0.9% Sodium Chloride

Hf Acquisition Co Llc, Dba Healthfirst
Human Prescription Drug
NDC 51662-1518

0.9% Sodium Chloride is a human prescription drug labeled by 'Hf Acquisition Co Llc, Dba Healthfirst'. National Drug Code (NDC) number for 0.9% Sodium Chloride is 51662-1518. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in 0.9% Sodium Chloride drug includes Sodium Chloride - 900 mg/100mL . The currest status of 0.9% Sodium Chloride drug is Active.

Drug Information:

Drug NDC:	51662-1518
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:	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:	0.9% Sodium Chloride
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Hf Acquisition Co Llc, Dba Healthfirst
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 - 900 mg/100mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	INTRAVENOUS
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:	07 Apr, 2020
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:	NDA016366
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:	HF Acquisition Co LLC, DBA HealthFirst
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	1807639
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.
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
51662-1518-1	1 BAG in 1 POUCH (51662-1518-1) / 1000 mL in 1 BAG	07 Apr, 2020	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.

Other medicines with the same generic name

Product Elements:

0.9% sodium chloride 0.9% sodium chloride water sodium chloride sodium cation chloride ion

Drug Interactions:

Drug interactions caution must be exercised in the administration of sodium chloride injection, usp to patients receiving corticosteroids or corticotropin. carcinogenesis, mutagenesis, impairment of fertility studies have not been performed with sodium chloride injection, usp to evaluate the potential for carcinogenesis, mutagenesis or impairment of fertility. 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. labor and delivery studies have not been conducted to evaluate the effects of sodium chloride injection, usp on labor and delivery. caution should be exercised when administering this drug during labor and delivery. nursing mothers it is not known w Read more...

hether this drug is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when sodium chloride injection, usp is administered to a nursing mother. pediatric use the use of sodium chloride injection, usp in pediatric patients is based on clinical practice. plasma electrolyte concentrations should be closely monitored in the pediatric population as this population may have impaired ability to regulate fluids and electrolytes. the infusion of hypotonic fluids (0.45% sodium chloride injection, usp) together with the non-osmotic secretion of adh may result in hyponatremia in patients with acute volume depletion. hyponatremia can lead to headache, nausea, seizures, lethargy, coma, cerebral edema and death, therefore acute symptomatic hyponatremic encephalopathy is considered a medical emergency. geriatric use clinical studies of sodium chloride injection, usp did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or drug therapy. this drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. do not administer unless solution is clear and container is undamaged. discard unused portion.

Indications and Usage:

Indications and usage intravenous solutions containing sodium chloride are indicated for parenteral replenishment of fluid and sodium chloride as required by the clinical condition of the patient.

Warnings:

Warnings sodium chloride injection, usp should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention. the intravenous administration of sodium chloride injection, usp can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. the risk of dilutive states is inversely proportional to the electrolyte concentration of the injections. the risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injections. in patients with diminished renal function, administration of sodium chloride injection, usp may result in sodium retention.

Dosage and Administration:

Dosage & administration the dose is dependent upon the age, weight and clinical condition of the patient. additives may be incompatible. consult with pharmacist, if available. when introducing additives, use aseptic technique, mix thoroughly and do not store. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. (see precautions .)

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 countermeasures and save the remainder of the fluid for examination if deemed necessary. in addition to the above listed adverse reactions hyponatremia has been reported for 0.45% sodium chloride injection, usp (see pediatric use section).

Drug Interactions:

Overdosage:

Overdosage in the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. (see warnings , precautions , and adverse reactions .)

Description:

Description sodium chloride injection, usp solutions are sterile and nonpyrogenic. they are parenteral solutions containing various concentrations of sodium chloride in water for injection intended for intravenous administration. for 0.45% sodium chloride injection, usp, each 100 ml contains 450 mg sodium chloride in water for injection. electrolytes per 1000 ml: sodium 77 meq; chloride 77 meq. the osmolarity is 154 mosmol/l (calc.). for 0.9% sodium chloride injection, usp, each 100 ml contains 900 mg sodium chloride in water for injection. electrolytes per 1000 ml: sodium 154 meq; chloride 154 meq. the osmolarity is 308 mosmol/l (calc.). the ph for both concentrations in the 100 ml and smaller containers is 6.0; for the 250 ml and larger containers, the ph is 5.6. the ph range is 4.5 to 7.0 for all containers. the solutions contain no bacteriostat, antimicrobial agent or added buffer and each is intended only as a single-dose injection. when smaller doses are required the unused portion should be discarded. the solutions are parenteral fluid and electrolyte replenishers. sodium chloride, usp is chemically designated nacl, a white crystalline powder freely soluble in water. water for injection, usp is chemically designated h2o. the flexible plastic container is fabricated from a specially formulated polyvinylchloride. water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. exposure to temperatures above 25Â°c (77Â°f) during transport and storage will lead to minor losses in moisture content. higher temperatures lead to greater losses. it is unlikely that these minor losses will lead to clinically significant changes within the expiration period.

Clinical Pharmacology:

Clinical pharmacology when administered intravenously, these solutions provide a source of water and electrolytes. solutions which provide combinations of hypotonic or isotonic concentrations of sodium chloride are suitable for parenteral maintenance or replacement of water and electrolyte requirements. isotonic concentrations of sodium chloride are suitable for parenteral replacement of chloride losses that exceed or equal the sodium loss. hypotonic concentrations of sodium chloride are suited for parenteral maintenance of water requirements when only small quantities of salt are desired. a hypertonic concentration of sodium chloride may be used to repair severe salt depletion syndrome. sodium chloride in water dissociates to provide sodium (na+) and chloride (clâ) ions. sodium (na+) is the principal cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte disturbances. chloride (clâ) has an integral role in buffering action when oxyge Read more...

n and carbon dioxide exchange occurs in the red blood cells. the distribution and excretion of sodium (na+) and chloride (clâ) are largely under the control of the kidney which maintains a balance between intake and output. water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. average normal adult daily requirements range 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.

How Supplied:

How supplied 0.9% sodium chloride injection, usp is supplied in the following dosage forms. ndc 51662-1518-1 0.9% sodium chloride injection, usp, 1000 ml bag hf acquisition co llc, dba healthfirst mukilteo, wa 98275 also supplied in the following manufacture supplied dosage forms sodium chloride injection, usp is supplied in single-dose flexible plastic containers in various sizes and concentrations as shown in the accompanying table. * manufactured by icu medical, inc., lake forest, illinois, 60045, usa â manufactured for icu medical, inc., lake forest, illinois, 60045, usa icu medical is transitioning ndc codes from "0409" to "0990" labeler code. both ndc codes are expected to be in the market for a period of time. store at 20 to 25Â°c (68 to 77Â°f). [see usp controlled room temperature.] protect from freezing. revised: 1/2018 en-4686 how supplied

Package Label Principal Display Panel:

Principal display panel bag label 1 bag label 2

Principal display panel - ndc 51662-1518-1 - serialized pouch hf label

Comments/ Reviews:

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