EPIVAL 125 MG — DIN 00596418
VALPROIC ACID (DIVALPROEX SODIUM) : 125 MG · BGP PHARMA ULC · TABLET (DELAYED-RELEASE) · wholesale supply in Canada
Health Canada status: MARKETED
What is EPIVAL?
EPIVAL 125 MG contains VALPROIC ACID (DIVALPROEX SODIUM) : 125 MG. It is listed in the Health Canada Drug Product Database under DIN 00596418, held by BGP PHARMA ULC, supplied as TABLET (DELAYED-RELEASE) for ORAL administration. Health Canada currently lists it as marketed, status dated 29-Nov-2016. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.
What is EPIVAL used for?
Sole or adjunctive therapy for simple/complex absence seizures and primary generalized seizures with tonic-clonic manifestations. Treatment of manic episodes associated with bipolar disorder.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
Is there a generic Valproic Acid in Canada, and who makes it?
Every market authorization holder with a Canadian DIN for this molecule, and how many of their listings Health Canada currently shows as marketed.
18 holders have a Canadian DIN containing Valproic Acid, across 70 DINs, of which 17 are currently marketed. Marketed count is the number that matters: an approval that is not marketed cannot be bought.
| Market authorization holder | DINs | Marketed | Brand names | Position |
|---|---|---|---|---|
| APOTEX INC | 10 | 4 | APO-DIVALPROEX, APO-VALPROIC ACID, APO-VALPROIC ACID ORAL SOLUTION, DIVALPROEX, VALPROIC ACID, +1 more | Sourceable in Canada |
| BGP PHARMA ULC | 5 | 4 | DEPAKENE, EPIVAL | Sourceable in Canada |
| MYLAN PHARMACEUTICALS ULC | 7 | 3 | MYL-DIVALPROEX, MYLAN-DIVALPROEX, MYLAN-VALPROIC | Sourceable in Canada |
| JAMP PHARMA CORPORATION | 4 | 3 | JAMP DIVALPROEX, JAMP VALPROIC ACID ORAL SOLUTION | Sourceable in Canada |
| PHARMASCIENCE INC | 6 | 2 | PMS-DIVALPROEX (125MG), PMS-DIVALPROEX (250MG), PMS-DIVALPROEX (500MG), PMS-VALPROIC ACID, PMS-VALPROIC ACID E.C. | Sourceable in Canada |
| ODAN LABORATORIES LTD | 1 | 1 | ODAN-VALPROIC ACID | Sourceable in Canada |
| TEVA CANADA LIMITED | 7 | 0 | NOVO-VALPROIC, RATIO-VALPROIC, TEVA-DIVALPROEX | No marketed DIN |
| DOMINION PHARMACAL | 6 | 0 | DOM-DIVALPROEX, DOM-VALPROIC ACID, DOM-VALPROIC ACID E.C. | No marketed DIN |
| PHARMEL INC | 6 | 0 | PHL-DIVALPROEX, PHL-VALPROIC ACID, PHL-VALPROIC ACID E.C. | No marketed DIN |
| PRO DOC LIMITEE | 4 | 0 | DIVALPROEX-125, DIVALPROEX-250, DIVALPROEX-500, VALPROIC-250 | No marketed DIN |
| RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED | 3 | 0 | RATIO-VALPROIC - ECC 500MG, RATIO-VALPROIC 50MG/ML SYRUP, RATIO-VALPROIC-CAP 250MG | No marketed DIN |
| SANIS HEALTH INC | 3 | 0 | DIVALPROEX | No marketed DIN |
Health Canada’s Drug Product Database does not flag which listing is the originator and which are subsequent-entry products, so Nexara does not label them here. Interchangeability is determined provincially, not federally — confirm for your province before a formulary switch. Nexara can confirm which of these is actually obtainable, and on what lead time, per order.
How is it supplied and stored?
Pack configuration, storage class and the handling constraints that drive cold-chain planning. One DIN can cover more than one pack size, and the pack — not the DIN — is what gets priced, shipped and invoiced.
| Strength on the label | 125 MG |
|---|---|
| Dosage form | TABLET (DELAYED-RELEASE) |
| Route | ORAL |
| Pack configuration (monograph) | 125 mg: Bottles of 100. 250 mg and 500 mg: Bottles of 100 and 500. |
| Storage | Not explicitly detailed in provided text (standard pharmaceutical storage typically applies, but section 11 was not fully provided). |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Valproic Acid |
|---|---|
| ATC code | N03AG01 |
| AHFS class | 28:12.92 |
| Biosimilar biologic | No |
Health Canada record and identifiers
The regulatory facts straight from the Drug Product Database, plus every identifier form Nexara accepts on a purchase order. A DIN written without its leading zeros is the commonest reason an order line fails to match.
| DIN (8-digit, as used in ordering) | 00596418 |
|---|---|
| DIN (unpadded, as printed on some documents) | 596418 |
| Brand name | EPIVAL |
| Generic / active ingredient | VALPROIC ACID (DIVALPROEX SODIUM) : 125 MG |
| Market authorization holder | BGP PHARMA ULC |
| Health Canada schedule | Prescription |
| ATC code | N03AG01 |
| ATC anatomical main group | N — Nervous system |
| ATC therapeutic subgroup | N03AG |
| Current status | MARKETED |
| Status date | 29-Nov-2016 |
| Original market date | 1984-12-31 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
Initial: 15 mg/kg/day, increase by 5-10 mg/kg/day weekly. Max: 60 mg/kg/day. Doses ≥250 mg should be divided. Acute mania: 250 mg TID. Swallow tablets whole; can be taken with food.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Hypersensitivity; Pregnancy (for bipolar; for epilepsy unless no alternative); Women of childbearing potential (unless PPP met); Hepatic disease; Mitochondrial/POLG disorders; Urea cycle disorders.
