. It is not an answer to how many units a person should take.
Check before splitting or opening
Before splitting, crushing, chewing or opening anything, find an explicit instruction for this exact product in its current label and ask a pharmacist. A score line or a previous pack is not enough by itself.
Put every product on one list
Include prescriptions, over-the-counter products, eye drops, creams, vitamins, minerals, herbs and supplements. A pharmacist or prescriber needs the whole list before any combination, alternation, switch or stop is considered.
Ask a specific pharmacogenetics question
Ask which medicine, which gene and what clinical decision a result could change. A gene–drug association does not mean broad genetic testing is needed for everyone and must not be used to change treatment without professional review.
Know when to seek urgent help
For a suspected overdose, a severe allergic reaction, fainting or difficulty breathing, use the local emergency or poison-information service now. Do not wait for a website reply or alter several medicines to test what caused it.
This card does not calculate a dose, decide whether medicines can be combined, or replace a clinician or pharmacist. Market-specific current labels and the person's full context still need review.
HOW IT WORKS · NOT A TREATMENT PLAN
Mechanism and concentration: sodium-channel stabilization does not justify self-titration
- A small dose change may cause a disproportionate concentration change; do not treat 30 mg and 100 mg strengths as freely interchangeable building blocks.
- Starting, stopping or changing an interacting medicine can alter phenytoin levels and response; a professional should set review timing.
- Balancing seizure control and toxicity requires the prescription, seizure record, symptoms, laboratory results and exact formulation; mechanism education cannot replace follow-up.
SOURCE EVIDENCE REGISTER
Source evidence map
Every public link is labelled with its market, document status and document type. A historical public record is not a current label, and an official lookup entry is not a product-specific record.
- DailyMed (NLM): current U.S. DILANTIN extended phenytoin sodium capsule brand label (30 mg and 100 mg; revised Aug 2023) ↗Current regulatory record · reviewed 2026-09-05
- FDA: 2021 DILANTIN approved label recording phenytoin's 1953 initial U.S. approval year ↗reviewed 2026-09-05
- FDA: 2007 bioequivalence review identifying DILANTIN 100 mg extended capsules as the reference listed drug (RLD) ↗reviewed 2026-09-05
SOURCE-TRACEABLE ARCHIVE
DILANTINextended phenytoin sodium capsules
This page includes an exact current U.S. public-label package panel for DILANTIN, alongside documentary primary-source material. It helps check product identity, but does not itself establish originator status, product quality, availability or sale eligibility.
DOCUMENT TIMELINE
Document timeline
Initial U.S. approval year for phenytoin
The FDA-approved label states Initial U.S. Approval: 1953.
FDA: 2021 DILANTIN approved label recording phenytoin's 1953 initial U.S. approval year ↗FDA reference-listed-drug review
FDA review material identifies DILANTIN 100 mg extended capsules as the Orange Book RLD and preserves the legacy application-number terminology.
FDA: 2007 bioequivalence review identifying DILANTIN 100 mg extended capsules as the reference listed drug (RLD) ↗Current DailyMed label revision
The label lists 30 mg and 100 mg extended capsules, exact NDCs and package panels.
DailyMed (NLM): current U.S. DILANTIN extended phenytoin sodium capsule brand label (30 mg and 100 mg; revised Aug 2023) ↗
MARKET SCOPE
Market-record boundary
United States
Current public brand labelTwo exact 100-capsule bottles are displayed; not proof of live supply.
Mainland China and other markets
Local approval, brand, reference, pack and supply not yet established market by marketNo other-market status is inferred from the U.S. label or legacy RLD record.
How to read this record
Read each document in its stated market, date and dosage-form context. A historical record is not a current label and does not support individual medical, substitution or purchasing conclusions.
RECORD FAQ
Record questions
Does 100 mg mean one capsule each time?
No. 100 mg is only the amount per capsule; capsule count, frequency and course require the exact prescription, formulation and professional monitoring.
Can phenytoin brands or dosage forms be switched directly?
Do not self-switch. Absorption and release may differ; the label calls for caution and level monitoring with brand or dosage-form changes. Bring both packs or official labels for review.
Is half the dose automatically safer for an older adult?
No. Clearance may decrease with age, but changes require formulation, prescription, seizure status, interactions, liver/kidney function, albumin and level monitoring; do not split or reduce capsules yourself.
READ NEXT
Related reading
Evidence status
The listed links are public sources selected for traceability. They must be rechecked against the current target-market record before any use beyond reading and research.