Active ingredient
Latanoprost
19 finished FDA listings contain Latanoprost as their only active ingredient; 1 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- LATANOPROST
- Dosage forms
- Solution, Solution/ Drops
- Routes
- Ophthalmic, Topical
- Manufacturers / labelers
- 18
- Strengths listed
- .05 mg/ml · 50 ug/ml
- Brand names in FDA listings
- Iyuzeh, Xalatan, Xelpros
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 43611
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 020597 | UPJOHN | 1996-06-05 | 2 |
| ANDA 091449 | SANDOZ | 2011-03-22 | 3 |
| ANDA 201006 | BAUSCH AND LOMB | 2011-03-22 | 3 |
| ANDA 201786 | SOMERSET | 2011-03-22 | 2 |
| ANDA 202442 | FDC LTD | 2016-04-22 | 1 |
| NDA 206185 | SUN PHARM | 2018-09-12 | 1 |
| ANDA 206519 | EUGIA PHARMA | 2019-09-03 | 1 |
| NDA 216472 | THEA PHARMA | 2022-12-13 | 1 |
| ANDA 218257 | GLAND | 2024-11-26 | 3 |
| ANDA 219306 | MICRO LABS | 2025-04-14 | 1 |
| ANDA 220360 | MANKIND PHARMA | 2025-12-17 | 1 |
Official labeling on DailyMed
- LATANOPROST SOLUTION [RISING PHARMA HOLDINGS, INC.] · version 15 · 2026-09-07
- LATANOPROST SOLUTION/ DROPS [NUCARE PHARMACEUTICALS,INC.] · version 4 · 2026-09-07
- LATANOPROST (LATANOPROST) SOLUTION/ DROPS [MICRO LABS LIMITED] · version 2 · 2026-01-26
- LATANOPROST SOLUTION/ DROPS [SOMERSET THERAPEUTICS, LLC] · version 6 · 2026-01-14
- XELPROS (LATANOPROST) SOLUTION/ DROPS [SUN PHARMACEUTICAL INDUSTRIES, INC.] · version 11 · 2025-12-23
- LATANOPROST SOLUTION/ DROPS [GLENMARK PHARMACEUTICALS INC] · version 3 · 2025-12-19
- LATANOPROST SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED] · version 19 · 2025-11-17
- LATANOPROST SOLUTION [NUCARE PHARMACEUTICALS, INC.] · version 1 · 2025-08-15
- LATANOPROST SOLUTION/ DROPS [SAGENT PHARMACEUTICALS] · version 1 · 2025-07-15
- LATANOPROST SOLUTION [MYLAN PHARMACEUTICALS INC.] · version 21 · 2025-05-05
- LATANOPROST SOLUTION/ DROPS [A-S MEDICATION SOLUTIONS] · version 11 · 2025-01-10
- LATANOPROST SOLUTION [SANDOZ INC] · version 9 · 2024-12-09
Showing the 12 most recent of 18 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.