Is there a generic for Fluorescein sodium?

Yes. The FDA Orange Book lists 3 approved generic (ANDA) applications for Fluorescein sodium, referencing the brand AK-FLUOR 10%. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Fluorescein sodium?

AK-FLUOR 10% (NDA 022186, LONG GROVE PHARMS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Fluorescein sodium are approved?

Fluorescein sodium is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Fluorescein sodium

Fluorescein sodium: 3 brands, 3 generics; first approved Mar 28, 2006; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 3 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

AK-FLUOR 10%RLDRS

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	—

FLUORESCITERLDRS

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

FUNDUSCEIN-25RLD

NOVARTISNDA 017869—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE	INJECTION	Discontinued	—

Abbreviated applications

Generic (ANDA) products (3)

FLUORESCEIN SODIUM

ZYDUS 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 SODIUM

BPI 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 SODIUM

NEXUSANDA 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	—

Orange Book patent file

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.

FDA approval span

Approval history

First approval

Mar 28, 2006

20 yr 7 mo ago

Most recent approval

Jun 01, 2026

1 mo ago

Approvals span 2006–2026 across 6 FDA applications.

Brand (NDA) 350%

Generic (ANDA) 350%

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.

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