What this pack is
DEPAKOTE is the brand name in this record; divalproex sodium delayed-release tablets is the generic name. Read both together with the dosage form (oral tablet).
PACK CHECK · MARKET FIRST
DEPAKOTEGeneric namedivalproex sodium delayed-release tablets
How this medicine works
Divalproex sodium dissociates to valproate ion in the gastrointestinal tract. Its antiepileptic mechanism is not fully established and is commonly thought to relate to increased brain concentrations of the inhibitory neurotransmitter GABA. Protein binding, age, liver or kidney status and other medicines affect total and unbound drug, so a laboratory number cannot be converted by this site into an individual's tablet count.
Read source: United States ↗Current regulatory record · reviewed 2026-08-29More 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
- DEPAKOTE
- Source-scoped market brand names
- DEPAKOTE · United StatesCurrent regulator record ↗NDA 018723; 125/250/500 mg are prescription RLD products and 500 mg is also the RS; the current label displays three exact 100-tablet bottle panels.
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
- divalproex sodium delayed-release tablets
- Dosage-form class
- Divalproex sodium delayed-release tablets: 125, 250 or 500 mg valproic acid activity per tablet; swallow whole without crushing or chewing; not a DEPAKOTE ER extended-release tablet or DEPAKOTE Sprinkle delayed-release capsule
- Route
- Oral (higher-risk delayed-release tablet exact-product identity field)
- 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.
How to read a score line: ‘scored’ or ‘unscored’ first identifies this labelled presentation. A score line by itself does not permit self-splitting, reducing or changing the product. Only an explicit statement in the current label for this exact presentation, checked with a pharmacist against the prescription, can support any further handling.
3 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 NDA brand label (updated 31 Mar 2026)
Equivalent to valproic acid 125 mg per tablet; 100-tablet bottle
- Product code
- NDC 0074-7325-13
- Form and route
- DEPAKOTE divalproex sodium delayed-release oral tablet · oral (intact delayed-release tablet product-identity field)
- Container
- 100-tablet prescription bottle label panel
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-29; actual marketing, stock and availability are not established.
- divalproex sodium (as valproic acid activity)
- 125 mglabel strength per tablet; not an individual's tablet count, frequency, course, switch or plasma-level conversion
- Package
- 100 tablets per bottle
- Labelled appearance
- salmon pink · oval, unscored delayed-release tablet · imprint NTUnscored; the cited label says to swallow it whole
United States label · Current U.S. DailyMed NDA brand label (updated 31 Mar 2026)
Equivalent to valproic acid 250 mg per tablet; 100-tablet bottle
- Product code
- NDC 0074-7326-13
- Form and route
- DEPAKOTE divalproex sodium delayed-release oral tablet · oral (intact delayed-release tablet product-identity field)
- Container
- 100-tablet prescription bottle label panel
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-29; actual marketing, stock and availability are not established.
- divalproex sodium (as valproic acid activity)
- 250 mglabel strength per tablet; not an individual's tablet count, frequency, course, switch or plasma-level conversion
- Package
- 100 tablets per bottle
- Labelled appearance
- peach · oval, unscored delayed-release tablet · imprint NRUnscored; the cited label says to swallow it whole
United States label · Current U.S. DailyMed NDA brand label (updated 31 Mar 2026)
Equivalent to valproic acid 500 mg per tablet; 100-tablet bottle
- Product code
- NDC 0074-7327-13
- Form and route
- DEPAKOTE divalproex sodium delayed-release oral tablet · oral (intact delayed-release tablet product-identity field)
- Container
- 100-tablet prescription bottle label panel
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-29; actual marketing, stock and availability are not established.
- divalproex sodium (as valproic acid activity)
- 500 mglabel strength per tablet; not an individual's tablet count, frequency, course, switch or plasma-level conversion
- Package
- 100 tablets per bottle
- Labelled appearance
- lavender · oval, unscored delayed-release tablet · imprint NSUnscored; the cited label says to swallow it whole
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
DEPAKOTE label reading: the same mg does not mean the same dosage form
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.
This page covers delayed-release tablets only. The 125, 250 and 500 mg figures are label strengths per tablet expressed as valproic acid activity; all three tablets must be swallowed whole and not crushed or chewed. DEPAKOTE ER is a different extended-release tablet and Sprinkle is a delayed-release capsule that may be sprinkled, so their instructions must not be transferred to this product.
