PDP-HYDROCODONE 5 MG / 5 ML — DIN 02324253
HYDROCODONE BITARTRATE : 5 MG / 5 ML · PENDOPHARM DIVISION OF PHARMASCIENCE INC · SYRUP · wholesale supply in Canada
Health Canada status: MARKETED
What is PDP-HYDROCODONE?
PDP-HYDROCODONE 5 MG / 5 ML contains HYDROCODONE BITARTRATE : 5 MG / 5 ML. It is listed in the Health Canada Drug Product Database under DIN 02324253, held by PENDOPHARM DIVISION OF PHARMASCIENCE INC, supplied as SYRUP for ORAL administration. Health Canada currently lists it as marketed, status dated 08-Jul-2016. 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.
Is there a generic Hydrocodone 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.
4 holders have a Canadian DIN containing Hydrocodone, across 5 DINs, of which 1 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 |
|---|---|---|---|---|
| PENDOPHARM DIVISION OF PHARMASCIENCE INC | 1 | 1 | PDP-HYDROCODONE | Sourceable in Canada |
| BRISTOL-MYERS SQUIBB CANADA | 2 | 0 | HYCODAN SYRUP, HYCODAN TABLETS | No marketed DIN |
| AYERST LABORATORIES | 1 | 0 | ROBIDONE SYR 1MG/ML | No marketed DIN |
| WYETH-AYERST CANADA INC. | 1 | 0 | ROBIDONE 1MG/ML SYR | 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 | 5 MG / 5 ML |
|---|---|
| Dosage form | SYRUP |
| Route | ORAL |
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 | Hydrocodone |
|---|---|
| ATC code | R05DA03 |
| 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) | 02324253 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2324253 |
| Brand name | PDP-HYDROCODONE |
| Generic / active ingredient | HYDROCODONE BITARTRATE : 5 MG / 5 ML |
| Market authorization holder | PENDOPHARM DIVISION OF PHARMASCIENCE INC |
| Health Canada schedule | NARCOTICS (CDSA I) |
| ATC code | R05DA03 |
| ATC anatomical main group | R — Respiratory system |
| ATC therapeutic subgroup | R05DA |
| Current status | MARKETED |
| Status date | 08-Jul-2016 |
| 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
1 of 5 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| HYCODAN SYRUP | 5 MG / 5 ML | SYRUP | BRISTOL-MYERS SQUIBB CANADA | CANCELLED POST MARKET | 01916580 |
| HYCODAN TABLETS | 5 MG | TABLET | BRISTOL-MYERS SQUIBB CANADA | CANCELLED POST MARKET | 01916599 |
| ROBIDONE 1MG/ML SYR | 1 MG | SYRUP | WYETH-AYERST CANADA INC. | CANCELLED POST MARKET | 02041677 |
| ROBIDONE SYR 1MG/ML | 1 MG | SYRUP | AYERST LABORATORIES | CANCELLED POST MARKET | 01923366 |
2 · Same class — other molecules in ATC R05DA
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Combinations | ACTIFED DM SYRUP · ACTIFED DM TABLETS · ANTITUSSIVE DECONG ANTIHISTAMINE SYR · BALMINIL DM + DECONGESTANT · +146 more | 165 | 11 | Yes |
| Dextromethorphan | ADULT HONEY WORKS · BALMINIL DM · BALMINIL DM (3MG/ML SUCROSE FREE) · BALMINIL DM CHILDREN · +75 more | 84 | 10 | Yes |
| Codeine | CODEINE 15 · CODEINE 30 · CODEINE CONTIN 100MG CONTROLLED RELEASE TAB · CODEINE CONTIN 150MG CONTROLLED RELEASE TAB · +17 more | 24 | 9 | Yes |
| Hydrocodone | HYCODAN SYRUP · HYCODAN TABLETS · PDP-HYDROCODONE · ROBIDONE 1MG/ML SYR · +1 more | 5 | 1 | 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 R05D
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| R05DB | Clofedanol | 1 | 1 |
4 · Fixed-dose combinations with Canadian supply
| Product | Active ingredients | Holder | Status | DIN |
|---|---|---|---|---|
| CODEINE CONTIN 100MG CONTROLLED RELEASE TAB | CODEINE (CODEINE MONOHYDRATE, CODEINE SULFATE TRIHYDRATE) : 100 MG | PURDUE PHARMA | MARKETED | 02163748 |
| CODEINE CONTIN 150MG CONTROLLED RELEASE TAB | CODEINE (CODEINE MONOHYDRATE, CODEINE SULFATE TRIHYDRATE) : 150 MG | PURDUE PHARMA | MARKETED | 02163780 |
| CODEINE CONTIN 200MG CONTROLLED RELEASE TAB | CODEINE (CODEINE MONOHYDRATE, CODEINE SULFATE TRIHYDRATE) : 200 MG | PURDUE PHARMA | MARKETED | 02163799 |
| CODEINE CONTIN 50MG CONTROLLED RELEASE TAB | CODEINE (CODEINE MONOHYDRATE, CODEINE SULFATE TRIHYDRATE) : 50 MG | PURDUE PHARMA | MARKETED | 02230302 |
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?
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.