FDA Orange Book · active-ingredient family
Hydrochlorothiazide; spironolactone
Hydrochlorothiazide; spironolactone: 1 brand, 18 generics; first approved May 24, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 18 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
18
Listed patents
0
Presentations
20
Brand (NDA) products
Originator applications
- ALDACTAZIDERLDPFIZERNDA 01261619822 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG;25MG TABLET ORAL Rx AB 50MG;50MG TABLET ORAL Discontinued —
Generic (ANDA) products (18)
Abbreviated applications
- RUBICON RESEARCHANDA 2208842026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG;25MG TABLET ORAL Rx AB - SUN PHARM INDUSTRIESANDA 0895341987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG;25MG TABLET ORAL Rx AB - PUREPAC PHARMANDA 0879991985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG;25MG TABLET ORAL Discontinued — - SUPERPHARMANDA 0891371985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG;25MG TABLET ORAL Discontinued — - ASCOTANDA 0880251984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG;25MG TABLET ORAL Discontinued — - PUREPAC PHARMANDA 0880541983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG;25MG TABLET ORAL Discontinued — - PARKE DAVISANDA 0879481983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG;25MG TABLET ORAL Discontinued — - IVAX PHARMSANDA 0870041982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG;25MG TABLET ORAL Discontinued — - CHARTWELL RXANDA 086881—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG;25MG TABLET ORAL Discontinued — - MUTUAL PHARMANDA 087267—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG;25MG TABLET ORAL Discontinued — - MYLANANDA 086513—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG;25MG TABLET ORAL Rx AB - WATSON LABSANDA 087398—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG;25MG TABLET ORAL Discontinued — - LEDERLEANDA 087511—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG;25MG TABLET ORAL Discontinued — - UPSHER SMITHANDA 087553—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG;25MG TABLET ORAL Discontinued — - USL PHARMAANDA 087651—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG;25MG TABLET ORAL Discontinued — - VANGARDANDA 087655—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG;25MG TABLET ORAL Discontinued — - WATSON LABSANDA 085974—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG;25MG TABLET ORAL Discontinued — - WATSON LABSANDA 086026—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG;25MG 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
45 yr ago
Most recent approval
12 d ago
Approvals span 1982–2026 across 19 FDA applications.
Brand (NDA) 15%
Generic (ANDA) 1895%
Hydrochlorothiazide; spironolactone: 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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