- The mg figure is strength per tablet, not a daily total, plasma concentration or tablet count. A shared 500 mg label does not permit one-for-one self-substitution between DEPAKOTE delayed-release and DEPAKOTE ER extended-release tablets; any formulation or co-medication change requires clinical and valproate-level review.
- DEPAKOTE delayed-release tablets are unscored and the label says to swallow whole. Do not crush, chew or divide one to make ‘half’. A swallowing difficulty requires review of the exact prescription and dosage form, not an unreviewed switch to Sprinkle, ER or a liquid.
- The boxed warning includes potentially fatal hepatotoxicity, fetal risk and pancreatitis. Persistent or severe abdominal pain with nausea or vomiting, marked jaundice or unusual fatigue, or altered awareness needs timely medical assessment; the site does not wait for symptoms to resolve.
- Older adults may be more sensitive to somnolence and may have a higher unbound drug fraction. Excessive sleepiness, reduced food or fluid intake, dehydration, falls, gait or awareness changes require prompt professional review with the complete medicine list; do not stop or sharply reduce treatment yourself.
- Carbapenem antibiotics may markedly reduce valproate concentrations; concomitant topiramate is associated with hyperammonaemia/encephalopathy; lamotrigine, aspirin, anticoagulants and antiplatelets also require item-by-item review. The site does not advise solving these interactions by self-separating times.
- Pregnancy or possible pregnancy carries major fetal risk, while abrupt withdrawal in epilepsy may precipitate status epilepticus. Obtain individual review promptly through the prescribing team or local medical service; the site does not replace contraception, preconception or pregnancy specialist counselling and does not direct abrupt withdrawal.
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 · 2026-08-29
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 · 4
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. DEPAKOTE divalproex sodium delayed-release tablet NDA brand label (updated 31 Mar 2026) ↗Current regulatory record · reviewed 2026-08-29
Other official market or version documents for this record
These are separately reviewed product documents for the same dossier. Their market, date, dosage form and document status must stay attached to each link; they do not establish interchangeability between products, strengths, packs, indications or countries.
- FDA · United States · Regulatory product record or label archive · 2026-08-29FDA Drugs@FDA: current DEPAKOTE NDA 018723 application, RLD and RS records ↗reviewed 2026-08-29
- U.S. National Library of Medicine DailyMed · United States · Public medicine label · 2026-08-29DailyMed (NLM): current U.S. DEPAKOTE ER divalproex sodium extended-release tablet label (used to distinguish dosage forms) ↗Current regulatory record · reviewed 2026-08-29
- U.S. National Library of Medicine DailyMed · United States · Public medicine label · 2026-08-29DailyMed (NLM): current U.S. DEPAKOTE Sprinkle divalproex sodium delayed-release capsule label (used to distinguish dosage forms) ↗Current regulatory record · reviewed 2026-08-29
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 DEPAKOTE (divalproex sodium delayed-release tablets). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
DEPAKOTE is the brand in this record and divalproex sodium delayed-release tablets is the active-ingredient name. Check both with the dosage form (Divalproex sodium delayed-release tablets: 125, 250 or 500 mg valproic acid activity per tablet; swallow whole without crushing or chewing; not a DEPAKOTE ER extended-release tablet or DEPAKOTE Sprinkle delayed-release capsule) 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.
MARKET DOCUMENTS · READ SEPARATELY
Enlarged market leaflets and regulator documents
Each link retains its own market, date, dosage form and document status. These documents support larger-print reading and item-by-item checking; they do not make products, strengths, packs, indications or use between countries or regions interchangeable.
- DailyMed (NLM): current U.S. DEPAKOTE divalproex sodium delayed-release tablet NDA brand label (updated 31 Mar 2026) ↗Current regulatory record · reviewed 2026-08-29
- FDA Drugs@FDA: current DEPAKOTE NDA 018723 application, RLD and RS records ↗reviewed 2026-08-29
- DailyMed (NLM): current U.S. DEPAKOTE ER divalproex sodium extended-release tablet label (used to distinguish dosage forms) ↗Current regulatory record · reviewed 2026-08-29
- DailyMed (NLM): current U.S. DEPAKOTE Sprinkle divalproex sodium delayed-release capsule label (used to distinguish dosage forms) ↗Current regulatory record · reviewed 2026-08-29
HOW IT WORKS · NOT A TREATMENT PLAN
How divalproex works: changing neuronal excitability does not convert symptoms into tablets
- Delayed release, extended release and sprinkle capsules describe release structure and use, not ‘stronger’ or ‘weaker’. Total milligrams alone do not permit self-alternation, combination or substitution.
