Active ingredient
Losartan
206 finished FDA listings contain Losartan as their only active ingredient; 111 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- LOSARTAN POTASSIUM
- Dosage forms
- Suspension, Tablet, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 46
- Strengths listed
- 10 mg/ml · 100 mg/1 · 25 mg/1 · 50 mg/1
- Brand names in FDA listings
- Arbli, Cozaar, Losartan Potassium, Losartan Potassium 100 Mg, Losartan Potassium 25 Mg, Losartan Potassium 50 Mg, Losartan Potassium Tablets, 100 Mg, Losartan Potassium Tablets, 25 Mg, Losartan Potassium Tablets, 50 Mg, Losortan Potassium
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 52175
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 020386 | ORGANON | 1995-04-14 | 3 |
| ANDA 078243 | ZYDUS PHARMS USA INC | 2010-10-06 | 32 |
| ANDA 090083 | AUROBINDO PHARMA | 2010-10-06 | 25 |
| ANDA 078232 | LUPIN LTD | 2010-10-06 | 13 |
| ANDA 090382 | STRIDES PHARMA | 2010-10-06 | 12 |
| ANDA 090544 | AIPING PHARM INC | 2010-10-06 | 3 |
| ANDA 090428 | ALEMBIC PHARMS LTD | 2010-10-06 | 6 |
| ANDA 091497 | PRINSTON INC | 2011-06-06 | 20 |
| ANDA 202230 | MACLEODS PHARMS LTD | 2012-05-30 | 6 |
| ANDA 201170 | JUBILANT CADISTA | 2012-09-18 | 11 |
| ANDA 091541 | MICRO LABS | 2012-09-24 | 1 |
| ANDA 203835 | HETERO LABS LTD V | 2015-08-12 | 55 |
| ANDA 203030 | UNICHEM | 2015-10-14 | 6 |
| ANDA 215959 | GRANULES | 2023-02-23 | 7 |
| ANDA 217396 | MSN | 2023-08-14 | 5 |
| NDA 218772 | SCIENTURE | 2025-03-13 | 1 |
Official labeling on DailyMed
- LOSARTAN POTASSIUM TABLET, FILM COATED [CARDINAL HEALTH 107, LLC] · version 21 · 2026-09-07
- LOSARTAN POTASSIUM TABLET, FILM COATED [REMEDYREPACK INC.] · version 4 · 2026-09-07
- LOSARTAN POTASSIUM TABLET, FILM COATED [REMEDYREPACK INC.] · version 7 · 2026-08-12
- LOSARTAN POTASSIUM TABLET, FILM COATED [MAJOR PHARMACEUTICALS] · version 10 · 2026-08-07
- LOSARTAN POTASSIUM TABLET, FILM COATED [REDPHARM DRUG] · version 1 · 2026-08-05
- LOSARTAN POTASSIUM TABLET, FILM COATED [REMEDYREPACK INC.] · version 11 · 2026-07-24
- LOSARTAN POTASSIUM TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.] · version 22 · 2026-07-21
- LOSARTAN POTASSIUM (LOSARTAN) TABLET [PREFERRED PHARMACEUTICALS INC.] · version 1 · 2026-07-20
- LOSARTAN POTASSIUM TABLET, FILM COATED [REMEDYREPACK INC.] · version 21 · 2026-07-20
- LOSARTAN POTASSIUM TABLET, FILM COATED [REMEDYREPACK INC.] · version 1 · 2026-07-13
- LOSARTAN POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] · version 14 · 2026-07-08
- LOSARTAN POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] · version 15 · 2026-07-08
Showing the 12 most recent of 137 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.