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Potassium Citrate

Potassium citrate is a potassium salt used to help manage kidney stones and renal tubular acidosis (a kidney problem that makes the body too acidic) by making urine less likely to form stones.

Brand names Urocit-kPotassium Citrate Extended Release
Drug classes Acidifying Activity
Rx Forms 2
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 31 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 8, 2026
Potassium Citrate at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Potassium citrate is a long-standing standby for managing calcium oxalate and uric acid kidney stones and renal tubular acidosis (a kidney problem that leaves the body too acidic) with calcium stones, on the market since about 1992 and available as a generic; it makes urine less acidic and richer in citrate, which binds calcium and helps uric acid dissolve. Most people tolerate it fairly well, and the side effects they notice are stomach upset, nausea and loose stools. The one thing to watch is high potassium in the blood (hyperkalemia), which can build silently and lead to cardiac arrest, so keep every blood test and ECG.

Clinical pearls

  • Take each dose with a meal or within 30 minutes after one, or after a bedtime snack, to spare your stomach.
  • Swallow extended-release tablets whole, never crushed or chewed; an empty tablet shell in your stool is expected.
  • Limit salt and drink enough to pass at least two liters of urine daily, or stone protection weakens.
  • Avoid potassium-sparing water pills such as spironolactone, and tell prescribers before starting ACE inhibitors, ARBs or regular NSAIDs.
How we write & review this content — our editorial policy →
How you get itPrescription only
Comes asExtended-release tablet, Tablet
Earliest FDA record1985
Companies listing it with the FDA15
FDA label last updatedDec 16, 2025
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Potassium Citrate, written from its FDA label.

What Potassium Citrate is used for

▾

Potassium citrate is used to manage these kidney stone conditions across the supported products:

  • Renal tubular acidosis (RTA) with calcium stones
  • Hypocitraturic calcium oxalate nephrolithiasis of any cause
  • Uric acid lithiasis, with or without calcium stones

Urocit-K, Potassium Citrate extended-release tablets and Potassium Citrate tablets each list these uses.

How Potassium Citrate works

▾

After you swallow it, your body breaks down the citrate, which makes your system more alkaline. This raises urine pH and urine citrate. Citrate ties up calcium and blocks crystals from forming, and higher pH helps uric acid dissolve.

It does not change calcium phosphate saturation, because the effects of citrate and pH offset each other.

Potassium Citrate dosage

▾

Potassium citrate is taken by mouth, in two or three doses a day. Take it with meals or within 30 minutes after a meal or bedtime snack. Your doctor sets the dose based on how low your urine citrate is, and checks urine tests to adjust it.

  • Pair it with low salt intake and plenty of fluids.
  • Doses above 100 mEq/day have not been studied and should be avoided.
  • Follow your prescriber and the label.

