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Urocit-K potassium citrate 5 meq Tablet, Extended Release, 100-count — NDC 00178-0600-01 package photo
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Urocit-K potassium citrate 5 meq Tablet, Extended Release, 100-count — NDC 0178-0600-01 (Billing 00178-0600-01)

by Mission Pharmacal Company · 100 TABLET, EXTENDED RELEASE in 1 BOTTLE

This is a package of 100 tablets of Urocit-K potassium citrate 5 meq Tablet, Extended Release from Mission Pharmacal Company, no longer marketed, no longer in the FDA NDC Directory. It is this product's only package size.

NDC 00178-0600-01
🏷️ FDA NDC (as labeled) 0178-0600-01 billing pads the labeler segment with a zero
Rx only Brand Discontinued Non-controlled ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 14, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
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NDC database record

One package, one record: these facts belong to NDC 0178-0600-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0178 labeler · 0600 product · 01 package
Billing quantity
100 EA per package
Barcode (UPC-A, from the NDC)
3 0178060001 6
FDA record last changed
Jul 14, 2026
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2024. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0178-0600-01
Product NDC 0178-0600
11-digit billing NDC 00178060001
NCPDP billing unit EA — each (per item)
Application # NDA019071
SPL Set ID 72cdea1b-2240-41db-987d-86d5c6aaa978
Physiologic effect Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity
DEA schedule Non-controlled
Marketing category NDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Dec 2024)
Route ORAL
Dosage form TABLET, EXTENDED RELEASE
Substance POTASSIUM CITRATE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 008250
GCN 14950
HICL code 000548
Ingredient (HICL) Potassium Citrate
HIC1 code R
Therapeutic class — broad (HIC1) Kidney/Urinary Tract
HIC2 code R1
Therapeutic class — intermediate (HIC2) Affect Primarily Kidneys/Urinary Tract
HIC3 code R1S
Therapeutic class — specific (HIC3) Urinary Ph Modifiers
AHFS code 40:08.00.00
AHFS class Alkalinizing Agents
FDB label name UROCIT-K SR 5 MEQ TABLET
FDB brand name Urocit-K
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 008250
  • GCN: 14950
  • HICL (First Databank): 000548
  • AHFS class code: 40:08.00.00
Why two NDCs? The FDA registers this code as 0178-0600-01 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00178-0600-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

Label name UROCIT-K SR 5 MEQ TABLET Ingredient Potassium Citrate
📖 What it is MedlinePlus · NLM

Potassium is essential for the proper functioning of the heart, kidneys, muscles, nerves, and digestive system. Usually the food you eat supplies all of the potassium you need. However, certain diseases (e.g., kidney disease and gastrointestinal disease with vomiting and diarrhea) and drugs, especially diuretics ('water pills'), remove potassium from the body. Potassium supplements are taken to replace potassium losses and prevent potassium deficiency. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • 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...
  • 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...
  • 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 y...
  • 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.
📖 Read our full Potassium Citrate guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00178-0600-01 You're viewing this Main listing 100 TABLET, EXTENDED RELEASE in 1 BOTTLE 2009-12-30 — Discontinued by firm

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Potassium Citrate 5 meq 00245-0070-11 Upsher-Smith 100 tablets $0.123 AB Availability likely —
Potassium Citrate 5 meq 00591-2682-01 Actavis 100 tablets $0.123 — Availability likely —
Potassium Citrate 540 mg 16571-0864-01 Rising 100 tablets $0.123 AB Availability likely —
Potassium Citrate 5 meq 31722-0129-01 Camber 100 tablets $0.123 AB Availability likely —
Potassium Citrate Extended Release 5 meq 42543-0406-01 Strides 100 tablets $0.123 AB Availability likely —
Potassium Citrate 5 meq 68382-0536-01 Zydus 100 tablets $0.123 AB Availability likely —
Potassium Citrate 5 meq 51407-0449-01 Golden 100 tablets — AB FDA listed —
Potassium Citrate 5 meq 65841-0536-01 Zydus 100 tablets — AB FDA listed —
Potassium Citrate 5 meq 72162-2122-01 Bryant 100 tablets — AB FDA listed —
Potassium Citrate Extended Release 5 meq 72162-2476-01 Bryant 100 tablets — AB FDA listed —
Potassium Citrate 5 meq 72865-0191-01 XLCare 100 tablets — AB FDA listed —
Urocit-K 5 meqthis 00178-0600-01 Mission 100 tablets — AB Discontinued —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color yellow
ShapeRectangle
ImprintM15
Size2 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII R12CBM0EIZ
    A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.

