Is there a generic for Methyclothiazide?

Yes. The FDA Orange Book lists 13 approved generic (ANDA) applications for Methyclothiazide, referencing the brand ENDURON. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Methyclothiazide?

ENDURON (NDA 012524, ABBVIE) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What dosage forms of Methyclothiazide are approved?

Methyclothiazide is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Methyclothiazide

Methyclothiazide: 2 brands, 13 generics; first approved Mar 11, 1982; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 13 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Brand (NDA) products

Originator applications

ENDURONRLD
ABBVIENDA 012524-2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Discontinued -
5MG TABLET ORAL Discontinued -
AQUATENSEN
MEDPOINTE PHARM HLCNDA 017364-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Discontinued -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Discontinued	-
5MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Discontinued	-

Generic (ANDA) products (13)

Abbreviated applications

METHYCLOTHIAZIDE
CHARTWELL RXANDA 0898351988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Discontinued -
METHYCLOTHIAZIDE
CHARTWELL RXANDA 0898371988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Discontinued -
METHYCLOTHIAZIDE
PAR PHARMANDA 0891351986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Discontinued -
METHYCLOTHIAZIDE
PAR PHARMANDA 0891361986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Discontinued -
METHYCLOTHIAZIDE
USL PHARMAANDA 0887451985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Discontinued -
METHYCLOTHIAZIDE
WATSON LABSANDA 0887501984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Discontinued -
METHYCLOTHIAZIDE
WATSON LABSANDA 0887241984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Discontinued -
METHYCLOTHIAZIDE
MYLANANDA 0876711982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Discontinued -
METHYCLOTHIAZIDE
PHARMOBEDIENTANDA 0876721982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Discontinued -
METHYCLOTHIAZIDE
IVAX PHARMSANDA 0879131982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Discontinued -
METHYCLOTHIAZIDE
IVAX PHARMSANDA 0877861982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Discontinued -
METHYCLOTHIAZIDE
WATSON LABSANDA 0854871982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Discontinued -
METHYCLOTHIAZIDE
WATSON LABSANDA 0854761982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Discontinued -

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

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Discontinued	-

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

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Discontinued	-

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

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Discontinued	-

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

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Discontinued	-

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

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Discontinued	-

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

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Discontinued	-

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

First approval

Mar 11, 1982

45 yr 3 mo ago

Most recent approval

Aug 18, 1988

38 yr 9 mo ago

Approvals span 1982–1988 across 15 FDA applications.

Brand (NDA) 213%

Generic (ANDA) 1387%

Methyclothiazide: 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.

Ask AI about Methyclothiazide

Key facts