TEVA-DOXYLAMINE/PYRIDOXINE DR 10 MG — DIN 02304503
PYRIDOXINE HYDROCHLORIDE : 10 MG DOXYLAMINE SUCCINATE : 10 MG · TEVA CANADA LIMITED · TABLET (DELAYED-RELEASE) · wholesale supply in Canada
Health Canada status: APPROVED
What is TEVA-DOXYLAMINE/PYRIDOXINE DR?
TEVA-DOXYLAMINE/PYRIDOXINE DR 10 MG contains PYRIDOXINE HYDROCHLORIDE : 10 MG DOXYLAMINE SUCCINATE : 10 MG. It is listed in the Health Canada Drug Product Database under DIN 02304503, held by TEVA CANADA LIMITED, supplied as TABLET (DELAYED-RELEASE) for ORAL administration. Health Canada currently lists it as approved, status dated 05-Oct-2017. 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.
Is there a generic Doxylamine, 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.
5 holders have a Canadian DIN containing Doxylamine, Combinations, across 5 DINs, of which 4 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 |
|---|---|---|---|---|
| ANALOG PHARMA CANADA INC. | 1 | 1 | ALOG-DOXYLAMINE/PYRIDOXINE | Sourceable in Canada |
| APOTEX INC | 1 | 1 | APO-DOXYLAMINE/B6 | Sourceable in Canada |
| DUCHESNAY INC | 1 | 1 | DICLECTIN | Sourceable in Canada |
| PHARMASCIENCE INC | 1 | 1 | PMS-DOXYLAMINE-PYRIDOXINE | Sourceable in Canada |
| TEVA CANADA LIMITED | 1 | 0 | TEVA-DOXYLAMINE/PYRIDOXINE DR | 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 | 10 MG |
|---|---|
| Dosage form | TABLET (DELAYED-RELEASE) |
| Route | ORAL |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Doxylamine, Combinations |
|---|---|
| ATC code | R06AA59 |
| AHFS class | 56:22.08 |
| 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) | 02304503 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2304503 |
| Brand name | TEVA-DOXYLAMINE/PYRIDOXINE DR |
| Generic / active ingredient | PYRIDOXINE HYDROCHLORIDE : 10 MG DOXYLAMINE SUCCINATE : 10 MG |
| Market authorization holder | TEVA CANADA LIMITED |
| Health Canada schedule | Prescription |
| ATC code | R06AA59 |
| ATC anatomical main group | R — Respiratory system |
| ATC therapeutic subgroup | R06AA |
| Current status | APPROVED |
| Status date | 05-Oct-2017 |
| 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
4 of 5 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| ALOG-DOXYLAMINE/PYRIDOXINE | 10 MG | TABLET (DELAYED-RELEASE) | ANALOG PHARMA CANADA INC. | MARKETED | 02552574 |
| APO-DOXYLAMINE/B6 | 10 MG | TABLET (DELAYED-RELEASE) | APOTEX INC | MARKETED | 02413248 |
| DICLECTIN | 10 MG | TABLET (DELAYED-RELEASE) | DUCHESNAY INC | MARKETED | 00609129 |
| PMS-DOXYLAMINE-PYRIDOXINE | 10 MG | TABLET (DELAYED-RELEASE) | PHARMASCIENCE INC | MARKETED | 02406187 |
2 · Same class — other molecules in ATC R06AA
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Diphenhydramine | AG-DIPHENHYDRAMINE 25 MG · AG-DIPHENHYDRAMINE 50 MG · ALLER-AIDE · ALLER-AIDE ELIXIR · +155 more | 183 | 51 | Yes |
| Dimenhydrinate | AG-DIMENHYDRINATE · ANTI-NAUSEANT · ANTI-NAUSEANT LIQUID GELS · ANTI-NAUSEANT TABLET · +56 more | 70 | 20 | Yes |
| Doxylamine, Combinations | ALOG-DOXYLAMINE/PYRIDOXINE · APO-DOXYLAMINE/B6 · DICLECTIN · PMS-DOXYLAMINE-PYRIDOXINE · +1 more | 5 | 4 | Yes |
| Diphenhydramine, Combinations | BENADRYL ALLERGY & SINUS · BUCKLEY'S NIGHTTIME COUGH & CONGESTION | 2 | 1 | Yes |
| Clemastine | TAVIST TABLETS 1MG | 1 | 0 | Not in Canada |
| Diphenylpyraline, Combinations | JAMP-COUGH SUPPOSITORIES ADULT | 1 | 0 | Not in Canada |
| Doxylamine | UNISOM-2 TABLETS | 1 | 0 | Not in Canada |
| Dimenhydrinate, Combinations | GRAVERGOL CAPSULES | 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 R06A
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| R06AX | Astemizole · Azatadine · Bilastine · Cyproheptadine · Desloratadine · +6 more | 84 | 38 |
| 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.
How can I get it?
This product is approved by Health Canada but not yet marketed in Canada, so there is no Canadian supply to draw on today. Nexara can tell you whether it has been launched, and can look at supply from other markets where a Canadian pack is not required or where importation is 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.