Budesonide
Sold as Entocord, Pulmicort nebulising, Budeflam, Aeromide nasal, Budeflam aquanase, Inflacor, Cipla budesonide dp-caps, Budeflam dp-caps, Pulmax mdi, Budoneb, Arrow budesonide, Aeromide, Budair, Inoxab, Pressido, Budeflam respules, Budesonide respules cipla, Budico, SPEC budesonide, Pulmicort turbuhaler /dose
(1S,2S,4R,8S,9S,11S,12S,13R)-11-Hydroxy-8-(2-hydroxyacetyl)-9,13-dimethyl-6-propyl-5,7-dioxapentacyclo[10.8.0.02,9.04,8.013,18]icosa-14,17-dien-16-one
Drag to rotate. Structure from PubChem CID 5281004.
Background
Registration
- Applicants
- 12
- Registrations
- 39
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Equity Pharmaceutical (Pty) Ltd | Entocord | 0,02 mg/ml, 3 mg | 290638, 310215 | Not determined | None |
| Astrazeneca Pharmaceuticals (Pty) Ltd3 of 6 cancelled | Pulmicort nebulising, Pulmicort turbuhaler /dose | 0,125 mg/ML, 0,25 mg/ml, 0,5 mg/ml, 100 ug, 200 ug, 400 ug | 300016, 300017, 300018, Y0171, Y0172, Z0266 | Not determined | None |
| Cipla Medpro (Pty) Ltd4 of 12 cancelled | Budeflam, Budeflam aquanase, Cipla budesonide dp-caps, Budeflam dp-caps, Budeflam respules, Budesonide respules cipla | 0,123 mg/ml, 0,125 mg/ml, 0,25 mg/ml, 0,5 mg/ml, 100, 200 | 300255, 320115, 330045, 360249, 360257, 360258, 570001, 570002, 570003, 570004.001, 570005.002, 570006.003 | Not determined | None |
| Activo Health (Pty) Ltd | Aeromide nasal | 50, 100 | 320532, 410238 | Not determined | None |
| Teva Pharmaceuticals (Pty) Ltd2 of 6 cancelled | Inflacor, Budoneb, Arrow budesonide | 0,25 mg/ml, 0,5 mg/ml, 200, 400 | 350164, 350165, 420953, 420954, 420955, 420956 | Not determined | None |
| Biotech Laboratories (Pty) LtdCancelled | Pulmax mdi | 100, 400 | 370013, 370015 | Not determined | None |
| Hexal Pharma (Pty) LtdCancelled | Pulmax mdi | 200 | 370014 | Not determined | None |
| Forrester Pharma (Pty) Ltd | Aeromide | Not stated | 500261 | Not determined | None |
| Ranbaxy Pharmaceutical (Pty) Ltd | Budair | 0,25 mg/ml, 0,5 mg/ml | 530237, 530238 | Not determined | None |
| Macleods Pharmaceuticals SA (Pty) Ltd | Inoxab, Pressido | 200 mg | 540610, 540611.610 | Not determined | PIPIL |
| Juno Pharma SA (Pty) Ltd | Budico | 0,25 mg/ml, 0,5 mg/ml | 590529, 590530 | Not determined | None |
| Specpharm (Pty) Ltd | SPEC budesonide | 100 | A400224 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Entocord 0,02 mg/ml EACH RECONSTITUDED ENEMA CONTAINS BUDESONIDE 2,3 mg | 0,02 mg/ml | 29063829/11.8/0638 | Registered | Not determined | None |
| Pulmicort nebulising suspension 0,5 mg/ml EACH 1,0 ml SUSPENSION CONTAINS BUDESONIDE 0,5 mg | 0,5 mg/mlSuspension | 30001630/21.5.1/0016 | Registered | Not determined | None |
| Pulmicort nebulising suspension 0,25 mg/ml EACH 1,0 ml SUSPENSION CONTAINS BUDESONIDE 0,25 mg | 0,25 mg/mlSuspension | 30001730/21.5.1/0017 | Registered | Not determined | None |
| Pulmicort nebulising suspension 0,125 mg/ml EACH 1 ml SUSPENSION CONTAINS BUDESONIDE 0,125 mg | 0,125 mg/MLSuspension | 30001830/21.5.1/0018 | Cancelled | Not determined | None |
| Budeflam EACH ACTUATION DELIVERS BUDESONIDE 100 mcg | Not listed | 30025530/21.5.1/0255 | Registered | Not determined | None |
| Entocord 3 MG EACH CAPSULE CONTAINS BUDESONIDE 3,0 mg | 3 mg | 31021531/21.5.1/0215 | Registered | Not determined | None |
