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Sodium Citrate and Citric Acid 334 mg/5mL; 500 mg/5mL Solution — NDC 81033-017-50 (Billing 81033-0017-50)

by Kesin Pharma Corporation · 100 CUP, UNIT-DOSE in 1 CASE / 15 mL in 1 CUP, UNIT-DOSE

This is a package of Sodium Citrate and Citric Acid 334 mg/5mL; 500 mg/5mL Solution from Kesin Pharma Corporation, marketed since Apr 2025 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 81033-0017-50
🏷️ FDA NDC (as labeled) 81033-017-50 billing pads the product segment with a zero
This package
Contains15 mL in 1 cup, unit-dose Pack sizes2 compare ↓
Main listing for product 81033-017 · Also comes in: 100 cups 81033-017-51
Rx only On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 81033-017-50
Product NDC 81033-017
11-digit billing NDC 81033001750
NCPDP billing unit ML — per mL (volume)
RxCUI 543014
UNII XF417D3PSL, 1Q73Q2JULR
SPL Set ID 3140f8fe-0644-7561-e063-6394a90a2c28
Established class (EPC) Calculi Dissolution Agent; Anti-coagulant
Mechanism of action Acidifying Activity; Calcium Chelating Activity
Physiologic effect Decreased Coagulation Factor Activity
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-04-01
Route ORAL
Dosage form SOLUTION
Substance ANHYDROUS CITRIC ACID; SODIUM CITRATE

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

GCN Seq No 043912
GCN 51957
HICL code 003682
Ingredient (HICL) Citric Acid/Sodium 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 SOD CITRATE-CITRIC ACID CUP
FDB brand name Sodium Citrate-Citric Acid
Legend status Q — Non-drug — dietary supplement, vitamin, medical food, or herbal preparation
Quick answers
  • GSN (GCN sequence number): 043912
  • GCN: 51957
  • HICL (First Databank): 003682
  • AHFS class code: 40:08.00.00
  • RxCUI (RxNorm): 543014
Why two NDCs? The FDA registers this code as 81033-017-50 — a 5-3-2 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 product segment → 81033-0017-50. 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.

Clinical

Label name SOD CITRATE-CITRIC ACID CUP Ingredient Citric Acid/Sodium Citrate
🧪 What is this product?

This is an oral solution containing sodium citrate and citric acid, marketed as an unapproved drug. These ingredients are commonly used together to help dissolve certain types of kidney stones and to reduce the acidity of urine. Sodium citrate and citric acid can also function as anticoagulants in stored blood products and have chelating properties that bind to calcium in the body. This product is dispensed by prescription.

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.

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 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.
Try another pack size: 100 cups
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
81033-0017-50 You're viewing this Main listing 100 CUP, UNIT-DOSE in 1 CASE / 15 mL in 1 CUP, UNIT-DOSE 2025-04-01 — Active
81033-0017-51 81033-017-51 100 CUP, UNIT-DOSE in 1 CASE / 30 mL in 1 CUP, UNIT-DOSE 2025-04-01 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 100 cup, unit-dose in 1 case / 15 ml in 1 cup, unit-dose.
What NDC number is used to bill for this package of Sodium Citrate and Citric Acid 334 mg/5mL; 500 mg/5mL Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sodium Citrate and Citric Acid 500 mg/5mL; 334 mg/5mL 62135-0434-47 Chartwell 473 ml $0.023 — Availability likely —
Sodium Citrate and Citric Acid 500 mg/5mL; 334 mg/5mL 00121-0595-00 Pharmaceutical 10 cups — — FDA listed —
Sodium Citrate and Citric Acid 500 mg/5mL; 334 mg/5mL 00121-1190-00 Pharmaceutical 10 cups — — FDA listed —
Sodium Citrate and Citric Acid 500 mg/5mL; 334 mg/5mL 17856-0595-04 Atlantic 1 cup — — FDA listed —
Sodium Citrate and Citric Acid 500 mg/5mL; 334 mg/5mL 50268-0182-15 AvPAK 40 cups — — FDA listed —
Sodium Citrate and Citric Acid 500 mg/5mL; 334 mg/5mL 50268-0183-30 AvPAK 40 cups — — FDA listed —
Sodium Citrate and Citric Acid 500 mg/5mL; 334 mg/5mL 55154-5777-05 Cardinal 5 cups — — FDA listed —
Sodium Citrate and Citric Acid 1500 mg/15mL; 1002 mg/15mL 60687-0832-16 American 10 cups — — FDA listed —
Sodium Citrate and Citric Acid 3000 mg/30mL; 2004 mg/30mL 60687-0834-76 American 10 cups — — FDA listed —
Sodium Citrate and Citric Acid 1500 mg/15mL; 1002 mg/15mL 62135-0868-24 Chartwell 10 cups — — FDA listed —
Sodium Citrate and Citric Acid 3000 mg/30mL; 2004 mg/30mL 62135-0869-24 Chartwell 10 cups — — FDA listed —
Sodium Citrate and Citric Acid 1500 mg/15mL; 1002 mg/15mL 68999-0868-24 Chartwell 10 cups — — FDA listed —
Sodium Citrate and Citric Acid 3000 mg/30mL; 2004 mg/30mL 68999-0869-24 Chartwell 10 cups — — FDA listed —
Sodium Citrate and Citric Acid 334 mg/5mL; 500 mg/5mLthis 81033-0017-50 Kesin 100 cups — — FDA listed —
Sodium Citrate and Citric Acid 500 mg/5mL; 334 mg/5mL 84447-0017-01 Belleview 200000 ml — — 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

🏛️
2025
On the market since
Apr 2025
📍
2026
Currently FDA-listed
1 year 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.

