0.9% Sodium Chloride

Hf Acquisition Co Llc, Dba Healthfirst
Human Prescription Drug
NDC 51662-1609

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 51662-1609. 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 - 9 g/1000mL . The currest status of 0.9% Sodium Chloride drug is Active.

Drug Information:

Drug NDC:	51662-1609
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 - 9 g/1000mL
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:	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:	31 Jul, 2022
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:	ANDA207956
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:	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.
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 NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
51662-1609-1	500 mL in 1 BAG (51662-1609-1)	31 Jul, 2022	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 sodium chloride chloride ion sodium cation water

Indications and Usage:

Indications & usage sodium chloride injection, usp is indicated as a source of water and electrolytes. 0.9% sodium chloride injection, usp is also indicated for use as a priming solution in hemodialysis procedures.

Warnings:

Warnings hypersensitivity hypersensitivity and infusion reactions, including hypotension, pyrexia, tremor, chills, urticaria, rash, and pruritus have been reported with 0.9% sodium chloride injection, usp. stop the infusion immediately if signs or symptoms of a hypersensitivity reaction develop, such as tachycardia, chest pain, dyspnea and flushing. appropriate therapeutic countermeasures must be instituted as clinically indicated. electrolyte imbalances fluid overload depending on the volume and rate of infusion, and the patientâs underlying clinical condition, the intravenous administration of sodium chloride injection, usp can cause fluid disturbances such as overhydration/hypervolemia and congested states, including pulmonary congestion and edema. avoid 0.9% sodium chloride injection, usp in patients with or at risk for fluid and/or solute overloading. if use cannot be avoided, monitor fluid balance, electrolyte concentrations, and acid base balance, as needed and especially d Read more...

uring prolonged use. hyponatremia sodium chloride injection, usp may cause hyponatremia. hyponatremia can lead to acute hyponatremic encephalopathy characterized by headache, nausea, seizures, lethargy, and vomiting. patients with brain edema are at particular risk of severe, irreversible and life-threatening brain injury. the risk of hospital-acquired hyponatremia is increased in patients with cardiac or pulmonary failure, and in patients with non-osmotic vasopressin release (including siadh) treated with high volume of sodium chloride injection, usp. the risk for hyponatremia is increased in pediatric patients, elderly patients, postoperative patients, those with psychogenic polydipsia, and in patients treated with medications that increase the risk of hyponatremia (such as diuretics, certain antiepileptic and psychotropic medications). see precautions, drug interactions . patients at increased risk for developing complications of hyponatremia such as hyponatremic encephalopathy, include pediatric patients, women (in particular pre-menopausal women), patients with hypoxemia, and patients with underlying central nervous system disease. avoid sodium chloride injection, usp in patients with or at risk for hyponatremia. if use cannot be avoided, monitor serum sodium concentrations. rapid correction of hyponatremia is potentially dangerous with risk of serious neurologic complications. brain adaptations reducing risk of cerebral edema make the brain vulnerable to injury when chronic hyponatremia is too rapidly corrected, which is known as osmotic demyelination syndrome (ods). to avoid complications, monitor serum sodium and chloride concentrations, fluid status, acid-base balance, and signs of neurologic complications. hypernatremia hypernatremia may occur with sodium chloride injection, usp. conditions that may increase the risk of hypernatremia, fluid overload and edema (central and peripheral), include patients with: primary hyperaldosteronism; secondary hyperaldosteronism associated with, for example, hypertension, congestive heart failure, liver disease (including cirrhosis), renal disease (including renal artery stenosis, nephrosclerosis); and pre-eclampsia. certain medications such as corticosteroids or corticotropin, may also increase risk of sodium and fluid retention, see precautions, drug interactions. avoid sodium chloride injection, usp in patients with, or at risk for, hypernatremia. if use cannot be avoided, monitor serum sodium concentrations. rapid correction of hypernatremia is potentially dangerous with risk of serious neurologic complications. excessively rapid correction of hypernatremia is also associated with a risk for serious neurologic complications such as osmotic demyelination syndrome (ods) with risk of seizures and cerebral edema.

