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Renacidin citric acid, gluconolactone and magnesium carbonate 6.602 g/100mL; .198 g/100mL; 3.268 g/100mL Solution — NDC 00327-0012-30 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Renacidin citric acid, gluconolactone and magnesium carbonate 6.602 g/100mL; .198 g/100mL; 3.268 g/100mL Solution — NDC 0327-0012-30 (Billing 00327-0012-30)

by United-Guardian, Inc. · 30 BOTTLE in 1 CARTON / 30 mL in 1 BOTTLE

This is a package of Renacidin citric acid, gluconolactone and magnesium carbonate 6.602 g/100mL; .198 g/100mL; 3.268 g/100mL Solution from United-Guardian, Inc., marketed since Feb 2016 and currently FDA-listed. It is this product's only package size.

NDC 00327-0012-30
🏷️ FDA NDC (as labeled) 0327-0012-30 billing pads the labeler segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 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

NDC database record

One package, one record: these facts belong to NDC 0327-0012-30 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0327 labeler · 0012 product · 30 package
Package marketed since
Feb 1, 2016
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 0327001230 9
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0327-0012-30
Product NDC 0327-0012
11-digit billing NDC 00327001230
NCPDP billing unit ML — per mL (volume)
RxCUI 1792396, 1792398
UNII XF417D3PSL, WQ29KQ9POT, 0E53J927NA
Application # NDA019481
SPL Set ID 13a9bbba-db21-4cba-991c-5d8afaf2ed74
Established class (EPC) Calculi Dissolution Agent; Anti-coagulant
Mechanism of action Acidifying Activity; Calcium Chelating Activity; Irrigation
Physiologic effect Decreased Coagulation Factor Activity
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-02-01
Route IRRIGATION
Dosage form SOLUTION
Substance ANHYDROUS CITRIC ACID; GLUCONOLACTONE; MAGNESIUM CARBONATE

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

GPI-14 56700020002000
GPI class Renacidin
GCN Seq No 075827
GCN 40976
HICL code 022673
Ingredient (HICL) Citric Ac/Gluconolact/Mag Carb
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 40:36.00.00
AHFS class Irrigating Solutions
FDB label name RENACIDIN IRRIGATION SOLUTION
FDB brand name Renacidin
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 075827
  • GCN: 40976
  • GPI-14 (Medi-Span): 56700020002000
  • HICL (First Databank): 022673
  • AHFS class code: 40:36.00.00
  • RxCUI (RxNorm): 1792396
Why two NDCs? The FDA registers this code as 0327-0012-30 — 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 → 00327-0012-30. 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 RENACIDIN IRRIGATION SOLUTION Ingredient Citric Ac/Gluconolact/Mag Carb

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.
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
00327-0012-30 You're viewing this Main listing 30 BOTTLE in 1 CARTON / 30 mL in 1 BOTTLE 2016-02-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Renacidin 6.602 g/100mL; .198 g/100mL; 3.268 g/100mLthis 00327-0012-30 United-Guardian, 30 bottles — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
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

🏛️
2016
On the market since
Feb 2016
📍
2026
Currently FDA-listed
10 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.

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 8SKN0B0MIM
    Benzoic acid is a naturally occurring organic acid used as a preservative in medicines and foods. It helps prevent bacterial and fungal growth to extend shelf life and maintain product stability.

1 inactive ingredient 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

LabelerUnited-Guardian, Inc.
Application holderUNITED GUARDIAN INC
FDA applicationNDA019481 (NDA)
Labeler code00327
First marketedFeb 2016
Product typeHuman Prescription Drug
Portfolio2 products on file

More NDCs from United-Guardian, Inc. labeler code 00327

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 ⚠️ Warnings 🤒 Adverse Reactions 🤰 Pregnancy 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 57 words ▾

INDICATIONS AND USAGE Renacidin is indicated for dissolution of bladder calculi of the struvite or apatite variety by local intermittent irrigation through a urethral catheter or cystostomy tube as an alternative or adjunct to surgical procedures. Renacidin is also indicated for use as an intermittent irrigating solution to prevent encrustations of indwelling urethral catheters and cystostomy tubes.

⏱️ Dosage and Administration ~1 min read ▾

DOSAGE AND ADMINISTRATION Renacidin for local irrigation within the lower urinary tract is available in single-use 30 mL containers. Prepare and Administer the Dose: Step 1: Inspect Renacidin visually for particulate matter and discoloration prior to administration. If particulate matter or discoloration are observed, do not administer.

Step 2: Remove the plastic tab connected to the conical tip of the Renacidin container by twisting the plastic tab. See Figure 1. Figure 1 Step 3: Connect the conical tip of the Renacidin container to the end of the urethral catheter or cystostomy tube.

