Quick answers
- What is Fluorescein used for?
- The FDA-approved label (Fluorescein, Nexus Pharmaceuticals LLC, October 25, 2023) says: “1. INDICATIONS & USAGE Fluoresecin Injection 10%,, (100 mg/mL) and Fluorescein Injection 25% (250 mg/mL) is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature. Fluorescein Injection, USP is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Fluorescein have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Fluorescein?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Fluorescein been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Fluorescein?
- 2 companies list prescription products of Fluorescein in the FDA NDC Directory, including Nexus Pharmaceuticals LLC and Alcon, Inc..
What Fluorescein is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
1. INDICATIONS & USAGE Fluoresecin Injection 10%,, (100 mg/mL) and Fluorescein Injection 25% (250 mg/mL) is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature. Fluorescein Injection, USP is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature.
— FDA label: Fluorescein, Nexus Pharmaceuticals LLC, effective October 25, 2023. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Injection · Injection, solution |
|---|---|
| Route | Intravenous · Ophthalmic |
| Prescription products | 3 in the FDA NDC Directory |
| Brand names | Fluorescite |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Nexus Pharmaceuticals LLC2 products
- Alcon, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021980 FLUORESCITE | Alcon Labs Inc | March 28, 2006 | 5, latest June 10, 2026 2026: Labeling · 2021: Labeling · 2016: Labeling |
Generic approvals (1)
- ANDA215709Nexus · September 25, 2023
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| SPL set ID of the quoted label | 0a2a65b1-dc88-445b-bfb7-53b2fd7bea2c |
|---|---|
| FDA labels (SPL) | 1 |
| FDA applications | NDA021980, 1 ANDA |
| Active ingredients (FDA) | FLUORESCEIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Fluorescein, Nexus Pharmaceuticals LLC, effective October 25, 2023; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →