Renacidin
Citric Acid, Gluconolactone And Magnesium Carbonate
United-guardian, Inc.
Human Prescription Drug
NDC 0327-0012Renacidin also known as Citric Acid, Gluconolactone And Magnesium Carbonate is a human prescription drug labeled by 'United-guardian, Inc.'. National Drug Code (NDC) number for Renacidin is 0327-0012. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Renacidin drug includes Anhydrous Citric Acid - 6.602 g/100mL Gluconolactone - .198 g/100mL Magnesium Carbonate - 3.268 g/100mL . The currest status of Renacidin drug is Active.
Drug Information:
| Drug NDC: | 0327-0012 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Renacidin |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Citric Acid, Gluconolactone And Magnesium Carbonate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | United-guardian, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | ANHYDROUS CITRIC ACID - 6.602 g/100mL
GLUCONOLACTONE - .198 g/100mL
MAGNESIUM CARBONATE - 3.268 g/100mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | IRRIGATION
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | NDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 01 Feb, 2016 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 20 Jan, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | NDA019481 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | United-Guardian, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1792396
1792398
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| NUI: | N0000175833
N0000175835
N0000175980
N0000008556
N0000175089
N0000175534
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | XF417D3PSL
WQ29KQ9POT
0E53J927NA
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class MOA: | Acidifying Activity [MoA]
Calcium Chelating Activity [MoA]
Irrigation [MoA]
|
| Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`. |
| Pharmacologic Class EPC: | Calculi Dissolution Agent [EPC]
Anti-coagulant [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class PE: | Decreased Coagulation Factor Activity [PE]
|
| Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`. |
| Pharmacologic Class: | Acidifying Activity [MoA]
Anti-coagulant [EPC]
Calcium Chelating Activity [MoA]
Calculi Dissolution Agent [EPC]
Decreased Coagulation Factor Activity [PE]
Irrigation [MoA]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0327-0012-30 | 30 BOTTLE in 1 CARTON (0327-0012-30) / 30 mL in 1 BOTTLE | 01 Feb, 2016 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Renacidin citric acid, gluconolactone and magnesium carbonate anhydrous citric acid anhydrous citric acid gluconolactone gluconolactone magnesium carbonate carbonate ion benzoic acid
Indications and Usage:
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.
Warnings:
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.
Dosage and Administration:
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 blad
Read more...der. 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:
Contraindications renacidin is contraindicated in the presence of demonstrable urinary tract extravasation.
Adverse Reactions:
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 âbladder irritabilityâ 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.
Use in Pregnancy:
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.
Description:
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
Clinical Pharmacology:
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.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
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.
How Supplied:
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
Package Label Principal Display Panel:
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 â 30 ml. each single dose â 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