Is there a generic for Iodixanol?

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Iodixanol, referencing the brand VISIPAQUE 270. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Iodixanol?

VISIPAQUE 270 (NDA 020351, GE HEALTHCARE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Iodixanol are approved?

Iodixanol is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Iodixanol

Iodixanol is approved as 2 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:VISIPAQUE 270 · NDA 020351

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
VISIPAQUE 270RLD×2	GE HEALTHCARE	NDA 020351	AP	Mar 22, 1996
VISIPAQUE 270×2	GE HEALTHCARE	NDA 020808	—	Aug 29, 1997

Generic (ANDA) products (1)

Product	Applicant	Application	TE	Approved
IODIXANOL×2	HENGRUI PHARMA	ANDA 214271	AP	May 19, 2022

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.

Iodixanol — frequently asked questions

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

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