Active ingredient
Beclomethasone
12 finished FDA listings contain Beclomethasone as their only active ingredient.
At a glance
From the FDA NDC Directory
- Ingredient names as written by FDA
- BECLOMETHASONE DIPROPIONATE, BECLOMETHASONE DIPROPIONATE MONOHYDRATE
- Dosage forms
- Aerosol, Metered
- Routes
- Nasal, Respiratory (Inhalation)
- Manufacturers / labelers
- 4
- Strengths listed
- 40 ug/1 · 80 ug/1
- Brand names in FDA listings
- Qnasl, Qvar Redihaler
Official drug information
Source coverage for Beclomethasone:
- FDA NDC Directory: linked
- RxNorm: linked
- Drugs@FDA: linked
- DailyMed: linked
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1347
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
- NDA 202813
- Sponsor
- TEVA BRANDED PHARM
- Original approval
- 2012-03-23
- Listings
- 2
- Application
- NDA 207921
- Sponsor
- NORTON WATERFORD
- Original approval
- 2017-08-03
- Listings
- 6
- Application
- ANDA 213811
- Sponsor
- AMNEAL IRELAND LTD
- Original approval
- 2025-12-16
- Listings
- 2
- Application
- ANDA 214418
- Sponsor
- AUROLIFE PHARMA LLC
- Original approval
- 2026-09-14
- Listings
- 2
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 202813 | TEVA BRANDED PHARM | 2012-03-23 | 2 |
| NDA 207921 | NORTON WATERFORD | 2017-08-03 | 6 |
| ANDA 213811 | AMNEAL IRELAND LTD | 2025-12-16 | 2 |
| ANDA 214418 | AUROLIFE PHARMA LLC | 2026-09-14 | 2 |
Official labeling on DailyMed
- BECLOMETHASONE DIPROPIONATE AEROSOL, METERED [AMNEAL PHARMACEUTICALS NY LLC] · version 12 · 2025-12-19
- QVAR REDIHALER (BECLOMETHASONE DIPROPIONATE HFA) AEROSOL, METERED [A-S MEDICATION SOLUTIONS] · version 31 · 2024-06-27
- QVAR REDIHALER (BECLOMETHASONE DIPROPIONATE HFA) AEROSOL, METERED [A-S MEDICATION SOLUTIONS] · version 7 · 2023-09-22
- QVAR REDIHALER (BECLOMETHASONE DIPROPIONATE HFA) AEROSOL, METERED [A-S MEDICATION SOLUTIONS] · version 8 · 2023-09-21
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.