Active ingredient
Potassium Citrate
57 finished FDA listings contain Potassium Citrate as their only active ingredient; 8 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- POTASSIUM CITRATE
- Dosage forms
- Pellet, Tablet, Tablet, Extended Release
- Routes
- Oral
- Manufacturers / labelers
- 16
- Strengths listed
- 1 [hp_m]/1 · 1 [hp_q]/1 · 10 meq/1 · 100 [hp_c]/1 · 1080 mg/1 · 12 [hp_c]/1 · 15 meq/1 · 200 [hp_c]/1 · 30 [hp_c]/1 · 5 meq/1 · 500 [hp_c]/1 · 540 mg/1 · 6 [hp_c]/1
- Brand names in FDA listings
- Potassium Citrate Extended Release, Urocit-K
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 54993
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 |
|---|---|---|---|
| NDA 019071 | MISSION PHARMA | 1985-08-30 | 6 |
| ANDA 077440 | RISING | 2006-06-08 | 2 |
| ANDA 203546 | ZYDUS PHARMS | 2014-08-06 | 10 |
| ANDA 206813 | STRIDES PHARMA | 2017-09-11 | 8 |
| ANDA 209758 | TEVA PHARMS USA INC | 2018-03-05 | 4 |
| ANDA 212779 | ANI PHARMS | 2020-01-14 | 8 |
| ANDA 214420 | ASCENT PHARMS INC | 2021-02-05 | 11 |
Official labeling on DailyMed
- UROCIT-K (POTASSIUM CITRATE) TABLET, EXTENDED RELEASE [MISSION PHARMACAL COMPANY] · version 30 · 2026-07-23
- POTASSIUM CITRATE TABLET, EXTENDED RELEASE [RISING PHARMA HOLDINGS, INC.] · version 6 · 2026-07-15
- POTASSIUM CITRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK] · version 104 · 2026-05-28
- POTASSIUM CITRATE EXTENDED RELEASE (POTASSIUM CITRATE) TABLET [STRIDES PHARMA INC.] · version 10 · 2026-05-21
- POTASSIUM CITRATE TABLET, EXTENDED RELEASE [REMEDYREPACK INC.] · version 6 · 2026-04-08
- POTASSIUM CITRATE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] · version 12 · 2026-04-08
- POTASSIUM CITRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK] · version 101 · 2026-03-30
- POTASSIUM CITRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK] · version 101 · 2026-03-30
- POTASSIUM CITRATE TABLET, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.] · version 6 · 2025-12-23
- POTASSIUM CITRATE TABLET [BIOCOMP PHARMA, INC.] · version 11 · 2025-12-18
- POTASSIUM CITRATE EXTENDED RELEASE (POTASSIUM CITRATE) TABLET [BRYANT RANCH PREPACK] · version 100 · 2025-11-17
- POTASSIUM CITRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK] · version 100 · 2025-11-17
Showing the 12 most recent of 30 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.