Sodium Chloride
Cardinal Health 107, Llc
Human Prescription Drug
NDC 55154-9357Sodium Chloride is a human prescription drug labeled by 'Cardinal Health 107, Llc'. National Drug Code (NDC) number for Sodium Chloride is 55154-9357. This drug is available in dosage form of Injection. The names of the active, medicinal ingredients in Sodium Chloride drug includes Sodium Chloride - 9 mg/mL . The currest status of Sodium Chloride drug is Active.
Drug Information:
| Drug NDC: | 55154-9357 |
| 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: | Cardinal Health 107, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Injection |
| 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 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | INTRAVENOUS
|
| 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: | ANDA |
| 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: | 10 Aug, 2000 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 17 Dec, 2025 |
| 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: | ANDA088912 |
| 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: | Cardinal Health 107, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1807637
|
| 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. |
| UPC: | 0055154935753
|
| UPC stands for Universal Product Code. |
| 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 |
|---|
| 55154-9357-5 | 5 VIAL, SINGLE-DOSE in 1 BAG (55154-9357-5) / 10 mL in 1 VIAL, SINGLE-DOSE | 10 Aug, 2000 | 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 hydrochloric acid sodium hydroxide
Indications and Usage:
Indications and usage: sodium chloride injection, usp, 0.9% preparations are indicated for diluting or dissolving drugs for intramuscular, intravenous or subcutaneous injection according to instructions of the manufacturer of the drug to be administered. sodium chloride injection, usp, 0.9% is also indicated for use in flushing of intravenous catheters.
Warnings:
Warnings: for use in newborns, when a sodium chloride solution is required for preparation or diluting medications or in flushing intravenous catheters, only preservative free sodium chloride injection, usp, 0.9% should be used.
Dosage and Administration:
Dosage and administration: before sodium chloride injection, usp, 0.9% is used as a vehicle for the administration of a drug, specific references should be checked for any possible incompatibility with sodium chloride. the volume of the preparation to be used for diluting or dissolving any drug for injection is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer. sodium chloride injection, usp, 0.9% is also indicated for use in flushing intravenous catheters. prior to and after administration of the medication, the intravenous catheter should be flushed in its entirety with sodium chloride injection, usp, 0.9%. use in accord with any warnings or precautions appropriate to the medication being administered. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Adverse Reactions:
Adverse reactions: reactions which may occur because of this solution, added drugs or the technique of reconstitution or administration include febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasation. if an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate countermeasures and, if possible, retrieve and save the remainder of the unused vehicle for examination.
Use in Pregnancy:
Pregnancy pregnancy category c âanimal reproduction studies have not been conducted with sodium chloride injection, usp, 0.9%. it is also not known whether sodium chloride injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. sodium chloride injection, usp, 0.9% should be given to a pregnant woman only if clearly needed.
Overdosage:
Overdosage: when used as a diluent, solvent or intravascular flushing solution, this parenteral preparation is unlikely to pose a threat of sodium chloride or fluid overload except possibly in very small infants. in the event these should occur, reevaluate the patient and institute appropriate corrective measures. (see precautions and adverse reactions ).
Description:
Description: sodium chloride injection, usp, 0.9% is a sterile, nonpyrogenic solution. the osmolarity is 300 mosmol per liter (calculated). each ml contains: sodium chloride 9 mg; water for injection q.s. it contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single dose containers. hydrochloric acid and/or sodium hydroxide may have been added for ph adjustment (ph 4.5-7.0). sodium chloride occurs as colorless cubic crystals or white crystalline powder and has a saline taste. sodium chloride is freely soluble in water. it is soluble in glycerin and slightly soluble in alcohol. the empirical formula for sodium chloride is nacl and the molecular weight is 58.44.
Clinical Pharmacology:
Clinical pharmacology: sodium chloride in water dissociates to provide sodium (na + ) and chloride (cl â ) ions. these ions are normal constituents of the body fluids (principally extracellular) and are essential for maintaining electrolyte balance. the distribution and excretion of sodium (na + ) and chloride (cl â ) are largely under the control of the kidney which maintains a balance between intake and output. the small volume of fluid and amount of sodium chloride provided by sodium chloride injection, usp, 0.9%, when used only as a vehicle for parenteral injection of drugs, is unlikely to exert a significant effect on fluid and electrolyte balance except possibly in very small infants. 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 to 1.5 liters each for insensible water loss by perspiration and urine production). water balance is main
Read more...tained 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.
How Supplied:
How supplied: sodium chloride injection, usp, 0.9%, preservative free, is available as follows: ndc# strength available over bagged with 5 x 10 ml single dose vials in a bag 55154-9357-5 0.9% (90 mg per 10 ml) (9 mg per ml) preservative free. discard unused portion. use only if solution is clear and seal intact. store at 20º to 25ºc (68º to 77ºf) [see usp controlled room temperature].
Package Label Principal Display Panel:
Package/label display panel sodium chloride injection, usp 0.9% 5 x 10 ml single dose vials bag label