Active ingredient
Ibandronate
9 finished FDA listings contain Ibandronate as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- IBANDRONATE SODIUM
- Dosage forms
- Injection, Injection, Solution, Tablet, Tablet, Film Coated
- Routes
- Intravenous, Oral
- Manufacturers / labelers
- 9
- Strengths listed
- 150 mg/1 · 3 mg/3ml
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 115264
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 078948 | APOTEX INC | 2012-03-19 | 1 |
| ANDA 078998 | ORBION PHARMS | 2012-03-19 | 1 |
| ANDA 078997 | DR REDDYS LABS LTD | 2012-04-30 | 2 |
| ANDA 090853 | SUN PHARM | 2014-02-14 | 1 |
| ANDA 205332 | EUGIA PHARMA | 2015-08-19 | 1 |
| ANDA 204222 | APOTEX | 2015-10-16 | 1 |
| ANDA 204502 | AUROBINDO PHARMA | 2016-03-11 | 1 |
| ANDA 206887 | MACLEODS PHARMS | 2017-10-31 | 1 |
Official labeling on DailyMed
- IBANDRONATE SODIUM TABLET [BIONPHARMA INC.] · version 6 · 2026-08-27
- IBANDRONATE SODIUM TABLET [DR. REDDY'S LABORATORIES LIMITED] · version 24 · 2026-06-15
- IBANDRONATE SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] · version 12 · 2026-03-26
- IBANDRONATE SODIUM INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.] · version 6 · 2026-03-04
- IBANDRONATE SODIUM TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] · version 12 · 2026-03-03
- IBANDRONATE SODIUM INJECTION, SOLUTION [EUGIA US LLC] · version 11 · 2026-02-20
- IBANDRONATE SODIUM TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] · version 12 · 2026-01-30
- IBANDRONATE SODIUM INJECTION [APOTEX CORP.] · version 10 · 2026-01-16
- IBANDRONATE SODIUM TABLET [A-S MEDICATION SOLUTIONS] · version 1 · 2025-09-25
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.