Dosing details from the FDA-approved label

From the Potassium Citrate prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Severe hypocitraturia (urinary citrate < 150 mg/day)
    • Initiate at 60 mEq/day (30 mEq two times/day or 20 mEq three times/day with meals or within 30 minutes after meals or bedtime snack)
    • Maximum: Doses greater than 100 mEq/day have not been studied and should be avoided
    • Measure 24-hour urinary citrate and/or urinary pH to determine adequacy of the initial dosage; measure urinary citrate and/or pH every four months
  • Mild to moderate hypocitraturia (urinary citrate > 150 mg/day)
    • Initiate at 30 mEq/day (15 mEq two times/day or 10 mEq three times/day with meals or within 30 minutes after meals or bedtime snack)
    • Maximum: Doses greater than 100 mEq/day have not been studied and should be avoided
    • Use 24-hour urinary citrate and/or urinary pH measurements to determine adequacy of the initial dosage and effect of any dosage change
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Objective: To restore normal urinary citrate (greater than 320 mg/day and as close to the normal mean of 640 mg/day as possible), and to increase urinary pH to a level of 6.0 to 7.0. Severe hypocitraturia (urinary citrate < 150 mg/day): therapy should be initiated at 60 mEq per day; a dose of 30 mEq two times per day or 20 mEq three times per day with meals or within 30 minutes after meals or bedtime snack ( 2.2 ) Mild to moderate hypocitraturia (urinary citrate >150 mg/day): therapy should be initiated at 30 mEq per day; a dose of 15 mEq two times per day or 10 mEq three times per day with meals or within 30 minutes after meals or bedtime snack ( 2.3 ) 2.1 Dosing Instructions Treatment with extended release potassium citrate should be added to a regimen that limits salt intake (avoidance of foods with high salt content and of added salt at the table) and encourages high fluid intake (urine volume should be at least two liters per day). The objective of treatment with potassium citrate extended-release tablets is to provide potassium citrate extended-release tablets in sufficient dosage to restore normal urinary citrate (greater than 320 mg/day and as close to the normal mean of 640 mg/day as possible), and to increase urinary pH to a level of 6.0 or 7.0. Monitor serum electrolytes (sodium, potassium, chloride and carbon dioxide), serum creatinine and complete blood counts every four months and more frequently in patients with cardiac disease, renal disease or acidosis. Perform electrocardiograms periodically. Treatment should be discontinued if there is hyperkalemia, a significant rise in serum creatinine or a significant fall in blood hematocrit or hemoglobin. 2.2 Severe Hypocitraturia In patients with severe hypocitraturia (urinary citrate < 150 mg/day), therapy should be initiated at a dosage of 60 mEq/day (30 mEq two times/day or 20 mEq three times/day with meals or within 30 minutes after meals or bedtime snack). Twenty-four hour urinary citrate and/or urinary pH measurements should be used to determine the adequacy of the initial dosage and to evaluate the effectiveness of any dosage change. In addition, urinary citrate and/or pH should be measured every four months. Doses of potassium citrate extended-release tablets greater than 100 mEq/day have not been studied and should be avoided.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Potassium Citrate side effects

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Most side effects are mild stomach complaints from irritation of the digestive tract.

Common side effects

  • Abdominal discomfort
  • Nausea
  • Vomiting
  • Diarrhea
  • Loose bowel movements
  • Seeing intact tablet shells (matrices) in your stool

When to get medical help

  • Call your doctor right away if you have severe vomiting, abdominal pain, or any gastrointestinal bleeding. The tablets should be stopped and a bowel blockage or hole checked for.
  • High potassium (hyperkalemia) can be dangerous and may cause no symptoms, so keep up with your blood tests and ECGs.
  • Your doctor may stop treatment if potassium is high, kidney function worsens, or hemoglobin or hematocrit (blood count) drops significantly.

Taking the dose with meals or snacks, or lowering the dose, may help. You may see intact tablet shells in your stool. Severe vomiting, abdominal pain or bleeding needs prompt medical attention.

Potassium Citrate warnings and precautions

▾
  • High potassium (hyperkalemia): can happen quickly, may cause no symptoms, and can cause cardiac arrest. Avoid use with chronic kidney failure, severe heart muscle damage, heart failure or other conditions that limit potassium removal.
  • Digestive tract injury: potassium tablets can cause bowel ulcers, narrowing, bleeding or blockage. Stop and seek care for severe vomiting, abdominal pain or bleeding.
  • Monitoring: blood electrolytes, kidney function and blood counts every four months, more often with heart disease, kidney disease or acidosis, plus periodic ECGs.

Potassium Citrate interactions

▾

Several medicines can raise potassium or increase stomach irritation.

  • Potassium-sparing diuretics (triamterene, spironolactone, amiloride): avoid, because severe high potassium can result.
  • Anticholinergics and other drugs that slow the gut: more irritation from potassium salts.
  • ACE inhibitors, ARBs, eplerenone, aliskiren: can cause potassium retention, so monitor potassium.
  • NSAIDs: can cause potassium retention, so monitor potassium.

