NDC 0409-4888 Sodium Chloride

Sodium Chloride

NDC Product Code 0409-4888

NDC 0409-4888-10

Package Description: 25 VIAL, SINGLE-DOSE in 1 TRAY > 10 mL in 1 VIAL, SINGLE-DOSE (0409-4888-02)

NDC 0409-4888-12

Package Description: 25 VIAL, SINGLE-DOSE in 1 TRAY > 10 mL in 1 VIAL, SINGLE-DOSE (0409-4888-01)

NDC 0409-4888-20

Package Description: 25 VIAL, SINGLE-DOSE in 1 TRAY > 20 mL in 1 VIAL, SINGLE-DOSE (0409-4888-03)

NDC 0409-4888-50

Package Description: 25 VIAL, SINGLE-DOSE in 1 TRAY > 50 mL in 1 VIAL, SINGLE-DOSE (0409-4888-06)

NDC Product Information

Sodium Chloride with NDC 0409-4888 is a a human prescription drug product labeled by Hospira, Inc.. The generic name of Sodium Chloride is sodium chloride. The product's dosage form is injection, solution and is administered via intramuscular; intravenous; subcutaneous form.

Labeler Name: Hospira, Inc.

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.

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 9 mg/mL

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)
  • HYDROCHLORIC ACID (UNII: QTT17582CB)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)

Administration Route(s)

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

  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Hospira, Inc.
Labeler Code: 0409
FDA Application Number: NDA018803 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: 02-28-2005 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.

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

Other

Injection, USPCarpuject™ with Luer LockFliptop Plastic VialLifeShield™ Fliptop Plastic VialPreservative-Free                                                                                                                                                     Rx only

Description

This preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection.0.9% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection. Each mL contains sodium chloride 9 mg. It contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection. 0.308 mOsmol/mL (calc.). 0.9% Sodium Chloride Injection, USP contains no preservatives. The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. pH 5.3 (4.5 to 7.0).Sodium Chloride, USP is chemically designated NaCl, a white crystalline compound freely soluble in water. The glass container is a Type I borosilicate glass and meets the requirements of the powdered glass test according to the USP standards.The semi-rigid vial is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper drug concentration.

Clinical Pharmacology

Sodium chloride in water dissociates to provide sodium (Na+) and chloride (Cl‾) 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‾) 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 0.9% Sodium Chloride Injection, USP when used only as an isotonic vehicle for parenteral injection of drugs, is unlikely to exert a significant effect on fluid and electrolyte balance except possibly in neonates and 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 (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production).Water balance is maintained 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.

Indications And Usage

This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.

Precautions

Consult the manufacturer's instructions for choice of vehicle, appropriate dilution or volume for dissolving the drugs to be injected, including the route and rate of injection.Inspect reconstituted (diluted or dissolved) drugs for clarity (if soluble) and freedom from unexpected precipitation or discoloration prior to administration.Pregnancy: Animal reproduction studies have not been conducted with 0.9% Sodium Chloride Injection, USP. It is also not known whether sodium chloride injection containing additives can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium chloride injection containing additives should be given to a pregnant woman only if clearly needed.Pediatric Use: The safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations. In neonates or very small infants the volume of fluid may affect fluid and electrolyte balance.Drug InteractionsSome drugs for injection may be incompatible in a given vehicle, or when combined in the same vehicle or in a vehicle containing benzyl alcohol. Consult with pharmacist, if available.Use aseptic technique for single or multiple entry and withdrawal from all containers.When diluting or dissolving drugs, mix thoroughly and use promptly.Do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute.Do not use unless the solution is clear and seal intact. Do not reuse single-dose containers, discard unused portion.

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.

Overdosage

Use only as a diluent or solvent. This parenteral preparation is unlikely to pose a threat of carbohydrate, sodium chloride or fluid overload except possibly in neonates or very small infants. In the event these should occur, re-evaluate the patient and institute appropriate corrective measures. See PRECAUTIONS and ADVERSE REACTIONS.

Dosage And Administration

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. This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

How Supplied

0.9% Sodium Chloride Injection, USP is supplied in the following:Unit of SaleEachNDC 0409-1918-32Tub of 50NDC 0409-1918-422 mL Carpuject™, Single-dose cartridge with Luer Lock for the Carpuject Syringe SystemNDC 0409-1918-33Tub of 25NDC 0409-1918-433 mL Carpuject™, Single-dose cartridge with Luer Lock for the Carpuject Syringe SystemNDC 0409-1918-35Tub of 25NDC 0409-1918-455 mL Carpuject™, Single-dose cartridge with Luer Lock for the Carpuject Syringe SystemNDC 0409-4888-10Tray of 25NDC 0409-4888-0210 mL Single-dose Plastic Fliptop VialNDC 0409-4888-20Tray of 25NDC 0409-4888-0320 mL Single-dose Plastic Fliptop VialNDC 0409-4888-50Tray of 25NDC 0409-4888-0650 mL Single-dose Plastic Fliptop VialNDC 0409-4888-12Tray of 25NDC 0409-4888-0110 mL Single-dose LifeShield™ Plastic Fliptop VialStore at controlled room temperature 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature.]Instructions for Use of the Syringe SystemsInstructions for using the Carpuject Syringe are available with the reusable Carpuject Holder, List 2049-02.Distributed by Hospira, Inc., Lake Forest, IL 60045 USA                                                                                 LAB-1097-1.09/2017

* Please review the disclaimer below.