| Budeflam 200 EACH METERED DOSE CONTAINS BUDESONIDE 200,0 ug | 200 | 32011532/21.5.1/0115 | Registered | Not determined | None |
| Aeromide nasal 50 EACH METERED DOSE CONTAINS BUDESONIDE 50,0 ug | 50 | 32053232/21.5.1/0532 | Registered | Not determined | None |
| Budeflam aquanase EACH METERED DOSE CONTAINS BUDESONIDE 100,0 ug | Not listed | 33004533/21.5.1/0045 | Cancelled | Not determined | None |
| Inflacor 200 EACH CAPSULE CONTAINS BUDESONIDE 200,0 ug | 200 | 35016435/21.5.1/0164 | Cancelled | Not determined | None |
| Inflacor 400 EACH CAPSULE CONTAINS BUDESONIDE 400,0 ug | 400 | 35016535/21.5.1/0165 | Cancelled | Not determined | None |
| Cipla budesonide 100 dp-caps EACH CAPSULE CONTAINS BUDESONIDE 100,0 ug | 100 | 36024936/21.5.1/0249 | Cancelled | Not determined | None |
| Budeflam 100 dp-caps EACH CAPSULE CONTAINS BUDESONIDE 100,0 ug | 100 | 36025736/21.5.1/0257 | Cancelled | Not determined | None |
| Budeflam 200 dp-caps EACH CAPSULE CONTAINS BUDESONIDE 200,0 ug | 200 | 36025836/21.5.1/0258 | Cancelled | Not determined | None |
| Pulmax 100 mdi EACH ACTUATION CONTAINS BUDESONIDE 100,0 ug | 100 | 37001337/21.5.1/0013 | Cancelled | Not determined | None |
| Pulmax 200 mdi EACH ACTUATION CONTAINS BUDESONIDE 200,0 ug | 200 | 37001437/21.5.1/0014 | Cancelled | Not determined | None |
| Pulmax 400 mdi EACH ACTUATION CONTAINS BUDESONIDE 400,0 ug | 400 | 37001537/21.5.1/0015 | Cancelled | Not determined | None |
| Aeromide nasal 100 EACH METERED DOSE CONTAINS BUDESONIDE 100,0 ug | 100 | 41023841/21.5.1/0238 | Registered | Not determined | None |
| Budoneb 0,25 mg/ml EACH 1,0 ml SUSPENSION CONTAINS BUDESONIDE 0,25 mg | 0,25 mg/ml | 42095342/21.5.1/0953 | Registered | Not determined | None |
| Budoneb 0,5 mg/ml EACH 1,0 ml SUSPENSION CONTAINS BUDESONIDE 0,5 mg | 0,5 mg/ml | 42095442/21.5.1/0954 | Registered | Not determined | None |
| Arrow budesonide 0,25 mg/ml EACH 1,0 ml SUSPENSION CONTAINS BUDESONIDE 0,25 mg | 0,25 mg/ml | 42095542/21.5.1/0955 | Registered | Not determined | None |
| Arrow budesonide 0,5 mg/ml EACH 1,0 ml SUSPENSION CONTAINS BUDESONIDE 0,5 mg | 0,5 mg/ml | 42095642/21.5.1/0956 | Registered | Not determined | None |
| Aeromide EACH METERED DOSE CONTAINS: BUDESONIDE 200,0 μg | Not listed | 50026150/21.5.1/0261 | Registered | Not determined | None |
| Budair 0,25 mg/ml EACH 1,0 ml SUSPENSION CONTAINS BUDESONIDE 0,25 mg | 0,25 mg/ml | 53023753/21.5.1/0237 | Registered | Not determined | None |
| Budair 0,5 mg/ml EACH 1,0 ml SUSPENSION CONTAINS BUDESONIDE 0,5 mg | 0,5 mg/ml | 53023853/21.5.1/0238 | Registered | Not determined | None |
| Inoxab 200 EACH DOSE CONTAINS BUDESONIDE 200,0 ug | 200 mgMetered dose inhaler | 54061054/21.5.1/0610Approved 24 October 2023 | Registered | Not determined | PIPIL |
| Pressido 200 EACH DOSE CONTAINS BUDESONIDE 200,0 ug | 200 mgMetered dose inhaler | 540611.61054/21.5.1/0611.610Approved 24 October 2023 | Registered | Not determined | PIPIL |
| Budeflam 0,123 mg/ml respules EACH 1,0 ml SUSPENSION CONTAINS BUDESONIDE 0,125 mg | 0,123 mg/ml | 57000157/21.5.1/0001 | Registered | Not determined | None |
| Budeflam 0,25 mg/ml respules EACH 1,0 ml SUSPENSION CONTAINS BUDESONIDE 0,25 mg | 0,25 mg/ml | 57000257/21.5.1/0002 | Registered | Not determined | None |