2 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerMission Pharmacal Company
Application holderMISSION PHARMACAL CO
FDA applicationNDA019071 (NDA)
Labeler code00178
Product typeHuman Prescription Drug
Portfolio26 products on file

More NDCs from Mission Pharmacal Company labeler code 00178

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🔬 Clinical Studies 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 117 words ▾

1 INDICATIONS AND USAGE

1.1Renal Tubular Acidosis (RTA) with Calcium Stones Potassium citrate is indicated for the management of renal tubular acidosis [see Clinical Studies (14.1)].

1.2Hypocitraturic Calcium Oxalate Nephrolithiasis of any Etiology Potassium citrate is indicated for the management of Hypocitraturic calcium oxalate nephrolithiasis [see Clinical Studies (14.2)].

1.3Uric Acid Lithiasis with or without Calcium Stones Potassium citrate is indicated for the management of Uric acid lithiasis with or without calcium stones [see Clinical Studies (14.3)]. Urocit-K is a citrate salt of potassium indicated for the management of: Renal tubular acidosis (RTA) with calcium stones (1.1) Hypocitraturic calcium oxalate nephrolithiasis of any etiology (1.2) Uric acid lithiasis with or without calcium stones (1.3)

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION

2.1Dosing 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 Urocit-K is to provide Urocit-K 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.

2.2Severe 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 Urocit-K greater than 100 mEq/day have not been studied and should be avoided.

2.3Mild to Moderate Hypocitraturia In patients with mild to moderate hypocitraturia (urinary citrate > 150 mg/day) therapy should be initiated 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). 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. Doses of Urocit-K greater than 100 mEq/day have not been studied and should be avoided.

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)

💊 Dosage Forms and Strengths 59 words ▾

3 DOSAGE FORMS AND STRENGTHS 10 mEq tablets are uncoated, tan to yellowish in color, elliptical shaped, with 610 debossed on one side and MISSION on the other 15 mEq tablets are uncoated, tan to yellowish in color, modified rectangle shaped, with M15 debossed on one side and blank on the other Tablets: 10 mEq and 15 mEq (3)

⛔ Contraindications ~1 min read ▾

4 CONTRAINDICATIONS Urocit ® -K is contraindicated: In patients with hyperkalemia (or who have conditions pre-disposing them to hyperkalemia), as a further rise in serum potassium concentration may produce cardiac arrest. Such conditions include: chronic renal failure, uncontrolled diabetes mellitus, acute dehydration, strenuous physical exercise in unconditioned individuals, adrenal insufficiency, extensive tissue breakdown or the administration of a potassium-sparing agent (such as triamterene, spironolactone or amiloride).

In patients in whom there is cause for arrest or delay in tablet passage through the gastrointestinal tract, such as those suffering from delayed gastric emptying, esophageal compression, intestinal obstruction or stricture, or those taking anticholinergic medication. In patients with peptic ulcer disease because of its ulcerogenic potential. In patients with active urinary tract infection (with either urea-splitting or other organisms, in association with either calcium or struvite stones).

The ability of Urocit ® -K to increase urinary citrate may be attenuated by bacterial enzymatic degradation of citrate. Moreover, the rise in urinary pH resulting from Urocit ® -K therapy might promote further bacterial growth. In patients with renal insufficiency (glomerular filtration rate of less than 0.7 ml/kg/min), because of the danger of soft tissue calcification and increased risk for the development of hyperkalemia.

Patients with hyperkalemia (or who have conditions predisposing them to hyperkalemia). Such conditions include chronic renal failure, uncontrolled diabetes mellitus, acute dehydration, strenuous physical exercise in unconditioned individuals, adrenal insufficiency, extensive tissue breakdown (4) Patients for whom there is cause for arrest or delay in tablet passage through the gastrointestinal tract such as those suffering from delayed gastric emptying, esophageal compression, intestinal obstruction or stricture (4) Patients with peptic ulcer disease (4) Patients with active urinary tract infection (4) Patients with renal insufficiency (glomerular filtration rate of less than 0.7 ml/kg/min) (4)

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS

5.1Hyperkalemia In patients with impaired mechanisms for excreting potassium, Urocit-K administration can produce hyperkalemia and cardiac arrest. Potentially fatal hyperkalemia can develop rapidly and be asymptomatic. The use of Urocit-K in patients with chronic renal failure, or any other condition which impairs potassium excretion such as severe myocardial damage or heart failure, should be avoided.

Closely monitor for signs of hyperkalemia with periodic blood tests and ECGs.

5.2Gastrointestinal Lesions Solid dosage forms of potassium chlorides have produced stenotic and/or ulcerative lesions of the small bowel and deaths. These lesions are caused by a high local concentration of potassium ions in the region of the dissolving tablets, which injured the bowel. In addition, perhaps because wax-matrix preparations are not enteric-coated and release some of their potassium content in the stomach, there have been reports of upper gastrointestinal bleeding associated with these products.

The frequency of gastrointestinal lesions with wax-matrix potassium chloride products is estimated at one per 100,000 patient-years. Experience with Urocit-K is limited, but a similar frequency of gastrointestinal lesions should be anticipated. If there is severe vomiting, abdominal pain or gastrointestinal bleeding, Urocit-K should be discontinued immediately and the possibility of bowel perforation or obstruction investigated.

Hyperkalemia: In patients with impaired mechanisms for excreting potassium, Urocit-K administration can produce hyperkalemia and cardiac arrest. Potentially fatal hyperkalemia can develop rapidly and be asymptomatic. The use of Urocit-K in patients with chronic renal failure, or any other condition which impairs potassium excretion such as severe myocardial damage or heart failure, should be avoided (5.1) Gastrointestinal lesions: if there is severe vomiting, abdominal pain or gastrointestinal bleeding, Urocit-K should be discontinued immediately and the possibility of bowel perforation or obstruction investigated (5.2)

🤒 Adverse Reactions 117 words ▾

6 ADVERSE REACTIONS

6.1Postmarketing Experience Some patients may develop minor gastrointestinal complaints during Urocit-K therapy, such as abdominal discomfort, vomiting, diarrhea, loose bowel movements or nausea. These symptoms are due to the irritation of the gastrointestinal tract, and may be alleviated by taking the dose with meals or snacks, or by reducing the dosage. Patients may find intact matrices in their feces.

Some patients may develop minor gastrointestinal complaints such as abdominal discomfort, vomiting, diarrhea, loose bowel movements or nausea. These may be alleviated by taking the dose with meals or snacks or by reducing the dosage (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Mission Pharmacal Company at 1-800-298-1087 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

🔄 Drug Interactions 211 words ▾

7 DRUG INTERACTIONS

7.1Potential Effects of Potassium Citrate on Other Drugs Potassium-sparing Diuretics: Concomitant administration of Urocit-K 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.

7.2Potential 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.

7.3Renin-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.

7.4Nonsteroidal 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. 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)

👥 Use in Specific Populations 206 words ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Animal reproduction studies have not been conducted. It is also not known whether Urocit-K can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Urocit-K should be given to a pregnant woman only if clearly needed.

8.3Nursing Mothers The normal potassium ion content of human milk is about 13 mEq/L. It is not known if Urocit-K has an effect on this content. Urocit-K should be given to a woman who is breastfeeding only if clearly needed.

8.4Pediatric Use Safety and effectiveness in children have not been established. ​ Pregnant women: Animal reproduction studies have not been conducted. It is not known whether Urocit-K can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Urocit-K should be given to a pregnant woman only if clearly needed (8.1) Nursing mothers: The normal potassium ion content of human milk is about 13 mEq/L.

It is not known if Urocit-K has an effect on this content. Urocit-K should be given to a woman who is breastfeeding only if clearly needed (8.3) Pediatric Use: Safety and effectiveness in children have not been established (8.4) See 17 for PATIENT COUNSELING INFORMATION Revised 12/2021

🆘 Overdosage ~1 min read ▾

10 OVERDOSAGE Treatment of Overdosage: The administration of potassium salts to persons without predisposing conditions for hyperkalemia rarely causes serious hyperkalemia at recommended dosages. It is important to recognize that hyperkalemia is usually asymptomatic and may be manifested only by an increased serum potassium concentration and characteristic electrocardiographic changes (peaking of T-wave, loss of P-wave, depression of S-T segment and prolongation of the QT interval). Late manifestations include muscle paralysis and cardiovascular collapse from cardiac arrest.

Treatment measures for hyperkalemia include the following: 1. Patients should be closely monitored for arrhythmias and electrolyte changes. 2.

Elimination of medications containing potassium and of agents with potassium-sparing properties such as potassium-sparing diuretics, ARBs, ACE inhibitors, NSAIDs, certain nutritional supplements and many others. 3. Elimination of foods containing high levels of potassium such as almonds, apricots, bananas, beans (lima, pinto, white), cantaloupe, carrot juice (canned), figs, grapefruit juice, halibut, milk, oat bran, potato (with skin), salmon, spinach, tuna and many others.

4. Intravenous calcium gluconate if the patient is at no risk or low risk of developing digitalis toxicity. 5.

Intravenous administration of 300-500 mL/hr of 10% dextrose solution containing 10-20 units of crystalline insulin per 1,000 mL. 6. Correction of acidosis, if present, with intravenous sodium bicarbonate.

7. Hemodialysis or peritoneal dialysis. 8.

Exchange resins may be used. However, this measure alone is not sufficient for the acute treatment of hyperkalemia. Lowering potassium levels too rapidly in patients taking digitalis can produce digitalis toxicity.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY When Urocit-K is given orally, the metabolism of absorbed citrate produces an alkaline load. The induced alkaline load in turn increases urinary pH and raises urinary citrate by augmenting citrate clearance without measurably altering ultrafilterable serum citrate. Thus, Urocit-K therapy appears to increase urinary citrate principally by modifying the renal handling of citrate, rather than by increasing the filtered load of citrate.

The increased filtered load of citrate may play some role, however, as in small comparisons of oral citrate and oral bicarbonate, citrate had a greater effect on urinary citrate. In addition to raising urinary pH and citrate, Urocit-K increases urinary potassium by approximately the amount contained in the medication. In some patients, Urocit-K causes a transient reduction in urinary calcium.

The changes induced by Urocit-K produce urine that is less conducive to the crystallization of stone-forming salts (calcium oxalate, calcium phosphate and uric acid). Increased citrate in the urine, by complexing with calcium, decreases calcium ion activity and thus the saturation of calcium oxalate. Citrate also inhibits the spontaneous nucleation of calcium oxalate and calcium phosphate (brushite).

The increase in urinary pH also decreases calcium ion activity by increasing calcium complexation to dissociated anions. The rise in urinary pH also increases the ionization of uric acid to the more soluble urate ion. Urocit-K therapy does not alter the urinary saturation of calcium phosphate, since the effect of increased citrate complexation of calcium is opposed by the rise in pH-dependent dissociation of phosphate.

Calcium phosphate stones are more stable in alkaline urine. In the setting of normal renal function, the rise in urinary citrate following a single dose begins by the first hour and lasts for 12 hours. With multiple doses the rise in citrate excretion reaches its peak by the third day and averts the normally wide circadian fluctuation in urinary citrate, thus maintaining urinary citrate at a higher, more constant level throughout the day.

When the treatment is withdrawn, urinary citrate begins to decline toward the pre-treatment level on the first day. The rise in citrate excretion is directly dependent on the Urocit-K dosage. Following long-term treatment, Urocit-K at a dosage of 60 mEq/day raises urinary citrate by approximately 400 mg/day and increases urinary pH by approximately 0.7 units.

In patients with severe renal tubular acidosis or chronic diarrheal syndrome where urinary citrate may be very low (<100 mg/day), Urocit-K may be relatively ineffective in raising urinary citrate. A higher dose of Urocit-K may therefore be required to produce a satisfactory citraturic response. In patients with renal tubular acidosis in whom urinary pH may be high, Urocit-K produces a relatively small rise in urinary pH.

12.1Mechanism of Action When Urocit ® -K is given orally, the metabolism of absorbed citrate produces an alkaline load. The induced alkaline load in turn increases urinary pH and raises urinary citrate by augmenting citrate clearance without measurably altering ultrafilterable serum citrate. Thus, Urocit ® -K therapy appears to increase urinary citrate principally by modifying the renal handling of citrate, rather than by increasing the filtered load of citrate.

The increased filtered load of citrate may play some role, however, as in small comparisons of oral citrate and oral bicarbonate, citrate had a greater effect on urinary citrate. In addition to raising urinary pH and citrate, Urocit ® -K increases urinary potassium by approximately the amount contained in the medication. In some patients, Urocit ® -K causes a transient reduction in urinary calcium.

The changes induced by Urocit ® -K produce urine that is less conducive to the crystallization of stone-forming salts (calcium oxalate, calcium phosphate and uric acid). Increased citrate in the urine, by complexing… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action ~2 min read ▾

12.1Mechanism of Action When Urocit ® -K is given orally, the metabolism of absorbed citrate produces an alkaline load. The induced alkaline load in turn increases urinary pH and raises urinary citrate by augmenting citrate clearance without measurably altering ultrafilterable serum citrate. Thus, Urocit ® -K therapy appears to increase urinary citrate principally by modifying the renal handling of citrate, rather than by increasing the filtered load of citrate.

The increased filtered load of citrate may play some role, however, as in small comparisons of oral citrate and oral bicarbonate, citrate had a greater effect on urinary citrate. In addition to raising urinary pH and citrate, Urocit ® -K increases urinary potassium by approximately the amount contained in the medication. In some patients, Urocit ® -K causes a transient reduction in urinary calcium.

The changes induced by Urocit ® -K produce urine that is less conducive to the crystallization of stone-forming salts (calcium oxalate, calcium phosphate and uric acid). Increased citrate in the urine, by complexing with calcium, decreases calcium ion activity and thus the saturation of calcium oxalate. Citrate also inhibits the spontaneous nucleation of calcium oxalate and calcium phosphate (brushite).

The increase in urinary pH also decreases calcium ion activity by increasing calcium complexation to dissociated anions. The rise in urinary pH also increases the ionization of uric acid to the more soluble urate ion. Urocit ® -K therapy does not alter the urinary saturation of calcium phosphate, since the effect of increased citrate complexation of calcium is opposed by the rise in pH-dependent dissociation of phosphate.

Calcium phosphate stones are more stable in alkaline urine. In the setting of normal renal function, the rise in urinary citrate following a single dose begins by the first hour and lasts for 12 hours. With multiple doses the rise in citrate excretion reaches its peak by the third day and averts the normally wide circadian fluctuation in urinary citrate, thus maintaining urinary citrate at a higher, more constant level throughout the day.

When the treatment is withdrawn, urinary citrate begins to decline toward the pre-treatment level on the first day. The rise in citrate excretion is directly dependent on the Urocit ® -K dosage. Following long-term treatment, Urocit ® -K at a dosage of 60 mEq/day raises urinary citrate by approximately 400 mg/day and increases urinary pH by approximately 0.7 units.

In patients with severe renal tubular acidosis or chronic diarrheal syndrome where urinary citrate may be very low (<100 mg/day), Urocit ® -K may be relatively ineffective in raising urinary citrate. A higher dose of Urocit ® -K may therefore be required to produce a satisfactory citraturic response. In patients with renal tubular acidosis in whom urinary pH may be high, Urocit ® -K produces a relatively small rise in urinary pH.

📦 How Supplied / Storage and Handling 79 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Urocit-K 10 mEq tablets are uncoated, tan to yellowish in color, elliptical shaped, with 610 debossed on one side and MISSION on the other, supplied in bottles as: NDC 0178-0610-01 Bottle of 100 Urocit-K 15 mEq tablets are uncoated, tan to yellowish in color, modified rectangle shaped, with M15 debossed on one side and blank on the other, supplied in bottles as: NDC 0178-0615-01 Bottle of 100 Storage : Store in a tight container.

📋 Description 60 words ▾

11 DESCRIPTION Urocit-K is a citrate salt of potassium. Its empirical formula is K3C6H507 • H20, and it has the following chemical structure: Urocit-K yellowish to tan, oral wax-matrix tablets, contain 5 mEq (540 mg) potassium citrate, 10 mEq (1080 mg) potassium citrate and 15 mEq (1620 mg) potassium citrate each. Inactive ingredients include carnauba wax and magnesium stearate. Structure

💬 Information for Patients 104 words ▾

17 PATIENT COUNSELING INFORMATION

17.1Administration of Drug Tell patients to take each dose without crushing, chewing or sucking the tablet. Tell patients to take this medicine only as directed. This is especially important if the patient is also taking both diuretics and digitalis preparations.

Tell patients to check with the doctor if there is trouble swallowing tablets or if the tablet seems to stick in the throat. Tell patients to check with the doctor at once if tarry stools or other evidence of gastrointestinal bleeding is noticed. Tell patients that their doctor will perform regular blood tests and electrocardiograms to ensure safety.

L061001R0625

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES The pivotal Urocit-K trials were non-randomized and non-placebo controlled where dietary management may have changed coincidentally with pharmacological treatment. Therefore, the results as presented in the following sections may overstate the effectiveness of the product.

14.1Renal Tubular Acidosis (RTA) with Calcium Stones The effect of oral potassium citrate therapy in a non-randomized, non-placebo controlled clinical study of five men and four women with calcium oxalate/calcium phosphate nephrolithiasis and documented incomplete distal renal tubular acidosis was examined. The main inclusion criterion was a history of stone passage or surgical removal of stones during the 3 years prior to initiation of potassium citrate therapy. All patients began alkali treatment with 60-80 mEq potassium citrate daily in 3 or 4 divided doses.

Throughout treatment, patients were instructed to stay on a sodium restricted diet (100 mEq/day) and to reduce oxalate intake (limited intake of nuts, dark roughage, chocolate and tea). A moderate calcium restriction (400-800 mg/day) was imposed on patients with hypercalciuria. X-rays of the urinary tract, available in all patients, were reviewed carefully to determine presence of pre-existing stones, appearance of new stones, or change in the number of stones.

Potassium citrate therapy was associated with inhibition of new stone formation in patients with distal tubular acidosis. Three of the nine patients continued to pass stones during the on-treatment phase. While it is likely that these patients passed pre-existing stones during therapy, the most conservative assumption is that the passed stones were newly formed.

Using this assumption, the stone-passage remission rate was 67%. All patients had a reduced stone formation rate. Over the first 2 years of treatment, the on-treatment stone formation rate was reduced from 13±27 to 1±2 per year.

14.2Hypocitraturic Calcium Oxalate Nephrolithiasis of any Etiology Eighty-nine patients with hypocitraturic calcium nephrolithiasis or uric acid lithiasis with or without calcium nephrolithiasis participated in this non-randomized, non-placebo controlled clinical study. Four groups of patients were treated with potassium citrate: Group 1 was comprised of 19 patients, 10 with renal tubular acidosis and 9 with chronic diarrheal syndrome, Group 2 was comprised of 37 patients, 5 with uric acid stones alone, 6 with uric acid lithiasis and calcium stones, 3 with type 1 absorptive hypercalciuria, 9 with type 2 absorptive hypercalciuria and 14 with hypocitraturia.

Group 3 was comprised of 15 patients with history of relapse on other therapy and Group 4 was comprised of 18 patients, 9 with type 1 absorptive hypercalciuria and calcium stones, 1 with type 2 absorptive hypercalciuria and calcium stones, 2 with hyperuricosuric calcium oxalate nephrolithiasis, 4 with uric acid lithiasis accompanied by calcium stones and 2 with hypocitraturia and hyperuricemia accompanied by calcium stones. The dose of potassium citrate ranged from 30 to 100 mEq per day, and usually was 20 mEq administered orally 3 times daily.

Patients were followed in an outpatient setting every 4 months during treatment and were studied over a period from 1 to 4.33 years. A three-year retrospective pre-study history for stone passage or removal was obtained and corroborated by medical records. Concomitant therapy (with thiazide or allopurinol) was allowed if patients had hypercalciuria, hyperuricosuria or hyperuricemia.

Group 2 was treated with potassium citrate alone. In all groups, treatment that included potassium citrate was associated with a sustained increase in urinary citrate excretion from subnormal values to normal values (400 to 700 mg/day), and a sustained increase in urinary pH from 5.6-6.0 to approximately 6.5. The stone formation rate was reduced in all groups as shown in Table 1.

Table 1. Effect of Urocit-K In Patients With Calcium Oxalate Nephrolithiasis. *Remission de… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 114 words ▾

PRINCIPAL DISPLAY PANEL - 10 mEq Bottle Label NDC 0178-0610-01 UROCIT ® -K 10 mEq (Potassium Citrate) Extended-release tablet 10 mEq (1080 mg) per tablet Rx only 100 Tablets Mission Pharmacal Company, San Antonio, TX USA 78230 URK537R0725 Label

PRINCIPAL DISPLAY PANEL - 15 mEq Bottle Label NDC 0178-0615-01 UROCIT ® -K 15 mEq (Potassium Citrate) Extended-release tablet 15 mEq (1620 mg) per tablet Rx only 100 Tablets Mission Pharmacal Company, San Antonio, TX USA 78230 URK537R0725 Image

PRINCIPAL DISPLAY PANEL - 5 mEq Bottle Label NDC0178-0600-01 UROCIT ®-K 10 mEq (Potassium Citrate)Extended-release tablet 5 mEq (540 mg) per tablet Rx only 100 Tablets Mission Pharmacal Company, San Antonio, TX USA 78230 1355 Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Urocit-K — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Urocit-K. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$17.3K
Claims incl. refills
62
Beneficiaries
47
Spend / beneficiary
$367.85
Spend / claim
$278.85
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for UROCIT-K (this brand).

Top reported reactions

Fatigue368
Nausea335
Diarrhoea332
Pain306
Nephrolithiasis276
Dizziness241
Dyspnoea227

Age at onset

Neonate5
Infant4
Child10
Adolescent9
Adult422
Elderly488

Reporter sex

5,450 reports
Male · 48%
Female · 52%
Unknown · 0%

Serious outcomes

Life-threatening149
Disabling93
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 516 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Who lists this product with the FDA?
Mission Pharmacal Company is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 00178-0500-01 · Mission 00178-0610-01 · Mission →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.