Medicine
Ibandronate 3 mg/3 mL injection
Ibandronate 3 mg/3 mL injection is a generic prescription medicine for intravenous use, made by 3 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 20° to 25°C (68° to 77°F), excursions permitted between 15° and 30°C…
Key facts
- Active ingredient (INN)
- Ibandronate
- Brand
- Sold under the generic name
- Strength
- 3 mg/3 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 syringe of 3 mL, 1 vial of 3 mL
- Manufacturers
- EugiaIndiaSun Pharmaceutical IndustriesIndiaApotex
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° and 30°C (59° and 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- M05BA06 Ibandronic acid
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 15 February 2014
- Identifiers
- RxCUI 904955, 904952DailyMed set ID be514be6-727a-4d6c-993b-52144f8e6de8, 9fad4982-95af-d711-f50a-867311835143, e81f2c5b-bead-48ac-be3e-016cf963d7edNDC 62756-218, 60505-6097, 55150-191Application ANDA090853, ANDA204222, ANDA205332
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 syringe, glass in 1 carton / 3 mL in 1 syringe, glass | 55150-191-83 | EugiaIndia | 19 August 2015 |
| 1 vial, single-dose in 1 carton / 3 mL in 1 vial, single-dose | 62756-218-40 | Sun Pharmaceutical IndustriesIndia | 15 February 2014 |
| 1 syringe, glass in 1 carton / 3 mL in 1 syringe, glass | 60505-6097-0 | Apotex | 13 January 2016 |
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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 16 May 2003 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
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 Ibandronate
Clinical summary
Ibandronate is a bisphosphonate indicated for the treatment and prevention of post-menopausal osteoporosis, among other approved uses. It is available as tablets and injection for oral and intravenous use. MedsAcross supplies Ibandronate 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 IbandronateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- IBANDRONATE SODIUM prescribing information (Bionpharma) · U.S. National Library of Medicine, DailyMed
Need Ibandronate 3 mg/3 mL injection for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.