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.

Manufacturer & labeler

LabelerKesin Pharma Corporation
Labeler code81033
First marketedApr 2025
Product typeHuman Prescription Drug
Portfolio38 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.

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 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 150 words ▾

INDICATIONS AND USAGE Sodium citrate and citric acid oral solution, USP is an effective alkalinizing agent. It is useful in those conditions where long-term maintenance of an alkaline urine is desirable, and is of value in the alleviation of chronic metabolic acidosis, such as results from chronic renal insuffi ciency or the syndrome of renal tubular acidosis, especially when the administration of potassium salts is undesirable or contraindicated. This product is also useful for buff ering and neutralizing gastric hydrochloric acid quickly and effectively.

Sodium citrate and citric acid oral solution is 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 the recommended dosage. This product is highly palatable, pleasant tasting, and tolerable, even when administered for long periods.

⏱️ Dosage and Administration 128 words ▾

DOSAGE AND ADMINISTRATION Sodium citrate and citric acid oral solution should be taken diluted in water, followed by additional water, if desired. SHAKE WELL BEFORE USING. For Systemic Alkalization Usual Adult Dose 2 to 6 teaspoonfuls (10 to 30 mL), diluted in 1 to 3 ounces 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 in 1 to 3 ounces of water, after meals and at bedtime, or as directed by a physician. For children under two years of age, use is based on consultation with a physician. As a neutralizing buffer 3 teaspoonfuls (15 mL), diluted with 15 mL water, taken as a single dose, or as directed by a physician.

⛔ Contraindications 10 words ▾

CONTRAINDICATIONS Patients on sodium-restricted diets or with severe renal impairment.

🤒 Adverse Reactions 76 words ▾

ADVERSE REACTIONS Sodium 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 alkalosis, especially in the presence of hypocalcemia. To report SUSPECTED ADVERSE REACTIONS, contact Kesin Pharma at 1-833-537-4679 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🆘 Overdosage 14 words ▾

OVERDOSAGE Overdosage with sodium salts may cause diarrhea, nausea and vomiting, hypernoia, and convulsions.

🧬 Clinical Pharmacology 49 words ▾

CLINICAL PHARMACOLOGY Sodium citrate is absorbed and metabolized to sodium 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 sodium citrate is excreted in the urine unchanged.

📦 How Supplied / Storage and Handling 55 words ▾

HOW SUPPLIED Sodium Citrate and Citric Acid Oral Solution, USP (colorless, grape flavor) is supplied in the following oral dosage forms: NDC 81033-017-15: 15 mL unit dose cup NDC 81033-017-50: Case containing 100 unit-dose cups of 15 mL NDC 81033-017-30: 30 mL unit dose cup NDC 81033-017-51: Case containing 100 unit-dose cups of 30 mL

📦 Storage and Handling 18 words ▾

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

📋 Description 88 words ▾

DESCRIPTION Sodium Citrate and Citric Acid Oral Solution, USP is a stable and pleasant-tasting systemic alkalizer containing sodium citrate and citric acid in a sugar-free base. It is a non-particulate neutralizing buffer. Sodium Citrate and Citric Acid Oral Solution, USP contains in each teaspoonful (5 mL): SODIUM CITRATE Dihydrate 500 mg (0.34 Molar) CITRIC ACID Monohydrate 334 mg (0.32 Molar) Each mL contains 1 mEq sodium ion and is equivalent to 1 mEq bicarbonate (HCO 3 ).

INACTIVE INGREDIENTS: grape flavoring, purified water, sodium benzoate, sorbitol and sucralose.

⚠️ Precautions 108 words ▾

PRECAUTIONS Sodium citrate and citric acid oral solution should be used with caution by patients with low urinary output unless under the supervision of a physician. This product should not be administered concurrently with aluminum-based antacids. Patients should be directed to dilute adequately with water and preferably, to take each dose after meals to avoid saline laxative effect.

Sodium salts should be used cautiously in patients with cardiac failure, hypertension, impaired renal function, peripheral and pulmonary edema, and toxemia of pregnancy. Periodic examinations and determinations of serum electrolytes, particularly serum bicarbonate level, should be carried out in those patients with renal disease in order to avoid these complications.

📄 Package Label / Principal Display Panel 64 words ▾

NDC 81033-017-50 Sodium Citrate and Citric Acid Oral Solution, USP 1.5g/1g per 15mL Delivers 15mL Case = 100 UD Cups (Do Not Break Case) QTY 1 15 mL UD Cup Case Label

NDC 81033-017-51 Sodium Citrate and Citric Acid Oral Solution, USP 3g/2g per 30mL Delivers 30mL Case = 100 D Cups (Do Not Break Case) QTY 1 30 mL UD Cup Case Label

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

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) — 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.
“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.
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.
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.
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 Kesin Pharma Corporation. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 100 cups (81033-0017-51). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Kesin Pharma Corporation 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.
← 81033-0016-50 · Kesin 81033-0019-01 · Kesin →
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.