Bacteriostatic Sodium Chloride
Sodium Chloride
Fresenius Kabi Usa, Llc
Human Prescription Drug
NDC 63323-924Bacteriostatic Sodium Chloride also known as Sodium Chloride is a human prescription drug labeled by 'Fresenius Kabi Usa, Llc'. National Drug Code (NDC) number for Bacteriostatic Sodium Chloride is 63323-924. This drug is available in dosage form of Injection. 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: | 63323-924 |
| 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: | Fresenius Kabi Usa, 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: | 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: | 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: | 08 Aug, 2000 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 25 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: | ANDA088911 |
| 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: | Fresenius Kabi USA, LLC
|
| 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. |
| 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 |
|---|
| 63323-924-10 | 25 VIAL, MULTI-DOSE in 1 TRAY (63323-924-10) / 10 mL in 1 VIAL, MULTI-DOSE (63323-924-01) | 08 Aug, 2000 | N/A | No |
| 63323-924-30 | 25 VIAL, MULTI-DOSE in 1 TRAY (63323-924-30) / 30 mL in 1 VIAL, MULTI-DOSE (63323-924-03) | 08 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:
Bacteriostatic sodium chloride sodium chloride benzyl alcohol hydrochloric acid sodium hydroxide sodium chloride sodium cation chloride ion
Indications and Usage:
Indications and usage these parenteral preparations are 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. not for inhalation .
Warnings:
Warnings benzyl alcohol as a preservative in bacteriostatic sodium chloride injection, usp, 0.9% has been associated with toxicity in newborns. data is unavailable on the toxicity of other preservatives in this age group. preservative-free sodium chloride injection, usp, 0.9% should be used for flushing intravascular catheters. where a sodium chloride solution is required for preparing or diluting medications for use in newborns, only preservative-free sodium chloride injection, usp, 0.9% should be used.
General Precautions:
General bacteriostatic sodium chloride injection, usp, 0.9% should not be used for those medicinals that specify the use of only sodium chloride injection, usp, 0.9% as a sterile solvent. sodium chloride must be used with caution in the presence of congestive heart failure, circulatory insufficiency, kidney dysfunction or hypoproteinemia. excessive amounts of sodium chloride by any route may cause hypopotassemia and acidosis. excessive amounts by the parenteral route may precipitate congestive heart failure and acute pulmonary edema, especially in patients with cardiovascular disease and in patients receiving corticosteroids or corticotropin or drugs that may give rise to sodium retention.
Dosage and Administration:
Dosage and administration not for inhalation . before bacteriostatic 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 or benzyl alcohol. 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. isotonic solutions may be given subcutaneously, intravenously, and occasionally, intramuscularly. use bacteriostatic sodium chloride injection, usp, 0.9% with due regard for the compatibility of the benzyl alcohol it contains with the particular medicinal substance that is to be dissolved or diluted. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Contraindications:
Contraindications due to potential toxicity of benzyl alcohol in newborns, bacteriostatic sodium chloride injection, usp, 0.9% containing benzyl alcohol must not be used in this patient population. bacteriostatic sodium chloride injection, usp, 0.9% should not be used for fluid or sodium chloride replacement.
Adverse Reactions:
Adverse reactions to report suspected adverse reactions, contact fresenius kabi usa, llc at 1-800-551-7176 or fda at 1-800-fda-1088 or www.fda.gov/medwatch. reactions which may occur because of bacteriostatic sodium chloride injection, usp, 0.9%, 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 es
Read more...timated 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 infant is potentially capable of producing blood pressure changes.
Use in Pregnancy:
Pregnancy pregnancy category c â animal reproduction studies have not been conducted with bacteriostatic sodium chloride injection, usp, 0.9%. it is also not known whether bacteriostatic sodium chloride injection, usp, 0.9% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. bacteriostatic sodium chloride injection, usp, 0.9% should be given to a pregnant woman only if clearly needed.
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 very small infants. in the event these should occur, reevaluate the patient and institute appropriate corrective measures. see precautions and adverse reactions .
Description:
Description bacteriostatic sodium chloride injection, usp, 0.9% is a sterile, nonpyrogenic, isotonic solution. each ml contains: sodium chloride 9 mg; benzyl alcohol 0.9%; water for injection q.s. 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 - ) 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 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 of insensible water loss by perspiration and urine production). water balance is m
Read more...aintained 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 sodium chloride injection, usp, 0.9%, preserved with benzyl alcohol is available as follows: product code unit of sale strength each 924810 ndc 63323-924-10 unit of 25 0.9% ndc 63323-924-01 10 ml multiple dose plastic vial 924830 ndc 63323-924-30 unit of 25 0.9% ndc 63323-924-03 30 ml multiple dose plastic vial use only if solution is clear and seal intact. store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature].
Package Label Principal Display Panel:
Package label - principal display - bacteriostatic sodium chloride 30 ml multiple dose vial label ndc 63323-924-03 924830 bacteriostatic sodium chloride injection, usp 0.9% not for use in newborns 30 ml multiple dose vial for drug diluent use only not for inhalation 924830-vial
Package label â principal display - bacteriostatic sodium chloride 30 ml multiple dose vial tray label ndc 63323-924-30 924830 bacteriostatic sodium chloride injection, usp 0.9 % not for use in newborns 30 ml multiple dose vial for drug diluent use only not for inhalation 25 vials package label â principal display - bacteriostatic sodium chloride 30 ml multiple dose vial tray label