Fluorescein sodium
Fluorescein sodium: 3 brands, 3 generics; first approved Mar 28, 2006; generic available.
Generic available: 3 ANDA applications approved.
Brand (NDA) products
- LONG GROVE PHARMSNDA 02218620082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE INTRAVENOUS Rx AP EQ 500MG BASE/2ML (EQ 250MG BASE/ML) INJECTABLE INTRAVENOUS Discontinued — - ALCON LABS INCNDA 0219802006
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE INTRAVENOUS Rx AP - NOVARTISNDA 017869—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25% INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (3)
- FLUORESCEIN SODIUMZYDUS LIFESCIENCESANDA 21865120262 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE INTRAVENOUS Rx AP EQ 500MG BASE/2ML (EQ 250MG BASE/ML) INJECTABLE INTRAVENOUS Rx — - FLUORESCEIN SODIUMBPI LABSANDA 2200462026
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE INTRAVENOUS Rx AP - FLUORESCEIN SODIUMNEXUSANDA 21570920232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE INTRAVENOUS Rx AP EQ 500MG BASE/2ML (EQ 250MG BASE/ML) INJECTABLE INTRAVENOUS Discontinued —
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
Approvals span 2006–2026 across 6 FDA applications.
Fluorescein sodium: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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