Active ingredient
Fluorescein
14 finished FDA listings contain Fluorescein as their only active ingredient; 4 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- FLUORESCEIN, FLUORESCEIN SODIUM
- Dosage forms
- Injection, Injection, Solution, Strip
- Routes
- Intravenous, Ophthalmic
- Manufacturers / labelers
- 9
- Strengths listed
- .12 mg/1 · .6 mg/1 · 1 mg/1 · 1 mg/mg · 100 mg/ml · 250 mg/ml · 500 mg/5ml · 500 mg/ml
- Brand names in FDA listings
- Ak-Fluor, C20h10na2o5 Fluorescein Sodium Ophthalmic Strips, Dry Eye Test, Fluorescite, Glostrips
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 25138
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 021980 | ALCON LABS INC | 2006-03-28 | 1 |
| NDA 022186 | LONG GROVE PHARMS | 2008-08-08 | 2 |
| ANDA 215709 | NEXUS | 2023-09-25 | 2 |
| ANDA 220046 | BPI LABS | 2026-04-30 | 1 |
| ANDA 218651 | ZYDUS LIFESCIENCES | 2026-06-01 | 4 |
Official labeling on DailyMed
- FLUORESCITE (FLUORESCEIN SODIUM) INJECTION, SOLUTION [ALCON, INC.] · version 19 · 2026-07-01
- FLUORESCEIN INJECTION [ZYDUS PHARMACEUTICALS USA INC.] · version 1 · 2026-06-03
- FLUORESCEIN INJECTION [ZYDUS LIFESCIENCES LIMITED] · version 1 · 2026-06-03
- FLUORESCEIN INJECTION, SOLUTION [BPI LABS LLC] · version 1 · 2026-05-21
- AK-FLUOR (FLUORESCEIN) INJECTION [LONG GROVE PHARMACEUTICALS, LLC] · version 4 · 2026-03-25
- C20H10NA2O5 FLUORESCEIN SODIUM OPHTHALMIC STRIPS (FLUORESCEIN SODIUM) STRIP [VISTAMERICA USA] · version 2 · 2025-06-27
- FLUORESCEIN INJECTION [NEXUS PHARMACEUTICALS LLC] · version 5 · 2023-10-26
- FLUORESCEIN INJECTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] · version 2 · 2021-08-10
- GLOSTRIPS (FLUORESCEIN SODIUM) STRIP [NOMAX INC.] · version 3 · 2019-12-24
- GLOSTRIPS (FLUORESCEIN SODIUM) STRIP [NOMAX INC.] · version 2 · 2019-12-24
- DRY EYE TEST (FLUORESCEIN SODIUM) STRIP [NOMAX INC.] · version 3 · 2019-12-24
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.