Acetic Acid
Baxter Healthcare Corporation
Human Prescription Drug
NDC 0338-0656Acetic Acid is a human prescription drug labeled by 'Baxter Healthcare Corporation'. National Drug Code (NDC) number for Acetic Acid is 0338-0656. 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: | 0338-0656 |
| 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: | Baxter Healthcare Corporation |
| 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: | 19 Feb, 1982 |
| 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: | NDA018523 |
| 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, 2024 |
| 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: | Baxter Healthcare Corporation
|
| 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 |
|---|
| 0338-0656-04 | 1000 mL in 1 BOTTLE, PLASTIC (0338-0656-04) | 19 Feb, 1982 | 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 not for injection. use of this solution in patients with mucosal lesions of the urinary bladder may be harmful due to irritation of the lesion. 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 no antimicrobial agent has been added.
Dosage and Administration:
Dosage and administration the volume of solution needed will vary with nature and duration of the urologic procedure, according to physicianâs instructions. irrigation drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Contraindications:
Contraindications none known
Adverse Reactions:
Adverse reactions systemic acidosis, pain and hematuria have been reported in patients receiving urinary bladder irrigation with 0.25% acetic acid irrigation, usp. should adverse reactions occur, discontinue the irrigation and reevaluate the clinical status of the patient.
Use in Pregnancy:
Pregnancy teratogenic effects animal reproduction studies have not been conducted with 0.25% acetic acid irrigation, usp. it is also not known whether 0.25% acetic acid irrigation, usp can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 0.25% acetic acid irrigation, usp should be given to a pregnant woman only if clearly needed.
Pediatric Use:
Pediatric use safety and effectiveness in pediatric patients have not been established. warm in oven to not more than 50°c for a maximum of 60 days. discard after 60 days of warming. do not administer unless the solution is clear and the seal is intact.
Description:
Description 0.25% acetic acid irrigation, usp, is a sterile, nonpyrogenic hypotonic solution for irrigation of the urinary bladder. each 100 ml contains 250 mg glacial acetic acid, usp, (ch 3 cooh) in water for injection, usp. ph 3.0 (2.8 to 3.4). osmolarity: 42 mosmol/l (calc.). no antimicrobial agent has been added. the container is made from specially formulated polyolefin (pl 325). the polyolefin is a copolymer of ethylene and propylene. it contains no plasticizers or other mobile additives. as a result, the container has virtually no extractability or leachability. the total extractables after two years of storage being less than 0.01 ppm. it is also relatively impermeable to water vapor transmission and, therefore, requires no vapor barrier to maintain the proper drug concentration.
Clinical Pharmacology:
Clinical pharmacology the minimal amount of acetic acid which may enter the systemic circulation is readily metabolized.
How Supplied:
How supplied 0.25% acetic acid irrigation, usp is supplied in a plastic pour bottle as follows: 2f7184 1000 ml ndc 0338-0656-04 exposure of pharmaceutical products to heat should be minimized. avoid excessive heat. it is recommended that the product be stored at room temperature (25°c): brief exposure up to 40ºc does not adversely affect the product.
Package Label Principal Display Panel:
Package label - principal display panel container label not for injection 2f7184 ndc 0338-0656-04 0.25% acetic acid irrigation, usp 1000 ml each 100 ml contains: 250 mg glacial acetic acid, usp. no antimicrobial agent has been added. ph 3.0 (2.8 to 3.4). osmolarity 42 mosmol/l (calc.). sterile, nonpyrogenic. pour bottle. hypotonic solution for irrigation only. dosage and administration: as directed by a physician. see directions. cautions: warm in oven to not more than 50°c for a maximum of 60 days. discard after 60 days of warming. do not use unless solution is clear and seal is intact. discard unused portion. rx only. recommended storage: room temperature (25°c). avoid excessive heat. see insert. pl 325 plastic baxter logo baxter healthcare corporation deerfield, il 60015 usa made in usa lot exp 07-09-00-0251 fpo (91)0709000251 bar code bar code posit ion only* (01) 00303380656042 acetic acid representative container label ndc 0338-0656-04