Drug
Who makes itraconazole?
13 companies list itraconazole as a human prescription drug, including under the names SPORANOX, Tolsura. Forms: capsule; capsule, coated pellets; capsule, gelatin coated; solution. 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 itraconazole
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Alembic Pharmaceuticals LimitedIndia | capsule | ANDAANDA206741 | 2 | 7 |
| Amneal Ireland LimitedIreland | capsule; solution | ANDAANDA205080, ANDA205573 | 2 | 1 |
| NATCO PHARMA LIMITEDIndia | solution | ANDAANDA212239 | 1 | 5 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | capsule | ANDAANDA205080 | 1 | 5 |
| Torrent Pharma, Inc.India | capsule | ANDAANDA209460 | 1 | 5 |
| Camber Pharmaceuticals, Inc.United States | solution | ANDAANDA212239 | 1 | 1 |
| Rising Pharma Holdings, Inc.United States | capsule | ANDAANDA205724 | 1 | 1 |
| ASCEND Therapeutics US, LLC | capsule, coated pellets | ANDAANDA208591 | 1 | 0 |
| AvPAK | capsule | ANDAANDA205080 | 1 | 0 |
| Janssen Pharmaceuticals, Inc. | capsule | NDANDA020083 | 1 | 0 |
| Mayne Pharma Commercial LLC. | capsule, gelatin coated | NDANDA208901 | 1 | 0 |
| NorthStar RxLLC | capsule, coated pellets | ANDAANDA208591 | 1 | 0 |
| Patriot Pharmaceuticals LLC | capsule | NDANDA020083 | 1 | 0 |
Bulk ingredient listings
- Alivus Life Sciences Limited · 1 NDC
- Aurore Pharmaceuticals Private LimitedIndia · 1 NDC
- Cohance Lifesciences LimitedIndia · 1 NDC
- Darmerica, LLCUnited States · 1 NDC
- Derivados Quimicos SAUSpain · 1 NDC
- EVEREST ORGANICS LIMITEDIndia · 1 NDC
- Janssen Pharmaceuticals, Inc. · 1 NDC
- Kalchem International Inc.United States · 1 NDC
- LETCO MEDICAL, LLCUnited States · 1 NDC
- MEDISCA Inc.United States · 1 NDC
- Matrix Pharmacorp Private LimitedIndia · 1 NDC
- Neuland Laboratories LimitedIndia · 1 NDC
- QUIMICA SINTETICA SASpain · 1 NDC
- SMS Pharmaceuticals LimitedIndia · 1 NDC
- Smilax Laboratories LimitedIndia · 1 NDC
- Spectrum Pharmaceuticals, Inc.United States · 1 NDC
- Vasudha Pharma Chem LimitedIndia · 1 NDC
- W. R. GRACE & CO.-CONN.United States · 1 NDC
Orange Book patents
6 unexpired patents list itraconazole as the active ingredient, expiring between Oct 2028 and Jun 2033. Application holders: MAYNE PHARMA INTERNATIONAL PTY LTD, SEBELA IRELAND LTD.
Enquiry
Common questions
- Who makes itraconazole?
- 13 companies list itraconazole as a human prescription drug in the openFDA NDC Directory, led by Alembic Pharmaceuticals Limited, Amneal Ireland Limited, NATCO PHARMA LIMITED, Pharma Packaging Solutions, LLC dba Tjoapack, LLC, Torrent Pharma, Inc.. 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 SPORANOX?
- 10 companies list itraconazole under an abbreviated new drug application (ANDA), the application type used for generics, and 3 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies itraconazole active ingredient?
- 18 companies list itraconazole as a bulk ingredient, including Alivus Life Sciences Limited, Aurore Pharmaceuticals Private Limited, Cohance Lifesciences Limited, Darmerica, LLC.