Active ingredient
Ivabradine
24 finished FDA listings contain Ivabradine as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- IVABRADINE, IVABRADINE HYDROCHLORIDE
- Dosage forms
- Solution, Tablet, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 12
- Strengths listed
- 5 mg/1 · 5 mg/5ml · 7.5 mg/1
- Brand names in FDA listings
- Corlanor
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1649480
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 206143 | AMGEN INC | 2015-04-15 | 2 |
| NDA 209964 | AMGEN INC | 2019-04-22 | 1 |
| ANDA 214051 | INGENUS PHARMS LLC | 2021-12-30 | 4 |
| ANDA 213366 | ANNORA PHARMA | 2022-10-05 | 3 |
| ANDA 213442 | ZYDUS PHARMS | 2023-11-29 | 4 |
| ANDA 213276 | BIONPHARMA | 2024-09-05 | 2 |
| ANDA 215238 | ALEMBIC | 2024-11-08 | 4 |
| ANDA 213483 | MSN | 2025-04-28 | 4 |
Official labeling on DailyMed
- IVABRADINE TABLET, FILM COATED [NOVADOZ PHARMACEUTICALS LLC] · version 2 · 2026-08-26
- IVABRADINE TABLET, FILM COATED [NORTHSTAR RX LLC] · version 3 · 2026-04-27
- CORLANOR (IVABRADINE) TABLET, FILM COATED CORLANOR (IVABRADINE) SOLUTION [AMGEN INC] · version 33 · 2025-11-17
- IVABRADINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] · version 2 · 2025-07-03
- IVABRADINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] · version 2 · 2025-04-24
- IVABRADINE TABLET, FILM COATED [INGENUS PHARMACEUTICALS, LLC] · version 2 · 2025-03-19
- IVABRADINE TABLET, FILM COATED [BIONPHARMA INC.] · version 1 · 2025-03-03
- IVABRADINE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] · version 1 · 2024-12-23
- IVABRADINE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS INC.] · version 5 · 2024-12-23
- IVABRADINE TABLET [ZYDUS LIFESCIENCES LIMITED] · version 2 · 2024-12-04
- IVABRADINE TABLET [ZYDUS PHARMACEUTICALS USA INC.] · version 1 · 2024-07-02
- IVABRADINE (IVABRADINE) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] · version 1 · 2024-05-01
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.