PHEBURANE 483 MG — DIN 02436663
SODIUM PHENYLBUTYRATE : 483 MG · MEDUNIK CANADA · GRANULES · wholesale supply in Canada
Health Canada status: MARKETED
What is PHEBURANE?
PHEBURANE 483 MG contains SODIUM PHENYLBUTYRATE : 483 MG. It is listed in the Health Canada Drug Product Database under DIN 02436663, held by MEDUNIK CANADA, supplied as GRANULES for ORAL administration. Health Canada currently lists it as marketed, status dated 27-Jan-2015. 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 PHEBURANE used for?
Adjunctive therapy in chronic management of urea cycle disorders (CPS, OTC, or AS deficiencies) in neonatal-onset or late-onset disease. Used with protein restriction and supplements.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How much does Sodium Phenylbutyrate cost around the world?
Sodium Phenylbutyrate is listed on 3 of the national price registers Nexara ingests. Each country publishes on a different basis, so those figures are not comparable with one another — or with a Canadian wholesale price.
What a market publishes matters more than the number it publishes. Australia publishes a ex-manufacturer; Czechia publishes a max producer price (ex-factory); Iceland publishes a max wholesale. Comparing an ex-factory ceiling against a pharmacy public price tells you nothing about either, and comparing either against a Canadian landed cost tells you less.
| Market | Price basis published there | Brands | Packs listed | Range |
|---|---|---|---|---|
| Australia | ex-manufacturer | 1 | 1 | AUD███.██ |
| Czechia | max producer price (ex-factory) | 1 | 1 | CZK███.██ |
| Iceland | max wholesale | 1 | 1 | ISK███.██ |
3 pack listings across 3 brand entries and 3 price bases, refreshed 08 Sep 2026. Ranges span every Sodium Phenylbutyrate pack in that market, so a high figure is usually a larger pack rather than the same product.
Canada publishes no comparable public list price. For a delivered Canadian price on a licensed account, verify your licence — it takes about a minute.
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 | 483 MG |
|---|---|
| Dosage form | GRANULES |
| Route | ORAL |
| Pack configuration (monograph) | Not explicitly detailed in text provided (mentions a calibrated dosing spoon is provided). |
| Storage | Solution (50 mg/ml) for tube administration: Store 2°C to 8°C, protect from light, use within 7 days. (General granule storage not specified in snippet). |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Sodium Phenylbutyrate |
|---|---|
| ATC code | A16AX03 |
| 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) | 02436663 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2436663 |
| Brand name | PHEBURANE |
| Generic / active ingredient | SODIUM PHENYLBUTYRATE : 483 MG |
| Market authorization holder | MEDUNIK CANADA |
| Health Canada schedule | Prescription |
| ATC code | A16AX03 |
| ATC anatomical main group | A — Alimentary tract and metabolism |
| ATC therapeutic subgroup | A16AX |
| Current status | MARKETED |
| Status date | 27-Jan-2015 |
| Original market date | 2015-01-27 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
Individualized based on protein tolerance. Neonates/children <20kg: 450-600 mg/kg/day. >20kg/Adults: 9.9-13.0 g/m2/day. Divide into equal amounts with each meal (4-6 times/day in small children).
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Hypersensitivity to sodium phenylbutyrate or ingredients; Pregnancy; Breastfeeding.
Warnings and precautions
Not for acute hyperammonemia. High sodium content (caution in CHF/renal failure). Contains sucrose (caution in diabetes/fructose intolerance). Neurotoxicity risk from metabolite phenylacetate.
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.
2 · Same class — other molecules in ATC A16AX
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Nitisinone | MDK-NITISINONE · NITISINONE TABLETS · ORFADIN | 12 | 8 | Yes |
| Sapropterin | KUVAN · REDDY-SAPROPTERIN · TEVA-SAPROPTERIN | 7 | 5 | Yes |
| Miglustat | OPFOLDA · SANDOZ MIGLUSTAT · ZAVESCA | 3 | 3 | Yes |
| Trientine | MAR-TRIENTINE · WAYMADE-TRIENTINE | 2 | 2 | Yes |
| Anethole Trithione | SIALOR · SIALOR TAB 25MG · SULFARLEM TAB 12.5MG | 3 | 1 | Yes |
| Migalastat | GALAFOLD | 1 | 1 | Yes |
| Lumasiran | OXLUMO | 1 | 1 | Yes |
| Glycerol Phenylbutyrate | RAVICTI | 1 | 1 | Yes |
| Givosiran | GIVLAARI | 1 | 1 | Yes |
| Sodium Phenylbutyrate | PHEBURANE | 1 | 1 | 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 A16A
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| A16AB | Agalsidase Alfa · Agalsidase Beta · Alglucosidase Alfa · Asfotase Alfa · Avalglucosidase Alfa · +12 more | 26 | 22 |
| A16AA | Betaine · Carglumic Acid · Levocarnitine · Mercaptamine · Metreleptin | 11 | 11 |
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.
What else is PHEBURANE called?
The same molecule, Sodium Phenylbutyrate, is registered under other names elsewhere. Buyers and prescribers searching from outside Canada — or working from a foreign prescription or tender document — often know it by one of these:
| Name | Script | Registered in |
|---|---|---|
| Ammonaps | Latin | Czechia, Iceland |
Names are taken from national medicine registers and published price lists. A product registered abroad is not authorized for sale in Canada unless it holds its own DIN; import is possible only through the routes Health Canada permits.
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.