NDC 52584-966 Bacteriostatic Sodium Chloride

Sodium Chloride

NDC Product Code 52584-966

NDC 52584-966-07

Package Description: 1 VIAL, MULTI-DOSE in 1 BAG > 30 mL in 1 VIAL, MULTI-DOSE

NDC 52584-966-12

Package Description: 1 VIAL, MULTI-DOSE in 1 BAG > 10 mL in 1 VIAL, MULTI-DOSE

NDC Product Information

Bacteriostatic Sodium Chloride with NDC 52584-966 is a a human prescription drug product labeled by General Injectables & Vaccines, Inc.. The generic name of Bacteriostatic Sodium Chloride is sodium chloride. The product's dosage form is injection, solution and is administered via intramuscular; intravenous; subcutaneous form.

Labeler Name: General Injectables & Vaccines, 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.

Bacteriostatic 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

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.

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)

Product Labeler Information

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

Labeler Name: General Injectables & Vaccines, Inc.
Labeler Code: 52584
FDA Application Number: NDA018800 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: 06-01-2010 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.

Bacteriostatic Sodium Chloride Product Label Images

Bacteriostatic 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

This preparation is designed for parenteral use only after
addition of drugs that require dilution or must be dissolved in an aqueous
vehicle prior to injection.Bacteriostatic 0.9% Sodium Chloride Injection, USP is a sterile,
nonpyrogenic, isotonic solution of sodium chloride in water for injection. Each
milliliter (mL) contains sodium chloride 9 mg and 0.9% (9 mg/mL) benzyl alcohol
added as a bacteriostatic preservative. May contain hydrochloric acid for pH
adjustment. It is supplied in a multiple-dose container from which repeated
withdrawals may be made to dilute or dissolve drugs for medication. The pH is
5.0 (4.5 to 7.0).Sodium Chloride, USP is chemically designated NaCl, a white crystalline
powder freely soluble in water.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
Bacteriostatic 0.9% Sodium Chloride Injection, USP, 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 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.

Contraindications

Due to the potential toxicity of benzyl alcohol in neonates,
solutions containing benzyl alcohol must not be used in this patient
population.Parenteral preparations with benzyl alcohol should not be used for fluid or
sodium chloride replacement.Parenteral preparations containing benzyl alcohol should not be used in
epidural or spinal anesthetic procedures.

Warnings

Benzyl alcohol, a preservative in Bacteriostatic Sodium Chloride Injection, USP
has been associated with toxicity in neonates. Data are unavailable on the
toxicity of other preservatives in this age group. Preservative-free Sodium
Chloride Injection should be used for flushing intravascular catheters. Where a
sodium chloride solution is required for preparing or diluting medications for
use in neonates, only preservative-free Sodium Chloride Injection should be
used.

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 Category C. Animal reproduction studies have not been conducted with Bacteriostatic 0.9% Sodium Chloride Injection, USP. It is also not known whether Bacteriostatic 0.9% Sodium Chloride Injection containing additives can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Bacteriostatic 0.9% Sodium Chloride Injection containing additives should be given to a pregnant woman only if clearly needed.Pediatric UseThe safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations. However, due to potential toxicity of benzyl alcohol in neonates, solutions containing benzyl alcohol are contraindicated in this patient population.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.

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.Although adverse reactions to intravenous, intramuscular or subcutaneous
injection of 0.9% benzyl alcohol are not known to occur in man, experimental
studies of small volume parenteral preparations containing 0.9% benzyl alcohol
in several species of animals have indicated that an estimated intravenous dose
up to 30 mL may be safely given to an adult without toxic effects.
Administration of an estimated 9 mL to a 6 kg neonate or infant is potentially
capable of producing blood pressure changes.

Overdosage

Use only as a diluent or solvent. This parenteral preparation is unlikely to
pose a threat of sodium chloride or fluid overload except possibly in neonates
and 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.Parenteral drug products should be inspected visually for particulate matter
and discoloration prior to administration, whenever solution and container
permit. See PRECAUTIONS.

How Supplied

Bacteriostatic 0.9% Sodium Chloride Injection, USP is supplied in multiple-dose 10, 20 and 30 mL plastic fliptop vials (List No. 1966) or in multiple-dose 10 and 30 mL plastic LifeShield fliptop vials*. (List No. 1966).*Intended for use with the LifeShield Blunt Cannula.Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]Revised: 6/2015HOSPIRA, INC., LAKE FOREST, IL 60045 USA

* Please review the disclaimer below.