MISOPROSTOL 200 MCG — DIN 02244023
MISOPROSTOL : 200 MCG · AA PHARMA INC · TABLET · wholesale supply in Canada
Health Canada status: MARKETED
What is MISOPROSTOL?
MISOPROSTOL 200 MCG contains MISOPROSTOL : 200 MCG. It is listed in the Health Canada Drug Product Database under DIN 02244023, held by AA PHARMA INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 06-Aug-2011. 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 MISOPROSTOL used for?
MISOPROSTOL (misoprostol) is indicated for the treatment and prevention of NSAID-induced gastroduodenal ulcers. MISOPROSTOL is also indicated for the treatment of duodenal ulcers caused by Peptic Ulcer Disease (PUD).
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How much does Misoprostol cost around the world?
Misoprostol 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. Brazil publishes a preco fabrica (ex-factory ceiling); Greece publishes a producer price (ex-factory); Norway publishes a max AUP (pharmacy retail). 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 | 2 | 17 | USD███.██ |
| South Africa | single exit price | 2 | 4 | ZAR███.██ |
| Brazil | preco fabrica (ex-factory ceiling) | 1 | 3 | BRL███.██ |
| Spain | PVP con IVA (public price) | 2 | 2 | EUR███.██ |
| Greece | producer price (ex-factory) | 2 | 2 | EUR███.██ |
| Norway | max AUP (pharmacy retail) | 2 | 2 | NOK███.██ |
| Romania | max producer price | 2 | 2 | RON███.██ |
| United Arab Emirates | public | 1 | 1 | AED███.██ |
| Saudi Arabia | public | 1 | 1 | SAR███.██ |
34 pack listings across 15 brand entries and 8 price bases, refreshed 07 Sep 2026. Ranges span every Misoprostol 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 Misoprostol 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 Misoprostol, across 10 DINs, of which 2 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 |
|---|---|---|---|---|
| AA PHARMA INC | 2 | 2 | MISOPROSTOL | Sourceable in Canada |
| NOVOPHARM LIMITED | 2 | 0 | NOVO-MISOPROSTOL TABLETS | No marketed DIN |
| PFIZER CANADA ULC | 2 | 0 | CYTOTEC 100 MCG, CYTOTEC 200 MCG | No marketed DIN |
| PHARMASCIENCE INC | 2 | 0 | PMS-MISOPROSTOL (0.1MG), PMS-MISOPROSTOL (0.2MG) | No marketed DIN |
| JAMP PHARMA CORPORATION | 1 | 0 | JAMP MISOPROSTOL | No marketed DIN |
| PRO DOC LIMITEE | 1 | 0 | MISOPROSTOL-200 | 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 | 200 MCG |
|---|---|
| Dosage form | TABLET |
| Route | ORAL |
| Pack configuration (monograph) | 100 mcg: Each round, white, flat-faced, beveled-edged tablet engraved “MISO” over "100" on one side contains 100 mcg misoprostol. Available in bottles of 100, 250 and 500. 200 mcg: Each hexagonal, white, flat-faced, beveled-edged tablet scored and engraved “MISO” over "200" on one side contains 200 mcg misoprostol. Available in bottles of 100 and 500. |
| Storage | Store between 15° and 30°C, protect from humidity. Keep container closed when not in use. |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation, because this listing covers more than one of them.
Substance and classification
| Active substance | Misoprostol |
|---|---|
| ATC code | A02BB01 |
| AHFS class | 84:80.00 |
| 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) | 02244023 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2244023 |
| Brand name | MISOPROSTOL |
| Generic / active ingredient | MISOPROSTOL : 200 MCG |
| Market authorization holder | AA PHARMA INC |
| Health Canada schedule | Prescription |
| ATC code | A02BB01 |
| ATC anatomical main group | A — Alimentary tract and metabolism |
| ATC therapeutic subgroup | A02BB |
| Current status | MARKETED |
| Status date | 06-Aug-2011 |
| Original market date | 2001-09-01 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
MISOPROSTOL (misoprostol) should be taken with food or milk. To minimize the risk of diarrhea, magnesium-containing antacids should be avoided. Aluminum-based antacids may be used as needed for relief of heartburn/epigastric pain. Treatment and Prevention of NSAID-Induced Gastroduodenal Ulcers: The recommended adult oral dose of MISOPROSTOL for the prevention and treatment of NSAID-induced gastroduodenal ulcer is 400 to 800 mcg a day in divided doses. NSAIDs should be taken according to the schedule prescribed by the physician. When appropriate, MISOPROSTOL and NSAIDs are to be taken simultaneously. MISOPROSTOL should be taken after a meal or with food or milk. Treatment of Duodenal Ulcer: The recommended adult oral dose of MISOPROSTOL for duodenal ulcer is 800 mcg per day for 4 weeks in two or four equally divided doses (i.e., 200 mcg qid or 400 mcg bid). The last dose should be taken at bedtime with food. Treatment should be continued for a total of 4 weeks unless healing in less time had been documented by endoscopic examination. In the small number of patients who may not have fully healed after 4 weeks, therapy with MISOPROSTOL may be continued for a further 4 weeks.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Known sensitivity to prostaglandins, prostaglandin analogues, or excipients. MISOPROSTOL (misoprostol), or misoprostol in any form, should not be used in pregnant women because it induces uterine contractions and therefore has abortifacient potential. Anecdotal reports, primarily from Brazil, of congenital anomalies and reports of fetal death subsequent to misuse of misoprostol as an abortifacient have been received. Uterine perforation has been reported with misuse of misoprostol for cervical ripening or labor induction.
