TARO-ZOLEDRONIC ACID 5 MG / 100 ML
ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) : 5 MG / 100 ML · DIN 02415100 · TARO PHARMACEUTICALS INC
Health Canada status: CANCELLED POST MARKET
What is TARO-ZOLEDRONIC ACID?
TARO-ZOLEDRONIC ACID 5 MG / 100 ML contains ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) : 5 MG / 100 ML. It is listed in the Health Canada Drug Product Database under DIN 02415100, held by TARO PHARMACEUTICALS INC, supplied as SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as cancelled post market, status dated 04-Mar-2025. 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.
What is TARO-ZOLEDRONIC ACID used for?
Treatment of osteoporosis (postmenopausal, men, glucocorticoid-induced); prevention of postmenopausal osteoporosis; treatment of Paget’s disease of the bone.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
Product details and regulatory record
| DIN | 02415100 |
|---|---|
| Brand name | TARO-ZOLEDRONIC ACID |
| Generic / active ingredient | ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) : 5 MG / 100 ML |
| Manufacturer | TARO PHARMACEUTICALS INC |
| Strength | 5 MG / 100 ML |
| Dosage form | SOLUTION |
| Route of administration | INTRAVENOUS |
| Schedule | Prescription |
| ATC code | M05BA08 ZOLEDRONIC ACID |
| AHFS class | 92:24.00 |
| Biosimilar | No |
| Health Canada status | CANCELLED POST MARKET |
| Status date | 04-Mar-2025 |
| Original market date | 2014-04-02 00:00:00 |
How is it administered?
5 mg single dose infused intravenously in no less than 15 minutes. Ensure adequate hydration and calcium/vitamin D supplementation. Frequency is usually once-yearly.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not explicitly detailed in the provided text snippet (Table of Contents lists page 32, but text ends before then).
How is it supplied?
100 mL solution in a vial.
Contraindications
Hypersensitivity to zoledronic acid or bisphosphonates; severe renal impairment (CrCl <35 mL/min) or acute renal impairment; pregnancy and nursing mothers; non-corrected hypocalcasemia.
Warnings and precautions
Risk of renal failure, osteonecrosis of the jaw (ONJ), atypical femur fractures, serious atrial fibrillation, cerebrovascular accidents, and severe musculoskeletal pain.
Is ZOLEDRONIC ACID in shortage in Canada?
A Canadian shortage report is on file for 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.
What can be used instead?
Other Canadian products sharing ATC code M05BA08 ZOLEDRONIC ACID. 9 of 26 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.
| Product | Strength | Form | Manufacturer | Health Canada status | DIN |
|---|---|---|---|---|---|
| ACLASTA | 5 MG / 100 ML | SOLUTION | SANDOZ CANADA INCORPORATED | MARKETED | DIN 02269198 |
| JAMP-ZOLEDRONIC ACID | 4 MG / 5 ML | SOLUTION | JAMP PHARMA CORPORATION | MARKETED | DIN 02482525 |
| TARO-ZOLEDRONIC ACID CONCENTRATE | 4 MG / 5 ML | SOLUTION | TARO PHARMACEUTICALS INC | MARKETED | DIN 02415186 |
| ZOLEDRONIC ACID - Z | 4 MG / 5 ML | SOLUTION | SANDOZ CANADA INCORPORATED | MARKETED | DIN 02401606 |
| ZOLEDRONIC ACID FOR INJECTION | 4 MG / 5 ML | SOLUTION | FRESENIUS KABI CANADA LTD | MARKETED | DIN 02434458 |
| ZOLEDRONIC ACID FOR INJECTION | 4 MG / 5 ML | SOLUTION | MARCAN PHARMACEUTICALS INC | MARKETED | DIN 02472805 |
| ZOLEDRONIC ACID FOR INJECTION CONCENTRATE | 4 MG / 5 ML | SOLUTION | DR REDDY'S LABORATORIES LTD | MARKETED | DIN 02422425 |
| ZOLEDRONIC ACID INJECTION | 5 MG / 100 ML | SOLUTION | DR REDDY'S LABORATORIES LTD | MARKETED | DIN 02422433 |
| ZOMETA CONCENTRATE | 4 MG / 5 ML | SOLUTION | NOVARTIS PHARMACEUTICALS CANADA INC | MARKETED | DIN 02248296 |
| ACT ZOLEDRONIC ACID | 5 MG / 100 ML | SOLUTION | ACTAVIS PHARMA COMPANY | CANCELLED PRE MARKET | DIN 02408449 |
Who else supplies ZOLEDRONIC ACID worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. ZOLEDRONIC ACID appears in 176 registered pack listings across 11 markets, published on 9 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.
Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.
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.
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.
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.