Is there a generic for Hydroflumethiazide; reserpine?

Yes. The FDA Orange Book lists 5 approved generic (ANDA) applications for Hydroflumethiazide; reserpine, referencing the brand SALUTENSIN. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Hydroflumethiazide; reserpine?

SALUTENSIN (NDA 012359, SHIRE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Hydroflumethiazide; reserpine are approved?

Hydroflumethiazide; reserpine is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Hydroflumethiazide; reserpine

Hydroflumethiazide; reserpine: 1 brand, 5 generics; first approved Mar 22, 1983; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 5 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

SALUTENSIN

SHIRENDA 012359—2 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG;0.125MG	TABLET	ORAL	Discontinued	—
25MG;0.125MG	TABLET	ORAL	Discontinued	—

Abbreviated applications

Generic (ANDA) products (5)

RESERPINE AND HYDROFLUMETHIAZIDE

PAR PHARMANDA 0889071985

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG;0.125MG	TABLET	ORAL	Discontinued	—

RESERPINE AND HYDROFLUMETHIAZIDE

IVAX PHARMSANDA 0889321985

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG;0.125MG	TABLET	ORAL	Discontinued	—

HYDROFLUMETHIAZIDE AND RESERPINE

USL PHARMAANDA 0881951983

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG;0.125MG	TABLET	ORAL	Discontinued	—

HYDROFLUMETHIAZIDE AND RESERPINE

WATSON LABSANDA 0881271983

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG;0.125MG	TABLET	ORAL	Discontinued	—

HYDROFLUMETHIAZIDE AND RESERPINE

WATSON LABSANDA 0881101983

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG;0.125MG	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

Mar 22, 1983

43 yr 11 mo ago

Most recent approval

Sep 20, 1985

41 yr 5 mo ago

Approvals span 1983–1985 across 6 FDA applications.

Brand (NDA) 117%

Generic (ANDA) 583%

Hydroflumethiazide; reserpine — 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

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo