Sterile Water
Water
B. Braun Medical Inc.
Human Prescription Drug
NDC 0264-2101Sterile Water also known as Water is a human prescription drug labeled by 'B. Braun Medical Inc.'. National Drug Code (NDC) number for Sterile Water is 0264-2101. This drug is available in dosage form of Irrigant. The names of the active, medicinal ingredients in Sterile Water drug includes Water - 1 mL/mL . The currest status of Sterile Water drug is Active.
Drug Information:
| Drug NDC: | 0264-2101 |
| 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: | Sterile Water |
| 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: | Water |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | B. Braun 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: | WATER - 1 mL/mL
|
| 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: | 10 Sep, 1970 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 17 Dec, 2025 |
| 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: | NDA016734 |
| 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: | B. Braun Medical Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 150985
|
| 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. |
| UPC: | 0302642101108
|
| UPC stands for Universal Product Code. |
| UNII: | 059QF0KO0R
|
| 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 |
|---|
| 0264-2101-00 | 16 CONTAINER in 1 CASE (0264-2101-00) / 1000 mL in 1 CONTAINER | 10 Sep, 1970 | N/A | No |
| 0264-2101-10 | 16 CONTAINER in 1 CASE (0264-2101-10) / 500 mL in 1 CONTAINER | 10 Sep, 1970 | N/A | No |
| 0264-2101-50 | 8 CONTAINER in 1 CASE (0264-2101-50) / 2000 mL in 1 CONTAINER | 10 Sep, 1970 | N/A | No |
| 0264-2101-70 | 4 CONTAINER in 1 CASE (0264-2101-70) / 4000 mL in 1 CONTAINER | 10 Sep, 1970 | 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:
Sterile water water water water
Indications and Usage:
Indications and usage sterile water for irrigation usp is indicated for use as an irrigating fluid or pharmaceutic aid. sterile water may also be used as an adjunct in the preparation of non-intravenously administered nutrient mixtures (see dosage and administration ).
Warnings:
Warnings sterile water for irrigation usp is hypotonic and will cause hemolysis, and is not recommended for use during surgical procedures. after opening container, its contents should be used promptly to minimize the possibility of bacterial growth or pyrogen formation. discard unused portion of irrigating solution since it contains no preservative.
Dosage and Administration:
Dosage and administration irrigation use as directed by physician. this drug product should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. nutrient mixtures sterile water for irrigation usp may be used to prepare non-intravenously administered nutrient mixtures. it contains no electrolytes or other added substances. refer to preparation instructions of particular mixture to be used. the plastic container may be used for administration of non-intravenous nutrient mixture to the patient as appropriate.
Contraindications:
Contraindications not for injection.
Adverse Reactions:
Adverse reactions none known.
Overdosage:
Overdosage none known.
Description:
Description sterile water for irrigation usp is a sterile, hypotonic, nonpyrogenic irrigating fluid or pharmaceutic aid (solvent) entirely composed of sterile water for injection usp. it is prepared by distillation and contains no antimicrobial or bacteriostatic agents or added buffers. the ph is 5.7 (5.0â7.0) the plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. the copolymer contains no plasticizers and exhibits virtually no leachability. the plastic container is also virtually impermeable to vapor transmission and therefore, requires no overwrap to maintain the proper drug concentration. the safety of the plastic container has been confirmed by biological evaluation procedures. the material passes class vl testing as specified in the u.s. pharmacopeia for biological testsâplastic containers. these tests have shown that the container is nontoxic and biologically inert. the pic⢠container is pvc-free and dehp-free.
Clinical Pharmacology:
Clinical pharmacology sterile water for irrigation usp is utilized for a variety of clinical indications. because of its low refractive index (1.3325), water provides excellent visibility during endoscopic urological procedures. it is also utilized as a pharmaceutic aid, as well as in the preparation of enteral nutrient products. water is hypotonic and will cause hemolysis and will be readily absorbed by the tissues during surgical procedures; therefore, its use under such conditions is not recommended.
How Supplied:
How supplied sterile water for irrigation usp is supplied sterile and nonpyrogenic in plastic irrigating containers. the 1000 ml and 500 ml containers are packaged 16 per case; the 2000 ml are packaged 8 per case and the 4000 ml are packaged 4 per case. ndc cat. no. size sterile water for irrigation usp (canada din 01963961) 0264-2101-00 r5000-01 1000 ml 0264-2101-10 r5001-01 500 ml 0264-2101-50 r5005-01 2000 ml 0264-2101-70 r5007 4000 ml exposure of pharmaceutical products to heat should be minimized. avoid excessive heat. protect from freezing. it is recommended that the product be stored at room temperature (25°c); however, brief exposure up to 40°c does not adversely affect the product. do not warm above 150°f (66°c).
Package Label Principal Display Panel:
Principal display panel - 1000 ml container sterile water for irrigation usp warnings: hypotonic and hemolytic lot exp. ref r5000-01 ndc 0264-2101-00 din 01963961 hk 23675 1000 ml y37-002-319 no antimicrobial agent or other substance has been added. ph: 5.7 (5.0-7.0) not for injection. see package insert. use only if solution is clear and container and seal are intact. sterile, nonpyrogenic. single unit container. discard unused portion. warning: do not warm above 150°f (66°c). recommended storage: room temperature (25°c). avoid excessive heat. protect from freezing. see package insert. rx only pvc-free and dehp-free b. braun medical inc. irvine, ca 92614-5895 usa made in usa in canada, distributed by: b. braun medical inc. scarborough, ontario m1h 2w4 1000 ml container label r5000-01
Principal display panel - 500 ml container sterile water for irrigation usp warnings: hypotonic and hemolytic lot exp. ref r5001-01 ndc 0264-2101-10 din 01963961 hk 23675 500 ml y37-002-321 no antimicrobial agent or other substance has been added. ph: 5.7 (5.0-7.0) not for injection. see package insert. use only if solution is clear and container and seal are intact. sterile, nonpyrogenic. single unit container. discard unused portion. warning: do not warm above 150°f (66°c). recommended storage: room temperature (25°c). avoid excessive heat. protect from freezing. see package insert. rx only pvc-free and dehp-free b. braun medical inc. irvine, ca 92614-5895 usa made in usa in canada, distributed by: b. braun medical inc. scarborough, ontario m1h 2w4 500 ml container label r5001-01
Principal display panel - 2000 ml container sterile water for irrigation usp warnings: hypotonic and hemolytic lot exp. ref r5005-01 ndc 0264-2101-50 din 01963961 hk 23675 2000 ml y37-002-322 no antimicrobial agent or other substance has been added. ph: 5.7 (5.0-7.0) not for injection. see package insert. use only if solution is clear and container and seal are intact. sterile, nonpyrogenic. single unit container. discard unused portion. warning: do not warm above 150°f (66°c). recommended storage: room temperature (25°c). avoid excessive heat. protect from freezing. see package insert. rx only pvc-free and dehp-free b. braun medical inc. irvine, ca 92614-5895 usa made in usa in canada, distributed by: b. braun medical inc. scarborough, ontario m1h 2w4 2000 ml container label r5005-01
Principal display panel - 4000 ml container sterile water for irrigation usp warnings: hypotonic and hemolytic lot exp. ref r5007 ndc 0264-2101-70 din 01963961 hk 23675 4000 ml y37-002-351 no antimicrobial agent or other substance has been added. ph: 5.7 (5.0-7.0) not for injection. see package insert. use only if solution is clear and container and seal are intact. sterile, nonpyrogenic. single unit container. discard unused portion. warning: do not warm above 150°f (66°c). recommended storage: room temperature (25°c). avoid excessive heat. protect from freezing. see package insert. rx only pvc-free and dehp-free b. braun medical inc. irvine, ca 92614-5895 usa made in usa in canada, distributed by: b. braun medical inc. scarborough, ontario m1h 2w4 4000 ml container label r5007