Active ingredient
Rabeprazole
38 finished FDA listings contain Rabeprazole as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- RABEPRAZOLE SODIUM
- Dosage forms
- Tablet, Delayed Release
- Routes
- Oral
- Manufacturers / labelers
- 21
- Strengths listed
- 20 mg/1
- Brand names in FDA listings
- Aciphex, Rabeprazole Sodium, Rabeprazole Sodium Dr
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 114979
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 020973 | WAYLIS THERAP | 1999-08-19 | 1 |
| ANDA 090678 | LANNETT CO INC | 2013-11-08 | 5 |
| ANDA 202376 | TORRENT | 2013-11-08 | 3 |
| ANDA 204179 | AMNEAL PHARMS | 2015-07-31 | 1 |
| ANDA 204237 | RUBICON RESEARCH | 2015-11-18 | 11 |
| ANDA 205761 | QUAGEN | 2017-02-17 | 4 |
| ANDA 208644 | ALKEM LABS LTD | 2018-04-24 | 13 |
Official labeling on DailyMed
- RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [ASCEND LABORATORIES, LLC] · version 19 · 2026-09-10
- RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.] · version 9 · 2026-08-27
- RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.] · version 4 · 2026-08-27
- RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [REMEDYREPACK INC.] · version 8 · 2026-08-06
- RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED] · version 18 · 2026-07-28
- RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [ST. MARY'S MEDICAL PARK PHARMACY] · version 8 · 2026-06-29
- RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [ST. MARY'S MEDICAL PARK PHARMACY] · version 3 · 2026-06-23
- RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK] · version 101 · 2026-05-25
- RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP] · version 5 · 2026-05-20
- RABEPRAZOLE SODIUM DR (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [ADVANCED RX PHARMACY OF TENNESSEE, LLC] · version 9 · 2026-03-30
- RABEPRAZOLE SODIUM DR (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [ADVANCED RX OF TENNESSEE, LLC] · version 10 · 2026-03-20
- RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK] · version 2 · 2026-03-18
Showing the 12 most recent of 36 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.