NRA-URSODIOL 250 MG — DIN 02544032
URSODIOL : 250 MG · NORA PHARMA INC · TABLET · wholesale supply in Canada
Health Canada status: MARKETED
What is NRA-URSODIOL?
NRA-URSODIOL 250 MG contains URSODIOL : 250 MG. It is listed in the Health Canada Drug Product Database under DIN 02544032, held by NORA PHARMA INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 17-Jul-2024. 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 NRA-URSODIOL used for?
Management of cholestatic liver diseases, such as primary biliary cirrhosis (PBC).
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 Ursodeoxycholic 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.
13 holders have a Canadian DIN containing Ursodeoxycholic Acid, across 26 DINs, of which 8 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 |
|---|---|---|---|---|
| PHARMASCIENCE INC | 3 | 2 | PMS-URSODIOL, PMS-URSODIOL C | Sourceable in Canada |
| GLENMARK PHARMACEUTICALS CANADA INC. | 2 | 2 | GLN-URSODIOL | Sourceable in Canada |
| JAMP PHARMA CORPORATION | 2 | 2 | JAMP-URSODIOL | Sourceable in Canada |
| NORA PHARMA INC | 2 | 2 | NRA-URSODIOL | Sourceable in Canada |
| ANGITA PHARMA INC. | 2 | 0 | AG-URSODIOL | No marketed DIN |
| APTALIS PHARMA CANADA ULC | 2 | 0 | URSO, URSO DS | No marketed DIN |
| DOMINION PHARMACAL | 2 | 0 | DOM-URSODIOL C | No marketed DIN |
| MINT PHARMACEUTICALS INC | 2 | 0 | MINT-URSODIOL | No marketed DIN |
| NOVOPHARM LIMITED | 2 | 0 | NOVO-URSODIOL | No marketed DIN |
| PENDOPHARM DIVISION OF PHARMASCIENCE INC | 2 | 0 | PENDO-URSODIOL C | No marketed DIN |
| PHARMEL INC | 2 | 0 | PHL-URSODIOL C | No marketed DIN |
| SANIS HEALTH INC | 2 | 0 | URSODIOL C | 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 | 250 MG |
|---|---|
| Dosage form | TABLET |
| Route | ORAL |
| Pack configuration (monograph) | Bottles of 100 and 500 tablets. |
| Storage | Not explicitly stated in provided text (refer to section 11). |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Ursodeoxycholic Acid |
|---|---|
| ATC code | A05AA02 |
| 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) | 02544032 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2544032 |
| Brand name | NRA-URSODIOL |
| Generic / active ingredient | URSODIOL : 250 MG |
| Market authorization holder | NORA PHARMA INC |
| Health Canada schedule | Prescription |
| ATC code | A05AA02 |
| ATC anatomical main group | A — Alimentary tract and metabolism |
| ATC therapeutic subgroup | A05AA |
| Current status | MARKETED |
| Status date | 17-Jul-2024 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
Adult PBC dosage: 13-15 mg/kg/day in two to four divided doses with food. 500 mg tablets are scored and can be halved.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Hypersensitivity to ursodiol or ingredients; complete biliary obstruction of extrahepatic origin; widespread intrahepatic obstruction.
Warnings and precautions
Monitor liver function tests regularly. Rare reports of bezoars in patients with intestinal stenosis. Caution in patients with variceal bleeding or hepatic encephalopathy.
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
8 of 26 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| GLN-URSODIOL | 250 MG | TABLET | GLENMARK PHARMACEUTICALS CANADA INC. | MARKETED | 02426900 |
| GLN-URSODIOL | 500 MG | TABLET | GLENMARK PHARMACEUTICALS CANADA INC. | MARKETED | 02426919 |
| JAMP-URSODIOL | 250 MG | TABLET | JAMP PHARMA CORPORATION | MARKETED | 02472392 |
| JAMP-URSODIOL | 500 MG | TABLET | JAMP PHARMA CORPORATION | MARKETED | 02472406 |
| NRA-URSODIOL | 500 MG | TABLET | NORA PHARMA INC | MARKETED | 02544024 |
| PMS-URSODIOL C | 500 MG | TABLET | PHARMASCIENCE INC | MARKETED | 02273500 |
| PMS-URSODIOL C | 250 MG | TABLET | PHARMASCIENCE INC | MARKETED | 02273497 |
| AG-URSODIOL | 250 MG | TABLET | ANGITA PHARMA INC. | DORMANT | 02505363 |
| AG-URSODIOL | 500 MG | TABLET | ANGITA PHARMA INC. | DORMANT | 02505371 |
| DOM-URSODIOL C | 250 MG | TABLET | DOMINION PHARMACAL | CANCELLED POST MARKET | 02281295 |
2 · Same class — other molecules in ATC A05AA
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Ursodeoxycholic Acid | AG-URSODIOL · DOM-URSODIOL C · GLN-URSODIOL · JAMP-URSODIOL · +11 more | 26 | 8 | Yes |
| Obeticholic Acid | OCALIVA | 2 | 2 | Yes |
| Bile Acid And Derivatives | DYCHOLIUM TABLET 300MG | 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 A05A
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| A05AX | A05ax04 · Elafibranor · Maraliximab Chloride · Odevixibat | 7 | 7 |
| A05AB | Preparations For Biliary Tract Therapy | 1 | 0 |
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.