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Potassium Citrate and Citric Acid 1100 mg/5mL; 334 mg/5mL Solution, 473 mL

by PAI Holdings, LLC dba PAI Pharma · 473 mL in 1 BOTTLE (0121-0676-16)
NDC 00121-0676-16
🏷️ FDA NDC (as labeled) 0121-0676-16 billing pads the labeler segment with a zero
Rx only On market Non-controlled
🗂️ Data synced Sep 10, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 0121-0676-16
Product NDC 0121-0676
11-digit billing NDC 00121067616
NCPDP billing unit ML — per mL (volume)
RxCUI 309318
UNII EE90ONI6FF, 2968PHW8QP
UPC 0301210676161
SPL Set ID ce42122f-8087-471f-b0a3-5524bdbd4526
Established class (EPC) Anti-coagulant; Calculi Dissolution Agent; Decreased Coagulation F
Mechanism of action Acidifying Activity; Calcium Chelating Activity
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1997-10-07
Route ORAL
Dosage form SOLUTION
Substance POTASSIUM CITRATE; CITRIC ACID MONOHYDRATE
GPI-14 56202022002025
GPI class Potassium Citrate-Citric Acid
GCN Seq No 048607
GCN 14065
HICL code 003680
Ingredient (HICL) Potassium Citrate/Citric Acid
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 POTASSIUM CIT-CITRIC ACID SOLN
FDB brand name Potassium Citrate-Citric Acid
Legend status Q — Non-drug — dietary supplement, vitamin, medical food, or herbal preparation
Why two NDCs? The FDA registers this code as 0121-0676-16 — 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 → 00121-0676-16. 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.

🏷️ RxNorm drug class

This medicine belongs to the Calculi Dissolution Agent class.

Pharmacologic class Calculi Dissolution Agent, Anti-coagulant
Drug family (ATC) Acid preparations
How it works Calcium Chelating Activity, Acidifying Activity
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerPAI Holdings, LLC dba PAI Pharma
Labeler code00121
First marketedOct 1997
Product typeHuman Prescription Drug
Portfolio142 products on file
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.

🩺 Clinical

Label name POTASSIUM CIT-CITRIC ACID SOLN Ingredient Potassium Citrate/Citric Acid
🧪 What is this product?

This is an unapproved oral solution containing potassium citrate and citric acid. These ingredients are typically used together to increase the alkalinity (pH) of urine. The combination is commonly given to help prevent or manage kidney stones and to treat certain urinary tract conditions where urine acidity may contribute to stone formation or discomfort. Because this product is marketed without an FDA-approved application, patients should consult their healthcare provider about its use and any associated risks.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

🧪 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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.

💲 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 mLPer package
Retail pharmacies payNADAC · weekly $0.054 $25.59 / 473 ml
Medicaid paysCMS SDUD · 12 mo $0.0580 $27.43 / 473 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per mL) — tap or hover for the price & month
Dec 2021 Nov 2022 Feb 2026 Aug 2026 $0.070 $0.041
▲ Up 3% over the last 19 months.
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Potassium Citrate and Citric Acid 1100 mg/5mL; 334 mg/5mLthis 00121-0676-16 PAI 473 ml $0.054 — Availability likely —
Potassium Citrate and Citric Acid 1100 mg/5mL; 334 mg/5mL 62135-0435-47 Chartwell 473 ml $0.054 — Availability likely —
Potassium Citrate and Citric Acid 1100 mg/5mL; 334 mg/5mL 68999-0435-24 Chartwell 10 cups — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where 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