Interactions listed in the FDA-approved label

From the Potassium Citrate prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Potassium-sparing diuretics (such as triamterene, spironolactone or amiloride): Simultaneous administration can produce severe hyperkalemia. Concomitant administration should be avoided.
  • Drugs that slow gastrointestinal transit time (such as anticholinergics): These agents can be expected to increase the gastrointestinal irritation produced by potassium salts.
  • Renin-angiotensin-aldosterone system inhibitors (ACE inhibitors, ARBs, spironolactone, eplerenone, aliskiren): They produce potassium retention by inhibiting aldosterone production. Closely monitor potassium in patients receiving concomitant RAAS therapy.
  • Nonsteroidal anti-inflammatory drugs (NSAIDs): NSAIDs may produce potassium retention by reducing renal synthesis of prostaglandin E and impairing the renin-angiotensin system. Closely monitor potassium in patients on concomitant NSAIDs.
Read the label’s full interactions text

7 DRUG INTERACTIONS The following drug interactions may occur with potassium citrate: Potassium-sparing diuretics: concomitant administration should be avoided since the simultaneous administration of these agents can produce severe hyperkalemia (7.1) Drugs that slow gastrointestinal transit time: These agents (such as anticholinergics) can be expected to increase the gastrointestinal irritation produced by potassium salts (7.2) Renin-angiotensin-aldosterone inhibitors: Monitor for hyperkalemia (7.3) Nonsteroidal Anti-inflammatory drugs (NSAIDs) monitor for hyperkalemia (7.4) 7.1 Potential Effects of Potassium citrate on Other Drugs Potassium-sparing Diuretics: Concomitant administration of potassium citrate extended-release tablets and a potassium-sparing diuretic (such as triamterene, spironolactone or amiloride) should be avoided since the simultaneous administration of these agents can produce severe hyperkalemia. 7.2 Potential Effects of Other Drugs on Potassium citrate Drugs that slow gastrointestinal transit time: These agents (such as anticholinergics) can be expected to increase the gastrointestinal irritation produced by potassium salts. 7.3 Renin-Angiotensin-Aldosterone System Inhibitors 7.3 Renin-Angiotensin-Aldosterone System Inhibitors Drugs that inhibit the renin-angiotensin-aldosterone system (RAAS) including angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), spironolactone, eplerenone, or aliskiren produce potassium retention by inhibiting aldosterone production. Closely monitor potassium in patients receiving concomitant RAAS therapy. 7.4 Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) NSAIDs may produce potassium retention by reducing renal synthesis of prostagladin E and impairing the renin-angiotensin system. Closely monitor potassium in patients on concomitant NSAIDs.

Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Check Potassium Citrate against a supplement or herb →

Before taking Potassium Citrate

▾
  • Should not be used with high potassium or conditions that raise it (chronic kidney failure, uncontrolled diabetes, dehydration, adrenal insufficiency, extensive tissue breakdown, strenuous exercise in unconditioned people).
  • Should not be used with delayed stomach emptying, esophageal compression, or intestinal obstruction or stricture.
  • Should not be used with peptic ulcer disease.
  • Should not be used with an active urinary tract infection.
  • Should not be used with reduced kidney function (GFR below 0.7 mL/kg/min).
  • Pregnancy and breastfeeding: use only if clearly needed.
  • Children: safety and effectiveness not established.

Potassium Citrate overdose

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In people without risk factors, serious high potassium is rare at recommended doses. High potassium often has no symptoms, but can show up on ECG and later cause muscle paralysis or cardiac arrest. Treatment is done in a medical setting and includes stopping potassium-containing medicines and foods, heart monitoring, and other measures such as intravenous treatments or dialysis.