See Figure 2. Figure 2 Step 4: Squeeze the Renacidin container to expel the entire contents into the urethral catheter or cystostomy tube. See Figure 3.

Figure 3 For Dissolution of Bladder Calculi: Instill 30 mL (one container) of Renacidin into the bladder via a urethral catheter or cystostomy tube. Clamp the urethral catheter or cystostomy tube for 30 to 60 minutes. Release the clamp and drain the bladder.

Repeat the instillation procedure 4 to 6 times a day. Monitor for dissolution of calculi. For Prevention of Encrustations in Urethral Catheters and Cystostomy Tubes: Instill 30 mL (one container) of Renacidin into the urethral catheter or cystostomy tube.

Clamp the urethral catheter or cystostomy tube for 10 minutes. Remove the clamp and drain the bladder. Repeat the instillation procedure 3 times a day.

Figure 1 Figure 2 Figure 3

⛔ Contraindications 12 words ▾

CONTRAINDICATIONS Renacidin is contraindicated in the presence of demonstrable urinary tract extravasation.

⚠️ Warnings 126 words ▾

WARNINGS Renacidin use should be stopped immediately if the patient develops fever, urinary tract infection, signs and symptoms consistent with urinary tract infection, or persistent flank pain. Irrigation should be stopped if elevated serum creatinine develops. The contents of individual Renacidin containers should not be combined for use as continuous irrigation of the urinary tract because of complications that may arise from inadequate aseptic technique.

Terminal sterilization processes that are not adequate may result in sepsis and/or injury to product handlers (e.g., irritation to exposed, unprotected areas of the skin). Serious adverse reactions, including sepsis and hypermagnesemia, have been reported to occur when Renacidin was used for continuous irrigation of the upper urinary tract. Renacidin is not indicated for continuous irrigation of the upper urinary tract.

🤒 Adverse Reactions 61 words ▾

ADVERSE REACTIONS The most common adverse reactions with use of Renacidin for dissolution of bladder calculi or prevention of encrustations of indwelling urethral catheters are “bladder irritability” and chemical cystitis, both reported to occur in approximately 3% of patients. A transient burning sensation in the bladder following Renacidin has been reported to occur in less than 1% of patients receiving Renacidin.

🤰 Pregnancy 46 words ▾

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

🧬 Clinical Pharmacology 77 words ▾

CLINICAL PHARMACOLOGY Renacidin's action on susceptible apatite calculi results from an exchange of magnesium from the irrigating solution for calcium contained in the stone matrix. The magnesium salts thereby formed are soluble in the gluconocitrate irrigating solution resulting in the dissolution of the calculus. Struvite calculi are composed mainly of magnesium ammonium phosphates which are solubilized by Renacidin due to its acidic pH.

Renacidin is not effective for dissolution of calcium oxalate, uric acid or cysteine stones.

📦 How Supplied / Storage and Handling 99 words ▾

HOW SUPPLIED Renacidin is available as a sterile, non-pyrogenic irrigation solution in 30 mL single-use, low density, polyethylene containers, supplied in boxes of 30 containers each. Exposure of Renacidin to heat or cold should be minimized. Renacidin should be stored at room temperature, 59° to 86°F (15° to 30°C).

Avoid excessive heat or cold (keep from freezing). Brief exposure to temperatures of up to 40°C or temperatures down to 5°C does not adversely affect the product. NDC: 0327-0012-30 PRODUCT CODE: RN030 Revised: December, 2018 Manufactured for GUARDIAN LABORATORIES A DIVISION OF UNITED-GUARDIAN, INC.

Hauppauge, N.Y. 11788 Company Logo Barcode

📋 Description 124 words ▾

DESCRIPTION Renacidin ® (Citric Acid, Glucono delta-lactone, and Magnesium Carbonate) is a sterile, non-pyrogenic irrigation solution for use within the lower urinary tract in the dissolution of bladder calculi of the struvite or apatite variety, and prevention of encrustations of urethral catheters and cystostomy tubes. Each 30 mL of Renacidin contains: Active ingredients: Citric Acid (anhydrous), USP 1980.6 mg C 6 H 8 O 7 Glucono delta-lactone, USP 59.4 mg C 6 H 10 O 6 Magnesium Carbonate, USP 980.4 mg (MgCO 3 ) 4 · Mg(OH) 2 · 5H 2 O Citric Acid Glucono delta-lactone Magnesium Carbonate (MgCO 3 ) 4 · Mg(OH) 2 · 5H 2 O Inert ingredients: Benzoic Acid, USP 6.9 mg Solution pH: 3.85 (3.5-4.2) citric acid glucono delta-lactone

⚠️ Precautions ~2 min read ▾

PRECAUTIONS Maintain Patency of the Urethral Catheter or Cystostomy Tube Care must be taken during therapy with Renacidin to maintain the patency of the urethral catheter or cystostomy tube. Calculus fragments and debris may obstruct the catheter. Catheter outflow blockage may be prevented by flushing the catheter with saline and repositioning of the catheter.

