MISOPROSTOL 200 MCG
MISOPROSTOL : 200 MCG · DIN 02244023 · AA PHARMA INC
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.
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.
Product details and regulatory record
| DIN | 02244023 |
|---|---|
| Brand name | MISOPROSTOL |
| Generic / active ingredient | MISOPROSTOL : 200 MCG |
| Manufacturer | AA PHARMA INC |
| Strength | 200 MCG |
| Dosage form | TABLET |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | A02BB01 MISOPROSTOL |
| AHFS class | 84:80.00 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 06-Aug-2011 |
| Original market date | 2001-09-01 00:00:00 |
How is this product identified?
Purchase orders, customs paperwork and tender documents each ask for a different identifier, and a DIN written without its leading zeros is the single most common reason an order line fails to match. Every form Nexara accepts for this product is listed here.
| DIN (8-digit, as used in Nexara ordering) | 02244023 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2244023 |
| Brand name | MISOPROSTOL |
| Active ingredient / INN | MISOPROSTOL : 200 MCG |
| ATC code | A02BB01 |
| ATC anatomical main group | A — Alimentary tract and metabolism |
| ATC therapeutic subgroup | A02 |
| AHFS class | 84:80.00 |
| Health Canada schedule | Prescription |
| Biosimilar biologic | No |
| Market authorization holder | AA PHARMA INC |
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.
How is it stored and handled?
Store between 15° and 30°C, protect from humidity. Keep container closed when not in use.
How is it supplied?
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.
Which pack is which?
| Strength on the label | 200 MCG |
|---|---|
| Dosage form | TABLET |
| Route | ORAL |
| Packaging as described in the 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. |
One DIN can cover more than one pack size, and the pack — not the DIN — is what gets priced, shipped and invoiced. 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.
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 04 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?
Other Canadian products sharing ATC code A02BB01 MISOPROSTOL. 2 of 10 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.
| Product | Strength | Form | Manufacturer | Health Canada status | DIN |
|---|---|---|---|---|---|
| MISOPROSTOL | 100 MCG | TABLET | AA PHARMA INC | MARKETED | DIN 02244022 |
| CYTOTEC 100 MCG | 100 MCG | TABLET | PFIZER CANADA ULC | CANCELLED POST MARKET | DIN 00813966 |
| CYTOTEC 200 MCG | 200 MCG | TABLET | PFIZER CANADA ULC | CANCELLED POST MARKET | DIN 00632600 |
| JAMP MISOPROSTOL | 200 MCG | TABLET | JAMP PHARMA CORPORATION | APPROVED | DIN 02545284 |
| MISOPROSTOL-200 | 200 MCG | TABLET | PRO DOC LIMITEE | CANCELLED POST MARKET | DIN 02248846 |
| NOVO-MISOPROSTOL TABLETS | 100 MCG | TABLET | NOVOPHARM LIMITED | CANCELLED POST MARKET | DIN 02240754 |
| NOVO-MISOPROSTOL TABLETS | 200 MCG | TABLET | NOVOPHARM LIMITED | CANCELLED POST MARKET | DIN 02240755 |
| PMS-MISOPROSTOL (0.1MG) | 100 MCG | TABLET | PHARMASCIENCE INC | CANCELLED POST MARKET | DIN 02244124 |
| PMS-MISOPROSTOL (0.2MG) | 200 MCG | TABLET | PHARMASCIENCE INC | CANCELLED POST MARKET | DIN 02244125 |
Who else supplies MISOPROSTOL worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. MISOPROSTOL appears in 17 registered pack listings across 9 markets, published on 7 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.
Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.
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.
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.
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.
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.