Warnings and precautions
Serious/fatal hepatotoxicity (especially <2 years); life-threatening pancreatitis; fetal harm/teratogenicity; risk of neurodevelopmental disorders from paternal exposure; mitochondrial disease risk.
What can be used instead?
Alternatives on every axis a buyer actually considers — the same molecule in another presentation, the same class, an adjacent class, or a fixed-dose combination. Every row is led by the marketed DIN count, because that is what can be bought this week.
1 · Same molecule, other Canadian presentations
17 of 70 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| APO-DIVALPROEX | 125 MG | TABLET (DELAYED-RELEASE) | APOTEX INC | MARKETED | 02239698 |
| APO-DIVALPROEX | 500 MG | TABLET (DELAYED-RELEASE) | APOTEX INC | MARKETED | 02239700 |
| APO-DIVALPROEX | 250 MG | TABLET (DELAYED-RELEASE) | APOTEX INC | MARKETED | 02239699 |
| APO-VALPROIC ACID | 250 MG | CAPSULE | APOTEX INC | MARKETED | 02238048 |
| DEPAKENE | 250 MG / 5 ML | SOLUTION | BGP PHARMA ULC | MARKETED | 00443832 |
| EPIVAL | 500 MG | TABLET (DELAYED-RELEASE) | BGP PHARMA ULC | MARKETED | 00596434 |
| EPIVAL | 250 MG | TABLET (DELAYED-RELEASE) | BGP PHARMA ULC | MARKETED | 00596426 |
| JAMP DIVALPROEX | 250 MG | TABLET (DELAYED-RELEASE) | JAMP PHARMA CORPORATION | MARKETED | 02551152 |
| JAMP DIVALPROEX | 500 MG | TABLET (DELAYED-RELEASE) | JAMP PHARMA CORPORATION | MARKETED | 02551160 |
| JAMP VALPROIC ACID ORAL SOLUTION | 250 MG / 5 ML | SOLUTION | JAMP PHARMA CORPORATION | MARKETED | 02532441 |
2 · Same class — other molecules in ATC N03AG
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Valproic Acid | APO-DIVALPROEX · APO-VALPROIC ACID · APO-VALPROIC ACID ORAL SOLUTION · DEPAKENE · +38 more | 70 | 17 | Yes |
| Vigabatrin | SABRIL · SABRIL PWR 1G/SACHET · SABRIL PWR 2G/SACHET · SABRIL PWR 3G/SACHET | 5 | 2 | Yes |
A molecule with zero marketed DINs cannot be sourced domestically, however many approvals it holds — if one of these sits on a formulary or in an older protocol, that is the line to check.
3 · Adjacent classes in ATC N03A
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| N03AX | Brivaracetam · Cannabidiol · Cenobamate · Lacosamide · Lamotrigine · +4 more | 391 | 197 |
| N03AF | Carbamazepine · Eslicarbazepine · Oxcarbazepine · Rufinamide | 86 | 33 |
| N03AA | Phenobarbital · Primidone | 39 | 13 |
| N03AB | Fosphenytoin · Phenytoin · Phenytoin, Combinations | 17 | 8 |
| N03AE | Clonazepam | 55 | 8 |
| N03AD | Ethosuximide · Mesuximide | 5 | 4 |
Not clinical advice. These tables describe what can be supplied in Canada, not what should be prescribed. Substitution within or across classes is a prescriber and pharmacist decision, and interchangeability is determined provincially.
How can I get it?
Nexara Health supplies this product to licensed Canadian buyers — pharmacies, hospitals, clinics, licensed distributors, and clinical trial sponsors or their CROs. We confirm stock, pack size, expiry and pricing at the time of quotation. If the product is on backorder or in shortage, we identify equivalent alternatives and import options where permitted.
Ordering questions
Who can buy this from Nexara?
Licensed entities only. Nexara holds Health Canada establishment licence DEL 3-002896-A and ships only to a licensed address. Patients and unlicensed buyers are routed to a partner pharmacy.
Is there a minimum order?
Yes, set per product line and per pack multiple rather than on the order total, so you are never asked to buy a part-pack. The minimum for this line is confirmed with your quote.
What is the lead time?
Confirmed per order at quotation, and it depends on current stock position and whether the product is in shortage.
Why is there no price on this page?
Nexara quotes a delivered Canadian price per order, against a verified licence. Foreign list prices are published on incompatible bases and are not a guide to what any buyer can obtain here, so this page shows which markets list the molecule and on what basis, and nothing more.
Can Nexara supply this for a clinical trial?
Yes — comparator and background-therapy supply, including sourcing from other markets where a Canadian pack will not satisfy the protocol. Clinical trial supply.