Dosage and Administration:

Dosage & administration important administration instructions sodium chloride injection, usp is intended for intravenous administration using sterile equipment. do not connect flexible plastic containers in series in order to avoid air embolism due to possible residual air contained in the primary container. set the vent to the closed position on a vented intravenous administration set to prevent air embolism. use a dedicated line without any connections to avoid air embolism. do not pressurize intravenous solutions contained in flexible plastic containers to increase flow rates in order to avoid air embolism due to incomplete evacuation of residual air in the container. prior to infusion, visually inspect the solution for particulate matter and discoloration. the solution should be clear and there should be no precipitates. do not administer unless solution is clear, and container is undamaged. dosing information the choice of product, dosage, volume, rate, and duration of administrat Read more...

ion is dependent upon the age, weight and clinical condition of the patient and concomitant therapy, and administration should be determined by a physician experienced in intravenous fluid therapy. introduction of additives additives may be incompatible. evaluate all additions to the plastic container for compatibility and stability of the resulting preparation. consult with a pharmacist, if available. if, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. mix thoroughly when additives have been introduced. after addition, if there is a discoloration and/or the appearance of precipitates, insoluble complexes or crystals, do not use. do not store solutions containing additives. discard any unused portion.

Contraindications:

Contraindications none known.

Adverse Reactions:

Adverse reactions post-marketing adverse reactions the following adverse reactions have been identified during post approval use of sodium chloride injection, usp. because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. the following adverse reactions have been reported in the post-marketing experience during use of 0.9% sodium chloride injection, usp and include the following: general disorders and administration site conditions: infusion site erythema, injection site streaking, burning sensation, and infusion site urticaria. hypersensitvity reactions: hypotension, pyrexia, tremor, chills, urticaria, rash, and pruritus. metabolism and nutrition disorders: hypernatremia, hyponatremia, hyperchloremic metabolic acidosis. nervous system disorders: hyponatremic encephalopathy. if an adverse reaction does occur, discontinue the infusion, evaluate Read more...

the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

Overdosage:

Overdosage excessive administration of 0.9% sodium chloride injection, usp can cause hypernatremia. hypernatremia can lead to cns manifestations, including seizures, coma, cerebral edema and death. excessive administration of sodium chloride injection, usp can cause fluid overload (which can lead to pulmonary and/or peripheral edema). see warnings and adverse reactions . when assessing an overdose, any additives in the solution must also be considered. the effects of an overdose may require immediate medical attention and treatment. interventions include discontinuation of sodium chloride injection, usp administration, dose reduction, and other measures as indicated for the specific clinical constellation (e.g., monitoring of fluid balance, electrolyte concentrations and acid base balance).

Description:

Description sodium chloride injection, usp is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. it contains no antimicrobial agents. the ph ranges from 4.5 to 7.0. composition, osmolarity, 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 (calc). it contains 154 meq/l sodium and 154 meq/l chloride. the fleboflex and fleboflex luer plastic containers are fabricated from latex-free polyolefins or polypropylene plastic materials. the solution contact materials do not contain pvc, dehp, or other plasticizers. the amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. the suitability of the container materials has been established through biological evaluations, which have shown the containers pass class vi u.s. pharmacopeia (usp) testing for plastic containers. these tests confirm the biological safety of the container systems.

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 ndc 51662-1609-1 0.9% sodium chloride injection, usp 500 ml bag hf acquisition co llc, dba healthfirst 11629 49th pl w. mukilteo, wa 98275 exposure of pharmaceutical products to heat should be minimized. avoid excessive heat. it is recommended the product be stored at 20Â° to 25Â°c (68Â° to 77Â°f); excursions are permitted between 15Â° to 30Â°c (59Â° to 86Â°f). [see usp controlled room temperature.]store unit in moisture barrier overwrap. brief exposure up to 40Â°c (104Â°f) does not adversely affect the product.

Package Label Principal Display Panel:

Principal display panel - ndc 51662-1609-1 bag label serialized and rfid labeling on bag bag serialized label

Comments/ Reviews:

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