What Potassium Citrate does in the body

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Potassium citrate raises urine pH and urine citrate, and increases urinary potassium by about the amount in the medicine. In some people it temporarily lowers urinary calcium. These changes make urine less likely to form calcium oxalate, calcium phosphate and uric acid crystals.

How your body processes Potassium Citrate

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In people with normal kidney function, urine citrate begins to rise within the first hour after a single dose and lasts about 12 hours. With repeated doses, the rise peaks by about the third day and keeps urine citrate higher and steadier through the day. When treatment stops, urine citrate begins to fall back toward its earlier level on the first day.

How to store Potassium Citrate

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Store in a tight container.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

Potassium Citrate: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Potassium Citrate — the kind of thing our pharmacy team would talk through with you at the counter.

What is this medicine for?

▾
It helps manage certain kinds of kidney stones: calcium oxalate stones with low urine citrate, uric acid stones, and calcium stones linked to renal tubular acidosis. It makes your urine less likely to form stones.

How should I take it?

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Take it by mouth with meals or within 30 minutes after a meal or bedtime snack, exactly as your prescriber directs. Also cut back on salt and drink plenty of fluids, enough for at least two liters of urine a day.

What side effects should I expect?

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Some people get an upset stomach, nausea, vomiting, diarrhea or loose stools. Taking it with food or a snack can help, and your doctor may lower the dose. Seeing tablet shells in your stool can happen.

When should I call my doctor?

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Call right away for severe vomiting, abdominal pain or any bleeding from your digestive tract. High potassium can cause no symptoms, so keep your blood tests and ECGs scheduled.

Can I take it with my other medicines?

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Tell me about everything you take. Potassium-sparing diuretics should be avoided, and ACE inhibitors, ARBs and NSAIDs can raise potassium, so your levels need monitoring. Anticholinergics can make stomach irritation worse.

Is it safe in pregnancy?

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It is not known whether it can harm a baby, so it should be used in pregnancy or breastfeeding only if clearly needed. Talk with your prescriber if you are pregnant or planning to be.

Is Potassium Citrate available over the counter?

▾
No. Potassium Citrate is a prescription medicine: every Potassium Citrate product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Potassium Citrate first available?

▾
The earliest FDA record we hold for Potassium Citrate is from 1985: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Potassium Citrate was first used.

Who makes Potassium Citrate?

▾
15 companies currently list Potassium Citrate products in the FDA's NDC Directory, including Bryant Ranch Prepack, Actavis Pharma, Inc., Camber Pharmaceuticals, Inc. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Potassium Citrate on HelloPharmacist

🌿Drug & Supplement CheckerPotassium Citrate vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Potassium Citrate NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Potassium Citrate Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Potassium Citrate forms and strengths (how it comes)

Potassium Citrate is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Potassium Citrate inactive ingredients by manufacturer.

Extended-release tablet

By mouth
Brands Urocit-k
How this form is used
What it may be used for
  • Urocit-K is used to manage renal tubular acidosis with calcium stones, hypocitraturic calcium oxalate stones, and uric acid stones.
  • Potassium Citrate extended-release tablets are used for the same three stone conditions.
Important instructions
  • Urocit-K is taken with meals or within 30 minutes after a meal or bedtime snack.
  • Potassium Citrate extended-release tablets are taken with meals or within 30 minutes after a meal or bedtime snack, as directed by your prescriber.
  • Urocit-K doses above 100 mEq/day have not been studied and should be avoided.
Available strengths 5 strengths
540 mg 1080 mg 5 mEq 10 mEq 15 mEq
77 FDA-listed product records ⓘ

Tablet

By mouth
Brands Potassium Citrate
How this form is used
What it may be used for
  • Potassium Citrate tablets are used to manage renal tubular acidosis with calcium stones, hypocitraturic calcium oxalate stones, and uric acid stones.
Important instructions
  • Potassium Citrate tablets are taken in divided doses with meals or within 30 minutes after a meal or bedtime snack, as directed by your prescriber.
  • Potassium Citrate tablets should be used along with limited salt and high fluid intake.
Available strengths 3 strengths
5 mEq 10 mEq 15 mEq
22 FDA-listed product records ⓘ

Potassium Citrate on the U.S. market: products, makers and brands

How Potassium Citrate appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

15 companies list 49 Potassium Citrate product records with the FDA, mostly as extended-release tablet, tablet; the earliest marketing or approval year on record is 1985. Brand names on the directory include Urocit-k, Potassium Citrate Extended Release; the rest are generics.

