DENTSPLY 4% PRILOCAINE AND EPINEPHRINE INJECTION 1:200,000 5 MCG — DIN 00519227
EPINEPHRINE (EPINEPHRINE BITARTRATE) : 5 MCG PRILOCAINE HYDROCHLORIDE : 40 MG · DENTSPLY CANADA LIMITED · SOLUTION · wholesale supply in Canada
Health Canada status: CANCELLED POST MARKET
What is DENTSPLY 4% PRILOCAINE AND EPINEPHRINE INJECTION 1:200,000?
DENTSPLY 4% PRILOCAINE AND EPINEPHRINE INJECTION 1:200,000 5 MCG contains EPINEPHRINE (EPINEPHRINE BITARTRATE) : 5 MCG PRILOCAINE HYDROCHLORIDE : 40 MG. It is listed in the Health Canada Drug Product Database under DIN 00519227, held by DENTSPLY CANADA LIMITED, supplied as SOLUTION for BLOCK/INFILTRATION administration. Health Canada currently lists it as cancelled post market, status dated 19-Jul-2012. 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.
What is DENTSPLY 4% PRILOCAINE AND EPINEPHRINE INJECTION 1:200,000 used for?
Indicated in dentistry for the production of local anesthesia by infiltration or nerve block.
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 Prilocaine, 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.
3 holders have a Canadian DIN containing Prilocaine, 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 |
|---|---|---|---|---|
| ASPEN PHARMACARE CANADA INC. | 2 | 2 | EMLA CREAM, EMLA PATCH | Sourceable in Canada |
| DENTSPLY CANADA LIMITED | 2 | 1 | 4% CITANEST FORTE DENTAL WITH EPINEPHRINE 1:200,000, DENTSPLY 4% PRILOCAINE AND EPINEPHRINE INJECTION 1:200,000 | Sourceable in Canada |
| NOVOCOL PHARMACEUTICAL OF CANADA INC | 1 | 1 | PRILOCAINE HCL 4% EPINEPH 1:200000INJ | Sourceable in Canada |
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 MCG |
|---|---|
| Dosage form | SOLUTION |
| Route | BLOCK/INFILTRATION |
| Pack configuration (monograph) | Dental cartridges (glass) for use with a syringe. |
| Storage | Cartridges should not be autoclaved. Avoid immersion in disinfectants. Store appropriately to protect from light and metal contact. |
Pack detail is kept as a regulatory record. This DIN is no longer authorized for sale in Canada, so Nexara does not quote this pack.
Substance and classification
| Active substance | Prilocaine, Combinations |
|---|---|
| ATC code | N01BB54 |
| AHFS class | 72:00.00 |
| 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) | 00519227 |
|---|---|
| DIN (unpadded, as printed on some documents) | 519227 |
| Brand name | DENTSPLY 4% PRILOCAINE AND EPINEPHRINE INJECTION 1:200,000 |
| Generic / active ingredient | EPINEPHRINE (EPINEPHRINE BITARTRATE) : 5 MCG PRILOCAINE HYDROCHLORIDE : 40 MG |
| Market authorization holder | DENTSPLY CANADA LIMITED |
| Health Canada schedule | Ethical |
| ATC code | N01BB54 |
| ATC anatomical main group | N — Nervous system |
| ATC therapeutic subgroup | N01BB |
| Current status | CANCELLED POST MARKET |
| Status date | 19-Jul-2012 |
| Original market date | 1968-12-31 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
Adults: 1-2 mL (40-80 mg) usually adequate; max 400 mg (10 mL) per procedure. Children <10 years: rarely more than 0.9-1 mL (36-40 mg). Inject slowly with frequent aspiration.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Known hypersensitivity to amide-type local anesthetics; congenital or idiopathic methemoglobinemia.
Warnings and precautions
Risk of dose-related toxicity and methemoglobinemia. Avoid intravascular injection. Epinephrine formulation contains sodium metabisulfite (allergic risk). Monitor CNS and cardiovascular signs.
