Active ingredient
Acebutolol
10 finished FDA listings contain Acebutolol as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- ACEBUTOLOL HYDROCHLORIDE
- Dosage forms
- Capsule
- Routes
- Oral
- Manufacturers / labelers
- 6
- Strengths listed
- 200 mg/1 · 400 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 149
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 |
|---|---|---|---|
| ANDA 074007 | ANI PHARMS | 1995-10-18 | 4 |
| ANDA 075047 | AMNEAL PHARM | 1999-12-30 | 6 |
Official labeling on DailyMed
- ACEBUTOLOL HYDROCHLORIDE CAPSULE [AMNEAL PHARMACEUTICALS LLC] · version 14 · 2026-05-04
- ACEBUTOLOL HYDROCHLORIDE CAPSULE [AVKARE] · version 2 · 2026-01-14
- ACEBUTOLOL HYDROCHLORIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] · version 4 · 2025-12-22
- ACEBUTOLOL HYDROCHLORIDE CAPSULE [ANI PHARMACEUTICALS, INC.] · version 6 · 2025-11-17
- ACEBUTOLOL HYDROCHLORIDE CAPSULE [AVPAK] · version 18 · 2025-09-22
- ACEBUTOLOL HYDROCHLORIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] · version 7 · 2025-01-07
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.