Active ingredient
Ranolazine
55 finished FDA listings contain Ranolazine as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- RANOLAZINE
- Dosage forms
- Granule, Tablet, Extended Release, Tablet, Film Coated, Extended Release
- Routes
- Oral
- Manufacturers / labelers
- 29
- Strengths listed
- 1000 mg/1 · 500 mg/1
- Brand names in FDA listings
- Aspruzyo Sprinkle
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 35829
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 201046 | CHARTWELL RX | 2013-07-29 | 2 |
| ANDA 210054 | AJANTA PHARMA LTD | 2019-05-28 | 3 |
| ANDA 211707 | SUN PHARM | 2019-05-28 | 2 |
| ANDA 211829 | SCIEGEN PHARMS | 2019-06-04 | 10 |
| ANDA 211082 | GLENMARK PHARMS LTD | 2019-07-05 | 2 |
| ANDA 210188 | CADILA | 2019-08-19 | 6 |
| ANDA 212284 | MANKIND PHARMA | 2020-02-12 | 2 |
| ANDA 212781 | QUAGEN | 2020-03-23 | 5 |
| ANDA 209953 | ALKEM LABS LTD | 2020-11-30 | 5 |
| ANDA 214035 | VKT PHARMA | 2022-01-19 | 2 |
| NDA 216018 | SPIL | 2022-02-28 | 1 |
| ANDA 213517 | PHARMAZONE | 2022-04-27 | 5 |
| ANDA 212788 | HETERO LABS LTD III | 2022-05-05 | 2 |
| ANDA 209081 | AUROBINDO PHARMA | 2022-12-23 | 2 |
| ANDA 213083 | UNICHEM | 2023-03-16 | 2 |
| ANDA 213085 | PIRAMAL | 2023-07-25 | 2 |
| ANDA 214551 | UMEDICA | 2026-08-05 | 2 |
Official labeling on DailyMed
- RANOLAZINE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING] · version 4 · 2026-08-20
- RANOLAZINE TABLET, EXTENDED RELEASE [UMEDICA LABORATORIES USA INC.] · version 1 · 2026-08-11
- RANOLAZINE TABLET, FILM COATED, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] · version 3 · 2026-06-15
- RANOLAZINE TABLET, FILM COATED, EXTENDED RELEASE [TORRENT PHARMA, INC.] · version 1 · 2026-05-12
- RANOLAZINE TABLET, FILM COATED, EXTENDED RELEASE [LIFESTAR PHARMA LLC] · version 7 · 2026-05-07
- RANOLAZINE TABLET, FILM COATED, EXTENDED RELEASE [ZAMEER PHARMACEUTICALS LLC] · version 4 · 2026-04-22
- RANOLAZINE TABLET, FILM COATED, EXTENDED RELEASE [SUNGEN PHARMA LLC] · version 14 · 2026-03-26
- RANOLAZINE TABLET, FILM COATED, EXTENDED RELEASE [RADHA PHARMACEUTICALS, INC] · version 2 · 2026-02-24
- RANOLAZINE TABLET, EXTENDED RELEASE [VIONA PHARMACEUTICALS INC] · version 5 · 2026-01-30
- RANOLAZINE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA] · version 5 · 2026-01-26
- RANOLAZINE TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] · version 1 · 2026-01-23
- RANOLAZINE TABLET, FILM COATED, EXTENDED RELEASE [AVKARE] · version 7 · 2026-01-16
Showing the 12 most recent of 31 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.