REBYOTA 50000000000 CFU — DIN 02555948
FECAL MICROBIOTA : 50000000000 CFU · FERRING INC · SUSPENSION · wholesale supply in Canada
Health Canada status: MARKETED
What is REBYOTA?
REBYOTA 50000000000 CFU contains FECAL MICROBIOTA : 50000000000 CFU. It is listed in the Health Canada Drug Product Database under DIN 02555948, held by FERRING INC, supplied as SUSPENSION for RECTAL administration. Health Canada currently lists it as marketed, status dated 10-Jun-2025. 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 REBYOTA used for?
Prevention of recurrence of Clostridioides difficile infection (CDI) in adults following antibiotic treatment for recurrent CDI. Not indicated for treatment of CDI.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
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 | 50000000000 CFU |
|---|---|
| Dosage form | SUSPENSION |
| Route | RECTAL |
| Pack configuration (monograph) | Carton containing one labeled single-dose 150 mL suspension bag. Administration Set is packaged separately. |
| Storage | Ultracold freezer at -60°C to -90°C until expiration, or refrigerator at 2°C to 8°C for up to 5 days (including 24h thawing). Do not refreeze. |
| Shipping class | Cold chain — validated shipper with temperature monitoring |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Cold chain. This product is stored refrigerated. Nexara ships it on a validated cold chain with temperature monitoring; a delivery address that cannot receive and store it at 2–8 °C on arrival must be flagged before the order is placed.
Substance and classification
| Active substance | Antidiarrheal Microorganisms |
|---|---|
| ATC code | A07FA |
| 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) | 02555948 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2555948 |
| Brand name | REBYOTA |
| Generic / active ingredient | FECAL MICROBIOTA : 50000000000 CFU |
| Market authorization holder | FERRING INC |
| Health Canada schedule | Schedule D |
| ATC code | A07FA |
| ATC anatomical main group | A — Alimentary tract and metabolism |
| ATC therapeutic subgroup | A07FA |
| Current status | MARKETED |
| Status date | 10-Jun-2025 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
Single 150 mL dose administered rectally 24-72 hours after the last dose of antibiotics for CDI. Do not administer during antibiotic treatment. Patient should stay on left side for 15 minutes.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Hypersensitivity to REBYOTA or any of its components, including non-medicinal ingredients or the container.
Warnings and precautions
May contain food allergens. Risk of transmitting infectious agents. Contains PEG 3350 (GI irritation) and saline (caution in sodium-restricted patients). Not for systemic absorption.
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 A07FA
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Antidiarrheal Microorganisms | REBYOTA | 1 | 1 | Yes |
| Lactic Acid Producing Organisms | ACIDOPHILUS BIFIDUM BULGARICUS · BAKTERA VOYAGE · FERMALAC ECC 1B · INTESTALIFE · +3 more | 7 | 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.
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.