ZOLEDRONIC ACID FOR INJECTION CONCENTRATE 4 MG / 5 ML — DIN 02413701
ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) : 4 MG / 5 ML · OMEGA LABORATORIES LIMITED · SOLUTION · wholesale supply in Canada
Health Canada status: CANCELLED POST MARKET
What is ZOLEDRONIC ACID FOR INJECTION CONCENTRATE?
ZOLEDRONIC ACID FOR INJECTION CONCENTRATE 4 MG / 5 ML contains ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) : 4 MG / 5 ML. It is listed in the Health Canada Drug Product Database under DIN 02413701, held by OMEGA LABORATORIES LIMITED, supplied as SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as cancelled post market, status dated 29-Jul-2026. 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 ZOLEDRONIC ACID FOR INJECTION CONCENTRATE used for?
Treatment of Tumour-Induced Hypercalcemia (cCa ≥ 12.0 mg/dL) and bone metastases from solid tumours or osteolytic lesions of multiple myeloma.
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 Zoledronic Acid 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.
17 holders have a Canadian DIN containing Zoledronic Acid, across 26 DINs, of which 9 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 |
|---|---|---|---|---|
| SANDOZ CANADA INCORPORATED | 3 | 2 | ACLASTA, ZOLEDRONIC ACID - A, ZOLEDRONIC ACID - Z | Sourceable in Canada |
| DR REDDY'S LABORATORIES LTD | 2 | 2 | ZOLEDRONIC ACID FOR INJECTION CONCENTRATE, ZOLEDRONIC ACID INJECTION | Sourceable in Canada |
| MARCAN PHARMACEUTICALS INC | 2 | 1 | ZOLEDRONIC ACID FOR INJECTION, ZOLEDRONIC ACID INJECTION | Sourceable in Canada |
| NOVARTIS PHARMACEUTICALS CANADA INC | 2 | 1 | ZOMETA CONCENTRATE, ZOMETA LYOPHILIZED POWDER | Sourceable in Canada |
| TARO PHARMACEUTICALS INC | 2 | 1 | TARO-ZOLEDRONIC ACID, TARO-ZOLEDRONIC ACID CONCENTRATE | Sourceable in Canada |
| FRESENIUS KABI CANADA LTD | 1 | 1 | ZOLEDRONIC ACID FOR INJECTION | Sourceable in Canada |
| JAMP PHARMA CORPORATION | 1 | 1 | JAMP-ZOLEDRONIC ACID | Sourceable in Canada |
| ACTAVIS PHARMA COMPANY | 2 | 0 | ACT ZOLEDRONIC ACID, ACT ZOLEDRONIC ACID CONCENTRATE | No marketed DIN |
| PFIZER CANADA ULC | 2 | 0 | ZOLEDRONIC ACID FOR INJECTION, ZOLEDRONIC ACID INJECTION A | No marketed DIN |
| TEVA CANADA LIMITED | 2 | 0 | ZOLEDRONIC ACID FOR INJECTION, ZOLEDRONIC ACID INJECTION | No marketed DIN |
| APOTEX INC | 1 | 0 | ZOLEDRONIC ACID CONCENTRATE | No marketed DIN |
| OMEGA LABORATORIES LIMITED | 1 | 0 | ZOLEDRONIC ACID FOR INJECTION CONCENTRATE | 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 | 4 MG / 5 ML |
|---|---|
| Dosage form | SOLUTION |
| Route | INTRAVENOUS |
| Pack configuration (monograph) | 4 mg/5 mL concentrate in vials (implied by 'Concentrate' and '5 mL' strength). |
| Storage | Not explicitly detailed in the provided text snippet (refer to STORAGE AND STABILITY section on page 32). |
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 | Zoledronic Acid |
|---|---|
| ATC code | M05BA08 |
| AHFS class | 92:24.00 |
| 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) | 02413701 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2413701 |
| Brand name | ZOLEDRONIC ACID FOR INJECTION CONCENTRATE |
| Generic / active ingredient | ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) : 4 MG / 5 ML |
| Market authorization holder | OMEGA LABORATORIES LIMITED |
| Health Canada schedule | Prescription |
| ATC code | M05BA08 |
| ATC anatomical main group | M — Musculo-skeletal system |
| ATC therapeutic subgroup | M05BA |
| Current status | CANCELLED POST MARKET |
| Status date | 29-Jul-2026 |
| Original market date | 2014-04-04 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
Administer as a single-dose IV infusion over no less than 15 minutes. Dose for TIH is 4 mg. For bone metastases, dose is 4 mg (adjusted for renal impairment) every 3-4 weeks.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Hypersensitivity to zoledronic acid or bisphosphonates; non-corrected hypocalcemia at time of infusion; pregnancy and breast-feeding.
