Is there a generic for Allopurinol sodium?

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

What is the reference-listed drug for Allopurinol sodium?

ALOPRIM (NDA 020298, MYLAN) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Allopurinol sodium are approved?

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

FDA Orange Book · active-ingredient family

Allopurinol sodium

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

Reference-listed drug:ALOPRIM · NDA 020298

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
ALOPRIMRLD	MYLAN	NDA 020298	AP	May 17, 1996

Generic (ANDA) products (2)

Product	Applicant	Application	TE	Approved
ALLOPURINOL SODIUM	GLAND	ANDA 212363	AP	Jan 26, 2022
ALLOPURINOL SODIUM	HIKMA	ANDA 076870	AP	Aug 26, 2004

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.

Allopurinol sodium — frequently asked questions

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

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