NDC 0338-0013 Sterile Water

Water

NDC Product Code 0338-0013

NDC 0338-0013-04

Package Description: 1000 mL in 1 BAG

NDC 0338-0013-06

Package Description: 2000 mL in 1 BAG

NDC 0338-0013-08

Package Description: 3000 mL in 1 BAG

NDC 0338-0013-29

Package Description: 5000 mL in 1 BAG

NDC Product Information

Sterile Water with NDC 0338-0013 is a 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.

Labeler Name: Baxter Healthcare Company

Dosage Form: Injection, 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.

Product Type: Human Prescription Drug 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.

Sterile Water Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • WATER 100 mL/100mL
  • WATER 100 mL/100mL

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.

Labeler Name: Baxter Healthcare Company
Labeler Code: 0338
FDA Application Number: NDA018632 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.

Marketing Category: NDA - A product marketed under an approved New Drug Application. 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.

Start Marketing Date: 06-30-1982 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 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.

Exclude Flag: N - NO 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".

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Sterile Water Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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 mL2B0306NDC 0338-0013-063000 mL2B0307NDC 0338-0013-085000 mL2B0309NDC 0338-0013-29Exposure 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 CorporationDeerfield, IL 60015 USAPrinted in USABaxter, Viaflex, and PL 146 are trademarks of Baxter International Inc. 07 19 73 676Rev. September 2014Distributed in Canada by Baxter CorporationMississauga, ON L5N 0C2

Package Label - Principle Display Panel

Container Label Container Label LOT EXP2B0306 2000 mLNDC 0338-0013-06 DIN 02014882Sterile WaterFor Injection USPPharmacy Bulk PackageNot For Direct InfusionRx OnlyNO ANTIMICROBIAL OR OTHER SUBSTANCE HAS BEEN ADDEDpH 5.5 (5.0 TO 7.0) OSMOLARITY 0 mOsmol/L (CALC)STERILE NONPYROGENICCONTAINS NO MORE THAN 25 μg/L OF ALUMINUMADDITIVES MAY BE INCOMPATIBLE WITH THE FLUIDWITHDRAWN FROM THIS CONTAINER CONSULT WITHPHARMACIST IF AVAILABLE WHEN COMPOUNDINGADMIXTURES USE ASEPTIC TECHNIQUEMIX THOROUGHLY DO NOT STOREDOSAGE ADMIX FOR INTRAVENOUS ADMINISTRATIONAS DIRECTED BY A PHYSICIAN SEE ACCOMPANYINGDIRECTIONS FOR USE ONCE CONTAINER CLOSUREHAS BEEN PENETRATED WITHDRAWAL OFCONTENTS SHOULD BE COMPLETED WITHOUTDELAY AFFIX ACCOMPANYING LABEL FOR DATE AND TIME OF ENTRY DISPENSE CONTENTS WITHIN 4 HOURS AFTER INITIAL ENTRYCAUTIONS SQUEEZE AND INSPECT INNER BAG WHICHMAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND DO NOT USE UNLESS SOLUTION IS CLEAR AND SEAL IS INTACTSTORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERTVIAFLEX CONTAINER PL 146 PLASTICBaxter logoBAXTER HEALTHCARE CORPORATIONDEERFIELD IL 60015 USA MADE IN USADISTRIBUTED IN CANADA BYBAXTER CORPORATIONMISSISSAUGA ON L5N 0C2BAXTER PL 146 AND VIAFLEX ARE TRADEMARKS OF BAXTER INTERNATIONAL INC1800160014001200100080060040020007-25-69-275/07-25-34-056Carton Label Carton Label 2B0306 6 - 2000 MLVIAFLEX CONTAINERSTERILE WATER FOR INJECTION, USP FOR DRUG DILUENT USE ONLYEXPXXXXXSECONDARY BAR CODE(17) YYMM00 (10) XXXXXLOTXXXXXPRIMARY BAR CODE(01) 50303380013062

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