COLYTE 10.65 MG — DIN 00677442
POTASSIUM CHLORIDE : 10.65 MG SODIUM SULFATE : 81.2 MG POLYETHYLENE GLYCOL 3350 : 857.69 MG SODIUM CHLORIDE : 20.87 MG SODIUM BICARBONATE : 24.02 MG · PENDOPHARM DIVISION OF PHARMASCIENCE INC · POWDER FOR SOLUTION · wholesale supply in Canada
Health Canada status: MARKETED
What is COLYTE?
COLYTE 10.65 MG contains POTASSIUM CHLORIDE : 10.65 MG SODIUM SULFATE : 81.2 MG POLYETHYLENE GLYCOL 3350 : 857.69 MG SODIUM CHLORIDE : 20.87 MG SODIUM BICARBONATE : 24.02 MG. It is listed in the Health Canada Drug Product Database under DIN 00677442, held by PENDOPHARM DIVISION OF PHARMASCIENCE INC, supplied as POWDER FOR SOLUTION for ORAL ; NASOGASTRIC administration. Health Canada currently lists it as marketed, status dated 01-Apr-2013. 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 COLYTE used for?
Colyte® (PEG 3350 and Electrolytes) is indicated for bowel cleansing prior to colonoscopy or barium enema x-ray examination or surgical procedures requiring a clean colon. It is also used for the treatment of constipation.
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 Macrogol, Combinations 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.
4 holders have a Canadian DIN containing Macrogol, Combinations, across 8 DINs, of which 3 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 |
|---|---|---|---|---|
| JAMP PHARMA CORPORATION | 4 | 1 | JAMP-ELECTROPEG, JAMP-ELECTROPEG WITH FLAVOUR PACKET, JAMPLYTE | Sourceable in Canada |
| PENDOPHARM DIVISION OF PHARMASCIENCE INC | 2 | 1 | COLYTE, KLEAN-PREP | Sourceable in Canada |
| ARALEZ PHARMACEUTICALS CANADA INC | 1 | 1 | MOVIPREP | Sourceable in Canada |
| BAUSCH HEALTH, CANADA INC. | 1 | 0 | PLENVU | 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 | 10.65 MG |
|---|---|
| Dosage form | POWDER FOR SOLUTION |
| Route | ORAL ; NASOGASTRIC |
| Pack configuration (monograph) | Each 278 g bottle of Colyte® powder, to be dissolved in 4 L of water |
| Storage | Store Colyte® powder at room temperature, between 15°C and 30°C. Once reconstituted, the solution should be used within 48 hours after mixing if stored at room temperature. If kept refrigerated (between 2°C and 8°C), use within 30 days. Discard unused portion. |
| 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 | Macrogol, Combinations |
|---|---|
| ATC code | A06AD65 |
| AHFS class | 56:12.00 |
| 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) | 00677442 |
|---|---|
| DIN (unpadded, as printed on some documents) | 677442 |
| Brand name | COLYTE |
| Generic / active ingredient | POTASSIUM CHLORIDE : 10.65 MG SODIUM SULFATE : 81.2 MG POLYETHYLENE GLYCOL 3350 : 857.69 MG SODIUM CHLORIDE : 20.87 MG SODIUM BICARBONATE : 24.02 MG |
| Market authorization holder | PENDOPHARM DIVISION OF PHARMASCIENCE INC |
| Health Canada schedule | Ethical |
| ATC code | A06AD65 |
| ATC anatomical main group | A — Alimentary tract and metabolism |
| ATC therapeutic subgroup | A06AD |
| Current status | MARKETED |
| Status date | 01-Apr-2013 |
| Original market date | 1986-12-31 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.
1 · Same molecule, other Canadian presentations
3 of 8 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| JAMPLYTE | 22.96 G / 280 G | POWDER | JAMP PHARMA CORPORATION | MARKETED | 02378329 |
| MOVIPREP | 2.691 G | POWDER FOR SOLUTION | ARALEZ PHARMACEUTICALS CANADA INC | MARKETED | 02359499 |
| JAMP-ELECTROPEG | 2.97 G | POWDER FOR SOLUTION | JAMP PHARMA CORPORATION | APPROVED | 02406780 |
| JAMP-ELECTROPEG WITH FLAVOUR PACKET | 2.97 G | POWDER FOR SOLUTION | JAMP PHARMA CORPORATION | APPROVED | 02406799 |
| JAMPLYTE | 0.76 G | POWDER FOR SOLUTION | JAMP PHARMA CORPORATION | APPROVED | 02368234 |
| KLEAN-PREP | 1.68 G | POWDER FOR SOLUTION | PENDOPHARM DIVISION OF PHARMASCIENCE INC | CANCELLED POST MARKET | 02147793 |
| PLENVU | 9 G | KIT ; POWDER FOR SOLUTION | BAUSCH HEALTH, CANADA INC. | CANCELLED PRE MARKET | 02550938 |
2 · Same class — other molecules in ATC A06AD
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Macrogol | CLARILAX · CLEARLAX · COLAXOR · COMFILAX · +17 more | 22 | 12 | Yes |
| Lactulose | CEPHULAC SYR 667MG/ML · CHRONULAC SYR · CHRONULAC SYR 667MG/ML · COMALOSE R SIROP 10GM/15ML · +20 more | 28 | 5 | Yes |
| Macrogol, Combinations | COLYTE · JAMP-ELECTROPEG · JAMP-ELECTROPEG WITH FLAVOUR PACKET · JAMPLYTE · +3 more | 8 | 3 | Yes |
| Mineral Salts In Combination | CEO-TWO BOWEL EVACUANT SUPPOSITORIES · EAU PURGATIVE RIGA · ELECTROPEG SOLUTION · GOLYTELY GI LAVAGE SOLUTION · +8 more | 13 | 1 | Yes |
| Magnesium Sulphate | EPSOM SALT PWS 100% · EPSOM SALTS · SEL D EPSOM | 6 | 0 | Not in Canada |
| Magnesium Sulphate, Combinations | AGOBYL GRANULE · AGOBYL LIQUIDE · FORMULE 1705 - LIQ | 3 | 0 | Not in Canada |
| Sodium Phosphate | EURO-PHOSPHATES SOLUTION · PHOSPHO-SODA BUFFERED SALINE LAXATIVE · PMS-PHOSPHATES SOLUTION | 3 | 0 | Not in Canada |
| Sorbitol | SORBITOL ROUGIER PWS 5GM | 1 | 0 | Not in Canada |
| Sodium Tartrate | LIMONADE RODECA | 1 | 0 | Not in Canada |
| Magnesium Oxide | MAGNESIUM CITRATE ORAL SOLUTION | 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 A06A
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| A06AB | Bisacodyl · Bisacodyl, Combinations · Cascara · Cascara, Combinations · Castor Oil · +9 more | 239 | 25 |
| A06AA | Docusate Sodium · Docusate Sodium, Combinations · Liquid Paraffin · Liquid Paraffin, Combinations | 144 | 22 |
| A06AX | Glycerol · Linaclotide · Lubiprostone · Other Laxatives · Plecanatide · +2 more | 30 | 14 |
| A06AH | Methylnaltrexone Bromide · Naloxegol | 5 | 3 |
| A06AG | Bisacodyl · Combinations · Docusate Sodium, Incl Combinations · Sodium Phosphate | 7 | 1 |
| A06AC | Ispaghula (Psylla Seeds) · Ispaghula, Combinations · Linseed · Methylcellulose · Polycarbophil Calcium · +2 more | 79 | 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.