FDA Orange Book · active-ingredient family
Chlorthalidone
Chlorthalidone: 3 brands, 60 generics; first approved Jul 14, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 60 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
3
Generics (ANDA)
60
Listed patents
1
Next patent expiry
Sep 04, 2045
in 19 yr 4 mo
Brand (NDA) products
Originator applications
- PRM PHARMANDA 2186472025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG TABLET ORAL Rx — - THALITONERLDCASPER PHARMA LLCNDA 01957419882 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET ORAL Rx — 25MG TABLET ORAL Discontinued — - HYGROTONRLDSANOFI AVENTIS USNDA 012283—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — 25MG TABLET ORAL Discontinued —
Generic (ANDA) products (60)
Abbreviated applications
- CHLORTHALIDONEMACLEODS PHARMS LTDANDA 21222920262 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB - CHLORTHALIDONEIPCA LABS LTDANDA 20916220242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB - CHLORTHALIDONEALEMBICANDA 21626220222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB - CHLORTHALIDONEMANKIND PHARMAANDA 21558720222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB - CHLORTHALIDONEPHARMOBEDIENTANDA 2128782022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB - CHLORTHALIDONEPHARMOBEDIENTANDA 2128752022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB - CHLORTHALIDONEINVENTIAANDA 21132020222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB - CHLORTHALIDONESUNNYANDA 20906820222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — - CHLORTHALIDONEAJANTA PHARMA LTDANDA 21412920202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB - CHLORTHALIDONEALKEM LABS LTDANDA 21341220202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB - CHLORTHALIDONEUNICHEMANDA 21162720192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB - CHLORTHALIDONEAMNEAL PHARMS COANDA 20720420192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB - CHLORTHALIDONEZYDUS PHARMSANDA 20781320192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB - CHLORTHALIDONECHARTWELL RXANDA 21106320192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB - CHLORTHALIDONEAPPCOANDA 21074220182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB - CHLORTHALIDONEUMEDICAANDA 20722220182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB - CHLORTHALIDONEINGENUS PHARMS LLCANDA 20690420172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB - CHLORTHALIDONEMUTUAL PHARMANDA 0897381988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - CHLORTHALIDONEMUTUAL PHARMANDA 0897391988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - CHLORTHALIDONEPIONEER PHARMSANDA 0895911988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - CHLORTHALIDONEUSL PHARMAANDA 0890511987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - CHLORTHALIDONEUSL PHARMAANDA 0890521987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - CHLORTHALIDONESUN PHARM INDUSTRIESANDA 08928619862 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB - CHLORTHALIDONEPUREPAC PHARMANDA 0881391986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - CHLORTHALIDONEBARR LABS INCANDA 0889021985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - CHLORTHALIDONEBARR LABS INCANDA 0889031985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - CHLORTHALIDONECOSETTE PHARMS NCANDA 0886511985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - CHLORTHALIDONEIVAX PHARMSANDA 0879471984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - CHLORTHALIDONEANI PHARMSANDA 0881641984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - CHLORTHALIDONEPUREPAC PHARMANDA 0881401983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - CHLORTHALIDONEVANGARDANDA 0880731983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - CHLORTHALIDONESUPERPHARMANDA 0874731983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - CHLORTHALIDONESUPERPHARMANDA 0872471983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - CHLORTHALIDONEWARNER CHILCOTTANDA 0875161983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - CHLORTHALIDONEWARNER CHILCOTTANDA 0875151983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - MONARCH PHARMSANDA 0880511982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - CHLORTHALIDONEASCOTANDA 0876981982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - CHLORTHALIDONEASCOTANDA 0876991982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - CHLORTHALIDONEVANGARDANDA 0880121982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - CHLORTHALIDONEABBOTTANDA 087364—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - CHLORTHALIDONEABBOTTANDA 087384—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - CHLORTHALIDONEAIPING PHARM INCANDA 087381—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — 25MG TABLET ORAL Discontinued — - CHLORTHALIDONEANI PHARMSANDA 087296—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - CHLORTHALIDONEANI PHARMSANDA 087706—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - CHLORTHALIDONEANI PHARMSANDA 087689—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - CHLORTHALIDONEDAVA PHARMS INCANDA 087451—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - CHLORTHALIDONEDAVA PHARMS INCANDA 087450—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - CHLORTHALIDONEIVAX PHARMSANDA 087555—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - CHLORTHALIDONEIVAX PHARMSANDA 087176—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - CHLORTHALIDONEKV PHARMANDA 087311—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - CHLORTHALIDONEKV PHARMANDA 087312—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - CHLORTHALIDONEMUTUAL PHARMANDA 087292—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - CHLORTHALIDONEMUTUAL PHARMANDA 087293—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - CHLORTHALIDONERLDMYLANANDA 086831—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB - CHLORTHALIDONESANDOZANDA 087118—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - CHLORTHALIDONEWATSON LABSANDA 087050—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - CHLORTHALIDONEWATSON LABSANDA 087100—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - CHLORTHALIDONEWATSON LABSANDA 087029—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - CHLORTHALIDONEWATSON LABSANDA 087082—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - CHLORTHALIDONEWATSON LABSANDA 087521—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 12667554 | in 19 yr 4 mo | Product |
Approval history
FDA approval span
First approval
44 yr 8 mo ago
Most recent approval
1 mo ago
Approvals span 1982–2026 across 63 FDA applications.
Brand (NDA) 35%
Generic (ANDA) 6095%
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.
Related FDA reference tools
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- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
