TOLBUTAMIDE 500 MG — DIN 00312762
TOLBUTAMIDE : 500 MG · AA PHARMA INC · TABLET · wholesale supply in Canada
Health Canada status: DORMANT
What is TOLBUTAMIDE?
TOLBUTAMIDE 500 MG contains TOLBUTAMIDE : 500 MG. It is listed in the Health Canada Drug Product Database under DIN 00312762, held by AA PHARMA INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as dormant, status dated 24-Jul-2020. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A). This DIN is not currently being marketed in Canada, so it is sourced to order where a compliant route exists rather than held in stock.
What is TOLBUTAMIDE used for?
To control hyperglycemia in tolbutamide responsive diabetes mellitus of stable, mild, nonketosis prone, maturity onset or adult type which cannot be controlled by proper dietary management and exercise or when insulin therapy is not appropriate.
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 Tolbutamide 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 Tolbutamide, across 7 DINs, of which 0 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 |
|---|---|---|---|---|
| HOECHST CANADA INC. | 2 | 0 | ORINASE 0.5GM, ORINASE 1GM | No marketed DIN |
| AA PHARMA INC | 1 | 0 | TOLBUTAMIDE | No marketed DIN |
| CARTER-HORNER CORP. | 1 | 0 | MOBENOL TABLETS 500MG | No marketed DIN |
| DUCHESNAY INC | 1 | 0 | TOLBUTAMIDE TAB 500MG | No marketed DIN |
| NOVOPHARM LIMITED | 1 | 0 | NOVO-BUTAMIDE 500MG | No marketed DIN |
| PRO DOC LIMITEE | 1 | 0 | TOLBUTAMIDE TAB 500MG | 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 | 500 MG |
|---|---|
| Dosage form | TABLET |
| Route | ORAL |
| Pack configuration (monograph) | Bottles of 100 and 1000 tablets |
| Storage | Store at room temperature (15 to 30°C) in a tightly closed container. |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Tolbutamide |
|---|---|
| ATC code | A10BB03 |
| AHFS class | 40:28.20 |
| 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) | 00312762 |
|---|---|
| DIN (unpadded, as printed on some documents) | 312762 |
| Brand name | TOLBUTAMIDE |
| Generic / active ingredient | TOLBUTAMIDE : 500 MG |
| Market authorization holder | AA PHARMA INC |
| Health Canada schedule | Prescription |
| ATC code | A10BB03 |
| ATC anatomical main group | A — Alimentary tract and metabolism |
| ATC therapeutic subgroup | A10BB |
| Current status | DORMANT |
| Status date | 24-Jul-2020 |
| Original market date | 1974-12-31 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
0 of 7 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| MOBENOL TABLETS 500MG | 500 MG | TABLET | CARTER-HORNER CORP. | CANCELLED POST MARKET | 00013889 |
| NOVO-BUTAMIDE 500MG | 500 MG | TABLET | NOVOPHARM LIMITED | CANCELLED POST MARKET | 00021849 |
| ORINASE 0.5GM | 500 MG | TABLET | HOECHST CANADA INC. | CANCELLED POST MARKET | 00012602 |
| ORINASE 1GM | 1 G | TABLET | HOECHST CANADA INC. | CANCELLED POST MARKET | 00012610 |
| TOLBUTAMIDE TAB 500MG | 500 MG | TABLET | PRO DOC LIMITEE | CANCELLED POST MARKET | 00156663 |
| TOLBUTAMIDE TAB 500MG | 500 MG | TABLET | DUCHESNAY INC | CANCELLED POST MARKET | 00431168 |
2 · Same class — other molecules in ATC A10BB
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Gliclazide | AG-GLICLAZIDE MR · APO-GLICLAZIDE · APO-GLICLAZIDE MR · AVA-GLICLAZIDE · +17 more | 30 | 16 | Yes |
| Glibenclamide | APO GLYBURIDE TAB 2.5MG · APO GLYBURIDE TAB 5MG · AVA-GLYBURIDE · DIABETA · +24 more | 44 | 4 | Yes |
| Glimepiride | AMARYL · APO-GLIMEPIRIDE · CO GLIMEPIRIDE · NOVO-GLIMEPIRIDE · +3 more | 22 | 3 | Yes |
| Chlorpropamide | APO CHLORPROPAMIDE TAB 100MG · APO CHLORPROPAMIDE TAB 250MG · CHLORPROPAMIDE 100 TAB USP · CHLORPROPAMIDE TAB 250MG · +3 more | 8 | 0 | Not in Canada |
| Tolbutamide | MOBENOL TABLETS 500MG · NOVO-BUTAMIDE 500MG · ORINASE 0.5GM · ORINASE 1GM · +2 more | 7 | 0 | Not in Canada |
| Acetohexamide | DIMELOR TABLET 1843 500MG | 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 A10B
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| A10BD | Combinations Of Oral Blood Glucose Lowering Drugs · Glimepiride And Rosiglitazone · Linagliptin And Empagliflozin · Metformin And Alogliptin · Metformin And Canagliflozin · +8 more | 123 | 67 |
| A10BH | Alogliptin · Linagliptin · Saxagliptin · Sitagliptin | 91 | 63 |
| A10BA | Metformin | 122 | 45 |
| A10BK | Canagliflozin · Dapagliflozin · Empagliflozin · Ertugliflozin | 42 | 30 |
| A10BX | Nateglinide · Repaglinide · Tirzepatide | 54 | 30 |
| A10BG | Pioglitazone · Rosiglitazone | 98 | 15 |
| A10BJ | Albiglutide · Dulaglutide · Exenatide · Liraglutide · Lixisenatide · +1 more | 34 | 13 |
| A10BF | Acarbose | 6 | 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 TOLBUTAMIDE called?
Also recorded in Canada as: tolbutamide 500 MG Oral Tablet (US).
How can I get it?
This DIN is dormant — it holds a Health Canada authorization but is not currently being marketed in Canada, so it cannot simply be ordered from Canadian stock. Where a patient need exists, supply may be possible through exceptional importation or the Special Access Programme, subject to Health Canada's requirements and the prescriber's application. Nexara can advise on the route and on marketed alternatives.
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.