0.9% Sodium Chloride
Hf Acquisition Co Llc, Dba Healthfirst
Human Prescription Drug
NDC 51662-13010.9% 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 51662-1301. This drug is available in dosage form of Irrigant. 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: | 51662-1301 |
| 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: | Irrigant |
| 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: | IRRIGATION
|
| 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: | 18 Oct, 2018 |
| 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: | NDA017514 |
| 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: | 486515
|
| 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 |
|---|
| 51662-1301-1 | 1000 mL in 1 BOTTLE, PLASTIC (51662-1301-1) | 18 Oct, 2018 | 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:
0.9% sodium chloride 0.9% sodium chloride sodium chloride sodium cation chloride ion water
Indications and Usage:
Indications & usage each of these solutions is indicated for all general irrigation, washing, rinsing and dilution purposes which permit use of a sterile, nonpyrogenic electrolyte solution.
Warnings:
Warnings for irrigation only. not for injection. entry of a hypotonic solution into the circulation may cause hemolysis. irrigating fluids have been demonstrated to enter the systemic circulation in relatively large volumes; thus each of these irrigations must be regarded as a systemic drug. absorption of large amounts can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. the risk of dilutional states is inversely proportional to the electrolyte concentrations of administered parenteral solutions. the risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions. do not heat container over 66°c (150°f).
Dosage and Administration:
Dosage & administration the dose is dependent upon the capacity or surface area of the structure to be irrigated and the nature of the procedure. when used as a diluent or vehicle for other drugs, the manufacturer's recommendations should be followed. drug interactions 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 container permits. see precautions .
Contraindications:
Contraindications not for injection by usual parenteral routes. an electrolyte solution should not be used for irrigation during electrosurgical procedures.
Adverse Reactions:
Adverse reactions possible adverse effects arising from the irrigation of body cavities, tissues, or indwelling catheters and tubes are usually avoidable when proper procedures are followed. displaced catheters or drainage tubes can lead to irrigation or infiltration of unintended structures or cavities. excessive volume or pressure during irrigation of closed cavities may cause undue distension or disruption of tissues. accidental contamination from careless technique may transmit infection. should any adverse reaction occur, discontinue the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.
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 these products are sterile, nonpyrogenic solutions of electrolytes in water for injection intended only for sterile irrigation, washing, rinsing and dilution purposes. each 100 ml of 0.45% sodium chloride irrigation, usp contains: sodium chloride 450 mg; ph 5.6 (4.5 to 7.0). the solution is hypotonic (154 mosmol/liter, calc.) and has the following electrolyte content (meq/liter): na+ 77; clâ 77. each 100 ml of 0.9% sodium chloride irrigation, usp contains: sodium chloride 900 mg; ph 5.6 (4.5 to 7.0). may contain sodium hydroxide and/or hydrochloric acid for ph adjustment. the solution is isotonic (308 mosmol/liter, calc.) and has the following electrolyte content (meq/liter): na+ 154; clâ 154. these irrigations contain no bacteriostat, antimicrobial agent or added buffer and are intended only for use as single-dose or short procedure irrigation. when smaller volumes are required the unused portion should be discarded. each of these irrigations may be classified as a sterile irrigant, wash, rinse, diluent and pharmaceutical vehicle. 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. the semi-rigid container is fabricated from a specially formulated polyolefin. it is a copolymer of ethylene and propylene. the container requires no vapor barrier to maintain the proper drug concentration. 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 25°c/77°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 each of these irrigation solutions exert a mechanical cleansing action for sterile irrigation of body cavities, tissues or wounds, indwelling urethral catheters and surgical drainage tubes and for washing, rinsing or soaking surgical dressings, instruments and laboratory specimens. each also serves as a diluent or vehicle for drugs used for irrigation or other pharmaceutical preparations. 0.45% sodium chloride irrigation, usp provides a hypotonic half-strength saline irrigation identical in composition with 0.45% sodium chloride injection, usp. 0.9% sodium chloride irrigation, usp provides an isotonic saline irrigation identical in composition with 0.9% sodium chloride injection, usp (normal saline). 0.9% sodium chloride irrigation, usp is considered generally compatible with living tissues and organs; 0.45% sodium chloride irrigation, usp may be used alone or combined with appropriate additives when 0.9% sodium chloride is considered too irritating for wounds or
Read more...other altered structures. 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 oxygen 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 requirement ranges 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 irrigation, usp is supplied in the following dosage forms. ndc 51662-1301-1 0.9% sodium chloride irrigation, usp 1000ml bottle hf acquisition co llc, dba healthfirst mukilteo, wa 98275 also supplied in the following manufacture supplied dosage forms 0.45% sodium chloride irrigation, usp: 0.9% sodium chloride irrigation, usp: store at 20 to 25°c (68 to 77°f). [see usp controlled room temperature.] protect from freezing. revised: may, 2009 how supplied 1 how supplied 2 how supplied 3
Package Label Principal Display Panel:
Principal display panel, 1000 ml bottle label 1000 ml bottel label
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