Sodium Chloride
Baxter Healthcare Corporation
Human Prescription Drug
NDC 0338-0047Sodium Chloride is a human prescription drug labeled by 'Baxter Healthcare Corporation'. National Drug Code (NDC) number for Sodium Chloride is 0338-0047. This drug is available in dosage form of Irrigant. The names of the active, medicinal ingredients in Sodium Chloride drug includes Sodium Chloride - 900 mg/100mL . The currest status of Sodium Chloride drug is Active.
Drug Information:
| Drug NDC: | 0338-0047 |
| 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 - 900 mg/100mL
|
| 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: | 30 May, 1980 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 19 Jun, 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: | NDA017867 |
| 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 |
|---|
| 0338-0047-27 | 4 BAG in 1 CARTON (0338-0047-27) / 3000 mL in 1 BAG | 30 May, 1980 | N/A | No |
| 0338-0047-29 | 2 BAG in 1 CARTON (0338-0047-29) / 5000 mL in 1 BAG | 30 May, 1980 | 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 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.
Warnings:
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.
Dosage and Administration:
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.
Contraindications:
Contraindications none known.
Adverse Reactions:
Adverse reactions none known.
Pediatric Use:
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.
Description:
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:
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.
How Supplied:
How supplied 0.9% sodium chloride irrigation, usp in arthromatic plastic container is available as follows: 2b7477 3000 ml ndc 0338-0047-27 2b7479 5000 ml ndc 0338-0047-29 exposure 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.
Package Label Principal Display Panel:
Package label.principle display panel 0.9% sodium chloride irrigation usp container label 0.9% sodium chloride irrigation usp container label not for injection 5000 ml 2b7479 ndc 0338-0047-29 0.9% sodium chloride irrigation usp each 100 ml contains 900 mg sodium chloride usp no antimicrobial agent has been added ph 5.5 (4.5 to 7.0) meq/l sodium 154 chloride 154 osmolarity 308 mosmol/l (calc) sterile nonpyrogenic single dose container do not use unless solution is clear discard unused portion cautions squeeze and inspect inner bag which maintains product sterility discard if leaks are found rx only store unit in moisture barrier overwrap at room temperature (25°c) until ready to use avoid excessive heat see insert 0.9% sodium chloride nacl irrigation usp arthromatic container pl 146 plastic baxter healthcare corporation deerfield il 60015 usa made in usa baxter arthromatic and pl 146 are trademarks of baxter international inc for product information 1-800-933-0303 0.9% sodium chloride irrigation usp carton label 0.9% sodium chloride irrigation usp carton label 0.9% sodium chloride irrigation, usp arthromatic cont 2-5000ml secondary bar code (17) yymm00 (10) xxxxx primary bar code (01) 50303380047296 lot xxxxx exp xxxxx 2b7479 0.9% sodium chloride irrigation usp container label 0.9% sodium chloride irrigation usp carton label