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 is approved as 3 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:AK-FLUOR 10% · NDA 022186

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
AK-FLUOR 10%RLD×2	LONG GROVE PHARMS	NDA 022186	AP	Aug 08, 2008
FLUORESCITERLD	ALCON LABS INC	NDA 021980	AP	Mar 28, 2006
FUNDUSCEIN-25RLD	NOVARTIS	NDA 017869	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (3)

Product	Applicant	Application	TE	Approved
FLUORESCEIN SODIUM×2	ZYDUS LIFESCIENCES	ANDA 218651	AP	Jun 01, 2026
FLUORESCEIN SODIUM	BPI LABS	ANDA 220046	AP	Apr 30, 2026
FLUORESCEIN SODIUM×2	NEXUS	ANDA 215709	AP	Sep 25, 2023

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.

Fluorescein sodium — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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