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 |
|---|---|---|---|---|---|
| 4% CITANEST FORTE DENTAL WITH EPINEPHRINE 1:200,000 | 0.005 MG | SOLUTION | DENTSPLY CANADA LIMITED | MARKETED | 02347695 |
| EMLA CREAM | 2.5 % | CREAM | ASPEN PHARMACARE CANADA INC. | MARKETED | 00886858 |
| EMLA PATCH | 2.5 % | PATCH | ASPEN PHARMACARE CANADA INC. | MARKETED | 02057794 |
| PRILOCAINE HCL 4% EPINEPH 1:200000INJ | 40 MG | SOLUTION | NOVOCOL PHARMACEUTICAL OF CANADA INC | MARKETED | 00393746 |
2 · Same class — other molecules in ATC N01BB
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Lidocaine | AMNIOCENTESIS TRAY 1% · ANTECUBITAL CENT VENOUS CATHETERIZATION KIT · ARTHROGRAM TRAY 1% · ATELOCOLLAGEN IMPLANT · +39 more | 72 | 26 | Yes |
| Lidocaine, Combinations | 2% LIDOCAINE AND EPINEPHRINE 1:100,000 INJECTION USP · 5% XYLOCAINE MPF WITH GLUCOSE 7.5% INJECTION · ARROW CENTRAL VENOUS CATHETERIZATION KIT · ARROW MULTI-LUMEN CENTRAL VENOUS CATHETER KIT · +55 more | 72 | 16 | Yes |
| Articaine, Combinations | 4% ASTRACAINE DENTAL WITH EPINEPHRINE 1:200,000 (0.005MG/ML) · 4% ASTRACAINE DENTAL WITH EPINEPHRINE FORTE 1:100,000 (0.01MG/ML) · ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE INJECTION · ORABLOC 1:100,000 · +10 more | 18 | 12 | Yes |
| Bupivacaine | BUPIVACAINE HEAVY INJECTION BP · BUPIVACAINE HYDROCHLORIDE IN DEXTROSE INJECTION USP · BUPIVACAINE HYDROCHLORIDE INJECTION USP · BUPIVACAINE HYDROCHLORIDE INJECTION USP .25% · +12 more | 42 | 10 | Yes |
| Mepivacaine | 3% POLOCAINE DENTAL · CARBOCAINE 1% · CARBOCAINE 2% · CARBOCAINE 3% · +7 more | 15 | 7 | Yes |
| Ropivacaine | NAROPIN · NAROPIN INJ 7.5MG/ML · ROPIVACAINE HYDROCHLORIDE INJECTION · ROPIVACAINE HYDROCHLORIDE INJECTION USP · +2 more | 13 | 6 | Yes |
| Bupivacaine, Combinations | BUPIVACAINE HCL 0.5% AND EPINEPHRINE 1:200,000 INJECTION · MARCAINE · MARCAINE 0.5% AND EPINEPHRINE 1:200,000 LIQ · MARCAINE E · +5 more | 12 | 5 | Yes |
| Prilocaine, Combinations | 4% CITANEST FORTE DENTAL WITH EPINEPHRINE 1:200,000 · DENTSPLY 4% PRILOCAINE AND EPINEPHRINE INJECTION 1:200,000 · EMLA CREAM · EMLA PATCH · +1 more | 5 | 4 | Yes |
| Combinations | CETACAINE LIQUID · ORAQIX | 2 | 2 | Yes |
| Prilocaine | 4% CITANEST PLAIN DENTAL · DENTSPLY 4% PRILOCAINE HYDROCHLORIDE DENTAL INJECTION | 2 | 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 N01B
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| N01BA | Benzocaine · Chloroprocaine · Combinations,Of Anesthetics · Procaine · Tetracaine | 13 | 1 |
| N01BX | Phenol | 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.
Can this still be bought in Canada?
No. This Drug Identification Number is cancelled post 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.