DICLOFENAC MISOPROSTOL 75 MG — DIN 02405482
DICLOFENAC SODIUM : 75 MG MISOPROSTOL : 200 MCG · ABRI PHARMACEUTICALS INC · TABLET (ENTERIC-COATED) · wholesale supply in Canada
Health Canada status: CANCELLED PRE MARKET
What is DICLOFENAC MISOPROSTOL?
DICLOFENAC MISOPROSTOL 75 MG contains DICLOFENAC SODIUM : 75 MG MISOPROSTOL : 200 MCG. It is listed in the Health Canada Drug Product Database under DIN 02405482, held by ABRI PHARMACEUTICALS INC, supplied as TABLET (ENTERIC-COATED) for ORAL administration. Health Canada currently lists it as cancelled pre market, status dated 12-Sep-2017. 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.
Is there a generic Diclofenac, 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.
6 holders have a Canadian DIN containing Diclofenac, Combinations, across 12 DINs, of which 6 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 |
|---|---|---|---|---|
| GENMED A DIVISION OF PFIZER CANADA ULC | 2 | 2 | GD-DICLOFENAC/MISOPROSTOL 50, GD-DICLOFENAC/MISOPROSTOL 75 | Sourceable in Canada |
| PFIZER CANADA ULC | 2 | 2 | ARTHROTEC 50, ARTHROTEC 75 | Sourceable in Canada |
| PHARMASCIENCE INC | 2 | 2 | PMS-DICLOFENAC-MISOPROSTOL | Sourceable in Canada |
| ABRI PHARMACEUTICALS INC | 2 | 0 | DICLOFENAC MISOPROSTOL | No marketed DIN |
| ACTAVIS PHARMA COMPANY | 2 | 0 | ACT DICLO-MISO | No marketed DIN |
| SANDOZ CANADA INCORPORATED | 2 | 0 | SANDOZ DICLOFENAC MISOPROSTOL | 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 | 75 MG |
|---|---|
| Dosage form | TABLET (ENTERIC-COATED) |
| Route | ORAL |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Diclofenac, Combinations |
|---|---|
| ATC code | M01AB55 |
| 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) | 02405482 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2405482 |
| Brand name | DICLOFENAC MISOPROSTOL |
| Generic / active ingredient | DICLOFENAC SODIUM : 75 MG MISOPROSTOL : 200 MCG |
| Market authorization holder | ABRI PHARMACEUTICALS INC |
| Health Canada schedule | Prescription |
| ATC code | M01AB55 |
| ATC anatomical main group | M — Musculo-skeletal system |
| ATC therapeutic subgroup | M01AB |
| Current status | CANCELLED PRE MARKET |
| Status date | 12-Sep-2017 |
| Original market date | 2013-12-09 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
6 of 12 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| ARTHROTEC 50 | 50 MG | TABLET (DELAYED-RELEASE) | PFIZER CANADA ULC | MARKETED | 01917056 |
| ARTHROTEC 75 | 200 MCG | TABLET (DELAYED-RELEASE) | PFIZER CANADA ULC | MARKETED | 02229837 |
| GD-DICLOFENAC/MISOPROSTOL 50 | 200 MCG | TABLET (DELAYED-RELEASE) | GENMED A DIVISION OF PFIZER CANADA ULC | MARKETED | 02341689 |
| GD-DICLOFENAC/MISOPROSTOL 75 | 200 MCG | TABLET (DELAYED-RELEASE) | GENMED A DIVISION OF PFIZER CANADA ULC | MARKETED | 02341697 |
| PMS-DICLOFENAC-MISOPROSTOL | 75 MG | TABLET (DELAYED-RELEASE) | PHARMASCIENCE INC | MARKETED | 02413477 |
| PMS-DICLOFENAC-MISOPROSTOL | 50 MG | TABLET (DELAYED-RELEASE) | PHARMASCIENCE INC | MARKETED | 02413469 |
| ACT DICLO-MISO | 50 MG | TABLET (ENTERIC-COATED) | ACTAVIS PHARMA COMPANY | CANCELLED POST MARKET | 02397145 |
| ACT DICLO-MISO | 75 MG | TABLET (ENTERIC-COATED) | ACTAVIS PHARMA COMPANY | CANCELLED POST MARKET | 02397153 |
| DICLOFENAC MISOPROSTOL | 200 MCG | TABLET (ENTERIC-COATED) | ABRI PHARMACEUTICALS INC | CANCELLED PRE MARKET | 02405474 |
| SANDOZ DICLOFENAC MISOPROSTOL | 50 MG | TABLET | SANDOZ CANADA INCORPORATED | CANCELLED PRE MARKET | 02400596 |
2 · Same class — other molecules in ATC M01AB
