NDC 0990-7118 Sterile Water

Water

NDC Product Code 0990-7118

NDC Product Information

Sterile Water with NDC 0990-7118 is a a human prescription drug product labeled by Icu Medical Inc.. The generic name of Sterile Water is water. The product's dosage form is injection, solution and is administered via intravenous form.

Labeler Name: Icu Medical Inc.

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 1 mL/mL

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.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Icu Medical Inc.
Labeler Code: 0990
FDA Application Number: NDA019869 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: 06-01-2019 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

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 a sterile, nonpyrogenic water for injection intended only for dilution purposes. The pH is 5.4 (5.0 to 7.0). The Pharmacy Bulk Package is a sterile dosage form which contains multiple single doses for use only in a pharmacy bulk admixture program.Sterile Water for Injection, USP contains no bacteriostat, antimicrobial agent or added buffer.Sterile Water for Injection, USP may be classified as a sterile diluent and pharmaceutical vehicle.Sterile Water for Injection, USP is chemically designated H2O.The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions inside the plastic container also can leach out certain of its chemical components in very small amounts before the expiration period is attained. However, the safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers.

Clinical Pharmacology

Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production).Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na+) plays a major role in maintaining physiologic equilibrium.

Indications And Usage

Sterile Water for Injection, USP in the Pharmacy Bulk Package is indicated for use with automated compounding devices for preparing intravenous admixtures in the pharmacy.

Contraindications

NOT FOR DIRECT INFUSION. DO NOT USE FOR NON-AUTOMATED ADMIXTURE PREPARATIONS.

Warnings

FOR DILUTION ONLY.Do not heat over 66°C (150°F).This preparation is solute-free and its entry into the circulation undiluted will cause hemolysis.Absorption of large amounts of Sterile Water for Injection, USP with additives can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of administered solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions.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 mcg/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 water is clear, seal is intact and container is undamaged.Aseptic technique is essential with the use of sterile preparations for compounding admixtures.Discard container within 4 hours of entering closure.

Adverse Reactions

Accidental contamination from careless technique may transmit infection.Should any adverse reaction occur, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination, if deemed necessary.

Dosage And Administration

Sterile Water for Injection, USP in the 2000 mL flexible Pharmacy Bulk Package is designed for use with automated compounding devices for preparing intravenous admixtures. Dosages will be in accordance with the recommendation of the prescribing physician.Sterile Water for Injection, USP is not intended for direct infusion. Admixtures should be made by or under the direction of a pharmacist using strict aseptic technique under a laminar flow hood. Compounded admixtures may be stored under refrigeration for up to 24 hours. Administration of admixtures should be completed within 24 hours after removal from refrigeration.Drug InteractionsThe Pharmacy Bulk Package is intended only for use in the preparation of sterile, intravenous admixtures using automated compounding devices.Additives may be incompatible with the fluid withdrawn from this container. Consult with pharmacist, if available. When compounding admixtures, use aseptic technique, mix thoroughly and do not store.Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution container permits. See PRECAUTIONS.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.Recommended Directions for Use of the Pharmacy Bulk PackageUse Aseptic Technique1.      During use, container must be stored, and all manipulations performed, in an appropriate laminar flow hood.2.      Remove cover from outlet port at bottom of container.3.      Insert piercing pin of transfer set and suspend unit in a laminar flow hood. Insertion of a piercing pin into the outlet port should be performed only once in a Pharmacy Bulk Package solution. Once the outlet site has been entered, the withdrawal of container contents should be completed promptly in one continuous operation. Should this not be possible, a maximum time of 4 hours from transfer set pin or implement insertion is permitted to complete fluid transfer operations; i.e., discard container no later than 4 hours after initial closure puncture.4.      Sequentially dispense aliquots of Sterile Water for Injection, USP into I.V. containers using appropriate transfer set. During fluid transfer operations, the Pharmacy Bulk Package should be maintained under the storage conditions recommended in the labeling.

How Supplied

Sterile Water for Injection, USP is supplied in 2000 mL flexible Pharmacy Bulk Packages.NDC No.ProductContainer Size (mL)0409-7118-07Sterile Water for Injection, USP20000990-7118-07Sterile Water for Injection, USP2000ICU Medical is transitioning NDC codes from the "0409" to a "0990" labeler code. Both codes are expected to be in the market for a period of time.Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.Patent 4,368,765Revised: July, 2018ICU Medical, Inc., Lake Forest, Illinois, 60045, USAEN-4665

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