Drug
Who makes budesonide?
32 companies list budesonide as a human prescription drug, including under the names Eohilia, PULMICORT FLEXHALER, PULMICORT RESPULES, Tarpeyo, Uceris. Forms: aerosol, foam; aerosol, powder; capsule; capsule, coated pellets; capsule, delayed release; inhalant; suspension; tablet, extended release; tablet, film coated, extended release. Routes: oral, rectal, respiratory (inhalation).
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 budesonide
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| International Medication Systems, Ltd.United States | aerosol, powder; inhalant; suspension | ANDA, NDAANDA077519, ANDA078202, ANDA211922 | 7 | 3 |
| AstraZeneca PLCUnited States | suspension | NDANDA020929 | 3 | 15 |
| Amneal Pharmaceuticals of New York, LLCIndia | capsule, delayed release; suspension | ANDAANDA078404, ANDA206200 | 3 | 14 |
| Sun Pharmaceutical Industries LimitedIndia | suspension | ANDAANDA211922 | 3 | 13 |
| CIPLA PHARMACEUTICALS LIMITEDIndia | inhalant | ANDAANDA205710 | 3 | 7 |
| Teva Pharmaceutical Industries Ltd.Canada | suspension | ANDAANDA077519, ANDA204548 | 3 | 6 |
| Exelan Pharmaceuticals, Inc. | inhalant | ANDAANDA205710 | 3 | 0 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | capsule, coated pellets; suspension | ANDAANDA206134, ANDA211922 | 2 | 5 |
| Padagis Israel Pharmaceuticals LtdUnited States | aerosol, foam; capsule | ANDA, NDAANDA215328, NDA021324 | 2 | 2 |
| Bryant Ranch PrepackUnited States | capsule; capsule, delayed release | ANDA, NDAANDA206200, NDA021324 | 2 | 1 |
| Preferred Pharmaceuticals Inc.United States | inhalant; suspension | ANDAANDA078404, ANDA205710 | 2 | 1 |
| Rising Pharma Holdings, Inc.United States | inhalant | ANDAANDA078202 | 2 | 1 |
| Rubicon Holdings Inc.CYM | aerosol, powder | NDANDA021949 | 2 | 1 |
| Chartwell RX, LLC. | suspension | ANDAANDA078202 | 2 | 0 |
| H2-Pharma, LLC | aerosol, powder | NDANDA021949 | 2 | 0 |
| Nephron Pharmaceuticals Corporation | inhalant | ANDAANDA078202 | 2 | 0 |
| Oceanside Pharmaceuticals. | aerosol, foam; tablet, extended release | NDA, NDA AUTHORIZED GENERICNDA203634, NDA205613 | 2 | 0 |
| Cardinal Health 418, Inc.United States | suspension | ANDAANDA077519 | 1 | 34 |
| Zydus Lifesciences LimitedIndia | capsule, coated pellets | ANDAANDA206134 | 1 | 12 |
| Takeda Pharmaceuticals U.S.A., Inc.Germany | suspension | NDANDA213976 | 1 | 7 |
| Aurobindo Pharma LimitedIndia | suspension | ANDAANDA216667 | 1 | 6 |
| Actavis LLCUnited States | tablet, film coated, extended release | ANDAANDA205457 | 1 | 1 |
| Amneal Ireland LimitedIreland | capsule, delayed release | ANDAANDA206200 | 1 | 1 |
| Golden State Medical Supply Inc.United States | capsule | NDANDA021324 | 1 | 1 |
| RemedyRepack, IncUnited States | capsule, coated pellets | ANDAANDA206134 | 1 | 1 |
| Zydus Pharmaceuticals USA Inc.India | capsule, coated pellets | ANDAANDA206134 | 1 | 1 |
| Calliditas Therapeutics AB | capsule, delayed release | NDANDA215935 | 1 | 0 |
| MAJOR Pharmaceuticals Inc. | capsule, coated pellets | ANDAANDA206134 | 1 | 0 |
| Mylan Pharmaceuticals, Inc. | tablet, film coated, extended release | ANDAANDA208851 | 1 | 0 |
| Northstar Rx, LLC, | capsule, coated pellets | ANDAANDA206134 | 1 | 0 |
| Salix Pharmaceuticals, Inc. | aerosol, foam | NDANDA205613 | 1 | 0 |
| Santarus, Inc.. | tablet, extended release | NDANDA203634 | 1 | 0 |
Bulk ingredient listings
- Farmabios S.p.A.Italy · 3 NDC
- Curia India Private LimitedItaly · 2 NDC
- Hubei Gedian Humanwell Pharmaceutical Co., LtdChina · 2 NDC
- Sterling Pharmaceutical Services, LLCUnited States · 2 NDC
- AARTI PHARMALABS LIMITEDIndia · 1 NDC
- AX Pharmaceutical CorpCanada · 1 NDC
- Amphastar Nanjing Pharmaceuticals, Inc.China · 1 NDC
- Aspen Oss B.V.Netherlands · 1 NDC
- CIPLA PHARMACEUTICALS LIMITEDIndia · 1 NDC
- Coral Drugs Private LimitedIndia · 1 NDC
- Darmerica, LLCUnited States · 1 NDC
- Henan Lihua Pharmaceutical Co LtdChina · 1 NDC
- Industriale Chimica SRLItaly · 1 NDC
- MEDISCA Inc.United States · 1 NDC
- MINAKEM Dunkerque ProductionFrance · 1 NDC
- SHAKTI LIFESCIENCE PRIVATE LIMITEDIndia · 1 NDC
- Sicor S.r.l. · 1 NDC
- Sicor de Mexico S.A. de C.V.Mexico · 1 NDC
- Spectrum Pharmaceuticals, Inc.United States · 1 NDC
- Sun Pharmaceutical Industries LimitedIndia · 1 NDC
- Symbiotica Speciality Ingredients Sdn. BhdMalaysia · 1 NDC
- Vamsi Labs LimitedIndia · 1 NDC
- Willow Birch Pharma, LLCUnited States · 1 NDC
- XENEX LABORATORIES INCCanada · 1 NDC
Orange Book patents
24 unexpired patents list budesonide as the active ingredient, expiring between Nov 2026 and Jan 2043. Application holders: CALLIDITAS THERAPEUTICS AB, SALIX PHARMACEUTICALS INC, SUN PHARMACEUTICAL INDUSTRIES INC, TAKEDA PHARMACEUTICALS USA INC.
Enquiry
Common questions
- Who makes budesonide?
- 32 companies list budesonide as a human prescription drug in the openFDA NDC Directory, led by International Medication Systems, Ltd., AstraZeneca PLC, Amneal Pharmaceuticals of New York, LLC, Sun Pharmaceutical Industries Limited, CIPLA PHARMACEUTICALS LIMITED. 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 Eohilia?
- 23 companies list budesonide under an abbreviated new drug application (ANDA), the application type used for generics, and 12 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies budesonide active ingredient?
- 24 companies list budesonide as a bulk ingredient, including Farmabios S.p.A., Curia India Private Limited, Hubei Gedian Humanwell Pharmaceutical Co., Ltd, Sterling Pharmaceutical Services, LLC.