Quick answers
- What is Fluorescein (fluorescein sodium) used for?
- The FDA-approved label (Ak-Fluor, Long Grove Pharmaceuticals, LLC, February 26, 2026) says: “AK-FLUOR ® 10% (100 mg/mL) is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature. AK-FLUOR 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 (fluorescein sodium) have a boxed warning?
- No. None of the 4 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Fluorescein (fluorescein sodium)?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Fluorescein (fluorescein sodium) been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Fluorescein (fluorescein sodium)?
- 6 companies list prescription products of Fluorescein (fluorescein sodium) in the FDA NDC Directory, including Zydus Lifesciences Limited, Zydus Pharmaceuticals USA Inc. and HF Acquisition Co LLC, DBA HealthFirst.
What Fluorescein (fluorescein sodium) is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
AK-FLUOR ® 10% (100 mg/mL) is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature. AK-FLUOR is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature.
— FDA label: Ak-Fluor, Long Grove Pharmaceuticals, LLC, effective February 26, 2026. Read the full label on DailyMed →
The FDA has 4 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
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.
0 of 4 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection · Injection, solution |
|---|---|
| Route | Intravenous |
| Prescription products | 8 in the FDA NDC Directory |
| Brand names | Ak-Fluor |
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.
- Zydus Lifesciences Limited2 products
- Zydus Pharmaceuticals USA Inc.2 products
- HF Acquisition Co LLC, DBA HealthFirst1 product
- BPI Labs LLC1 product
- Anthea Pharma Private Limited1 product
- Long Grove Pharmaceuticals, LLC1 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 |
|---|---|---|---|
| NDA022186 AK-FLUOR 10%, AK-FLUOR 25% | Long Grove Pharms | August 8, 2008 | 3, latest March 17, 2026 2026: Manufacturing (CMC) · 2025: Labeling · 2015: Manufacturing (CMC) |
Generic approvals (2)
- ANDA220046Bpi Labs · April 30, 2026
- ANDA218651Zydus Lifesciences · June 1, 2026
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 | 73511e79-c050-4dc0-aa2f-a79ed320b5b0 |
|---|---|
| FDA labels (SPL) | 4 |
| FDA applications | NDA022186, 2 ANDA |
| Active ingredients (FDA) | FLUORESCEIN SODIUM |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Ak-Fluor, Long Grove Pharmaceuticals, LLC, effective February 26, 2026; 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 →