Active ingredient
Olmesartan
128 finished FDA listings contain Olmesartan as their only active ingredient; 178 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- OLMESARTAN MEDOXOMIL
- Dosage forms
- Tablet, Tablet, Coated, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 32
- Strengths listed
- 20 mg/1 · 40 mg/1 · 5 mg/1
- Brand names in FDA listings
- Benicar
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 321064
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 021286 | COSETTE | 2002-04-25 | 6 |
| ANDA 206763 | ALKEM LABS LTD | 2017-04-24 | 14 |
| ANDA 207662 | ACCORD HLTHCARE | 2017-04-24 | 12 |
| ANDA 205482 | JUBILANT GENERICS | 2017-04-24 | 3 |
| ANDA 204814 | MACLEODS PHARMS | 2017-04-24 | 9 |
| ANDA 203012 | ALEMBIC | 2017-04-24 | 6 |
| ANDA 204798 | AUROBINDO PHARMA | 2017-04-24 | 11 |
| ANDA 203281 | GLENMARK PHARMS LTD | 2017-05-25 | 7 |
| ANDA 208130 | SCIEGEN PHARMS | 2018-06-29 | 15 |
| ANDA 211049 | SUNSHINE | 2019-02-22 | 11 |
| ANDA 207135 | PHARMAZONE | 2019-07-18 | 6 |
| ANDA 208659 | ADAPTIS | 2020-05-18 | 7 |
| ANDA 206720 | PRINSTON INC | 2022-12-02 | 8 |
| ANDA 217399 | MSN | 2023-01-18 | 4 |
| ANDA 205499 | HETERO LABS LTD V | 2024-10-31 | 3 |
| ANDA 210682 | CADILA PHARMS LTD | 2024-11-08 | 6 |
Official labeling on DailyMed
- OLMESARTAN MEDOXOMIL TABLET, FILM COATED [REMEDYREPACK INC.] · version 5 · 2026-08-31
- OLMESARTAN MEDOXOMIL TABLET [NORTHSTAR RXLLC] · version 1 · 2026-08-07
- OLMESARTAN MEDOXOMIL TABLET, FILM COATED [BRYANT RANCH PREPACK] · version 1 · 2026-08-05
- OLMESARTAN MEDOXOMIL TABLET, COATED [BRYANT RANCH PREPACK] · version 2 · 2026-07-06
- OLMESARTAN MEDOXOMIL TABLET, FILM COATED [DIRECT_RX] · version 2 · 2026-06-24
- OLMESARTAN MEDOXOMIL TABLET, FILM COATED [REMEDYREPACK INC.] · version 3 · 2026-06-15
- OLMESARTAN MEDOXOMIL TABLET [UMEDICA LABORATORIES USA INC.] · version 3 · 2026-06-05
- OLMESARTAN MEDOXOMIL TABLET [MACLEODS PHARMACEUTICALS LIMITED] · version 5 · 2026-06-03
- OLMESARTAN MEDOXOMIL TABLET [A-S MEDICATION SOLUTIONS] · version 1 · 2026-06-01
- OLMESARTAN MEDOXOMIL TABLET [A-S MEDICATION SOLUTIONS] · version 1 · 2026-06-01
- OLMESARTAN MEDOXOMIL TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] · version 3 · 2026-05-28
- OLMESARTAN MEDOXOMIL TABLET, FILM COATED [BRYANT RANCH PREPACK] · version 101 · 2026-05-14
Showing the 12 most recent of 72 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.