Is there a generic for Diatrizoate sodium?

Yes. The FDA Orange Book lists 2 approved generic (ANDA) applications for Diatrizoate sodium, referencing the brand HYPAQUE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Diatrizoate sodium?

HYPAQUE (NDA 011386, 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 Diatrizoate sodium are approved?

Diatrizoate sodium is approved in the following dosage forms: for solution, injectable, solution.

FDA Orange Book · active-ingredient family

Diatrizoate sodium

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

Reference-listed drug:HYPAQUE · NDA 011386

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · for solution, injectable, solution

Product	Applicant	Application	TE	Approved
HYPAQUE×2	GE HEALTHCARE	NDA 011386	—	Approved Prior to Jan 1, 1982
HYPAQUE×3	GE HEALTHCARE	NDA 009561	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (2)

Product	Applicant	Application	TE	Approved
UROVIST SODIUM 300	BAYER HLTHCARE	ANDA 087725	—	Sep 23, 1982
MD-50	MALLINCKRODT	ANDA 087075	—	Approved Prior to Jan 1, 1982

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.

Diatrizoate sodium — frequently asked questions

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

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