Acetic Acid
Icu Medical Inc.
Human Prescription Drug
NDC 0990-6143Acetic Acid is a human prescription drug labeled by 'Icu Medical Inc.'. National Drug Code (NDC) number for Acetic Acid is 0990-6143. This drug is available in dosage form of Irrigant. The names of the active, medicinal ingredients in Acetic Acid drug includes Acetic Acid - 250 mg/100mL . The currest status of Acetic Acid drug is Active.
Drug Information:
| Drug NDC: | 0990-6143 |
| 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: | Acetic Acid |
| 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: | Acetic Acid |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Icu Medical Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Irrigant |
| 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: | ACETIC ACID - 250 mg/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: | 25 Nov, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 02 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: | NDA017656 |
| 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: | ICU Medical Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 307707
|
| 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. |
| UNII: | Q40Q9N063P
|
| 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. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0990-6143-09 | 12 BOTTLE, PLASTIC in 1 CASE (0990-6143-09) / 1000 mL in 1 BOTTLE, PLASTIC | 25 Nov, 2019 | N/A | No |
| 0990-6143-22 | 24 BOTTLE, PLASTIC in 1 CASE (0990-6143-22) / 250 mL in 1 BOTTLE, PLASTIC | 25 Jan, 2020 | 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:
Acetic acid acetic acid acetic acid acetic acid water
Indications and Usage:
Indications and usage 0.25% acetic acid irrigation, usp is indicated as a constant or intermittent bladder rinse to help prevent the growth and proliferation of susceptible urinary pathogens (especially ammonia-forming bacteria) in the management of patients who require prolonged placement of an indwelling urethral catheter. it also may be used for periodic irrigation of an indwelling catheter to help maintain patency by reducing the formation of calcium encrustations.
Warnings:
Warnings for irrigation only. not for injection. use of this solution in patients with mucosal lesions of the urinary bladder may be harmful due to irritation of the lesions. absorption via open lesions of the bladder mucosa may result in systemic acidosis. the contents of an opened container should be used promptly to minimize the possibility of bacterial growth or pyrogen formation. discard the unused portion of irrigating solution since it contains no preservative. do not heat over 66°c (150°f).
Dosage and Administration:
Dosage and administration 0.25% acetic acid irrigation, usp may be administered by gravity drip via an administration set connected to an indwelling urethral catheter designed for continuous or intermittent two-way flow. a disposable dispensing set should be used. a bulb or piston syringe may be used for periodic irrigation of an indwelling catheter. for continuous or intermittent irrigation, the rate of administration will correspond roughly to the rate of urine flow and should be adjusted to maintain a urinary effluent ph of 4.5 to 5.0. nitrazine or other ph paper may be used to monitor ph, preferably at least four times daily. drip rate should be adjusted as necessary to maintain desired ph; increasing flow rate reduces ph value and vice versa. with continuous or intermittent irrigation, each patient will require a volume of approximately 500 to 1500 ml per 24 hours. for periodic irrigation of an indwelling catheter to maintain patency, about 50 ml is required for each irrigation an
Read more...d may be administered using a bulb or piston syringe for injection and aspiration as often as desired. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. see precautions.
Contraindications:
Contraindications not for injection by usual parenteral routes. this solution is contraindicated for irrigation during transurethral surgical procedures.
Adverse Reactions:
Adverse reactions systemic acidosis has been reported in patients receiving urinary bladder irrigation with 0.25% acetic acid solution. urologic pain and hematuria have been reported in patients receiving urinary bladder irrigation with 0.25% acetic acid solution.
Overdosage:
Overdosage systemic absorption is unlikely unless there are open lesions of the bladder mucosa that have gone undetected. in such event, discontinue the irrigation, evaluate the patient for possible systemic acidosis, intravascular hemolysis and circulatory overload and institute appropriate countermeasures as indicated. see warnings, precautions and adverse reactions. oral ld 50 in mice: 5 g/kg.
Description:
Description 0.25% acetic acid irrigation, usp, is a sterile, nonpyrogenic aqueous solution of glacial acetic acid, usp for irrigation of the urinary bladder by the transurethral route (not for tur). each 100 ml contains 250 mg of glacial acetic acid, in water for injection. the solution is hypotonic, 42 mosmol/liter (calc.), in relation to the extracellular fluid compartment of the body (280 mosmol/liter) and has a ph of 3.1 (2.8 to 3.4). other than the active ingredient, acetic acid, the solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single-dose irrigation. when smaller volumes are required the unused portion should be discarded. the solution is a urinary bladder antimicrobial, acidifying irrigant. glacial acetic acid, usp is chemically designated acetic acid (c 2 h 4 o 2 ) a liquid miscible with water. it has the following structural formula: ch 3 cooh water for injection is chemically designated h 2 o. the semi-rigid container is fabricated from a specially formulated polyolefin. it is a copolymer of ethylene and propylene. the container requires no vapor barrier to maintain the proper drug concentration. solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. exposure to temperatures above 25°c/77°f during transport and storage will lead to minor losses in moisture content. higher temperatures lead to greater losses. it is unlikely that these minor losses will lead to clinically significant changes within the expiration period.
Clinical Pharmacology:
Clinical pharmacology irrigation of the urinary bladder with acetic acid solution in a concentration of 0.25% has been shown to exert an antimicrobial action against a variety of microorganisms (especially ammonia-forming bacteria) that frequently gain access to the urinary bladder in patients who require prolonged indwelling urethral catheterization. its antimicrobial action is dependent on administration via the indwelling catheter at a sufficient rate (continuous or intermittent) to maintain an effluent ph of at least 5.0. maintenance of low ph of bladder urine also helps reduce formation of calcium encrustations in the indwelling catheter.
How Supplied:
How supplied 0.25% acetic acid irrigation, usp is supplied in single-dose irrigation containers as follows: list container size (ml) 6143 semi-rigid 250 & 1000 exposure of pharmaceutical products to heat should be minimized. avoid excessive heat. protect from freezing. store at 20 to 25°c (68 to 77°f). [see usp controlled room temperature.] revised: december, 2018 en-5788 manufactured for icu medical, inc., lake forest, illinois, 60045, usa
Package Label Principal Display Panel:
Principal display panel - 1000 ml bottle label 1000 ml ndc 0990-6143-09 0.25% acetic acid irrigation, usp each 100 ml contains glacial acetic acid, 250 mg. 42 mosmol/liter (calc.). ph 3.1 (2.8 to 3.4). sterile, nonpyrogenic. not for injection or transurethral surgery. use only if clear and seal intact. warning: do not heat bottle over 66°c (150°f). store at 20 to 25°c (68 to 77°f). [see usp controlled room temperature.] avoid excessive heat. protect from freezing. see insert. single-dose container. contains no bacteriostat. discard unused portion. usual dosage: see insert. rx only pat. pend. aqualite⢠system manufactured for icu medical, inc., lake forest, illinois, 60045 usa rl-7281 lot exp principal display panel - 1000 ml bottle label