NDC 0338-0691 Potassium Chloride In Sodium Chloride

Potassium Chloride And Sodium Chloride

NDC Product Code 0338-0691

NDC Code: 0338-0691

Proprietary Name: Potassium Chloride In Sodium Chloride 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.

Non-Proprietary Name: Potassium Chloride And Sodium Chloride 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.

NDC Code Structure

  • 0338 - Baxter Healthcare Corporation
    • 0338-0691 - Potassium Chloride In Sodium Chloride

NDC 0338-0691-04

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

NDC Product Information

Potassium Chloride In Sodium Chloride with NDC 0338-0691 is a a human prescription drug product labeled by Baxter Healthcare Corporation. The generic name of Potassium Chloride In Sodium Chloride is potassium chloride and sodium chloride. The product's dosage form is injection, solution and is administered via intravenous form.

Labeler Name: Baxter Healthcare Corporation

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.

Potassium Chloride In 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
  • POTASSIUM CHLORIDE 150 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)
  • 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.

  • Intravenous - Administration within or into a vein or veins.

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)
  • Potassium Compounds - [CS]
  • Potassium Salt - [EPC] (Established Pharmacologic Class)
  • 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: NDA017648 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: 02-02-1979 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.

Potassium Chloride In 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

Potassium Chloride in Sodium Chloride Injection, USP is a sterile, nonpyrogenic, solution for fluid and electrolyte replenishment in a single dose container for intravenous administration. It contains no antimicrobial agents. Composition, osmolarity, pH and ionic concentration are shown in Table 1.Table 1Size (mL)Composition (g/L)Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. Administration of substantially hypertonic solutions (≥ 600 mOsmol/L) may cause vein damage.Osmolarity (mOsmol/L) (Calc.)pHIonic Concentration (mEq/L)Sodium Chloride, USP (NaCl)Potassium Chloride, USP (KCl)SodiumPotassiumChloride20 mEq/L Potassium Chloride in 0.45% Sodium Chloride Injection, USP10004.51.51945.5(3.5 to 6.5)77209720 mEq/L Potassium Chloride in 0.9% Sodium Chloride Injection, USP100091.53485.5(3.5 to 6.5)1542017440 mEq/L Potassium Chloride in 0.9% Sodium Chloride Injection, USP1000933885.5(3.5 to 6.5)15440194The VIAFLEX Plus plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). VIAFLEX Plus on the container indicates the presence of a drug additive in a drug vehicle. The VIAFLEX Plus plastic container system utilizes the same container as the VIAFLEX plastic container system. 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-ethylhexyl phthalate (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

Potassium Chloride in Sodium Chloride Injection, USP has value as a source of water and electrolytes. It is capable of inducing diuresis depending on the clinical condition of the patient.

Indications And Usage

Potassium Chloride in Sodium Chloride Injection, USP is indicated as a source of water and electrolytes.

Contraindications

None known

Warnings

Potassium Chloride in Sodium Chloride Injection, USP should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention.Potassium Chloride in Sodium Chloride Injection, USP should be used with great care, if at all, in patients with hyperkalemia, severe renal failure and in conditions in which potassium retention is present.The intravenous administration of Potassium Chloride in Sodium Chloride Injection, USP 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 the injection. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injection.In patients with diminished renal function, administration of Potassium Chloride in Sodium Chloride Injection, USP may result in sodium or potassium retention.Potassium salts should never be administered by IV push.

Precautions

Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations and acid base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation.Caution must be exercised in the administration of Potassium Chloride in Sodium Chloride Injection, USP to patients receiving corticosteroids or corticotropin.

Pregnancy Category C

Animal reproduction studies have not been conducted with Potassium Chloride in Sodium Chloride Injection, USP. It is also not known whether Potassium Chloride in Sodium Chloride Injection, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Potassium Chloride in Sodium Chloride Injection, USP should be given to a pregnant woman only if clearly needed.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Studies with Potassium Chloride in Sodium Chloride Injection, USP have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Potassium Chloride in Sodium Chloride Injection, USP is administered to a nursing mother.

