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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 074461

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NDA 074461 describes INDAPAMIDE, which is a drug marketed by Actavis Elizabeth, Ani Pharms, Aurobindo Pharma Usa, Chartwell Rx, Rising, Teva, and Watson Labs, and is included in nine NDAs. It is available from seven suppliers. Additional details are available on the INDAPAMIDE profile page.

The generic ingredient in INDAPAMIDE is indapamide. There are seven drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the indapamide profile page.

Summary for 074461

Tradename:	INDAPAMIDE
Applicant:	Rising
Ingredient:	indapamide
Patents:	0

Pharmacology for NDA: 074461

Physiological Effect	Increased Diuresis

Medical Subject Heading (MeSH) Categories for 074461

Antihypertensive Agents
Diuretics
Sodium Chloride Symporter Inhibitors

Suppliers and Packaging for NDA: 074461

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
INDAPAMIDE	indapamide	TABLET;ORAL	074461	ANDA	Rising Pharma Holdings, Inc.	16571-875	16571-875-01	100 TABLET in 1 BOTTLE (16571-875-01)
INDAPAMIDE	indapamide	TABLET;ORAL	074461	ANDA	Rising Pharma Holdings, Inc.	16571-876	16571-876-01	100 TABLET in 1 BOTTLE (16571-876-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2.5MG
Approval Date:	Mar 27, 1996	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1.25MG
Approval Date:	Mar 26, 1997	TE:	AB	RLD:	No

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