Warnings and precautions
Serious risks: Osteonecrosis of the jaw (ONJ), deterioration in renal function (may progress to failure), and hypocalcemia. Single doses must not exceed 4 mg.
Is Zoledronic Acid in shortage in Canada?
A Canadian shortage report is on file for a product containing this molecule: Active — reported by FRESENIUS KABI CANADA LTD, last seen 04 Sep 2026. A shortage on one presentation does not always affect every DIN of the molecule — the alternatives below list what else is marketed in Canada. Nexara can confirm current availability and identify substitutions or import options where permitted.
Check availability for ZOLEDRONIC ACID FOR INJECTION CONCENTRATE
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
9 of 26 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| ACLASTA | 5 MG / 100 ML | SOLUTION | SANDOZ CANADA INCORPORATED | MARKETED | 02269198 |
| JAMP-ZOLEDRONIC ACID | 4 MG / 5 ML | SOLUTION | JAMP PHARMA CORPORATION | MARKETED | 02482525 |
| TARO-ZOLEDRONIC ACID CONCENTRATE | 4 MG / 5 ML | SOLUTION | TARO PHARMACEUTICALS INC | MARKETED | 02415186 |
| ZOLEDRONIC ACID - Z | 4 MG / 5 ML | SOLUTION | SANDOZ CANADA INCORPORATED | MARKETED | 02401606 |
| ZOLEDRONIC ACID FOR INJECTION | 4 MG / 5 ML | SOLUTION | FRESENIUS KABI CANADA LTD | MARKETED | 02434458 |
| ZOLEDRONIC ACID FOR INJECTION | 4 MG / 5 ML | SOLUTION | MARCAN PHARMACEUTICALS INC | MARKETED | 02472805 |
| ZOLEDRONIC ACID FOR INJECTION CONCENTRATE | 4 MG / 5 ML | SOLUTION | DR REDDY'S LABORATORIES LTD | MARKETED | 02422425 |
| ZOLEDRONIC ACID INJECTION | 5 MG / 100 ML | SOLUTION | DR REDDY'S LABORATORIES LTD | MARKETED | 02422433 |
| ZOMETA CONCENTRATE | 4 MG / 5 ML | SOLUTION | NOVARTIS PHARMACEUTICALS CANADA INC | MARKETED | 02248296 |
| ACT ZOLEDRONIC ACID | 5 MG / 100 ML | SOLUTION | ACTAVIS PHARMA COMPANY | CANCELLED PRE MARKET | 02408449 |
2 · Same class — other molecules in ATC M05BA
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Risedronic Acid | AA-RISEDRONATE DR · ACTONEL · ACTONEL DR · APO-RISEDRONATE · AURO-RISEDRONATE · DOM-RISEDRONATE · JAMP-RISEDRONATE · MYLAN-RISEDRONATE · NB-RISEDRONATE · NTP-RISEDRONATE · PENDO-RISEDRONATE · PHL-RISEDRONATE · PMS-RISEDRONATE · Q-RISEDRONATE · RATIO-RISEDRONATE · RISEDRONATE · RIVA-RISEDRONATE · SANDOZ RISEDRONATE · TEVA-RISEDRONATE | 40 | 20 | Yes |
