NDC 0338-0047 Sodium Chloride

Sodium Chloride

NDC Product Code 0338-0047

NDC 0338-0047-27

Package Description: 4 BAG in 1 CARTON > 3000 mL in 1 BAG

NDC 0338-0047-29

Package Description: 2 BAG in 1 CARTON > 5000 mL in 1 BAG

NDC 0338-0047-44

Package Description: 14 BAG in 1 CARTON > 1000 mL in 1 BAG

NDC 0338-0047-46

Package Description: 6 BAG in 1 CARTON > 2000 mL in 1 BAG

NDC 0338-0047-47

Package Description: 4 BAG in 1 CARTON > 3000 mL in 1 BAG

NDC Product Information

Sodium Chloride with NDC 0338-0047 is a a human prescription drug product labeled by Baxter Healthcare Corporation. The generic name of Sodium Chloride is sodium chloride. The product's dosage form is irrigant and is administered via irrigation form.

Labeler Name: Baxter Healthcare Corporation

Dosage Form: Irrigant - A sterile solution intended to bathe or flush open wounds or body cavities; they're used topically, never parenterally.

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.

Sodium Chloride 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.

  • SODIUM CHLORIDE 900 mg/100mL
  • SODIUM CHLORIDE 900 mg/100mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Irrigation - Administration to bathe or flush open wounds or body cavities.
  • Irrigation - Administration to bathe or flush open wounds or body cavities.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Osmotic Laxative - [EPC] (Established Pharmacologic Class)
  • Increased Large Intestinal Motility - [PE] (Physiologic Effect)
  • Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
  • Osmotic Activity - [MoA] (Mechanism of Action)
  • Osmotic Laxative - [EPC] (Established Pharmacologic Class)
  • Increased Large Intestinal Motility - [PE] (Physiologic Effect)
  • Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
  • Osmotic Activity - [MoA] (Mechanism of Action)

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 Corporation
Labeler Code: 0338
FDA Application Number: NDA017867 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: 05-30-1980 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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Sodium Chloride 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

0.9% Sodium Chloride Irrigation, USP is a sterile nonpyrogenic, isotonic solution in a single dose ARTHROMATIC plastic container for use as an arthroscopic irrigating solution. Each liter contains 9 g Sodium Chloride, USP (NaCl) in Water for Injection. pH 5.5 (4.5 to 7.0). Milliequivalents per liter: Sodium - 154, Chloride - 154. Osmolarity 308 mOsmol/L (calc.). No antimicrobial agent has been added.The ARTHROMATIC 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 can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexylphthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.

Clinical Pharmacology

0.9% Sodium Chloride Irrigation, USP is useful as an irrigating fluid for body joints because the solution is isotonic, and provides a transparent fluid medium with optical properties suitable for good visualization of the interior joint surface during endoscopic examination. During arthroscopic surgical procedures, the solution acts as a lavage for removing blood, tissue fragments, and bone fragments.

Indications And Usage

0.9% Sodium Chloride Irrigation, USP is indicated for use as an arthroscopic irrigating fluid with endoscopic instruments during arthroscopic procedures requiring distension and irrigation of the knee, shoulder, elbow, or other bone joints.

Contraindications

None known.

Warnings

Not for injection.Because fluids used to irrigate joints may be absorbed into the general circulation, solutions containing sodium ion should be used with great care in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which there exists edema with sodium retention.The contents of an opened container should be used promptly to minimize the possibility of bacterial growth or pyrogen formation. Discard the unused portion of irrigating solution since no antimicrobial agent has been added.

Precautions

Because some of the fluid used to irrigate joints may be absorbed, caution must be exercised in the volume of irrigating fluid used especially with solutions containing the sodium ion in patients receiving corticosteroids or corticotropin.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.Do not administer unless the solution is clear and the seal is intact.

Adverse Reactions

None known.

Dosage And Administration

The volume of solution needed will vary with the nature and duration of the arthroscopic procedure.If desired, warm in overpouch to near body temperature in a water bath or oven heated to not more than 45º C.Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

How Supplied

0.9% Sodium Chloride Irrigation, USP in ARTHROMATIC Plastic Container is available as follows:2B74773000 mLNDC 0338-0047-272B74795000 mLNDC 0338-0047-29Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25º C); brief exposure up to 40º C does not adversely affect the product.

Directions For Use

  • 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 bag firmly. If leaks are found, discard solution as sterility may be impaired.Use Aseptic Technique.1.Suspend container using hanger hole. 2.Remove protector from outlet port. 3.Attach irrigation set. Refer to complete directions accompanying set.Baxter Healthcare CorporationDeerfield, IL 60015 USAPrinted in USA07-19-00-0407Rev. July 2018Baxter and Arthromatic are trademarks of Baxter International Inc.

Package Label.Principle Display Panel

0.9% Sodium Chloride Irrigation USP Container Label 0.9% Sodium Chloride Irrigation USP Container Label NOT FOR INJECTION5000 mL2B7479NDC 0338-0047-290.9% SODIUM CHLORIDE Irrigation USPEACH 100 mL CONTAINS 900 mg SODIUMCHLORIDE USP NO ANTIMICROBIAL AGENT HAS BEENADDED pH 5.5 (4.5 to 7.0) mEq/L SODIUM 154CHLORIDE 154 OSMOLARITY 308 mOsmol/L(CALC) STERILE NONPYROGENIC SINGLE DOSECONTAINERDO NOT USE UNLESS SOLUTION IS CLEARDISCARD UNUSED PORTIONCAUTIONS SQUEEZE AND INSPECT INNER BAG WHICHMAINTAINS PRODUCT STERILITY DISCARD IF LEAKSARE FOUND RX ONLY STORE UNIT IN MOISTUREBARRIER OVERWRAP AT ROOM TEMPERATURE (25°C)UNTIL READY TO USE AVOID EXCESSIVE HEAT SEEINSERT0.9% Sodium Chloride NaCl Irrigation USPARTHROMATIC CONTAINER PL 146 PLASTICBAXTER HEALTHCARE CORPORATIONDEERFIELD IL 60015 USAMADE IN USABAXTER ARTHROMATIC ANDPL 146 ARE TRADEMARKS OFBAXTER INTERNATIONAL INCFOR PRODUCT INFORMATION1-800-933-03030.9% Sodium Chloride Irrigation USP Carton Label 0.9% Sodium Chloride Irrigation USP Carton Label 0.9% SODIUM CHLORIDE IRRIGATION, USPARTHROMATIC CONT2-5000MLSECONDARY BAR CODE(17) YYMM00 (10) XXXXXPRIMARY BAR CODE(01) 50303380047296LOT XXXXXEXP XXXXX2B7479

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