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Diclofenac | APO-DICLO · APO-DICLO RAPIDE 50 MG TABLETS · APO-DICLO SR · AVA-DICLOFENAC · AVA-DICLOFENAC SR · CAMBIA · DICLOFENAC EC · DICLOFENAC ECT 25MG · DICLOFENAC K · DICLOFENAC SR · DICLOFENAC-SR · DICLOTEC · DOM-DICLOFENAC · DOM-DICLOFENAC-SR · NTP-DICLOFENAC POTASSIUM · NTP-DICLOFENAC SODIUM · NTP-DICLOFENAC SODIUM SR · NU-DICLO ENTERIC COATED TAB 25MG · NU-DICLO ENTERIC COATED TAB 50MG · NU-DICLO RAPIDE · NU-DICLO SR - SRT 100MG · NU-DICLO SR - SRT 75MG · PENTA-DICLOFENAC - 25MG · PENTA-DICLOFENAC - 50MG · PMS-DICLOFENAC · PMS-DICLOFENAC K · PMS-DICLOFENAC-SR · PRO-DICLO RAPIDE - 50 · PRO-DICLOFENAC · RHO-DICLOFENAC · RIVA-DICLOFENAC 100MG SR TABLETS · RIVA-DICLOFENAC 50MG TABLETS · RIVA-DICLOFENAC 75MG SR TABLETS · RIVA-DICLOFENAC-K 50MG TABLETS · SANDOZ DICLOFENAC · SANDOZ DICLOFENAC RAPIDE · SANDOZ-DICLOFENAC · SANDOZ-DICLOFENAC SR · TARO-DICLOFENAC TAB 25MG · TARO-DICLOFENAC TAB 50MG · TEVA-DICLOFENAC · TEVA-DICLOFENAC EC · TEVA-DICLOFENAC SR · TEVA-DICLOFENAC-K · VOLTAREN · VOLTAREN RAPIDE · VOLTAREN SR · VOLTAREN TAB 25MG | 74 | 15 | Yes |
| Ketorolac | APO-KETOROLAC · APO-KETOROLAC INJECTABLE · JAMP KETOROLAC · KETOROLAC TROMETHAMINE INJECTION USP · KETOROLAC TROMETHAMINE INJECTION, USP · MAR-KETOROLAC · MINT-KETOROLAC · NOVO-KETOROLAC - TAB 10MG · NU-KETOROLAC · RIVA-KETOROLAC 10 MG · TORADOL · TORADOL IM · TORADOL IM 30MG/ML · TORADOL INJ 10MG/ML · TORADOL TAB 10MG · WAYMADE-KETOROLAC TROMETHAMINE | 25 | 8 | Yes |
| Indometacin | APO-INDOMETHACIN · AURO-INDOMETHACIN · FTP-INDOMETHACIN · INDOCID CAP 25MG · INDOCID CAP 50MG · INDOCID SR 75MG · INDOCID SUP 100MG · INDOCID SUP 50MG · MINT-INDOMETHACIN · NOVO-METHACIN - 100MG SUP · NOVO-METHACIN - SUP 50MG · NTP-INDOMETHACIN · NU-INDO CAP 25MG · NU-INDO CAP 50MG · ODAN-INDOMETHACIN · PRO-INDO 25 CAP 25MG · PRO-INDO 50 CAP 50MG · RATIO-INDOMETHACIN · RHODACINE - CAP 25MG · RHODACINE - CAP 50MG · RHODACINE - SUP 50MG · TEVA-INDOMETHACIN | 31 | 7 | Yes |
| Diclofenac, Combinations | ACT DICLO-MISO · ARTHROTEC 50 · ARTHROTEC 75 · DICLOFENAC MISOPROSTOL · GD-DICLOFENAC/MISOPROSTOL 50 · GD-DICLOFENAC/MISOPROSTOL 75 · PMS-DICLOFENAC-MISOPROSTOL · SANDOZ DICLOFENAC MISOPROSTOL | 12 | 6 | Yes |
| Sulindac | APO-SULIN TAB 150MG · APO-SULIN TAB 200MG · CLINORIL TAB 150MG · CLINORIL TAB 200MG · NU-SULINDAC TAB 150MG · NU-SULINDAC TAB 200MG · PENTA-SULINDAC · SULINDAC-150 TAB 150MG · SULINDAC-200 TAB 200MG · TEVA-SULINDAC | 12 | 2 | Yes |
| Etodolac | ETODOLAC · GEN-ETODOLAC 200MG · GEN-ETODOLAC 300MG · NOVO-ETODOLAC 200 MG · NOVO-ETODOLAC 300 MG · TARO-ETODOLAC · TARO-ETODOLAC 200 MG · ULTRADOL - CAP 200MG · ULTRADOL - CAP 300MG | 12 | 0 | Not in Canada |
| Tolmetin | NOVO-TOLMETIN CAPSULES 400MG · TOLECTIN 200 TAB 200MG · TOLECTIN 400 CAP 400MG · TOLECTIN TAB 600MG | 4 | 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 M01A
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| M01AE | Fenoprofen · Flurbiprofen · Ibuprofen · Ibuprofen, Combinations · Ketoprofen · Naproxen · Naproxen And Diphenhydramine · Naproxen And Esomeprazole · Oxaprozin · Tiaprofenic Acid | 398 | 101 |
| M01AH | Celecoxib · Rofecoxib | 72 | 30 |
| M01AC | Meloxicam · Piroxicam · Tenoxicam | 67 | 14 |
| M01AG | Mefenamic Acid | 7 | 1 |
| M01AX | Nabumetone | 12 | 1 |
| M01AA | Oxyphenbutazone · Phenylbutazone · Phenylbutazone, Combinations | 7 | 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.
Can this still be bought in Canada?
No. This Drug Identification Number is cancelled pre 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.