2
Dose forms ⓘ
15
Labelers (makers, repackagers, distributors)
3
Brand names
49
FDA-listed product records ⓘ
1985
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Bryant Ranch Prepack31%
Actavis Pharma, Inc.6%
Camber Pharmaceuticals, Inc6%
Golden State Medical Supply, Inc.6%
Strides Pharma Inc.6%
XLCare Pharmaceuticals, Inc.6%
Other makers39%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Potassium Citrate is used (Medicaid data)

A general measure of how commonly Potassium Citrate is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Potassium Citrate is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

79,544
Medicaid prescriptions filled (Q1–Q4 2025)
$2.7M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Potassium Citrate prescribed? Of the 1,601 medications we measure, Potassium Citrate ranks #548 by Medicaid prescriptions — more than 66% of them.

Where Potassium Citrate ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #548 of 1,601
#543 Calcium Acetate 81,167 Rx #544 Budesonide and Albuter... 81,119 Rx #545 Crisaborole Topical 80,367 Rx #546 Gadobutrol 80,211 Rx #547 Alfuzosin 80,100 Rx #548 Potassium Citrate 79,544 Rx #549 Methotrexate Injection 78,302 Rx #550 Amlodipine / Valsartan 77,462 Rx #551 Rifampin 77,313 Rx #552 Clindamycin Vaginal 76,615 Rx #553 Ruxolitinib Topical 76,226 Rx

Utilization by Potassium Citrate product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 10 mEq extended release oral tablet is the most-dispensed Potassium Citrate product — about 66% of these Medicaid prescriptions.

potassium citrate 10 MEQ Extended Release Oral Tablet Most dispensed

52,837 Medicaid prescriptions (Q1–Q4 2025) 66% of Potassium Citrate prescriptions shown $1.8M gross reimbursement (before rebates) ≈ $33 per prescription (gross)

Summed across the 8 of 47 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 199381

potassium citrate 15 MEQ Extended Release Oral Tablet

23,980 Medicaid prescriptions (Q1–Q4 2025) 30% of Potassium Citrate prescriptions shown $826,859 gross reimbursement (before rebates) ≈ $34 per prescription (gross)

Summed across the 5 of 36 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 898490

potassium citrate 5 MEQ Extended Release Oral Tablet

2,727 Medicaid prescriptions (Q1–Q4 2025) 3% of Potassium Citrate prescriptions shown $78,367 gross reimbursement (before rebates) ≈ $29 per prescription (gross)

Summed across the 6 of 29 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 199376

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Potassium Citrate, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 19 of 112 listed Potassium Citrate NDCs with Medicaid activity.

Compare Potassium Citrate products

A representative set of FDA-listed product records for Potassium Citrate — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 49 of 49 products — FDA National Drug Code Directory. See every product, package size and price: browse all 49 Potassium Citrate NDCs →

Potassium Citrate side effects reported to the FDA (FAERS)

After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Potassium Citrate — a signal of what to watch for, not proof the drug caused it.

The effects most often named in FDA reports that mention Potassium Citrate are fatigue, nausea, diarrhoea; about 60% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.

5,488
Reports mentioning it
60%
Reported as serious
12
Distinct effects shown
Most reported effects
Fatigue
368
Nausea
336
Diarrhoea
335
Pain
306
Nephrolithiasis
276
Dizziness
241
Dyspnoea
227
Headache
215
Fall
203
Vomiting
185
Age groups
Elderly · 494Adult · 422Child · 11Adolescent · 10Neonate · 5Infant · 5

Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Potassium Citrate in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.

