Active ingredient
Nadolol
53 finished FDA listings contain Nadolol as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- NADOLOL
- Dosage forms
- Tablet
- Routes
- Oral
- Manufacturers / labelers
- 16
- Strengths listed
- 20 mg/1 · 40 mg/1 · 80 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 7226
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 201893 | AUROBINDO PHARMA | 2015-09-16 | 7 |
| ANDA 203455 | INVAGEN PHARMS | 2015-12-18 | 12 |
| ANDA 208832 | AMNEAL PHARMS CO | 2017-06-02 | 4 |
| ANDA 207761 | ZYDUS PHARMS | 2017-07-28 | 7 |
| ANDA 210955 | REGCON HOLDINGS | 2018-07-23 | 13 |
| ANDA 212856 | SOMERSET THERAPS LLC | 2019-09-13 | 3 |
| ANDA 211763 | ALEMBIC | 2023-06-02 | 7 |
Official labeling on DailyMed
- NADOLOL TABLET [BLUEPOINT LABORATORIES] · version 3 · 2026-09-08
- NADOLOL TABLET [AMERICAN HEALTH PACKAGING] · version 3 · 2026-08-06
- NADOLOL TABLET [AMNEAL PHARMACEUTICALS NY LLC] · version 11 · 2026-06-30
- NADOLOL TABLET [A-S MEDICATION SOLUTIONS] · version 2 · 2026-06-22
- NADOLOL TABLET [BRYANT RANCH PREPACK] · version 103 · 2026-06-01
- NADOLOL TABLET [REMEDYREPACK INC.] · version 1 · 2026-05-20
- NADOLOL TABLET [BRYANT RANCH PREPACK] · version 1 · 2026-05-01
- NADOLOL TABLET [BRYANT RANCH PREPACK] · version 103 · 2026-03-20
- NADOLOL TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] · version 2 · 2026-03-03
- NADOLOL TABLET [UNICHEM PHARMACEUTICALS (USA), INC.] · version 5 · 2026-01-28
- NADOLOL TABLET [AMERICAN HEALTH PACKAGING] · version 7 · 2025-07-25
- NADOLOL TABLET [BLUEPOINT LABORATORIES] · version 3 · 2025-04-10
Showing the 12 most recent of 24 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.