Active ingredient
Chlorthalidone
104 finished FDA listings contain Chlorthalidone as their only active ingredient; 19 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- CHLORTHALIDONE
- Dosage forms
- Tablet
- Routes
- Oral
- Manufacturers / labelers
- 38
- Strengths listed
- 12.5 mg/1 · 15 mg/1 · 25 mg/1 · 50 mg/1
- Brand names in FDA listings
- Chlorthalidone Chlorthalidone, Hemiclor, Thalitone
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2409
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 086831 | MYLAN | 1981-02-26 | 5 |
| ANDA 089286 | SUN PHARM INDUSTRIES | 1986-07-21 | 9 |
| NDA 019574 | CASPER PHARMA LLC | 1988-12-20 | 1 |
| ANDA 206904 | INGENUS PHARMS LLC | 2017-03-30 | 3 |
| ANDA 207222 | UMEDICA | 2018-05-24 | 12 |
| ANDA 210742 | APPCO | 2018-10-12 | 8 |
| ANDA 211063 | CHARTWELL RX | 2019-02-26 | 2 |
| ANDA 207813 | ZYDUS PHARMS | 2019-05-10 | 8 |
| ANDA 207204 | AMNEAL PHARMS CO | 2019-07-01 | 3 |
| ANDA 211627 | UNICHEM | 2019-08-06 | 6 |
| ANDA 213412 | ALKEM LABS LTD | 2020-02-11 | 13 |
| ANDA 214129 | AJANTA PHARMA LTD | 2020-11-27 | 6 |
| ANDA 211320 | ADAPTIS | 2022-02-09 | 8 |
| ANDA 212878 | PHARMOBEDIENT | 2022-02-24 | 3 |
| ANDA 212875 | PHARMOBEDIENT | 2022-02-24 | 2 |
| ANDA 215587 | MANKIND PHARMA | 2022-08-04 | 6 |
| ANDA 216262 | ALEMBIC | 2022-08-26 | 4 |
| ANDA 209162 | IPCA LABS LTD | 2024-11-12 | 2 |
| NDA 218647 | PRM PHARMA | 2025-03-17 | 1 |
| ANDA 212229 | MACLEODS PHARMS | 2026-07-01 | 2 |
Official labeling on DailyMed
- CHLORTHALIDONE TABLET [MAJOR PHARMACEUTICALS] · version 6 · 2026-08-07
- CHLORTHALIDONE TABLET [MACLEODS PHARMACEUTICALS LIMITED] · version 1 · 2026-08-06
- CHLORTHALIDONE TABLET [PREFERRED PHARMACEUTICALS INC.] · version 1 · 2026-07-27
- CHLORTHALIDONE TABLET [AMNEAL PHARMACEUTICALS LLC] · version 13 · 2026-07-06
- THALITONE (CHLORTHALIDONE) TABLET THALITONE (CHLORTHALIDONE) TABLET [CASPER PHARMA LLC] · version 7 · 2026-06-26
- CHLORTHALIDONE TABLET [PD-RX PHARMACEUTICALS, INC.] · version 19 · 2026-06-15
- CHLORTHALIDONE TABLET [REMEDYREPACK INC.] · version 7 · 2026-06-03
- CHLORTHALIDONE TABLET [BRYANT RANCH PREPACK] · version 9 · 2026-06-03
- CHLORTHALIDONE TABLET [MYLAN PHARMACEUTICALS INC.] · version 13 · 2026-05-06
- CHLORTHALIDONE TABLET [UMEDICA LABORATORIES USA INC.] · version 3 · 2026-04-27
- CHLORTHALIDONE TABLET [BRYANT RANCH PREPACK] · version 1 · 2026-04-22
- CHLORTHALIDONE TABLET [REMEDYREPACK INC.] · version 5 · 2026-04-17
Showing the 12 most recent of 78 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.