Fluorescein
Fluorescein is an FDA drug label for the active ingredient FLUORESCEIN manufactured by Zydus Lifesciences Limited administered by INTRAVENOUS. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260602.
- Generic name
- FLUORESCEIN
- Manufacturer
- Zydus Lifesciences Limited
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- INTRAVENOUS
- Dosage form
- N/A
- NDC
- 70771-1969
- Application
- ANDA218651
- Label effective
- 20260602
About this product
Fluorescein is an FDA-registered drug product whose active ingredient is FLUORESCEIN. It is labelled by Zydus Lifesciences Limited taken by intravenous and marketed as a human prescription drug product. Identifiers on file: NDC 70771-1969, application ANDA218651, label effective 20260602. It is one of 4 FDA drug label records sharing the active ingredient FLUORESCEIN. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.
What it is used for
Across FDA labelling, products containing FLUORESCEIN are most often described in connection with: indicated diagnostic, fluorescein angiography, iris vasculature, indications usage, fluoresecin injection. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
More products with the same ingredient
FLUORESCEINHow products containing FLUORESCEIN compare
FDA lists 4 drug label records with FLUORESCEIN as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.
| Dosage form | Products | Manufacturer | Products |
|---|---|---|---|
| — | — | BPI Labs LLC | 1 |
| — | — | HF Acquisition Co LLC, DBA HealthFirst | 1 |
| — | — | Nexus Pharmaceuticals LLC | 1 |
| — | — | Zydus Lifesciences Limited | 1 |
| — | — | — | — |
Recall and safety notices
5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.
| Recall | Product | Firm | Class | Status | Reported |
|---|---|---|---|---|---|
| D-0350-2026 | CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count box, NDC 83851-100-10; b) 300-count box, NDC 83851-100-30. Manufactured by Wizcure Pharmaa PVT. LTD, H-681, Phase 3, RIICO Industrial Area, Bhiwadi- 301019 INDIA, Vistamerica USA, 20 Perkins Dr. Prescott, AZ 86301, Vistamerica USA, Made in India, | Wizcure Pharmaa Private Limited | Class II | Ongoing | 20260304 |
| D-0351-2026 | Bio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manufactured Omni Lens Pvt Ltd 5 - Samruddhi, Opp. Sakar - III, Navrangpura, Ahmedabad - 380014, India, Email:[email protected], Manufactured for & distributed by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-30. | Wizcure Pharmaa Private Limited | Class II | Ongoing | 20260304 |
| D-0352-2026 | BioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manufactured by Omni Lens PVT. Ltd., 5 - Samrudhhi, Opp. Sakar-III, Navrangpura, Ahmedabad, Gujarat, India - 380014, Email:[email protected], Manufactured for & disibruted by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-11. | Wizcure Pharmaa Private Limited | Class II | Ongoing | 20260304 |
| D-0607-2025 | Fluorescein 2% Ophth, 3 ML, Boothwyn Pharmacy, 800-476-7496 | Boothwyn Pharmacy LLC | Class III | Ongoing | 20250910 |
| D-0462-2024 | GloStrips, Fluorescein Sodium Ophthalmic Strips USP (0.6 mg Fluorescein), Rx Only, a) 100 strips per carton, NDC 51801-003-40; b) 300 strips per carton, NDC 51801-003-50, Nomax, Inc., St. Louis, MO 63123. | Nomax Inc | Class II | Ongoing | 20240501 |
Frequently asked questions
What is Fluorescein used for?
The FDA label on file for this product does not include a full indications section. Other FDA labels sharing the active ingredient FLUORESCEIN describe it in connection with: indicated diagnostic, fluorescein angiography, iris vasculature, indications usage, fluoresecin injection. Check the specific product label or ask a prescriber before use.
Who makes Fluorescein?
Zydus Lifesciences Limited is the labeler of record for Fluorescein. 4 FDA label records share the active ingredient FLUORESCEIN, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.
What form does Fluorescein come in?
administered by intravenous. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.
Is Fluorescein prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.
Are there other products containing FLUORESCEIN?
Yes. 4 FDA drug label records list FLUORESCEIN as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.
Has Fluorescein been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.
Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.