NDC 0338-0013 Sterile Water
Water Injection, Solution Intravenous

Product Information

Product Code0338-0013
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Sterile Water
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Water
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Human Prescription Drug
Dosage FormInjection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Intravenous - Administration within or into a vein or veins.
  • Intravenous - Administration within or into a vein or veins.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Baxter Healthcare Company
Labeler Code0338
FDA Application Number What is the FDA Application Number?
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.
NDA018632
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
06-30-1982
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2022
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

Usage Information


Product Packages

NDC 0338-0013-04

Package Description: 1000 mL in 1 BAG

Price per Unit: $0.00213 per ML

NDC 0338-0013-06

Package Description: 2000 mL in 1 BAG

Price per Unit: $0.00213 per ML

NDC 0338-0013-08

Package Description: 3000 mL in 1 BAG

Price per Unit: $0.00213 per ML

NDC 0338-0013-29

Package Description: 5000 mL in 1 BAG

Product Details

Sterile Water is a human prescription drug product labeled by Baxter Healthcare Company. The generic name of Sterile Water is water. The product's dosage form is injection, solution and is administered via intravenous form.


What are Sterile Water Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.


* Please review the disclaimer below.

Sterile Water Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Description



Sterile Water for Injection, USP is sterile, nonpyrogenic, distilled water in a Pharmacy Bulk Package. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion. No antimicrobial or other substance has been added. pH 5.5 (5.0 to 7.0). Osmolarity O mOsmol/L (calc.).

The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). 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. 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



Sterile Water for Injection, USP is used for fluid replacement only after suitable admixing to approximate isotonicity.


Indications And Usage



Sterile Water for Injection, USP is indicated in the aseptic preparation of parenteral admixtures.


Contraindications



Sterile Water for Injection, USP is a hemolytic agent due to its hypotonicity. Therefore, it is contraindicated for intravenous administration without admixing.


Warnings



This solution is for compounding only, not for direct infusion. Hemolysis may occur following infusion of Sterile Water for Injection, USP.  Hemoglobin induced renal failure has been reported following hemolysis.

WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 µg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.


Precautions



Do not use unless solution is clear and seal is intact.

Drug product contains no more than 25 µg/L of aluminum.


Pediatric Use:



Safety and effectiveness have been established in pediatric patients. However, in neonates or very small infants the volume of fluid may affect fluid and electrolyte balance.


Adverse Reactions



The administration of a suitable admixture of prescribed drugs 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.


Dosage And Administration



Following suitable admixture of prescribed drugs, the dosage is usually dependent upon the age, weight and clinical condition of the patient as well as laboratory determinations. See directions accompanying drugs.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Use of a final filter is recommended during administration of all parenteral solutions where possible.

Sterile Water for Injection, USP in the Pharmacy Bulk Package is intended for use in the preparation of sterile, intravenous admixtures. Additives may be incompatible with the fluid withdrawn from this container. Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist, if available. When compounding admixtures, use aseptic technique. Mix thoroughly. Do not store any unused portion of Sterile Water for Injection, USP.


To Open



Tear overwrap down side at slit and remove solution container. Visually inspect the container. If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Check for minute leaks by squeezing inner bag firmly, if leaks are found, discard solution as sterility may be impaired.

For compounding only, not for direct infusion.


Preparation For Admixing



  • 1.The Pharmacy Bulk Package is to be used only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area).
  • 2.Suspend container from eyelet support.
  • 3.Remove plastic protector from outlet port at bottom of container.
  • 4.Attach solution transfer set. Refer to complete directions accompanying set.
    Note: The closure shall be penetrated only one time with a suitable sterile transfer device or dispensing set which allows measured dispensing of the contents.
  • 5.VIAFLEX containers should not be written on directly since ink migration has not been investigated. Affix accompanying label for date and time of entry.
  • 6.Once container closure has been penetrated, withdrawal of contents should be completed without delay. After initial entry, maintain contents at room temperature (25°C/77°F) and dispense within 4 hours.

How Supplied



Sterile Water for Injection, USP is supplied in a VIAFLEX plastic Pharmacy Bulk Package container as follows:

2000 mL

2B0306

NDC 0338-0013-06

3000 mL

2B0307

NDC 0338-0013-08

5000 mL

2B0309

NDC 0338-0013-29

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C/77°F).

Baxter Healthcare Corporation
Deerfield, IL 60015 USA

Printed in USA

Baxter, Viaflex, and PL 146 are trademarks of Baxter International Inc.

07 19 73 676

Rev. September 2014

Distributed in Canada by
Baxter Corporation
Mississauga, ON L5N 0C2


Package Label - Principle Display Panel



Container Label

Container Label

LOT EXP

2B0306 2000 mL
NDC 0338-0013-06 DIN 02014882

Sterile Water
For Injection USP

Pharmacy Bulk Package
Not For Direct Infusion

Rx Only

NO ANTIMICROBIAL OR OTHER SUBSTANCE HAS BEEN ADDED
pH 5.5 (5.0 TO 7.0) OSMOLARITY 0 mOsmol/L (CALC)
STERILE NONPYROGENIC

CONTAINS NO MORE THAN 25 μg/L OF ALUMINUM

ADDITIVES MAY BE INCOMPATIBLE WITH THE FLUID
WITHDRAWN FROM THIS CONTAINER CONSULT WITH
PHARMACIST IF AVAILABLE WHEN COMPOUNDING
ADMIXTURES USE ASEPTIC TECHNIQUE
MIX THOROUGHLY DO NOT STORE

DOSAGE ADMIX FOR INTRAVENOUS ADMINISTRATION
AS DIRECTED BY A PHYSICIAN SEE ACCOMPANYING
DIRECTIONS FOR USE ONCE CONTAINER CLOSURE
HAS BEEN PENETRATED WITHDRAWAL OF
CONTENTS SHOULD BE COMPLETED WITHOUT
DELAY AFFIX ACCOMPANYING LABEL FOR DATE AND
TIME OF ENTRY DISPENSE CONTENTS WITHIN 4 HOURS
AFTER INITIAL ENTRY

CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH
MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS
ARE FOUND DO NOT USE UNLESS SOLUTION IS CLEAR
AND SEAL IS INTACT

STORE UNIT IN MOISTURE BARRIER OVERWRAP AT
ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO USE
AVOID EXCESSIVE HEAT SEE INSERT

VIAFLEX CONTAINER PL 146 PLASTIC

Baxter logo

BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA

MADE IN USA

DISTRIBUTED IN CANADA BY
BAXTER CORPORATION
MISSISSAUGA ON L5N 0C2

BAXTER PL 146 AND VIAFLEX ARE TRADEMARKS OF BAXTER INTERNATIONAL INC

1800

1600

1400

1200

1000

800

600

400

200

07-25-69-275/
07-25-34-056

Carton Label

Carton Label

2B0306 6 - 2000 ML
VIAFLEX CONTAINER

STERILE WATER FOR INJECTION, USP
FOR DRUG DILUENT USE ONLY

EXP
XXXXX

SECONDARY BAR CODE

(17) YYMM00 (10) XXXXX

LOT
XXXXX

PRIMARY BAR CODE

(01) 50303380013062


* Please review the disclaimer below.