Pediatric Use:

Safety and effectiveness of Potassium Chloride in Sodium Chloride Injection, USP in pediatric patients have not been established by adequate and well-controlled studies. However, the use of potassium chloride injection in pediatric patients to treat potassium deficiency states when oral replacement therapy is not feasible is referenced in the medical literature.For patients receiving potassium supplement at greater than maintenance rates, frequent monitoring of serum potassium levels and serial EKGs are recommended.

Geriatric Use

Clinical studies of Potassium Chloride in Sodium Chloride Injection, USP did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.Do not administer unless solution is clear and seal is intact.

Adverse Reactions

Reactions which may occur because of the solution or the technique of administration include 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

As directed by a physician. Dosage is dependent upon the age, weight and clinical condition of the patient as well as laboratory determinations.Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Use of final filter is recommended during administration of all parenteral solutions, where possible.All injections in VIAFLEX Plus 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. Mix thoroughly when additives have been introduced. Do not store solutions containing additives.

How Supplied

Potassium Chloride in Sodium Chloride Injection, USP in VIAFLEX Plus Plastic Container is available as follows:CodeSize (mL)NDCProduct Name2B135710000338-0704-3420 mEq/L Potassium Chloride in 0.45% Sodium Chloride Injection, USP2B176410000338-0691-0420 mEq/L Potassium Chloride in 0.9% Sodium Chloride Injection, USP2B198410000338-0695-0440 mEq/L Potassium Chloride in 0.9% Sodium Chloride Injection, USPExposure 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); brief exposure up to 40° C (104° F) does not adversely affect the product.

Direction For Use Of Viaflex Plus Plastic Container

Warning: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed.

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. If supplemental medication is desired, follow directions below.

Preparation For Administration

  • 1.Suspend container from eyelet support.2.Remove plastic protector from outlet port at bottom of container.3.Attach administration set. Refer to complete directions accompanying set.

To Add Medication

Warning: Additives may be incompatible.

To Add Medication Before Solution Administration

  • 1.Prepare medication site.2.Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.3.Mix solution and medication thoroughly. For high density medication such as potassium chloride, squeeze ports while ports are upright and mix thoroughly.

To Add Medication During Solution Administration

  • 1.Close clamp on the set.2.Prepare medication site.3.Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.4.Remove container from IV pole and/or turn to an upright position.5.Evacuate both ports by squeezing them while container is in the upright position.6.Mix solution and medication thoroughly.7.Return container to in use position and continue administration.

Other

Baxter Healthcare CorporationDeerfield, IL 60015 USAPrinted in USA07-19-73-072Rev. May 2014Baxter, VIAFLEX and PL 146 are trademarks of Baxter International Inc.For Product Information1-800-933-0303

