ZADITEN 1 MG / 5 ML — DIN 00600784
KETOTIFEN (KETOTIFEN FUMARATE) : 1 MG / 5 ML · TEVA CANADA LIMITED · SYRUP · wholesale supply in Canada
Health Canada status: CANCELLED POST MARKET
What is ZADITEN?
ZADITEN 1 MG / 5 ML contains KETOTIFEN (KETOTIFEN FUMARATE) : 1 MG / 5 ML. It is listed in the Health Canada Drug Product Database under DIN 00600784, held by TEVA CANADA LIMITED, supplied as SYRUP for ORAL administration. Health Canada currently lists it as cancelled post market, status dated 30-Jul-2021. 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.
What is ZADITEN used for?
Add-on medication in the chronic treatment of mild atopic asthmatic children. Prophylactic agent; not for acute asthma attacks.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How much does Ketotifen cost around the world?
Ketotifen is listed on 9 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. Bahrain publishes a retail (max); Czechia publishes a max producer price (ex-factory); Greece publishes a producer price (ex-factory). 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 |
|---|---|---|---|---|
| Saudi Arabia | public | 19 | 19 | SAR███.██ |
| Greece | producer price (ex-factory) | 8 | 8 | EUR███.██ |
| South Africa | single exit price | 3 | 5 | ZAR███.██ |
| Romania | max producer price | 4 | 4 | RON███.██ |
| Bahrain | retail (max) | 3 | 3 | BHD███.██ |
| United States | acquisition | 1 | 3 | USD███.██ |
| Czechia | max producer price (ex-factory) | 1 | 2 | CZK███.██ |
| Iceland | max wholesale | 1 | 2 | ISK███.██ |
| United Arab Emirates | public | 1 | 1 | AED███.██ |
47 pack listings across 41 brand entries and 8 price bases, refreshed 03 Sep 2026. Ranges span every Ketotifen 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.
Is there a generic Ketotifen 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.
6 holders have a Canadian DIN containing Ketotifen, across 9 DINs, of which 1 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 |
|---|---|---|---|---|
| TEVA CANADA LIMITED | 2 | 1 | ZADITEN | Sourceable in Canada |
| NOVOPHARM LIMITED | 2 | 0 | NOVO-KETOTIFEN - SYR 1MG/5ML, NOVO-KETOTIFEN TAB 1MG | No marketed DIN |
| PHARMASCIENCE INC | 2 | 0 | PMS-KETOTIFEN | No marketed DIN |
| APOTEX INC | 1 | 0 | APO-KETOTIFEN - SYR 1MG/5ML | No marketed DIN |
| NOVARTIS PHARMACEUTICALS CANADA INC | 1 | 0 | ZADITEN - DPS 1MG/ML | No marketed DIN |
| NU-PHARM INC | 1 | 0 | NU-KETOTIFEN SYRUP - 1MG/5ML | 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 | 1 MG / 5 ML |
|---|---|
| Dosage form | SYRUP |
| Route | ORAL |
| Pack configuration (monograph) | Tablets: Packs of 56 (4 blister strips of 14 tablets). Syrup: 250 mL bottles. |
| Storage | Store at temperatures not exceeding 25°C. Tablets should be stored in a dry place. |
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 | Ketotifen |
|---|---|
| ATC code | R06AX17 |
| AHFS class | 04:92.00 |
| 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) | 00600784 |
|---|---|
| DIN (unpadded, as printed on some documents) | 600784 |
| Brand name | ZADITEN |
| Generic / active ingredient | KETOTIFEN (KETOTIFEN FUMARATE) : 1 MG / 5 ML |
| Market authorization holder | TEVA CANADA LIMITED |
| Health Canada schedule | Prescription |
| ATC code | R06AX17 |
| ATC anatomical main group | R — Respiratory system |
| ATC therapeutic subgroup | R06AX |
| Current status | CANCELLED POST MARKET |
| Status date | 30-Jul-2021 |
| Original market date | 1990-12-31 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
Children >3 years: 1 mg twice daily. Children 6 months to 3 years: 0.05 mg/kg twice daily. Slow increase recommended during first week to minimize sedation. Administer orally.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Known hypersensitivity to ketotifen or any components. Patients sensitive to benzoate compounds should not take Zaditen syrup.
Warnings and precautions
Not for acute attacks. Do not stop other anti-asthmatic drugs abruptly. May lower seizure threshold (caution in epilepsy). May cause drowsiness; caution with activities requiring alertness.