Potassium Citrate FDA approval history

How Potassium Citrate went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.

Potassium Citrate was first approved by the FDA in 1985 (Brand: UROCIT-K · Mission Pharma); the first generic version was approved in 2006. It remains available in U.S. pharmacies today.

1985
Brand approved
Brand: UROCIT-K · Mission Pharma
2006
First generic approved
Lower-cost ANDA competition begins
2026
Available today
Active in U.S. pharmacies

Source: Drugs@FDA.

Potassium Citrate recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Potassium Citrate recalls since July 2021.

✅No Potassium Citrate recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Potassium Citrate RxCUI 54993 2 dose forms · 4 strengths
  1. Dose form (SCDF) Extended Release Oral Tablet RxCUI 373529 In current FDA listings
    Clinical drug / strength (SCD) 5 MEQ RxCUI 199376 10 MEQ RxCUI 199381 15 MEQ RxCUI 898490
  2. Dose form (SCDF) Oral Capsule RxCUI 373526 No current FDA listing
    Clinical drug / strength (SCD) 99 MG RxCUI 248421

Look up RxCUI 54993 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Potassium Citrate costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Tablet, Extended Release · Oral 5 mEq $0.123 per tablet NDC details & price history
Tablet, Extended Release · Oral 540 mg $0.123 per tablet NDC details & price history
Tablet, Extended Release · Oral 1080 mg $0.175 per tablet NDC details & price history
Tablet · Oral 10 mEq $0.175 per tablet NDC details & price history
Tablet · Oral 5 mEq $0.123 per tablet NDC details & price history
Tablet · Oral 15 mEq $0.174 per tablet NDC details & price history
Tablet, Extended Release 5 mEq $0.123 per tablet NDC details & price history
Tablet, Extended Release 10 mEq $0.175 per tablet NDC details & price history
Tablet, Extended Release 15 mEq $0.174 per tablet NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Potassium Citrate brand names

Potassium Citrate is sold under 2 brand names in the FDA directory — Urocit-k, Potassium Citrate Extended Release. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Urocit-k Potassium Citrate Extended Release

Who makes Potassium Citrate: manufacturers and labelers

15 companies list Potassium Citrate products with the FDA. By number of product records, the largest are Bryant Ranch Prepack, Actavis Pharma, Inc., Camber Pharmaceuticals, Inc. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Bryant Ranch Prepack 15 Actavis Pharma, Inc. 3 Camber Pharmaceuticals, Inc 3 Golden State Medical Supply, Inc. 3 Strides Pharma Inc. 3 XLCare Pharmaceuticals, Inc. 3 Zydus Lifesciences Limited 3 Zydus Pharmaceuticals (USA) Inc. 3 ANI Pharmaceuticals, Inc. 2 Biocomp Pharma, Inc. 2 Mission Pharmacal Company 2 Remedyrepack Inc. 2 Rising Pharma Holdings, Inc. 2 Upsher-Smith Laboratories, LLC 2 American Health Packaging 1

Potassium Citrate drug class (RxNorm)

Potassium Citrate belongs to the Potassium class.

Drug family (ATC) Potassium

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Potassium Citrate page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Dec 16, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Potassium Citrate.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Potassium Citrate after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
31
Finished products in the current FDA directory
49
Companies listing them (makers, repackagers, distributors)
15
FDA labeler codes behind them ⓘ
17
Linked representative label ⓘ
Biocomp Pharma, Inc.
Linked label effective
Dec 16, 2025
Composite sections available
20
Linked SPL Set ID
b32fe71a-4a58-04a1-64d3-bc3cc4a895bf
Linked SPL Document ID
461546fa-70f8-dad0-e063-6394a90a4675
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Biocomp Pharma, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →