Potassium Citrate and Citric Acid 1100 mg/5mL; 334 mg/5mL Solution — NDC 62135-435-24 (Billing 62135-0435-24)
This is a package of Potassium Citrate and Citric Acid 1100 mg/5mL; 334 mg/5mL Solution from Chartwell RX, LLC, marketed since Dec 2022 and currently FDA-listed.
NDC database record
One package, one record: these facts belong to NDC 62135-435-24 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 62135 labeler · 435 product · 24 package
- Package marketed since
- Apr 4, 2025
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC)
- 0362135435479
- FDA record last changed
- Oct 8, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 048607
- GCN: 14065
- GPI-14 (Medi-Span): 56202022002025
- HICL (First Databank): 003680
- AHFS class code: 40:08.00.00
- RxCUI (RxNorm): 309318
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 8, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Calculi Dissolution Agent class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 8, 2026
Clinical
This is an unapproved oral liquid solution containing potassium citrate and citric acid. These ingredients are typically used together to make urine less acidic and to help prevent certain types of kidney stones. Potassium citrate and citric acid are alkalizing agents that increase the citrate level in urine, which can help dissolve or prevent stone formation in people with recurrent kidney stone problems.
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per mL | Per 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. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 9, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 62135-0435-47 62135-435-47 Main listing | 473 mL in 1 BOTTLE | $0.0517 / mL | $24.45 | 2022-12-08 | — | Active |
| 62135-0435-24 You're viewing this | 2 TRAY in 1 BOX / 10 CUP in 1 TRAY / 5 mL in 1 CUP | — | — | 2025-04-04 | — | Active |
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of Potassium Citrate and Citric Acid 1100 mg/5mL; 334 mg/5mL Solution?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Potassium Citrate and Citric Acid 1100 mg/5mL; 334 mg/5mL 00121-0676-16 | PAI | 473 ml | $0.052 | — | Availability likely | — |
| Potassium Citrate and Citric Acid 1100 mg/5mL; 334 mg/5mLthis 62135-0435-24 | Chartwell | 10 cups | — | — | FDA listed | — |
| Potassium Citrate and Citric Acid 1100 mg/5mL; 334 mg/5mL 68999-0435-24 | Chartwell | 10 cups | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 8, 2026
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.
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UNII WZB9127XOA
A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
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UNII SB8ZUX40TY
Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
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UNII OJ245FE5EU
Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
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UNII 8KW3E207O2
A liquid sweetener made from sorbitol, a sugar alcohol derived from glucose. It sweetens the medicine and also acts as a humectant to help retain moisture and improve texture in liquid formulations.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
5 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
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.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Chartwell RX, LLC labeler code 62135
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- butalbital, aspirin, and caffeine 50 mg; 325 mg; 40 mg Capsule NDC 62135-433-90
- Sodium Citrate and Citric Acid 500 mg/5mL; 334 mg/5mL Solution NDC 62135-434-47
- Sucralfate 1 g Tablet NDC 62135-436-01
- Prednisolone 5 mg Tablet NDC 62135-437-30
- Tricitrates 550 mg/5mL; 500 mg/5mL; 334 mg/5mL Solution NDC 62135-438-24
- Ergocalciferol 1.25 mg Capsule NDC 62135-439-90
- Benzonatate 100 mg Capsule NDC 62135-440-01
- Benzonatate 200 mg Capsule NDC 62135-441-31
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Potassium citrate and citric acid oral solution is an effective alkalinizing agent useful in those conditions where long-term maintenance of an alkaline urine is desirable, such as in patients with uric acid and cystine calculi of the urinary tract, especially when the administration of sodium salts is undesirable or contraindicated. In addition, it is a valuable adjuvant when administered with uricosuric agents in gout therapy, since urates tend to crystallize out of an acid urine. It is also effective in correcting the acidosis of certain renal tubular disorders where the administration of potassium citrate may be preferable.
This product is highly concentrated, and when administered after meals and before bedtime, allows one to maintain an alkaline urinary pH around the clock, usually without the necessity of a 2 A.M. dose. This product alkalinizes the urine without producing a systemic alkalosis in recommended dosage. It is highly palatable, pleasant tasting and tolerable, even when administered for long periods.
Potassium citrate does not neutralize the gastric juice or disturb digestion.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Potassium Citrate and Citric Acid Oral Solution, USP should be taken diluted in water according to directions, followed by additional water, if desired. Palatability is enhanced if chilled before taking. Usual Adult Dose 3 to 6 teaspoonfuls (15 to 30 mL), diluted with 1 glass of water, after meals and at bedtime, or as directed by a physician.
Usual Pediatric Dose 1 to 3 teaspoonfuls (5 to 15 mL), diluted with 1/2 glass of water, after meals and at bedtime, or as directed by a physician. Usual Dosage Range 2 to 3 teaspoonfuls (10 to 15 mL), diluted with a glassful of water, taken four times a day. Potassium Citrate and Citric Acid Oral Solution USP, diluted with a glassful of water, taken four times a day will usually maintain a urinary pH of 7.0-7.6 throughout most of the 24 hours without unpleasant side effects.
To check urinary pH, HYDRION Paper (pH 6.0-8.0) or NITRAZINE Paper (pH 4.5-7.5) are available and easy to use.
⛔ Contraindications ▾
CONTRAINDICATIONS Severe renal impairment with oliguria or azotemia, untreated Addison's disease, adynamia episodica hereditaria, acute dehydration, heat cramps, anuria, severe myocardial damage, and hyperkalemia from any cause.
⚠️ Warnings ▾
WARNINGS Large doses may cause hyperkalemia and alkalosis, especially in the presence of renal disease. Concurrent administration of potassium-containing medication, potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors, or cardiac glycosides may lead to toxicity.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Potassium citrate and citric acid oral solution is generally well tolerated without any unpleasant side effects when given in recommended doses to patients with normal renal function and urinary output. However, as with any alkalinizing agent, caution must be used in certain patients with abnormal renal mechanisms to avoid development of hyperkalemia or alkalosis. Potassium intoxication causes listlessness, weakness, mental confusion, tingling of extremities, and other symptoms associated with a high concentration of potassium in the serum.
Periodic determinations of serum electrolytes should be carried out in those patients with renal disease in order to avoid these complications. Hyperkalemia may exhibit the following electrocardiographic abnormalities: Disappearance of the P wave, widening and slurring of QRS complex, changes of the S-T segment, tall peaked T waves, etc.
🆘 Overdosage ▾
OVERDOSAGE The administration of oral potassium salts to persons with normal excretory mechanisms for potassium rarely causes serious hyperkalemia. However, if excretory mechanisms are impaired, hyperkalemia can result (see Contraindications and Warnings ). Hyperkalemia, when detected, must be treated immediately because lethal levels can be reached in a few hours.
TREATMENT OF HYPERKALEMIA Should hyperkalemia occur, treatment measures include the following: (1) Elimination of foods or medications containing potassium. (2) The intravenous administration of 300 to 500 mL/hr of dextrose solution (10 to 25%), containing 10 units of insulin/20 gm dextrose. (3) The use of exchange resins, hemodialysis, or peritoneal dialysis.
In treating hyperkalemia, it should be recalled that in patients who have been stabilized on digitalis, too rapid a lowering of the plasma potassium concentration can produce digitalis toxicity.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Potassium Citrate and Citric Acid Oral Solution, USP (Red color liquid with cherry flavor) is supplied in the following oral dosage form: 16 fl oz (473 mL) bottle NDC 62135-435-47 5 mL Unit-Dose Cup NDC 62135-435-05 20 Unit-Dose Cups of 5 mL each NDC 62135-435-24 STORAGE Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). Protect from excessive heat and freezing.
Manufactured for: Chartwell RX, LLC Congers, NY 10920 L71146 Rev. 03/2025
📋 Description ▾
DESCRIPTION Potassium Citrate and Citric Acid Oral Solution, USP is a stable red colored and cherry flavored oral systemic alkalizer containing potassium citrate and citric acid in a sugar-free, non-alcoholic base. Potassium Citrate and Citric Acid Oral Solution, USP contains in each teaspoonful (5 mL): Potassium Citrate Monohydrate, USP 1100 mg Citric Acid Monohydrate, USP 334 mg Each mL contains 2 mEq potassium ion and is equivalent to 2 mEq bicarbonate (HCO 3 ). Inactive Ingredients: saccharin sodium, sodium benzoate, sorbitol solution, FD&C red # 40, purified water, and wild cherry flavor.
ACTIONS Potassium citrate is absorbed and metabolized to potassium bicarbonate, thus acting as a systemic alkalizer. The effects are essentially those of chlorides before absorption and those of bicarbonates subsequently. Oxidation is virtually complete so that less than 5% of the potassium citrate is excreted in the urine unchanged.
⚠️ Precautions ▾
PRECAUTIONS Should be used with caution by patients with low urinary output unless under the supervision of a physician. As with all liquids containing a high concentration of potassium, patients should be directed to dilute adequately with water to minimize the possibility of gastrointestinal injury associated with the oral ingestion of concentrated potassium salt preparations; and preferably, to take each dose after meals to avoid saline laxative effect.
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL Potassium Citrate and Citric Acid Oral Solution, USP - NDC 62135-435-47 - 16 fl oz (473 mL) Bottle Label Potassium Citrate and Citric Acid Oral Solution, USP - NDC 62135-435- 05 - 5 mL Unit-Dose Cup Label Potassium Citrate and Citric Acid Oral Solution, USP - NDC 62135-435-47 - 16 fl oz (473 mL) Bottle Label Potassium Citrate and Citric Acid Oral Solution, USP - NDC 62135-435-05 - 5mL Unit-Dose Cup Label
Reported adverse events (FAERS)
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Reporter sex
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About this NDC listing & data coverage
Listed without an FDA application
This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.
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 | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| 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. |