Drug
Who makes ursodiol?
27 companies list ursodiol as a human prescription drug, including under the names Urso 250, Urso Forte, Reltone 200 mg, Reltone 400 mg, URSOLIGN. Forms: capsule; tablet; tablet, film coated. Routes: oral.
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 ursodiol
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Bryant Ranch PrepackUnited States | capsule; tablet, film coated | ANDAANDA075517, ANDA202540, ANDA214849 | 6 | 1 |
| Zydus Lifesciences LimitedIndia | capsule; tablet | ANDAANDA211145, ANDA214295 | 3 | 12 |
| Strides Pharma Science LimitedIndia | capsule; tablet | ANDAANDA210344, ANDA213504 | 3 | 5 |
| Zydus Pharmaceuticals USA Inc.India | capsule; tablet | ANDAANDA211145, ANDA214295 | 3 | 1 |
| Glenmark Pharmaceuticals Inc., USAIndia | tablet | ANDAANDA090801 | 2 | 9 |
| Allergan, Inc.United States | tablet, film coated | NDANDA020675 | 2 | 7 |
| Par Health USA, LLCIndia | tablet, film coated | ANDAANDA202540 | 2 | 5 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | capsule; tablet | ANDAANDA079082, ANDA211145 | 2 | 5 |
| AvKARE | capsule; tablet, film coated | ANDA, NDA AUTHORIZED GENERICANDA202540, NDA019594 | 2 | 0 |
| AvPAK | capsule | ANDAANDA211301, ANDA214295 | 2 | 0 |
| BluePoint Laboratories Inc. | tablet | ANDAANDA090801 | 2 | 0 |
| FH2 Pharma LLC | capsule | ANDAANDA205789 | 2 | 0 |
| Intra-Sana Laboratories | capsule | ANDAANDA205789 | 2 | 0 |
| MAJOR Pharmaceuticals Inc. | capsule; tablet, film coated | ANDAANDA075517, ANDA202540 | 2 | 0 |
| PuraCap Laboratories LLC dba Blu Pharmaceuticals | capsule | ANDAANDA075517 | 2 | 0 |
| Cardinal Health 418, Inc.United States | tablet, film coated | ANDAANDA202540 | 1 | 34 |
| Aurobindo Pharma LimitedIndia | capsule | ANDAANDA214849 | 1 | 6 |
| LAURUS LABS LIMITEDIndia | capsule | ANDAANDA213200 | 1 | 5 |
| Epic Laboratories, LLCUnited States | capsule | ANDAANDA075517 | 1 | 3 |
| Actavis LLCUnited States | capsule | NDA AUTHORIZED GENERICNDA019594 | 1 | 1 |
| Golden State Medical Supply Inc.United States | capsule | ANDAANDA210344 | 1 | 1 |
| Lannett Company, LLCUnited States | capsule | ANDAANDA079082 | 1 | 1 |
| Amneal Pharmaceuticals NY LLC | capsule | ANDAANDA211301 | 1 | 0 |
| Chartwell RX, LLC. | capsule | ANDAANDA213555 | 1 | 0 |
| Northstar Rx, LLC, | capsule | ANDAANDA214849 | 1 | 0 |
| Pangea Pharmaceuticals, LLC | capsule | ANDAANDA210344 | 1 | 0 |
| VGYAAN Pharmaceuticals LLC | capsule | ANDAANDA214329 | 1 | 0 |
Bulk ingredient listings
- Dipharma Francis SrlItaly · 4 NDC
- Alivus Life Sciences Limited · 1 NDC
- Arch Pharmalabs LimitedIndia · 1 NDC
- Fagron Services B.V.Netherlands · 1 NDC
- ICE SpAItaly · 1 NDC
- Kalchem International Inc.United States · 1 NDC
- LETCO MEDICAL, LLCUnited States · 1 NDC
- MEDISCA Inc.United States · 1 NDC
- Professional Compounding Centers of America dba PCCAUnited States · 1 NDC
- Sichuan Xieli Pharmaceutical Co LtdChina · 1 NDC
- Spectrum Pharmaceuticals, Inc.United States · 1 NDC
Enquiry
Common questions
- Who makes ursodiol?
- 27 companies list ursodiol as a human prescription drug in the openFDA NDC Directory, led by Bryant Ranch Prepack, Zydus Lifesciences Limited, Strides Pharma Science Limited, Zydus Pharmaceuticals USA Inc., Glenmark Pharmaceuticals Inc., USA. 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 Urso 250?
- 25 companies list ursodiol under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies ursodiol active ingredient?
- 11 companies list ursodiol as a bulk ingredient, including Dipharma Francis Srl, Alivus Life Sciences Limited, Arch Pharmalabs Limited, Fagron Services B.V..