Warnings and precautions
Women of childbearing potential should employ adequate contraception (i.e., oral contraceptives or intrauterine devices) while receiving MISOPROSTOL (misoprostol) (see CONTRAINDICATIONS). Nursing Mothers: It is unlikely that misoprostol is excreted in human milk since it is rapidly metabolized throughout the body. However, it is not known if the active metabolite (misoprostol acid) is excreted in human milk. Therefore, MISOPROSTOL should not be administered to nursing mothers because the potential excretion of misoprostol acid could cause significant diarrhea in nursing infants. Symptomatic responses to misoprostol do not preclude the presence of gastric malignancy. Keep MISOPROSTOL out of the reach of children.
Is Misoprostol in shortage in Canada?
A Canadian shortage report is on file for a product containing this molecule: Resolved — reported by AA PHARMA INC, last seen 09 Sep 2026. A shortage on one presentation does not always affect every DIN of the molecule — the alternatives below list what else is marketed in Canada. Nexara can confirm current availability and identify substitutions or import options where permitted.
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
2 of 10 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| MISOPROSTOL | 100 MCG | TABLET | AA PHARMA INC | MARKETED | 02244022 |
| CYTOTEC 100 MCG | 100 MCG | TABLET | PFIZER CANADA ULC | CANCELLED POST MARKET | 00813966 |
| CYTOTEC 200 MCG | 200 MCG | TABLET | PFIZER CANADA ULC | CANCELLED POST MARKET | 00632600 |
| JAMP MISOPROSTOL | 200 MCG | TABLET | JAMP PHARMA CORPORATION | APPROVED | 02545284 |
| MISOPROSTOL-200 | 200 MCG | TABLET | PRO DOC LIMITEE | CANCELLED POST MARKET | 02248846 |
| NOVO-MISOPROSTOL TABLETS | 200 MCG | TABLET | NOVOPHARM LIMITED | CANCELLED POST MARKET | 02240755 |
| NOVO-MISOPROSTOL TABLETS | 100 MCG | TABLET | NOVOPHARM LIMITED | CANCELLED POST MARKET | 02240754 |
| PMS-MISOPROSTOL (0.1MG) | 100 MCG | TABLET | PHARMASCIENCE INC | CANCELLED POST MARKET | 02244124 |
| PMS-MISOPROSTOL (0.2MG) | 200 MCG | TABLET | PHARMASCIENCE INC | CANCELLED POST MARKET | 02244125 |
2 · Same class — other molecules in ATC A02BB
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Misoprostol | CYTOTEC 100 MCG · CYTOTEC 200 MCG · JAMP MISOPROSTOL · MISOPROSTOL · +4 more | 10 | 2 | 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 A02B
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| A02BC | Dexlansoprazole · Esomeprazole · Lansoprazole · Omeprazole · Pantoprazole · +1 more | 288 | 108 |
| A02BA | Cimetidine · Famotidine · Famotidine, Combinations · Nizatidine · Ranitidine · +1 more | 235 | 26 |
| A02BX | Alginic Acid · Pirenzepine · Sucralfate | 32 | 4 |
| A02BD | Bismuth Subcitrate,Tetracycline And Metronidazole · Lansoprazole, Amoxicillin And Clarithromycin | 3 | 2 |
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 MISOPROSTOL called?
Also recorded in Canada as: misoprostol 0.2 MG Oral Tablet [Cytotec] (US), diclofenac sodium 50 MG / misoprostol 0.2 MG Delayed Release Oral Tablet [Arthrotec] (US), diclofenac sodium 75 MG / misoprostol 0.2 MG Delayed Release Oral Tablet [Arthrotec] (US), misoprostol 0.1 MG Oral Tablet [Cytotec] (US), diclofenac sodium 75 MG / misoprostol 0.2 MG Delayed Release Oral Tablet (US), misoprostol 0.1 MG Oral Tablet (US), misoprostol 0.2 MG Oral Tablet (US), diclofenac sodium 50 MG / misoprostol 0.2 MG Delayed Release Oral Tablet (US), DICLOENAC SODIUM AND MISOPROSTOL (US), DICLOENAC SODIUM AND MISOPROSTOL DR (US), DICLOFENAC SODIUM AND MISOPROSTOL (US), DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE (US), DICLOFENAC SODIUM AND MISOPROSTOL DR (US), DICLOFENAC SODIUM MISOPROSTOL (US), DICLOFENAC SODIUM/MISOPROSTOL (US).
The same molecule, Misoprostol, 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 |
|---|---|---|
| PROSTOKOS | Latin | Brazil |
| Acemiso | Latin | South Africa |
| Misoprostol Pfizer | Latin | South Africa |
| Angusta | Latin | Norway |
| Cytotec | Latin | Saudi Arabia |
| Topogyne | Latin | Norway |
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.