Medicine
Zoledronic acid 4 mg/5 mL injection
Zoledronic acid 4 mg/5 mL injection is a generic prescription medicine for intravenous use, made by 13 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F).
Key facts
- Active ingredient (INN)
- Zoledronic acid
- Brand
- Sold under the generic name
- Strength
- 4 mg/5 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 vial of 5 mL, 5 mL and 14 more
- Manufacturers
- Dr. Reddy's LaboratoriesIndiaGland PharmaIndiaAccord HealthcareIndiaAuroMedics PharmaIndiaAvet PharmaceuticalsIndiaBPI LabsAvenacyBluePoint LaboratoriesFresenius KabiHikma Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- M05BA08 Zoledronic acid
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 4 March 2013
- Identifiers
- RxCUI 351114DailyMed set ID 00a5bd5a-e5ee-4bad-b510-a4d4485485c8, bbb29627-76b5-e742-0e79-ef3bf22021b8, f3f9de47-3d85-4d0c-a29e-1635cad3a970 +13NDC 23155-170, 43598-330, 63323-961 +14Application ANDA201783, ANDA091186, ANDA202923 +6
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 vial, glass in 1 carton / 5 mL in 1 vial, glass | 43598-233-11 | Dr. Reddy's LaboratoriesIndia | 21 August 2023 |
| 1 vial, glass in 1 carton / 5 mL in 1 vial, glass | 43598-330-11 | Dr. Reddy's LaboratoriesIndia | 19 August 2013 |
| 1 vial, glass in 1 carton / 5 mL in 1 vial, glass | 55111-685-07 | Dr. Reddy's LaboratoriesIndia | 4 March 2013 |
| 1 vial in 1 carton / 5 mL in 1 vial | 68083-116-01 | Gland PharmaIndia | 20 September 2013 |
| 1 vial, glass in 1 carton / 5 mL in 1 vial, glass | 68083-615-01 | Gland PharmaIndia | 8 November 2023 |
| 1 vial in 1 carton / 5 mL in 1 vial | 16729-242-31 | Accord HealthcareIndia | 16 October 2017 |
| 1 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose | 55150-266-05 | AuroMedics PharmaIndia | 26 September 2016 |
| 1 vial, glass in 1 carton / 5 mL in 1 vial, glass | 23155-170-31 | Avet PharmaceuticalsIndia | 31 August 2023 |
| 1 vial in 1 carton / 5 mL in 1 vial | 54288-100-01 | BPI Labs | 2 April 2018 |
| 1 vial, glass in 1 carton / 5 mL in 1 vial, glass | 54288-183-01 | BPI Labs | 5 June 2025 |
| 1 vial in 1 carton / 5 mL in 1 vial | 63323-961-98 | Fresenius Kabi | 4 September 2014 |
| 5 mL in 1 vial | 0143-9642-01 | Hikma Pharmaceuticals | 3 June 2013 |
| 1 vial in 1 carton / 5 mL in 1 vial | 67457-390-54 | Mylan Institutional | 10 March 2014 |
| 1 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose | 83634-801-05 | Avenacy | 15 January 2025 |
| 1 vial, glass in 1 carton / 5 mL in 1 vial, glass | 68001-610-25 | BluePoint Laboratories | 28 February 2024 |
| 1 vial, glass in 1 carton / 5 mL in 1 vial, glass | 72603-198-01 | Northstar RX | 1 November 2023 |
| 1 vial in 1 carton / 5 mL in 1 vial | 69367-190-50 | Westminster Pharmaceuticals | 2 February 2023 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Zoledronic acid
Clinical summary
Zoledronic acid is a bisphosphonate indicated for treatment and prevention of postmenopausal osteoporosis, among other approved uses. It is available as injection for intravenous use. MedsAcross supplies Zoledronic acid for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about Zoledronic acidFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Reclast prescribing information (Sandoz) · U.S. National Library of Medicine, DailyMed
- Aclasta: European public assessment report (EPAR) · European Medicines Agency
- Zometa: European public assessment report (EPAR) · European Medicines Agency
Need Zoledronic acid 4 mg/5 mL injection for your hospital or patient?
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