| Budeflam 0,5 mg/ml respules EACH 1,0 ml SUSPENSION CONTAINS BUDESONIDE 0,5 mg | 0,5 mg/ml | 57000357/21.5.1/0003 | Registered | Not determined | None |
| Budesonide 0,125 mg/ml respules cipla EACH 1,0 ml SUSPENSION CONTAINS BUDESONIDE 0,125 mg | 0,125 mg/ml | 570004.00157/21.5.1/0004.001 | Registered | Not determined | None |
| Budesonide 0,25 mg/ml respules cipla EACH 1,0 ml SUSPENSION CONTAINS BUDESONIDE 0,25 mg | 0,25 mg/ml | 570005.00257/21.5.1/0005.002 | Registered | Not determined | None |
| Budesonide 0,5 mg/ml respules cipla EACH 1,0 ml SUSPENSION CONTAINS BUDESONIDE 0,5 mg | 0,5 mg/ml | 570006.00357/21.5.1/0006.003 | Registered | Not determined | None |
| Budico 0,25 mg/ml EACH 1,0 ml SUSPENSION CONTAINS: BUDESONIDE 0,25 mg | 0,25 mg/ml | 59052959/21.5.1/0529 | Registered | Not determined | None |
| Budico 0,5 mg/ml EACH 1,0 ml SUSPENSION CONTAINS: BUDESONIDE 0,5 mg | 0,5 mg/ml | 59053059/21.5.1/0530 | Registered | Not determined | None |
| SPEC budesonide 100 EACH METERED DOSE CONTAINS BUDESONIDE 100,0 ug | 100 | A400224A40/21.5.1/0224 | Registered | Not determined | None |
| Pulmicort turbuhaler 100 ug/dose EACH METERED DOSE CONTAINS BUDESONIDE 100,0 mcg | 100 ug | Y0171Y/21.5.1/171 | Cancelled | Not determined | None |
| Pulmicort turbuhaler 200 ug/dose EACH METERED DOSE CONTAINS BUDESONIDE 200,0 ug | 200 ug | Y0172Y/21.5.1/172 | Registered | Not determined | None |
| Pulmicort turbuhaler 400 ug/dose EACH METERED DOSE CONTAINS BUDESONIDE 400 ug | 400 ug | Z0266Z/21.5.1/266 | Cancelled | Not determined | None |
Regulatory status
This product is still scheduled by law even when this site could not determine which tier it falls under. The label carries the S number in a square border; ask a pharmacist if you need to know its schedule.
Listings for this ingredient that could not be applied to this product
S4: Budesonide
- except when intended for the prophylaxis and treatment of seasonal and perennial allergic rhinitis in adults and children aged 12 years and older; (S2)
- except when intended for inhalation or nasal administration, unless listed in another Schedule. (S3)
Consolidated Schedules 06 July 2026, lines 5577 to 5582
S3: Budesonide
- when intended inhalation or nasal administration, unless listed in another Schedule. (S4)
- except when intended for the prophylaxis and treatment of seasonal and perennial allergic rhinitis in adults and children aged 12 years and older. (S2)
Consolidated Schedules 06 July 2026, lines 3237 to 3242
S2: Budesonide
- when intended for the prophylaxis and treatment of seasonal and perennial allergic rhinitis in adults and children aged 12 years and older; (S3)
- except when intended for inhalation and nasal administration, unless listed in another Schedule. (S4)
Consolidated Schedules 06 July 2026, lines 1696 to 1701
This is an informational summary of the Medicines and Related Substances Act 101 of 1965 and its 2017 General Regulations. It is not medical advice and not legal advice. Always check the medicine's label, which carries the schedule number inside a square border, or ask a pharmacist if you are unsure.
SAHPRA documents
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.