Is there a generic for Indomethacin sodium?

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

What is the reference-listed drug for Indomethacin sodium?

INDOCIN (NDA 018878, RECORDATI RARE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Indomethacin sodium are approved?

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

FDA Orange Book · active-ingredient family

Indomethacin sodium

Indomethacin sodium is approved as 1 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:INDOCIN · NDA 018878

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
INDOCINRLD	RECORDATI RARE	NDA 018878	—	Jan 30, 1985

Generic (ANDA) products (3)

Product	Applicant	Application	TE	Approved
INDOMETHACIN SODIUM	NAVINTA LLC	ANDA 206561	—	Jul 19, 2017
INDOMETHACIN SODIUM	HOSPIRA	ANDA 204118	—	Apr 19, 2016
INDOMETHACIN SODIUM	HIKMA	ANDA 078713	—	Jul 16, 2008

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.

Indomethacin sodium — frequently asked questions

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

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