Frequent monitoring of the system should be performed by a nurse, an aide or any person with sufficient skills to be able to detect any problems with the patency of the catheter. At the first sign of obstruction, Renacidin should be discontinued. Caution in Patients with Vesicoureteral Reflux Patients with an indwelling urethral catheter or a cystostomy tube may have undiagnosed vesicoureteral reflux.

Appropriate evaluation prior to initiation of Renacidin is recommended. If reflux is demonstrated, the potential benefits of therapy should outweigh the risks, and all recommended safety monitoring precautions should be strictly implemented. Safety Monitoring While on Therapy with Renacidin Patients should be monitored throughout the course of therapy with Renacidin.

Serum creatinine, phosphate and magnesium should be obtained every several days. Urine specimens should be collected for culture and antibacterial sensitivity approximately every three days and at the first sign of fever. Therapy with Renacidin should be stopped if any culture exhibits growth and appropriate antibacterial therapy should be initiated.

Therapy with Renacidin may be started again after a course of antibacterial therapy upon demonstration of sterile urine. Struvite calculi frequently contain bacteria within the stone and antibacterial therapy should therefore be continued throughout the course of dissolution therapy. An elevated serum creatinine concentration is also an indication to stop therapy with Renacidin.

Concomitant Use with Medications Containing Magnesium Concomitant use of Renacidin and medications containing magnesium may contribute to hypermagnesemia in susceptible individuals, such as patients with vesicoureteral reflux. Renacidin Irrigation should be used with caution in patients taking concomitant medications containing magnesium. Carcinogenesis, Mutagenesis, Impairment of Fertility Long term studies to evaluate carcinogenic potential of Renacidin in animals have not been conducted.

Mutagenicity studies have not been conducted. Pregnancy Category C Animal reproduction studies have not been conducted with Renacidin. It is also not known whether Renacidin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

Renacidin should be given to a pregnant woman only if clearly needed. Nursing Mothers Magnesium is known to be excreted into human milk. It is not known whether Renacidin is excreted in human milk.

Because many drugs are excreted in human milk, caution should be exercised when Renacidin is administered to a nursing woman.

🍼 Nursing Mothers 42 words ▾

Nursing Mothers Magnesium is known to be excreted into human milk. It is not known whether Renacidin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Renacidin is administered to a nursing woman.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 26 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility Long term studies to evaluate carcinogenic potential of Renacidin in animals have not been conducted. Mutagenicity studies have not been conducted.

📄 Package Label / Principal Display Panel 148 words ▾

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Carton Label NDC 0327-0012-30 Rx Only RENACIDIN ® (Citric acid, Glucono delta-lactone, and Magnesium Carbonate) Irrigation Solution For Urological Irrigation Only Each 30 ml. contains: Active ingredients: Citric acid, anhydrous, USP 1,980.6 mg.; Glucono delta-lactone, USP 59.4 mg.; Magnesium carbonate, USP, 980.4 mg. Inert ingredient: Benzoic acid, USP, 6.9 mg. Solution pH: 3.85 (3.5 - 4.2) Read accompanying package insert for complete instructions on use.

Store at room temperature (59-86°F) (15-30°C). Use only if container seal is intact, there is no leakage evident and solution is clear. Box of thirty units – 30 ml. each Single Dose – Sterile, Non-pyrogenic Product code: RN030 Made in U.S.A.

RENACIDIN ® (Citric acid, Glucono delta-lactone, and Magnesium Carbonate) Irrigation Solution For Urological Irrigation Only Manufactured for GUARDIAN LABORATORIES a division of United-Guardian, Inc., Hauppauge, NY 11788 Rev. 3 - Dec 2018 Principal Dispaly Panel - Carton 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 Renacidin — 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 Renacidin. 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
$793.8K
Claims incl. refills
3.7K
Beneficiaries
1.7K
Spend / beneficiary
$468.85
Spend / claim
$214.65
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.

About this NDC listing & data coverage

Finished prescription product
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.
“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.
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 United-Guardian, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
United-Guardian, Inc. 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.
← 00327-0001-10 · United-Guardian, 00338-0003-44 · Baxter →
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.