🏛️
1997
On the market since
Oct 1997
📍
2026
Currently FDA-listed
29 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 00121-0676-16, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
6.4K
Units reimbursed last 4 qtrs
4.7M
Gross reimbursed last 4 qtrs
$271K
Avg / prescription
$42.60
Avg / unit
$0.0580
Latest quarter Q4 2025
1.4KRx
Medicaid pays / mL
$0.0580
gross reimbursed
vs
NADAC / mL
$0.0541
acquisition cost
=
Spread
+$0.0039
+7% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
54% FFS 46% MCO
Fee-for-service · 3,462 Rx Managed care · 2,900 Rx
State Medicaid map
Alaska: no data reported AK Maine: 69,607 units · 4,990 per 100k residents ME Washington: 155,141 units · 1,986 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 258,641 units · 4,508 per 100k residents MN Wisconsin: 123,965 units · 2,098 per 100k residents WI Michigan: 229,625 units · 2,288 per 100k residents MI New York: 113,282 units · 579 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 33,215 units · 785 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: 21,455 units · 2,335 per 100k residents SD Iowa: 96,926 units · 3,022 per 100k residents IA Illinois: 128,759 units · 1,026 per 100k residents IL Indiana: 106,100 units · 1,546 per 100k residents IN Ohio: 321,098 units · 2,725 per 100k residents OH Pennsylvania: 236,495 units · 1,825 per 100k residents PA New Jersey: 121,154 units · 1,304 per 100k residents NJ Massachusetts: 363,339 units · 5,190 per 100k residents MA California: 511,826 units · 1,314 per 100k residents CA Utah: 17,849 units · 522 per 100k residents UT Colorado: 79,065 units · 1,345 per 100k residents CO Nebraska: 33,268 units · 1,682 per 100k residents NE Missouri: 130,095 units · 2,100 per 100k residents MO Kentucky: no data reported KY West Virginia: 74,568 units · 4,213 per 100k residents WV Virginia: 52,660 units · 604 per 100k residents VA Maryland: 22,085 units · 357 per 100k residents MD Connecticut: 28,589 units · 790 per 100k residents CT Rhode Island: no data reported RI Arizona: 158,544 units · 2,134 per 100k residents AZ New Mexico: 16,866 units · 798 per 100k residents NM Kansas: 17,741 units · 603 per 100k residents KS Arkansas: no data reported AR Tennessee: 110,209 units · 1,547 per 100k residents TN North Carolina: 84,428 units · 779 per 100k residents NC South Carolina: 112,063 units · 2,086 per 100k residents SC Delaware: 21,616 units · 2,097 per 100k residents DE Oklahoma: 25,038 units · 618 per 100k residents OK Louisiana: 58,419 units · 1,277 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 107,385 units · 974 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 542,847 units · 1,780 per 100k residents TX Florida: 89,834 units · 397 per 100k residents FL
Units reimbursed · per 100k residents
3575,190
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Massachusetts 5,190 /100k
2 Maine 4,990 /100k
3 Minnesota 4,508 /100k
4 West Virginia 4,213 /100k
5 Iowa 3,022 /100k
6 Ohio 2,725 /100k
7 South Dakota 2,335 /100k
8 Michigan 2,288 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

🔬 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 Potassium Citrate and Citric Acid (this brand).

Top reported reactions

Death3
Diarrhoea1
Drug Hypersensitivity1
Lethargy1
Mental Status Changes1
Neurotoxicity1
Toxicity To Various Agents1

Age at onset

Infant1
Elderly2

Reporter sex

6 reports
Male · 60%
Female · 40%

Serious outcomes

Hospitalization1
Reports over time (by year) — tap or hover for the count & year
2024 2025 2026 2 1
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00121-0676-16 You're viewing this 473 mL in 1 BOTTLE (0121-0676-16) 1997-10-07 Active

🧭 About this NDC listing & data coverage

Finished prescription product Marketed without an FDA application

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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) ✓ Available
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) ✓ Available
“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

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Unapproved Drug Other". Products approved under an application carry an NDA, ANDA, or BLA number.
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 FDA registers it as 0121-0676-16, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00121-0676-16, written without dashes as 00121067616. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 00121-0676-16, the first segment (00121) is the labeler code FDA assigned to PAI Holdings, LLC dba PAI Pharma; the middle segment (0676) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (16) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by PAI Holdings, LLC dba PAI Pharma. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
PAI Holdings, LLC dba PAI Pharma 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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description
🎯 Indications and Usage 172 words ▾

INDICATIONS AND USAGE Potassium Citrate and Citric Acid Oral Solution USP 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 167 words ▾

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 27 words ▾

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 33 words ▾

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 146 words ▾

ADVERSE REACTIONS Potassium Citrate and Citric Acid Oral Solution USP 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. To report SUSPECTED ADVERSE REACTIONS, contact Pharmaceutical Associates, Inc. at 1-800-845-8210 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🆘 Overdosage 50 words ▾

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.

🧬 Mechanism of Action 49 words ▾

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.

📦 How Supplied / Storage and Handling 50 words ▾

HOW SUPPLIED Potassium Citrate and Citric Acid Oral Solution USP (clear pink to red colored; berry-citrus flavored) is supplied in the following oral dosage form: NDC 0121-0676-16: 16 fl oz (473 mL) bottle STORAGE Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). Protect from excessive heat and freezing.

📦 Storage and Handling 17 words ▾

STORAGE Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). Protect from excessive heat and freezing.

📋 Description 87 words ▾

DESCRIPTION Potassium Citrate and Citric Acid Oral Solution USP is a stable and pleasant-tasting 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 1100 mg CITRIC ACID Monohydrate 334 mg Each mL contains 2 mEq potassium ion and is equivalent to 2 mEq bicarbonate (HCO 3 ). Inactive Ingredients: FD&C Red No.

40, flavoring, polyethylene glycol, propylene glycol, purified water, sodium benzoate, and sorbitol solution.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00121-0675-16 · PAI 00121-0677-16 · PAI →
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.