Package Labeling - Principle Display Panel

Container Label Container Label LOT EXP2B1357 NDC 0338-0704-3420 mEqPotassium Chloride(20 mEq/L)Potassium Chloride in0.45% Sodium Chloride Injection USP1000 mLEACH 100 mL CONTAINS 450 mg SODIUM CHLORIDE USP150 mg POTASSIUM CHLORIDE USP pH 5.5 (3.5 TO 6.5)mEq/L SODIUM 77 POTASSIUM 20 CHLORIDE 97OSMOLARITY 194 mOsmol/L (CALC) HYPOTONIC STERILENONPYROGENIC SINGLE DOSE CONTAINER ADDITIVES MAY BEINCOMPATIBLE CONSULT WITH PHARMACIST IF AVAILABLE WHENINTRODUCING ADDITIVES USE ASEPTIC TECHNIQUE MIXTHOROUGHLY DO NOT STORE USUAL DOSAGE INTRAVENOUSLYAS DIRECTED BY A PHYSICIAN SEE DIRECTIONS CAUTIONSSQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCTSTERILITY DISCARD IF LEAKS ARE FOUND MUST NOT BE USEDIN SERIES CONNECTIONS DO NOT USE UNLESS SOLUTION ISCLEAR RX ONLY STORE UNIT IN MOISTURE BARRIER OVERWRAPAT ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO USEAVOID EXCESSIVE HEAT SEE INSERTVIAFLEX PLUS CONTAINER PL 146 PLASTICBAXTER VIAFLEX AND PL 146 ARE TRADEMARKS OFBAXTER INTERNATIONAL INCBaxter BAXTER HEALTHCARE CORPORATIONDEERFIELD IL 60015 USAMADE IN USAFOR PRODUCT INFORMATION1-800-933-0303Carton Label2B-13-57X 14-1000 ML VIAFLEX PLUS CONTAINER 20 mEq POTASSIUM CHLORIDE IN 0.45% SODIUM CHLORIDE INJ EXP XXXXX SECONDARY BAR CODE (17) YYMM00 (10) XXXXX LOT XXXXX PRIMARY BAR CODE (01) 50303380704342Container LabelLOT EXP2B1764NDC 0338-0691-04DIN 007862091000 mLEACH 100 mL CONTAINS 900 mg SODIUM CHLORIDE USP150 mg POTASSIUM CHLORIDE USP pH 5.5 (3.5 TO 6.5)mEq/L SODIUM 154 POTASSIUM 20 CHLORIDE 174OSMOLARITY 348 mOsmol/L (CALC) STERILENONPYROGENIC SINGLE DOSE CONTAINER ADDITIVES MAY BEINCOMPATIBLE CONSULT WITH PHARMACIST IF AVAILABLE WHEN INTRODUCING ADDITIVES USE ASEPTIC TECHNIQUE MIXTHOROUGHLY DO NOT STORE DOSAGE INTRAVENOUSLY AS DIRECTED BY A PHYSICIAN SEE DIRECTIONS CAUTIONSSQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCTSTERILITY DISCARD IF LEAKS ARE FOUND MUST NOT BE USEDIN SERIES CONNECTIONS DO NOT USE UNLESS SOLUTION ISCLEAR RX ONLY STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERTVIAFLEX PLUS CONTAINER PL 146 PLASTICBAXTER VIAFLEX AND PL 146 ARE TRADEMARKS OFBAXTER INTERNATIONAL INCFOR PRODUCT INFORMATION 1-800-933-0303Baxter BAXTER HEALTHCARE CORPORATIONDEERFIELD IL 60015 USAMADE IN USADISTRIBUTED IN CANADA BYBAXTER CORPORATIONTORONTO ONTARIO CANADACarton Label2B1764X 14-1000 MLVIAFLEX ® PLUS CONTAINER20 MEQ POTASSIUM CHLORIDE IN0.9% SODIUM CHLORIDE INJEXPXXXXXSECONDARY BAR CODE(17) XXXXX (10) XXXXXLOTXXXXXPRIMARY BAR CODE(01) 50303380691048Container LabelLOT EXP2B1984NDC 0338-0695-04DIN 007862171000 mLEACH 100 mL CONTAINS 900 mg SODIUM CHLORIDE USP300 mg POTASSIUM CHLORIDE USP pH 5.5 (3.5 TO 6.5)mEq/L SODIUM 154 POTASSIUM 40 CHLORIDE 194OSMOLARITY 388 mOsmol/L (CALC) STERILENONPYROGENIC SINGLE DOSE CONTAINER ADDITIVES MAY BEINCOMPATIBLE CONSULT WITH PHARMACIST IF AVAILABLE WHEN INTRODUCING ADDITIVES USE ASEPTIC TECHNIQUE MIXTHOROUGHLY DO NOT STORE DOSAGE INTRAVENOUSLY AS DIRECTED BY A PHYSICIAN SEE DIRECTIONS CAUTIONSSQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCTSTERILITY DISCARD IF LEAKS ARE FOUND MUST NOT BE USEDIN SERIES CONNECTIONS DO NOT USE UNLESS SOLUTION ISCLEAR RX ONLY STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERTVIAFLEX PLUS CONTAINER PL 146 PLASTICBAXTER VIAFLEX AND PL 146 ARE TRADEMARKS OFBAXTER INTERNATIONAL INCFOR PRODUCT INFORMATION 1-800-933-0303Baxter BAXTER HEALTHCARE CORPORATIONDEERFIELD IL 60015 USAMADE IN USADISTRIBUTED IN CANADA BYBAXTER CORPORATIONTORONTO ONTARIO CANADACarton Label2B-19-84X 14-1000 MLVIAFLEX ® PLUS CONTAINER40 mEq POTASSIUM CHLORIDE IN0.9% SODIUM CHLORIDE INJEXPXXXXXSECONDARY BAR CODE(17) YYMM00 (10) XXXXXLOTXXXXXPRIMARY BAR CODE(01) 50303380695046

* Please review the disclaimer below.