Bacteriostatic Sodium Chloride

Sodium Chloride


Hospira, Inc.
Human Prescription Drug
NDC 0409-1966
Bacteriostatic Sodium Chloride also known as Sodium Chloride is a human prescription drug labeled by 'Hospira, Inc.'. National Drug Code (NDC) number for Bacteriostatic Sodium Chloride is 0409-1966. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Bacteriostatic Sodium Chloride drug includes Sodium Chloride - 9 mg/mL . The currest status of Bacteriostatic Sodium Chloride drug is Active.

Drug Information:

Drug NDC: 0409-1966
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: Bacteriostatic 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: Hospira, Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Injection, Solution
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:INTRAMUSCULAR
INTRAVENOUS
SUBCUTANEOUS
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 Apr, 2005
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: NDA018800
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:Hospira, Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:313002
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.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
0409-1966-0525 VIAL, MULTI-DOSE in 1 TRAY (0409-1966-05) / 20 mL in 1 VIAL, MULTI-DOSE (0409-1966-01)02 May, 2005N/ANo
0409-1966-0725 VIAL, MULTI-DOSE in 1 TRAY (0409-1966-07) / 30 mL in 1 VIAL, MULTI-DOSE (0409-1966-02)30 Apr, 2005N/ANo
0409-1966-1225 VIAL, MULTI-DOSE in 1 TRAY (0409-1966-12) / 10 mL in 1 VIAL, MULTI-DOSE (0409-1966-06)07 Oct, 2005N/ANo
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:

Bacteriostatic sodium chloride sodium chloride sodium chloride chloride ion sodium cation benzyl alcohol hydrochloric acid water

Drug Interactions:

Drug interactions some 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.

Boxed Warning:

Warning: not for use in neonates.

Indications and Usage:

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.

Warnings:

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.

Dosage and Administration:

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 .

Contraindications:

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.

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. 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 capab
le of producing blood pressure changes.

Drug Interactions:

Drug interactions some 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.

Use in Pregnancy:

Pregnancy 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 Use:

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. however, due to potential toxicity of benzyl alcohol in neonates, solutions containing benzyl alcohol are contraindicated in this patient population.

Overdosage:

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 .

Description:

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:

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 produc
tion). 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.

How Supplied:

How supplied bacteriostatic 0.9% sodium chloride injection, usp is supplied as: unit of sale concentration ndc 0409-1966-05 0.9% (20 ml) tray of 25 multiple-dose plastic fliptop vials ndc 0409-1966-07 0.9% (30 ml) tray of 25 multiple-dose plastic fliptop vials ndc 0409-1966-12 0.9% (10 ml) tray of 25 multiple-dose lifeshield ® plastic fliptop vials store at 20 to 25°c (68 to 77°f). [see usp controlled room temperature.] lifeshield ® is the trademark of icu medical, inc. and is used under license. distributed by hospira, inc., lake forest, il 60045 usa lab-1096-3.0 revised: 02/2019 hospira logo

Package Label Principal Display Panel:

Principal display panel - 30 ml vial label 30 ml multiple-dose bacteriostatic 0.9% sodium chloride injection, usp hospira lot ##–###–aa exp dmmmyyyy principal display panel - 30 ml vial label

Principal display panel - 30 ml vial tray 30 ml multiple-dose fliptop vial bacteriostatic 0.9% sodium chloride injection, usp rx only ndc 0409-1966-07 contains 25 of ndc 0409-1966-02 not for inhalation warning: not for use in neonates. for drug diluent use only. hospira principal display panel - 30 ml vial tray

Principal display panel - 10 ml vial label 10 ml multiple-dose lifeshield ® vial bacteriostatic 0.9% sodium chloride injection, usp lot ##–###–aa exp dmmmyyyy principal display panel - 10 ml vial label

Principal display panel - 10 ml vial tray 10 ml multiple-dose lifeshield ® vial bacteriostatic 0.9% sodium chloride injection, usp rx only ndc 0409-1966-12 contains 25 of ndc 0409-1966-06 not for inhalation. warning: not for use in neonates. for drug diluent use only. hospira principal display panel - 10 ml vial tray

Principal display panel - 20 ml vial label 20 ml multiple-dose bacteriostatic 0.9% sodium chloride injection, usp hospira lot ##–###–aa exp dmmmyyyy principal display panel - 20 ml vial label

Principal display panel - 20 ml vial tray 20 ml multiple-dose fliptop vial bacteriostatic 0.9% sodium chloride injection, usp rx only ndc 0409-1966-05 contains 25 of ndc 0409-1966-01 not for inhalation warning: not for use in neonates. for drug diluent use only. hospira principal display panel - 20 ml vial tray


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