- A plasma concentration is interpreted with clinical status, sampling time, albumin, liver and kidney function, blood counts and the complete medicine list; in older adults or low-albumin states, total concentration may understate unbound drug.
- Not everyone needs whole-genome screening. Current labelling identifies known POLG-related mitochondrial disease as an important contraindication and advises assessment for urea-cycle disorders in selected histories. Testing decisions belong to the clinical team based on age, history, symptoms and indication.
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. DEPAKOTE divalproex sodium delayed-release tablet NDA brand label (updated 31 Mar 2026) ↗Current regulatory record · reviewed 2026-08-29
- FDA Drugs@FDA: current DEPAKOTE NDA 018723 application, RLD and RS records ↗reviewed 2026-08-29
- DailyMed (NLM): current U.S. DEPAKOTE ER divalproex sodium extended-release tablet label (used to distinguish dosage forms) ↗Current regulatory record · reviewed 2026-08-29
- DailyMed (NLM): current U.S. DEPAKOTE Sprinkle divalproex sodium delayed-release capsule label (used to distinguish dosage forms) ↗Current regulatory record · reviewed 2026-08-29
SOURCE-TRACEABLE ARCHIVE
DEPAKOTEdivalproex sodium delayed-release tablets
This page includes an exact current U.S. public-label package panel for DEPAKOTE, 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
FDA approved DEPAKOTE 250/500 mg
The current Orange Book lists both strengths as RLD products and 500 mg as the RS.
FDA Drugs@FDA: current DEPAKOTE NDA 018723 application, RLD and RS records ↗FDA approved DEPAKOTE 125 mg
The current Orange Book lists the 125 mg delayed-release tablet as an RLD.
FDA Drugs@FDA: current DEPAKOTE NDA 018723 application, RLD and RS records ↗Current DailyMed label updated
The current record displays three exact bottle panels, the Medication Guide, boxed warnings, whole-tablet handling and older-adult somnolence boundaries.
DailyMed (NLM): current U.S. DEPAKOTE divalproex sodium delayed-release tablet NDA brand label (updated 31 Mar 2026) ↗
MARKET SCOPE
Market-record boundary
United States
Current prescription RLD delayed-release tablets; 500 mg is RSThree 100-tablet bottle panels are recorded individually. Regulatory and package records do not establish real-time stock, purchasing eligibility, individual suitability or interchangeability with another valproate formulation.
Mainland China, EU, Japan and other markets
Current market records not establishedNo local approval, dosage form, supply, originator/generic relationship or interchangeability is inferred from a U.S. brand name, shared ingredient or mg figure.
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.
Keep international and mainland China records separate
This page has a U.S. public history/regulatory archive but no mainland China record for this specific product. That does not establish whether the medicine exists, is approved or is available in mainland China. Verify product identity, dosage form, strength, holder and the current label item by item.
RECORD FAQ
Record questions
Are DEPAKOTE 500 mg and DEPAKOTE ER 500 mg the same?
They are not the same dosage form. This page covers delayed-release tablets; ER is a different extended-release tablet. A shared mg strength does not establish the same release profile, frequency or switching method. Do not make a one-for-one switch yourself.
The tablet is large. Can it be halved or crushed?
All three DEPAKOTE delayed-release tablets on this page are unscored, and the current label says to swallow whole and not crush or chew. A swallowing difficulty requires review of the exact prescription and a suitable formulation by a pharmacist or prescriber, not a self-switch to Sprinkle or ER.
Why is whole-genome screening not routine for everyone?
The label focuses on specific high-risk clues such as known POLG-related mitochondrial disease and histories suggestive of a urea-cycle disorder. That does not mean every user needs whole-genome screening. The clinical team determines testing from age, history, indication and symptoms.
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.