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
1 of 9 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| ZADITEN | 1 MG | TABLET | TEVA CANADA LIMITED | MARKETED | 00577308 |
| APO-KETOTIFEN - SYR 1MG/5ML | 1 MG / 5 ML | SYRUP | APOTEX INC | CANCELLED POST MARKET | 02221330 |
| NOVO-KETOTIFEN - SYR 1MG/5ML | 1 MG / 5 ML | SYRUP | NOVOPHARM LIMITED | CANCELLED POST MARKET | 02176084 |
| NOVO-KETOTIFEN TAB 1MG | 1 MG | TABLET | NOVOPHARM LIMITED | CANCELLED POST MARKET | 02230730 |
| NU-KETOTIFEN SYRUP - 1MG/5ML | 1 MG / 5 ML | SYRUP | NU-PHARM INC | CANCELLED POST MARKET | 02218305 |
| PMS-KETOTIFEN | 1 MG / 5 ML | SYRUP | PHARMASCIENCE INC | CANCELLED POST MARKET | 02231679 |
| PMS-KETOTIFEN | 1 MG | TABLET | PHARMASCIENCE INC | CANCELLED POST MARKET | 02231680 |
| ZADITEN - DPS 1MG/ML | 1 MG | DROPS | NOVARTIS PHARMACEUTICALS CANADA INC | APPROVED | 02172585 |
2 · Same class — other molecules in ATC R06AX
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Loratadine | 24 HOUR ALLERGY REMEDY · ALLERGY REMEDY · ALLERTIN · ALLERTIN TABLETS 10MG · +13 more | 20 | 11 | Yes |
| Bilastine | AURO-BILASTINE · BLEXTEN · GLN-BILASTINE · JAMP BILASTINE · +4 more | 10 | 10 | Yes |
| Rupatadine | APO-RUPATADINE · PMS-RUPATADINE · RIVA-RUPATADINE · RUPALL | 5 | 5 | Yes |
| Desloratadine | AERIUS · AERIUS KIDS · ALLERGY CONTROL DESLORATADINE · ALLERNIX MULTI SYMPTOM · +3 more | 9 | 4 | Yes |
| Cyproheptadine | EURO-CYPROHEPTADINE 2MG/5ML · EURO-CYPROHEPTADINE 4 MG/TABLET · JAMP CYPROHEPTADINE SYRUP · JAMP-CYPROHEPTADINE · +6 more | 10 | 3 | Yes |
| Fexofenadine | ALLEGRA 12 HOUR · ALLEGRA 24 HOUR · ALLEGRA HIVES | 3 | 3 | Yes |
| Ketotifen | APO-KETOTIFEN - SYR 1MG/5ML · NOVO-KETOTIFEN - SYR 1MG/5ML · NOVO-KETOTIFEN TAB 1MG · NU-KETOTIFEN SYRUP - 1MG/5ML · +3 more | 9 | 1 | Yes |
| Other Antihistamines For Systemic Use | APO-BILASTINE ORAL SOLUTION · APO-BILASTINE ORODISPERSIBLE TABLETS · APO-BILASTINE TABLETS | 3 | 1 | Yes |
| Terfenadine | ALLERGY RELIEF · APO-TERFENADINE TAB 120MG · APO-TERFENADINE TABLETS 60MG · NOVO-TERFENADINE TAB 60MG · +7 more | 11 | 0 | Not in Canada |
| Astemizole | HISMANAL - TAB 10MG · HISMANAL SUSPENSION 2MG/ML · HISMANAL TAB 10MG | 3 | 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 R06A
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| R06AA | Clemastine · Dimenhydrinate · Dimenhydrinate, Combinations · Diphenhydramine · Diphenhydramine, Combinations · +3 more | 264 | 76 |
| R06AE | Cetirizine · Cyclizine · Meclozine · Meclozine, Combinations | 69 | 27 |
| R06AB | Brompheniramine · Chlorpheniramine · Dexchlorpheniramine | 17 | 1 |
| R06AD | Alimemazine · Promethazine | 17 | 1 |
| R06AC | Tripelennamine | 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.
What else is ZADITEN called?
The same molecule, Ketotifen, 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 |
|---|---|---|
| Ketotifen | Latin | Iceland |
| KETOTIFEN AL | Latin | Czechia |
| Adco-Ketotifen | Latin | South Africa |
| Adco-Zetofen | Latin | South Africa |
| APIZAD | Latin | Bahrain |
| ASMAFORT | Latin | Bahrain |
| Fenobat | Latin | Saudi Arabia |
| HISTOFEN | Latin | Saudi Arabia |
| Keta | Latin | Saudi Arabia |
| PROFILAR | Latin | Bahrain |
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.