Is there a generic for Indapamide?

Yes. The FDA Orange Book lists 9 approved generic (ANDA) applications for Indapamide, referencing the brand LOZOL. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Indapamide?

LOZOL (NDA 018538, SANOFI AVENTIS US) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What dosage forms of Indapamide are approved?

Indapamide is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Indapamide

Indapamide: 1 brand, 9 generics; first approved Jul 06, 1983; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 9 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Brand (NDA) products

Originator applications

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LOZOLRLD
SANOFI AVENTIS USNDA 01853819932 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Discontinued -
1.25MG TABLET ORAL Discontinued -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Discontinued	-
1.25MG	TABLET	ORAL	Discontinued	-

Generic (ANDA) products (9)

Abbreviated applications

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INDAPAMIDE
ANI PHARMSANDA 07520119982 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.25MG TABLET ORAL Discontinued -
2.5MG TABLET ORAL Discontinued -
INDAPAMIDE
AUROBINDO PHARMA USAANDA 07510519982 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.25MG TABLET ORAL Discontinued -
2.5MG TABLET ORAL Discontinued -
INDAPAMIDE
ANI PHARMSANDA 07449819982 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Discontinued -
1.25MG TABLET ORAL Discontinued -
INDAPAMIDE
TEVAANDA 07466519972 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.25MG TABLET ORAL Discontinued -
2.5MG TABLET ORAL Discontinued -
INDAPAMIDE
RISINGANDA 07446119972 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Rx AB
1.25MG TABLET ORAL Rx AB
INDAPAMIDE
WATSON LABSANDA 07458519962 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.25MG TABLET ORAL Discontinued -
2.5MG TABLET ORAL Discontinued -
INDAPAMIDE
ACTAVIS ELIZABETHANDA 07472219962 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.25MG TABLET ORAL Rx AB
2.5MG TABLET ORAL Rx AB
INDAPAMIDE
CHARTWELL RXANDA 07459419962 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.25MG TABLET ORAL Discontinued -
2.5MG TABLET ORAL Discontinued -
INDAPAMIDE
ANI PHARMSANDA 07429919962 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Rx AB
1.25MG TABLET ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.25MG	TABLET	ORAL	Discontinued	-
2.5MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.25MG	TABLET	ORAL	Discontinued	-
2.5MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Discontinued	-
1.25MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.25MG	TABLET	ORAL	Discontinued	-
2.5MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Rx	AB
1.25MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.25MG	TABLET	ORAL	Discontinued	-
2.5MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.25MG	TABLET	ORAL	Rx	AB
2.5MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.25MG	TABLET	ORAL	Discontinued	-
2.5MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Rx	AB
1.25MG	TABLET	ORAL	Rx	AB

Listed patents

Orange Book patent file

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.

Approval history

FDA approval span

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First approval

Jul 06, 1983

43 yr 11 mo ago

Most recent approval

Dec 04, 1998

28 yr 4 mo ago

Approvals span 1983–1998 across 10 FDA applications.

Brand (NDA) 110%

Generic (ANDA) 990%

Indapamide: frequently asked questions

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

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Related FDA reference tools

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