Is there a generic for Chlorothiazide sodium?

Yes. The FDA Orange Book lists 6 approved generic (ANDA) applications for Chlorothiazide sodium, referencing the brand DIURIL. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Chlorothiazide sodium?

DIURIL (NDA 011145, RISING) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Chlorothiazide sodium are approved?

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

FDA Orange Book · active-ingredient family

Chlorothiazide sodium

Chlorothiazide sodium is approved as 1 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:DIURIL · NDA 011145

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
DIURILRLD	RISING	NDA 011145	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (6)

Product	Applicant	Application	TE	Approved
CHLOROTHIAZIDE SODIUM	GLAND	ANDA 218630	AP	Oct 03, 2024
CHLOROTHIAZIDE SODIUM	SAGENT PHARMS INC	ANDA 202462	AP	May 29, 2015
CHLOROTHIAZIDE SODIUM	RK PHARMA	ANDA 202493	—	Jun 18, 2014
CHLOROTHIAZIDE SODIUM	AM REGENT	ANDA 202561	AP	Apr 22, 2013
CHLOROTHIAZIDE SODIUM	SUN PHARM	ANDA 091546	AP	Jul 26, 2011
CHLOROTHIAZIDE SODIUM	FRESENIUS KABI USA	ANDA 090896	AP	Oct 16, 2009

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.

Chlorothiazide sodium — frequently asked questions

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

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