Haemonetics 0.9 % Sodium Chloride
Sodium Chloride
Haemonetics Corporation
Human Prescription Drug
NDC 57826-441Haemonetics 0.9 % Sodium Chloride also known as Sodium Chloride is a human prescription drug labeled by 'Haemonetics Corporation'. National Drug Code (NDC) number for Haemonetics 0.9 % Sodium Chloride is 57826-441. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Haemonetics 0.9 % Sodium Chloride drug includes Sodium Chloride - 900 mg/100mL . The currest status of Haemonetics 0.9 % Sodium Chloride drug is Active.
Drug Information:
| Drug NDC: | 57826-441 |
| 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: | Haemonetics 0.9 % 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: | Haemonetics Corporation |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | 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 - 900 mg/100mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | EXTRACORPOREAL
|
| 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: | 07 Jan, 2013 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 23 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: | ANDA076316 |
| 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: | Haemonetics Corporation
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1807634
|
| 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 |
|---|
| 57826-441-06 | 500 mL in 1 BAG (57826-441-06) | 07 Jan, 2013 | 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:
Haemonetics 0.9 % sodium chloride sodium chloride water sodium chloride sodium cation
Indications and Usage:
Indications and usage sodium chloride injection, usp is indicated as a source of water and electrolytes. 0.9% sodium chloride in hemodialysis procedures.
Warnings:
Warnings sodium chloride injection, usp should be used with great care, if at all, in patients with congestive heart failure, servere renal insufficiency, and in clinical states in which there exist ederna with sodium retention. in patients with diminshed renal function administration of sodium chloride injection, usp may result in sodium retention.
Warnings and Cautions:
Directions for use warnings: do not use plastic containers in series connections. such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed. to open tear overwrap down side at slit and remove solution container. some opacity of the plastic due to moisture absorption during the sterilization process may be observed. this is normal and does not affect the solution quality of safety. the opacity will diminish gradually. check for minute leaks by equeezing inner bag firmly. if leaks are found, discard solutions as sterility may be impaired. if supplemental medication is desired, follow directions below. preparation for administration 1. suspend container from eyelet support. 2. remove plastic protector from outlet port at bottom of container. 3. attach administration set. refer to complete directions accompanying set.
Dosage and Administration:
Dosage and administration as directed by a physician. dosage is dependent upon the age, weight and clinical condition of the patient as well as laboratory determinations. parenteral drug products should be inspected visually for participate matter and discoloration prior to administration whenever solution and container permit. all injections in plastic containers are intended for intravenous administration using sterile equipment. additives may be incompatible. complete information is not available. those additives known to be incompatible should not be used. consult with pharmacist, if available. if, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic techniques. mix thoroughly when additives have been introduced. do not store solutions containing additives.
Contraindications:
Contraindications none known
Adverse Reactions:
Adverse reactions reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation, and hypervolemia. if an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic counter measures and save the remainder of the fluid for examination if deemed necessary.
Use in Pregnancy:
Pregnancy: teratogenic effects. pregnancy category c: animal reproduction studies have not been conducted with sodium chloride injection, usp. it is also not known whether sodium chloride injection, usp can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. sodium chloride injection, usp should be given to a pregnant woman only if clearly needed.
Pediatric Use:
Pediatric use safety and effectiveness of sodium chloride injection, usp in pediatric patients have not been established by adequate and well controlled trials; however, the use of sodium chloride solutions in the pediatric populations is referenced in the medical literature. the warnings, precautions and adverse reactions identified in the label copy should be observed in the pediatric population. do not administer unless solution is clear and seal is intact.
Description:
Description sodium chloride injection, usp is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in a single dose container for intravenous administration. it contains no antimicrobial agents. the ph is 4.5 to 7.0. composition, osrnolarity, and ionic concentration are shown below: 0.9% sodium chloride injection, usp contains 9 g/l. sodium chloride, usp (nacl) with an osmolarity of 308 mosmol/l (cale). it contains 154 meq/l sodium and 154 meq/l chloride. the amount of water that can permeate from inside the container into the overlap in insufficient to affect the solution significantly. solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (dehp) up to 5 parts per million. however, the safety of the plastic has been confirmed in tests in animals according to usp biological tests for plastic containers as well as by tissue culture toxicity studies.
Clinical Pharmacology:
Clinical pharmacology sodium chloride injection, usp has value as a source of water and electrolytes. it is capable of inducing diuresis depending on the clinical condition of the patient.
How Supplied:
How supplied 500ml of 0.9% sodium chloride injection, usp are contained in a flexible plastic bag and individually overwrapped. the product code is 441a and the ndc is 057826 441. exposure of pharmaceutical products to beat should be minimized. avoid excessive heat. it is recommended the product be stored at room temperature (25 degree c): brief exposure up to 40 c does not adversely affect the product.
Information for Patients:
Haemonetics 0.9 sodium chloride injection, usp 500 ml l352, rev. b product code 441a haemonetics corporation braintree, ma 02184 usa lot no. exp. date
Package Label Principal Display Panel:
Haemonetics sodium chloride injection, usp in plastic container
Directions for use to add medication
Haemonetics 0.9% sodium chloride injection, usp 500 ml haemonetics corporation braintree, ma 02184 usa
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