Drug
Who makes zoledronic acid?
18 companies list zoledronic acid as a human prescription drug, including under the names Reclast. Forms: injection; injection, solution; injection, solution, concentrate. Routes: intravenous.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing zoledronic acid
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Dr. Reddy's Laboratories LimitedIndia | injection, solution; injection, solution, concentrate | ANDAANDA091186, ANDA091363, ANDA204344 | 6 | 15 |
| GLAND PHARMA LIMITEDIndia | injection; injection, solution; injection, solution, concentrate | ANDAANDA202930, ANDA204217, ANDA205749 | 6 | 4 |
| BluePoint Laboratories Inc. | injection; injection, solution, concentrate | ANDAANDA201783, ANDA205279, ANDA209578 | 3 | 0 |
| Mylan Institutional Inc. | injection, solution; injection, solution, concentrate | ANDAANDA202650, ANDA203841, ANDA205254 | 3 | 0 |
| Fresenius Kabi USA, LLCUnited States | injection; injection, solution | ANDAANDA202923, ANDA204217 | 2 | 6 |
| BPI Labs, DBA Ally LabsUnited States | injection, solution, concentrate | ANDAANDA202930, ANDA207341 | 2 | 2 |
| Sagent Pharmaceuticals | injection, solution | ANDA, NDAANDA202828, NDA203231 | 2 | 0 |
| Sandoz Industrial Products S.AAustria | injection, solution | NDANDA021817 | 1 | 5 |
| Hikma Pharmaceuticals USA Inc.United States | injection, solution, concentrate | ANDAANDA202182 | 1 | 4 |
| ACCORD HEALTHCARE LIMITEDUnited Kingdom | injection | ANDAANDA205279 | 1 | 2 |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.United States | injection, solution, concentrate | ANDAANDA201783 | 1 | 1 |
| AuroMedics Pharma LLC | injection, solution, concentrate | ANDAANDA207751 | 1 | 0 |
| Avenacy, Inc. | injection, solution, concentrate | ANDAANDA201783 | 1 | 0 |
| Eugia US LLC | injection, solution | ANDAANDA209125 | 1 | 0 |
| Fosun Pharma USA Inc. | injection | ANDAANDA209578 | 1 | 0 |
| Meitheal Pharmaceuticals, Inc. | injection, solution | ANDAANDA213371 | 1 | 0 |
| Northstar Rx, LLC, | injection, solution, concentrate | ANDAANDA201783 | 1 | 0 |
| Westminster Pharmaceuticals, LLC | injection | ANDAANDA202923 | 1 | 0 |
Bulk ingredient listings
- Emcure Pharmaceuticals LimitedIndia · 2 NDC
- Assia Chemical Industries Ltd. - Teva Tech SiteIsrael · 1 NDC
- GADOR S.A.Argentina · 1 NDC
- Hetero Labs LimitedIndia · 1 NDC
- Jubilant Biosys LimitedIndia · 1 NDC
- Maprimed S.A.Argentina · 1 NDC
- NATCO PHARMA LIMITEDIndia · 1 NDC
- SHILPA PHARMA LIFESCIENCES LIMITEDIndia · 1 NDC
- ScinoPharm Taiwan, Ltd.Taiwan · 1 NDC
- USV Private LimitedIndia · 1 NDC
- Yung Shin Pharmaceutical Ind. Co., Ltd. · 1 NDC
Orange Book patents
2 unexpired patents list zoledronic acid as the active ingredient, expiring between Feb 2028 and Aug 2028. Application holders: NOVARTIS PHARMACEUTICALS CORP, SANDOZ INC.
Enquiry
Common questions
- Who makes zoledronic acid?
- 18 companies list zoledronic acid as a human prescription drug in the openFDA NDC Directory, led by Dr. Reddy's Laboratories Limited, GLAND PHARMA LIMITED, BluePoint Laboratories Inc., Mylan Institutional Inc., Fresenius Kabi USA, LLC. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic Reclast?
- 17 companies list zoledronic acid under an abbreviated new drug application (ANDA), the application type used for generics, and 2 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies zoledronic acid active ingredient?
- 11 companies list zoledronic acid as a bulk ingredient, including Emcure Pharmaceuticals Limited, Assia Chemical Industries Ltd. - Teva Tech Site, GADOR S.A., Hetero Labs Limited.