Sodium Chloride
Baxter Healthcare Corporation
Human Prescription Drug
NDC 0338-0051Sodium Chloride is a human prescription drug labeled by 'Baxter Healthcare Corporation'. National Drug Code (NDC) number for Sodium Chloride is 0338-0051. This drug is available in dosage form of Irrigant. The names of the active, medicinal ingredients in Sodium Chloride drug includes Sodium Chloride - 9 g/1000mL . The currest status of Sodium Chloride drug is Active.
Drug Information:
| Drug NDC: | 0338-0051 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Sodium Chloride |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Sodium Chloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Baxter Healthcare Corporation |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Irrigant |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | SODIUM CHLORIDE - 9 g/1000mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | IRRIGATION
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | NDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 17 May, 1985 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 20 Jan, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | NDA019319 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Baxter Healthcare Corporation
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 486515
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 451W47IQ8X
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Increased Large Intestinal Motility [PE]
Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
Osmotic Activity [MoA]
Osmotic Laxative [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0338-0051-44 | 1000 mL in 1 BAG (0338-0051-44) | 17 May, 1985 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Sodium chloride sodium chloride sodium chloride sodium cation chloride ion water
Indications and Usage:
Indications and usage slushed solution is used to create regional hypothermia in order to reduce and minimize manifestations of warm-temperature ischemia. temperature probes may be used to determine requirements for replacement or addition of slushed solution.
Warnings:
Warnings not for injection. for use in slush preparation for regional hypothermia.
General Precautions:
General precautions avoid prolonged direct contact between ice crystals and body tissues. experience in use of slushed solutions in pediatrics is limited.
Dosage and Administration:
Dosage and administration the volume of slushed solution required will vary with patientâs age, clinical condition, cooling effect desired and duration of cooling effect desired, according to physicianâs instructions.
Contraindications:
Contraindications none known
Adverse Reactions:
Adverse reactions no serious adverse reactions are known.
Use in Pregnancy:
Pregnancy teratogenic effects animal reproduction studies have not been conducted with slushed 0.9% sodium chloride irrigation, usp. it is also not known whether slushed 0.9% sodium chloride irrigation, usp can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. slushed 0.9% sodium chloride irrigation, usp should be given to a pregnant woman only if clearly needed.
Pediatric Use:
Pediatric use safety and effectiveness of slushed 0.9% sodium chloride irrigation, usp in pediatric patients have not been established by adequate and well controlled trials; however, the use of electrolyte solutions in the pediatric population is referenced in the medical literature. the warnings, precautions and adverse reactions identified in the label copy should be observed in the pediatric population. do not administer unless seals of outer dispensing bag are intact.
Description:
Description 0.9% sodium chloride irrigation, usp in the baxter sterile container system is a sterile, nonpyrogenic, isotonic solution for the preparation of slushed solution. it contains no antimicrobial agents. composition, osmolarity, ph and ionic concentration are shown in table 1. table 1 size (ml) composition (g/l) osmolarity (mosmol/l) (calc) ph ionic concentration (meq/l) sodium chloride, usp (nacl) sodium chloride 0.9 % sodium chloride irrigation, usp 1000 9 308 5.0 (4.5 to 7.0) 154 154 the baxter sterile container system is designed to provide a slush container with a sterile exterior surface for use within the surgical field. within the overwrap, the unit is packaged in a dispensing bag which maintains the sterility of this surface. the flexible plastic slush 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-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 culture toxicity studies.
Clinical Pharmacology:
Clinical pharmacology slushed solution is used to induce regional hypothermia in conditions such as certain open heart and kidney surgical procedures by direct application of slushed solution. the objective of regional hypothermia is to reduce cellular metabolic activity so that body tissues can tolerate a period of total or relative ischemia thereby inhibiting the formation and buildup of destructive autolytic enzymes and anaerobic by-products usually produced and accumulated in ischemic tissues.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis, mutagenesis, impairment of fertility studies performed with slushed 0.9% sodium chloride irrigation, usp have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.
How Supplied:
How supplied/storage and handling .9% sodium chloride irrigation, usp in the baxter sterile container system is supplied as follows: code size (ml) ndc din 2b7231 1000 0338-0051-44 786160 exposure of pharmaceutical products to heat should be minimized. avoid excessive heat. avoid freezing except during controlled slushing procedure. it is recommended that this product be stored at room temperature (25ºc); brief exposure up to 40ºc does not adversely affect this product.
Package Label Principal Display Panel:
Principal display panel - packaging labeling 1000 ml 2b7231 ndc 0338-0051-44 din 00786160 not for injection 0.9% sodium chloride irrigation, usp baxter sterile container system each 100 ml contains 900 mg sodium chloride usp ph 5.0 (4.5 to 7.0) meq/l sodium 154 chloride 154 osmolarity 308 mosmol/l (calc) sterile nonpyrogenic single dose container for use only in slush preparation for regional hypothermia see accompanying directions for use dosage as directed by a physician caution rx only baxter logo baxter healthcare corporation deerfield il 60015 usa made in usa distributed in canada by baxter corporation misissauga on l5n 0c2 pl 146 plastic baxter and pl 146 are trademarks of baxter international inc 2b7231 6-1000 ml baxter's sterile container system 0.9% sodium chloride irrigation, usp exp xxxxx secondary bar code (17) yymm00 (10) xxxxx lot xxxxx primary bar code (01) 50303380051446 representative container label for 0.9% sodium chloride irrigation usp sodium chloride representative carton label