PMS-SULFASALAZINE 500MG/TAB USP 500 MG — DIN 00598461
SULFASALAZINE : 500 MG · PHARMASCIENCE INC · TABLET · wholesale supply in Canada
Health Canada status: MARKETED
What is PMS-SULFASALAZINE 500MG/TAB USP?
PMS-SULFASALAZINE 500MG/TAB USP 500 MG contains SULFASALAZINE : 500 MG. It is listed in the Health Canada Drug Product Database under DIN 00598461, held by PHARMASCIENCE INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 31-Dec-1984. 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 PMS-SULFASALAZINE 500MG/TAB USP used for?
Adjunctive therapy for severe ulcerative colitis, proctitis, distal ulcerative colitis, and Crohn's disease. E.C. tablets also indicated for active rheumatoid arthritis.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How much does Sulfasalazine cost around the world?
Sulfasalazine is listed on 7 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; Greece publishes a producer price (ex-factory); Morocco publishes a PPV (public price). 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 | 1 | 12 | USD███.██ |
| Australia | ex-manufacturer | 3 | 6 | AUD███.██ |
| United Kingdom | hospital | 3 | 3 | GBP███.██ |
| United Arab Emirates | public | 1 | 1 | AED███.██ |
| Greece | producer price (ex-factory) | 1 | 1 | EUR███.██ |
| Morocco | PPV (public price) | 1 | 1 | MAD███.██ |
| Saudi Arabia | public | 1 | 1 | SAR███.██ |
25 pack listings across 11 brand entries and 6 price bases, refreshed 08 Sep 2026. Ranges span every Sulfasalazine 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.
Is there a generic Sulfasalazine 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.
8 holders have a Canadian DIN containing Sulfasalazine, across 14 DINs, of which 5 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 |
|---|---|---|---|---|
| PFIZER CANADA ULC | 3 | 2 | SALAZOPYRIN EN-TABS 500 MG, SALAZOPYRIN ENEMA 3GM/100ML, SALAZOPYRIN TAB 500MG | Sourceable in Canada |
| PHARMASCIENCE INC | 2 | 2 | PMS-SULFASALAZINE 500MG/TAB USP, PMS-SULFASALAZINE-E.C. TAB 500MG | Sourceable in Canada |
| JAMP PHARMA CORPORATION | 1 | 1 | JAMP SULFASALAZINE | Sourceable in Canada |
| ICN CANADA LTD. | 3 | 0 | S.A.S. ENTERIC 500MG, SAS ENEMA 3GM/100ML, SAS TAB 500MG | No marketed DIN |
| RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED | 2 | 0 | RATIO-SULFASALAZINE EN, RATIO-SULFASALAZINE TAB 500MG | No marketed DIN |
| APOTEX INC | 1 | 0 | APO SULFASALAZINE TAB 500MG | No marketed DIN |
| KABI PHARMACIA CANADA INC. | 1 | 0 | SALAZOPYRIN ENEMA 3.0GM/100ML | No marketed DIN |
| ORBUS PHARMA INC | 1 | 0 | ORB-SULFASALAZINE EC | 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 | 500 MG |
|---|---|
| Dosage form | TABLET |
| Route | ORAL |
| Pack configuration (monograph) | Not explicitly detailed in the provided text (standard DIN 598461 reference). |
| Storage | Not explicitly detailed in the provided text (standard USP storage usually 15-30°C). |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Sulfasalazine |
|---|---|
| ATC code | A07EC01 |
| AHFS class | 08:12.20 |
| 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) | 00598461 |
|---|---|
| DIN (unpadded, as printed on some documents) | 598461 |
| Brand name | PMS-SULFASALAZINE 500MG/TAB USP |
| Generic / active ingredient | SULFASALAZINE : 500 MG |
| Market authorization holder | PHARMASCIENCE INC |
| Health Canada schedule | Prescription |
| ATC code | A07EC01 |
| ATC anatomical main group | A — Alimentary tract and metabolism |
| ATC therapeutic subgroup | A07EC |
| Current status | MARKETED |
| Status date | 31-Dec-1984 |
| 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?
Administered under medical supervision. Dosage is adjusted based on patient response and tolerance. Proctoscopy and sigmoidoscopy may be required for monitoring.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Hypersensitivity to sulfasalazine, sulfonamides, or salicylates; infants <2 years; intestinal/urinary obstructions; porphyria; ASA-induced asthma/allergic manifestations; severe renal/hepatic impairment.
Warnings and precautions
Risk of serious blood dyscrasias, liver/renal damage, and severe skin reactions (SJS/TEN/DRESS). Monitor CBC and liver/renal function regularly, especially in the first 3 months.
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
5 of 14 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| JAMP SULFASALAZINE | 500 MG | TABLET | JAMP PHARMA CORPORATION | MARKETED | 02544652 |
| PMS-SULFASALAZINE-E.C. TAB 500MG | 500 MG | TABLET (ENTERIC-COATED) | PHARMASCIENCE INC | MARKETED | 00598488 |
| SALAZOPYRIN EN-TABS 500 MG | 500 MG | TABLET (ENTERIC-COATED) | PFIZER CANADA ULC | MARKETED | 02064472 |
| SALAZOPYRIN TAB 500MG | 500 MG | TABLET | PFIZER CANADA ULC | MARKETED | 02064480 |
| APO SULFASALAZINE TAB 500MG | 500 MG | TABLET | APOTEX INC | CANCELLED POST MARKET | 00410640 |
| ORB-SULFASALAZINE EC | 500 MG | TABLET (ENTERIC-COATED) | ORBUS PHARMA INC | CANCELLED (UNRETURNED ANNUAL) | 02246803 |
| RATIO-SULFASALAZINE EN | 500 MG | TABLET (ENTERIC-COATED) | RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED | CANCELLED POST MARKET | 00685925 |
| RATIO-SULFASALAZINE TAB 500MG | 500 MG | TABLET | RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED | CANCELLED POST MARKET | 00685933 |
| S.A.S. ENTERIC 500MG | 500 MG | TABLET (ENTERIC-COATED) | ICN CANADA LTD. | CANCELLED POST MARKET | 00445126 |
| SALAZOPYRIN ENEMA 3.0GM/100ML | 3 G / 100 ML | SUSPENSION | KABI PHARMACIA CANADA INC. | CANCELLED POST MARKET | 02004682 |
2 · Same class — other molecules in ATC A07EC
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Mesalazine | 5-ASA · ASACOL · ASACOL 800 · MESALAMINE · +13 more | 29 | 18 | Yes |
| Sulfasalazine | APO SULFASALAZINE TAB 500MG · JAMP SULFASALAZINE · ORB-SULFASALAZINE EC · PMS-SULFASALAZINE 500MG/TAB USP · +10 more | 14 | 5 | Yes |
| Olsalazine | DIPENTUM | 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 A07E
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| A07EA | Betamethasone · Budesonide · Hydrocortisone · Tixocortol | 16 | 6 |
| A07EB | Cromoglicic Acid | 1 | 1 |
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 PMS-SULFASALAZINE 500MG/TAB USP called?
The same molecule, Sulfasalazine, 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 |
|---|---|---|
| Salazopyrin | Latin | Australia, Morocco |
| Pyralin EN | Latin | Australia |
| Salazopyrin-EN | 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.
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.