| Alendronic Acid | ACCEL-ALENDRONATE · ACH-ALENDRONATE · ACT ALENDRONATE · AG-ALENDRONATE · AG-ALENDRONATE SODIUM · ALENDRONATE · ALENDRONATE-10 · ALENDRONATE-40 · ALENDRONATE-5 · ALENDRONATE-70 · APO-ALENDRONATE · AURO-ALENDRONATE · AVA-ALENDRONATE · DOM-ALENDRONATE · DOM-ALENDRONATE-FC · FOSAMAX · GEN-ALENDRONATE · JAMP ALENDRONATE SODIUM · JAMP-ALENDRONATE · M-ALENDRONATE · MINT-ALENDRONATE · MYLAN-ALENDRONATE · NRA-ALENDRONATE · PHL-ALENDRONATE · PMS-ALENDRONATE · PMS-ALENDRONATE-FC · Q-ALENDRONATE · RAN-ALENDRONATE · RATIO ALENDRONATE · RIVA ALENDRONATE · RIVA-ALENDRONATE · RIVA-ALENDRONATE FC · SANDOZ ALENDRONATE · TEVA-ALENDRONATE · VAN-ALENDRONATE | 79 | 17 | Yes |
| Zoledronic Acid | ACLASTA · ACT ZOLEDRONIC ACID · ACT ZOLEDRONIC ACID CONCENTRATE · JAMP-ZOLEDRONIC ACID · PMS-ZOLEDRONIC ACID · TARO-ZOLEDRONIC ACID · TARO-ZOLEDRONIC ACID CONCENTRATE · VAL-ZOLEDRONIC ACID · ZOLEDRONIC ACID - A · ZOLEDRONIC ACID - Z · ZOLEDRONIC ACID CONCENTRATE · ZOLEDRONIC ACID CONCENTRATE FOR INJECTION · ZOLEDRONIC ACID FOR INJECTION · ZOLEDRONIC ACID FOR INJECTION CONCENTRATE · ZOLEDRONIC ACID INJECTION · ZOLEDRONIC ACID INJECTION A · ZOMETA CONCENTRATE · ZOMETA LYOPHILIZED POWDER | 26 | 9 | Yes |
| Pamidronic Acid | AREDIA · AREDIA 30MG · AREDIA 90MG · AREDIA LIQ INJ 3MG/ML · PAMIDRONATE DISODIUM FOR INJECTION · PAMIDRONATE DISODIUM OMEGA 3 MG/ML · PAMIDRONATE DISODIUM OMEGA 6 MG/ML · PAMIDRONATE DISODIUM OMEGA 9 MG/ML · PMS-PAMIDRONATE · VAL-PAMIDRONATE DISODIUM | 23 | 8 | Yes |
| Clodronic Acid | BONEFOS · CLASTEON · OSTAC CAP 400MG | 4 | 1 | Yes |
| Etidronic Acid | ACT ETIDRONATE · APO-ETIDRONATE · DIDRONEL INJ 50MG/ML · DIDRONEL TAB 200MG · ETIDRONATE · MYLAN-ETIDRONATE | 9 | 0 | Not in Canada |
| Ibandronic Acid | BONDRONAT | 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 M05B
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| M05BX | Burosumab · Denosumab · Romosozumab | 9 | 8 |
| M05BB | Alendronic Acid And Cholecalciferol · Etidronic Acid And Calcium, Sequential · Risedronic Acid And Calcium, Sequential · Risedronic Acid, Calcium And Cholecalciferol, Sequential | 22 | 6 |
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 ZOLEDRONIC ACID FOR INJECTION CONCENTRATE called?
The same molecule, Zoledronic Acid, is registered under other names elsewhere. Buyers and prescribers searching from outside Canada — or working from a foreign prescription or tender document — often know it by one of these:
| Name | Script | Registered in |
|---|---|---|
| ZOMABON | Latin | South Africa |
Names are taken from national medicine registers and published price lists. A product registered abroad is not authorized for sale in Canada unless it holds its own DIN; import is possible only through the routes Health Canada permits.
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.