Sterile Water
Water
Baxter Healthcare Company
Human Prescription Drug
NDC 0338-0013Sterile Water also known as Water is a human prescription drug labeled by 'Baxter Healthcare Company'. National Drug Code (NDC) number for Sterile Water is 0338-0013. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Sterile Water drug includes Water - 100 mL/100mL . The currest status of Sterile Water drug is Active.
Drug Information:
| Drug NDC: | 0338-0013 |
| 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: | Baxter Healthcare Company |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Injection, 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: | WATER - 100 mL/100mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | INTRAVENOUS
|
| 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: | 30 Jun, 1982 |
| 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: | NDA018632 |
| 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: | Baxter Healthcare Company
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| 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 |
|---|
| 0338-0013-04 | 1000 mL in 1 BAG (0338-0013-04) | 30 Jun, 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:
Sterile water water water water
Indications and Usage:
Indications and usage sterile water for injection, usp is indicated in the aseptic preparation of parenteral solutions.
Warnings:
Warnings do not use for intravenous injection unless adjusted to approximate isotonicity with a suitable solute. hemolysis may occur following infusion of sterile water for injection, usp. hemoglobin induced renal failure has been reported following hemolysis.
Dosage and Administration:
Dosage and administration following suitable admixture of prescribed additives, the dosage is usually dependent upon the age, weight and clinical condition of the patient as well as laboratory determinations. see directions accompanying additive drug. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. injections in viaflex plastic containers are intended for intravenous administration using sterile equipment. additives may be incompatible. complete information is not available. those additives known to be incompatible should not be used. consult with pharmacist, if available. if, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. do not store an unused portion of sterile water for injection, usp . mix thoroughly when additives have been introduced. do not store solutions containing additives.
Contraindications:
Contraindications sterile water for injection, usp is a hemolytic agent due to its hypotonicity. therefore, it is contraindicated for intravenous administration without additives.
Adverse Reactions:
Adverse reactions the administration of a suitable admixture of prescribed additives may be associated with adverse reactions because of the solution or the technique of administration including febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation, and hypervolemia. if an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.
Description:
Description sterile water for injection, usp, is sterile, nonpyrogenic, distilled water in a single dose container for intravenous administration after addition of a suitable solute. it may also be used as a dispensing container for diluent use. no antimicrobial or other substance has been added. the ph is 5.5 (5.0 to 7.0). the osmolarity is 0. the viaflex plastic container is fabricated from a specially formulated polyvinyl chloride (pl 146 plastic). the amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. 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.
Clinical Pharmacology:
Clinical pharmacology sterile water for injection, usp is used for fluid replacement only after suitable additives are introduced to approximate isotonicity and to serve as a vehicle for suitable medications.
How Supplied:
How supplied sterile water for injection, usp is supplied in viaflex plastic containers as follows: 1000 ml 2b0304 ndc 0338-0013-04 exposure of pharmaceutical products to heat should be minimized. avoid excessive heat. it is recommended the product be stored at room temperature (25°c); brief exposure up to 40°c does not adversely affect the product.
Package Label Principal Display Panel:
Package label.principle display panel sterile water container label sterile water container label lot exp 2b0304 ndc 0338-0013-04 sterile water sterile water for injection usp for drug diluent use only 1000ml no antimicrobial or other substance has been added ph 5.5 (5.0 to 7.0) sterile nonpyrogenic single dose container administer intravenously only after rendering approximately isotonic with suitable solute additives may be incompatible consult with pharmacist if available when introducing additives use aseptic technique mix thoroughly do no store dosage intravenously as directed by a physician see directions cautions squeeze and inspect inner bag which maintains product sterility discard if leaks are found must not be used in series connections do not use unless solution is clear rx only store unit in moisture barrier overwrap at room temperature (25°c) until ready to use avoid excessive heat see insert viaflex plus container pl 146 plastic baxter viaflex and pl 146 are trademarks of baxter international inc for product information 1-800-933-0303 baxter baxter healthcare corporation deerfield il 60015 usa made in the usa sterile water carton label sterile water carton label 2b0304x 14-1000 ml units viaflex® container sterile water for inj., usp exp xxxxx secondary bar code (17) xxxxx (10) xxxxx lot xxxxx primary bar code (01) 50303380013048 note: lot and exp. date added at time of printing. secondary bar code human readable is variable and will be added at time of printing. the parenthesis are not encoded in actual bar code. sterile water container label ndc 0338-0013-04 sterile water carton label ndc 0338-0013-04