Is there a generic for Chlorothiazide; methyldopa?

Yes. The FDA Orange Book lists 2 approved generic (ANDA) applications for Chlorothiazide; methyldopa, referencing the brand ALDOCLOR-150. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Chlorothiazide; methyldopa?

ALDOCLOR-150 (NDA 016016, MERCK) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Chlorothiazide; methyldopa are approved?

Chlorothiazide; methyldopa is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Chlorothiazide; methyldopa

Chlorothiazide; methyldopa: 1 brand, 2 generics; first approved Nov 06, 1987; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 2 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

ALDOCLOR-150

MERCKNDA 016016—2 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
150MG;250MG	TABLET	ORAL	Discontinued	—
250MG;250MG	TABLET	ORAL	Discontinued	—

Abbreviated applications

Generic (ANDA) products (2)

METHYLDOPA AND CHLOROTHIAZIDE

PAR PHARMANDA 0707831987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
150MG;250MG	TABLET	ORAL	Discontinued	—

METHYLDOPA AND CHLOROTHIAZIDE

PAR PHARMANDA 0706541987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG;250MG	TABLET	ORAL	Discontinued	—

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

Nov 06, 1987

39 yr 3 mo ago

Most recent approval

Nov 06, 1987

39 yr 3 mo ago

All 3 applications were approved in 1987.

Brand (NDA) 133%

Generic (ANDA) 267%

Chlorothiazide; methyldopa — 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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