Quick answers
- What is Potassium citrate used for?
- The FDA-approved label (Urocit-K, Mission Pharmacal Company, December 2, 2021) says: “Renal Tubular Acidosis (RTA) with Calcium Stones Potassium citrate is indicated for the management of renal tubular acidosis […]. 1.2 Hypocitraturic Calcium Oxalate Nephrolithiasis of any Etiology Potassium citrate is indicated for the management of Hypocitraturic calcium oxalate nephrolithiasis […]. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Potassium citrate have a boxed warning?
- No. None of the 29 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Potassium citrate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Potassium citrate been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started July 18, 2018 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Potassium citrate?
- 15 companies list prescription products of Potassium citrate in the FDA NDC Directory, including Bryant Ranch Prepack, Actavis Pharma, Inc. and Camber Pharmaceuticals, Inc..
What Potassium citrate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Renal Tubular Acidosis (RTA) with Calcium Stones Potassium citrate is indicated for the management of renal tubular acidosis […]. 1.2 Hypocitraturic Calcium Oxalate Nephrolithiasis of any Etiology Potassium citrate is indicated for the management of Hypocitraturic calcium oxalate nephrolithiasis […]. …
— FDA label: Urocit-K, Mission Pharmacal Company, effective December 2, 2021. Read the full label on DailyMed →
The FDA has 29 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 29 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, extended release · Tablet |
|---|---|
| Route | Oral |
| Prescription products | 49 in the FDA NDC Directory |
| Brand names | Urocit-K |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| potassium citrate 10 meq tablet | Generic | $0.1728 per tablet |
| potassium citrate 10 meq tablet, extended release | Generic | $0.1728 per tablet |
| potassium citrate 1080 mg tablet, extended release | Generic | $0.1728 per tablet |
| potassium citrate 15 meq tablet | Generic | $0.1743 per tablet |
| potassium citrate 15 meq tablet, extended release | Generic | $0.1743 per tablet |
| potassium citrate 5 meq tablet | Generic | $0.1145 per tablet |
| potassium citrate 5 meq tablet, extended release | Generic | $0.1145 per tablet |
| potassium citrate 540 mg tablet, extended release | Generic | $0.1145 per tablet |
NADAC list of November 4, 2026; these prices took effect between October 21, 2026 and October 28, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack15 products
- Actavis Pharma, Inc.3 products
- Camber Pharmaceuticals, Inc.3 products
- XLCare Pharmaceuticals, Inc.3 products
- Strides Pharma Inc.3 products
- Golden State Medical Supply, Inc.3 products
- Zydus Pharmaceuticals USA Inc.3 products
- Zydus Lifesciences Limited3 products
- Mission Pharmacal Company2 products
- BioComp Pharma, Inc.2 products
- ANI Pharmaceuticals, Inc.2 products
- Rising Pharma Holdings, Inc.2 products
- Upsher-Smith Laboratories, LLC2 products
- Remedyrepack Inc.2 products
- American Health Packaging1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA019071 UROCIT-K | Mission Pharma | August 30, 1985 | 9, latest December 10, 2021 2021: Labeling · 2009: Manufacturing (CMC) · 2002: Manufacturing (CMC) |
Generic approvals (6)
- ANDA077440Rising · June 8, 2006
- ANDA203546Zydus Pharms · August 6, 2014
- ANDA206813Strides Pharma · September 11, 2017
- ANDA209758Teva Pharms USA Inc · March 5, 2018
- ANDA212779Ani Pharms · January 14, 2020
- ANDA214420Ascent Pharms Inc · February 5, 2021
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
July 18, 2018 · Class II · Terminated · D-1018-2018
Failed Tablet/Capsule Specifications: Tablet breakage
Potassium Citrate Extended-Release Tablets, USP, 10 mEq, 100-count bottles, Rx only, Manufactured for: Vensun Pharmaceuticals, Inc. Yardley, PA 19067, Manufactured by: Strides Shasun Limited, Puducherry - 605 014, India, — VENSUN PHARMACEUTICALS INC
-
July 18, 2018 · Class II · Terminated · D-1017-2018
Failed Tablet/Capsule Specifications: Tablet breakage
Potassium Citrate Extended-Release Tablets, USP, 15 mEq, 100-count bottles, Rx only, Manufactured for: Vensun Pharmaceuticals, Inc. Yardley, PA 19067, Manufactured by: Strides Shasun Limited, Puducherry - 605 014, India, — VENSUN PHARMACEUTICALS INC
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Urocit-K, Mission Pharmacal Company, effective December 2, 2021; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →