Active ingredient
Budesonide
72 finished FDA listings contain Budesonide as their only active ingredient; 20 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- BUDESONIDE
- Dosage forms
- Aerosol, Foam, Aerosol, Powder, Capsule, Capsule, Coated Pellets, Capsule, Delayed Release, Inhalant, Spray, Metered, Suspension, Tablet, Extended Release, Tablet, Film Coated, Extended Release
- Routes
- Nasal, Oral, Rectal, Respiratory (Inhalation)
- Manufacturers / labelers
- 40
- Strengths listed
- .25 mg/2ml · .5 mg/2ml · 1 mg/2ml · 180 ug/1 · 2 mg/1 · 2 mg/10ml · 3 mg/1 · 32 ug/1 · 4 mg/1 · 9 mg/1 · 90 ug/1
- Brand names in FDA listings
- Budesonide Inhalation, Budesonide Inhalation Suspension, Eohilia, Pulmicort Flexhaler, Pulmicort Respules, Tarpeyo, Uceris
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 19831
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 |
|---|---|---|---|
| NDA 020929 | ASTRAZENECA | 2000-08-08 | 3 |
| NDA 021324 | PADAGIS US | 2001-10-02 | 3 |
| NDA 021949 | CHEPLAPHARM | 2006-07-12 | 7 |
| ANDA 077519 | TEVA PHARMS | 2008-11-18 | 6 |
| ANDA 078202 | NEPHRON | 2009-03-30 | 7 |
| ANDA 078404 | IMPAX LABS INC | 2012-07-31 | 3 |
| NDA 203634 | SALIX | 2013-01-14 | 2 |
| ANDA 078949 | APOTEX | 2014-05-12 | 6 |
| NDA 205613 | SALIX | 2014-10-07 | 2 |
| ANDA 204548 | TEVA PHARMS USA | 2016-03-08 | 1 |
| ANDA 206134 | ZYDUS PHARMS | 2017-05-04 | 6 |
| ANDA 206200 | AMNEAL PHARMS | 2017-07-31 | 3 |
| ANDA 205710 | CIPLA | 2017-11-16 | 7 |
| ANDA 205457 | ACTAVIS LABS FL INC | 2018-07-03 | 1 |
| ANDA 210897 | LUPIN | 2018-11-09 | 4 |
| ANDA 208851 | MYLAN | 2020-09-17 | 1 |
| ANDA 211922 | SUN PHARM | 2021-04-14 | 6 |
| NDA 215935 | CALLIDITAS | 2021-12-15 | 1 |
| ANDA 215328 | PADAGIS ISRAEL | 2023-04-12 | 1 |
| ANDA 216667 | EUGIA PHARMA | 2023-11-29 | 1 |
| NDA 213976 | TAKEDA PHARMS USA | 2024-02-09 | 1 |
Official labeling on DailyMed
- PULMICORT FLEXHALER (BUDESONIDE) AEROSOL, POWDER [RUBICON HOLDINGS INC.] · version 3 · 2026-07-31
- BUDESONIDE INHALANT [RISING PHARMA HOLDINGS, INC.] · version 3 · 2026-07-30
- BUDESONIDE INHALATION SUSPENSION (BUDESONIDE) INHALANT [CIPLA USA INC.] · version 13 · 2026-06-12
- BUDESONIDE SUSPENSION [AMERICAN HEALTH PACKAGING] · version 3 · 2026-05-22
- BUDESONIDE CAPSULE, COATED PELLETS [REMEDYREPACK INC.] · version 2 · 2026-05-22
- BUDESONIDE SUSPENSION [CARDINAL HEALTH 107, LLC] · version 7 · 2026-04-21
- BUDESONIDE SUSPENSION [SUN PHARMACEUTICAL INDUSTRIES, INC.] · version 4 · 2026-04-20
- BUDESONIDE CAPSULE, COATED PELLETS [AMERICAN HEALTH PACKAGING] · version 4 · 2026-03-30
- BUDESONIDE INHALATION (BUDESONIDE) SUSPENSION [PREFERRED PHARMACEUTICALS INC.] · version 4 · 2026-03-23
- BUDESONIDE INHALATION SUSPENSION [PREFERRED PHARMACEUTICALS, INC.] · version 4 · 2026-03-23
- BUDESONIDE CAPSULE [PADAGIS US LLC] · version 10 · 2026-03-10
- BUDESONIDE SPRAY, METERED [RUGBY LABORATORIES] · version 12 · 2026-03-02
Showing the 12 most recent of 56 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.