ISOTREX GEL 0.05% 0.05 % — DIN 00784338
ISOTRETINOIN : 0.05 % · STIEFEL CANADA ULC · GEL · wholesale supply in Canada
Health Canada status: CANCELLED POST MARKET
What is ISOTREX GEL 0.05%?
ISOTREX GEL 0.05% 0.05 % contains ISOTRETINOIN : 0.05 %. It is listed in the Health Canada Drug Product Database under DIN 00784338, held by STIEFEL CANADA ULC, supplied as GEL for TOPICAL administration. Health Canada currently lists it as cancelled post market, status dated 03-May-2005. This Drug Identification Number is no longer authorized for sale in Canada, so Nexara does not supply it. The record is kept here because buyers still meet the number on old formularies, purchase orders and tender documents; Nexara can help identify an authorized alternative.
How much does Isotretinoin cost around the world?
Isotretinoin is listed on 14 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; Austria publishes a KVP (Kassenverkaufspreis); Bahrain publishes a retail (max). 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 |
|---|---|---|---|---|
| United States | acquisition | 5 | 79 | USD███.██ |
| Australia | ex-manufacturer | 9 | 20 | AUD███.██ |
| Sweden | AIP (pharmacy purchase price) | 5 | 19 | SEK███.██ |
| South Africa | single exit price | 15 | 16 | ZAR███.██ |
| Saudi Arabia | public | 13 | 14 | SAR███.██ |
| United Arab Emirates | public | 11 | 13 | AED███.██ |
| Czechia | max producer price (ex-factory) | 4 | 12 | CZK███.██ |
| Greece | producer price (ex-factory) | 11 | 11 | EUR███.██ |
| Austria | KVP (Kassenverkaufspreis) | 5 | 5 | EUR███.██ |
| Bahrain | retail (max) | 3 | 5 | BHD███.██ |
| Luxembourg | reimbursement | 3 | 5 | EUR███.██ |
| United Kingdom | hospital | 4 | 4 | GBP███.██ |
| Norway | max AUP (pharmacy retail) | 1 | 3 | NOK███.██ |
| Romania | max producer price | 3 | 3 | RON███.██ |
209 pack listings across 92 brand entries and 13 price bases, refreshed 08 Sep 2026. Ranges span every Isotretinoin pack in that market, so a high figure is usually a larger pack rather than the same product.
This table is a regulatory record of where the molecule is listed. The DIN on this page is no longer authorized for sale in Canada, so Nexara does not quote it — see the alternatives above.
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 | 0.05 % |
|---|---|
| Dosage form | GEL |
| Route | TOPICAL |
Pack detail is kept as a regulatory record. This DIN is no longer authorized for sale in Canada, so Nexara does not quote this pack.
Substance and classification
| Active substance | Isotretinoin |
|---|---|
| ATC code | D10AD04 |
| AHFS class | 84:92.00 |
| 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) | 00784338 |
|---|---|
| DIN (unpadded, as printed on some documents) | 784338 |
| Brand name | ISOTREX GEL 0.05% |
| Generic / active ingredient | ISOTRETINOIN : 0.05 % |
| Market authorization holder | STIEFEL CANADA ULC |
| Health Canada schedule | Prescription |
| ATC code | D10AD04 |
| ATC anatomical main group | D — Dermatologicals |
| ATC therapeutic subgroup | D10AD |
| Current status | CANCELLED POST MARKET |
| Status date | 03-May-2005 |
| Original market date | 1992-12-31 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
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 D10AD
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Tretinoin | ALTRENO · REJUVA-A · RENOVA · RETIN-A · +16 more | 31 | 6 | Yes |
| Adapalene, Combinations | SANDOZ ADAPALENE / BENZOYL PEROXIDE · SANDOZ ADAPALENE / BENZOYL PEROXIDE FORTE · TACTUPUMP · TACTUPUMP FORTE · +2 more | 6 | 6 | Yes |
| Adapalene | DIFFERIN · DIFFERIN XP | 5 | 3 | Yes |
| Trifarotene | AKLIEF | 1 | 1 | Yes |
| Tretinoin, Combinations | RETISOL-A | 4 | 0 | Not in Canada |
| Isotretinoin | ISOTREX GEL 0.05% | 1 | 0 | Not in Canada |
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 D10A
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| D10AE | Benzoyl Peroxide · Benzoyl Peroxide, Combinations | 214 | 35 |
| D10AF | Chloramphenicol, Combinations · Clindamycin · Clindamycin, Combinations · Erythromycin, Combinations | 23 | 8 |
| D10AX | Aluminium Oxide · Azelaic Acid · Clascoterone · Dapsone · Various Combinations | 6 | 3 |
| D10AA | Corticosteroids,Combinations For Treatment Of Acne · Methylprednisolone | 3 | 0 |
| D10AB | Sulphur · Sulphur, Combinations | 33 | 0 |
4 · Fixed-dose combinations with Canadian supply
| Product | Active ingredients | Holder | Status | DIN |
|---|---|---|---|---|
| CABTREO | CLINDAMYCIN PHOSPHATE 1.2 %; ADAPALENE 0.15 %; BENZOYL PEROXIDE 3.1 % | BAUSCH HEALTH, CANADA INC. | MARKETED | 02550423 |
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 ISOTREX GEL 0.05% called?
The same molecule, Isotretinoin, 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 |
|---|---|---|
| Isotretinoin Ebb | Latin | Sweden |
| Isotretinoin Orifarm | Latin | Norway, Sweden |
| CURACN� | Latin | Czechia |
| Oratane | Latin | Australia |
| Dermatane | Latin | Australia |
| Roaccutane | Latin | Australia, Bahrain |
| AKNENORMIN | Latin | Czechia |
| APO-Isotretinoin | Latin | Australia |
| ASOTIORGA | Latin | Czechia |
| Capitan | Latin | Saudi Arabia |
| Isotracin | Latin | Sweden |
| Isotretinoin Actavis | Latin | Sweden |
| ISOTRETINOIN BELUPO | Latin | Czechia |
| Isotretinoin Dr.Reddy's | Latin | Australia |
| Isotretinoin GX | Latin | Australia |
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.
Can this still be bought in Canada?
No. This Drug Identification Number is cancelled post market in Health Canada's Drug Product Database, so the product is no longer authorized for sale in Canada and Nexara does not supply it. This page is kept as a regulatory record.
If you are looking for a current equivalent, the alternatives above list every product sharing this therapeutic class, with the marketed ones first. Ask us to source an alternative
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.