Active ingredient
Betaxolol
8 finished FDA listings contain Betaxolol as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- BETAXOLOL HYDROCHLORIDE
- Dosage forms
- Solution/ Drops, Suspension/ Drops, Tablet, Coated, Tablet, Film Coated
- Routes
- Ophthalmic, Oral
- Manufacturers / labelers
- 5
- Strengths listed
- 10 mg/1 · 2.8 mg/ml · 20 mg/1 · 5.6 mg/ml
- Brand names in FDA listings
- Betoptic S
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1520
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 019270 | SANDOZ | 1985-08-30 | 1 |
| NDA 019845 | NOVARTIS | 1989-12-29 | 1 |
| ANDA 075541 | EPIC PHARMA | 1999-10-22 | 4 |
| ANDA 078962 | KVK TECH | 2008-06-27 | 2 |
Official labeling on DailyMed
- BETOPTIC S (BETAXOLOL HYDROCHLORIDE) SUSPENSION/ DROPS [NOVARTIS PHARMACEUTICALS CORPORATION] · version 4 · 2025-01-23
- BETAXOLOL TABLET, FILM COATED [EPIC PHARMA LLC] · version 12 · 2024-12-23
- BETAXOLOL HYDROCHLORIDE TABLET, COATED [KVK-TECH, INC.] · version 10 · 2024-05-02
- BETAXOLOL HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC] · version 9 · 2023-11-21
- BETAXOLOL TABLET, FILM COATED [PURACAP LABORATORIES LLC] · version 4 · 2019-11-01
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.