Is there a generic for Atenolol; chlorthalidone?

Yes. The FDA Orange Book lists 9 approved generic (ANDA) applications for Atenolol; chlorthalidone, referencing the brand TENORETIC 100. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Atenolol; chlorthalidone?

TENORETIC 100 (NDA 018760, TWI PHARMS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Atenolol; chlorthalidone are approved?

Atenolol; chlorthalidone is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Atenolol; chlorthalidone

Atenolol; chlorthalidone: 1 brand, 9 generics; first approved Jun 08, 1984; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 9 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

TENORETIC 100RLD

TWI PHARMSNDA 01876019842 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG;25MG	TABLET	ORAL	Discontinued	—
50MG;25MG	TABLET	ORAL	Discontinued	—

Abbreviated applications

Generic (ANDA) products (9)

ATENOLOL AND CHLORTHALIDONE

NOVITIUM PHARMAANDA 21556020212 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG;25MG	TABLET	ORAL	Rx	AB
100MG;25MG	TABLET	ORAL	Rx	AB

ATENOLOL AND CHLORTHALIDONE

UNICHEMANDA 21330220202 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG;25MG	TABLET	ORAL	Rx	AB
100MG;25MG	TABLET	ORAL	Rx	AB

ATENOLOL AND CHLORTHALIDONE

ZYDUS PHARMSANDA 21002820192 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG;25MG	TABLET	ORAL	Rx	AB
100MG;25MG	TABLET	ORAL	Rx	AB

ATENOLOL AND CHLORTHALIDONE

NOSTRUM LABSANDA 07440419982 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG;25MG	TABLET	ORAL	Discontinued	—
100MG;25MG	TABLET	ORAL	Discontinued	—

ATENOLOL AND CHLORTHALIDONE

PLIVAANDA 07410719972 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG;25MG	TABLET	ORAL	Discontinued	—
100MG;25MG	TABLET	ORAL	Discontinued	—

ATENOLOL AND CHLORTHALIDONE

AUROBINDO PHARMA USAANDA 07420319932 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG;25MG	TABLET	ORAL	Discontinued	—
100MG;25MG	TABLET	ORAL	Discontinued	—

ATENOLOL AND CHLORTHALIDONE

SUN PHARM INDUSTRIESANDA 07358219932 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG;25MG	TABLET	ORAL	Discontinued	—
50MG;25MG	TABLET	ORAL	Discontinued	—

ATENOLOL AND CHLORTHALIDONE

WATSON LABSANDA 07366519922 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG;25MG	TABLET	ORAL	Rx	AB
100MG;25MG	TABLET	ORAL	Rx	AB

ATENOLOL AND CHLORTHALIDONE

AIPING PHARM INCANDA 07230219902 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG;25MG	TABLET	ORAL	Rx	AB
50MG;25MG	TABLET	ORAL	Rx	AB

Orange Book patent file

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.

FDA approval span

Approval history

First approval

Jun 08, 1984

42 yr 8 mo ago

Most recent approval

Oct 25, 2021

4 yr 9 mo ago

Approvals span 1984–2021 across 10 FDA applications.

Brand (NDA) 110%

Generic (ANDA) 990%

Atenolol; chlorthalidone — 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.

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