Sodium Chloride
Fresenius Medical Care North America
Human Prescription Drug
NDC 49230-300Sodium Chloride is a human prescription drug labeled by 'Fresenius Medical Care North America'. National Drug Code (NDC) number for Sodium Chloride is 49230-300. This drug is available in dosage form of Injection. The names of the active, medicinal ingredients in Sodium Chloride drug includes Sodium Chloride - 900 mg/100mL . The currest status of Sodium Chloride drug is Active.
Drug Information:
| Drug NDC: | 49230-300 |
| 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: | 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 Medical Care North America |
| 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 - 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: | 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: | 12 Apr, 2007 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 12 Jan, 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: | ANDA078177 |
| 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 Medical Care North America
|
| 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. |
| 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 |
|---|
| 49230-300-10 | 12 BAG in 1 CARTON (49230-300-10) / 1000 mL in 1 BAG | 12 Apr, 2007 | 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:
Sodium chloride sodium chloride water sodium chloride sodium cation chloride ion
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 0.9% 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 0.9% 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 0.9% sodium chloride injection, usp may result in sodium retention.
Dosage and Administration:
Dosage and 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 .) instructions for use to open tear outer wrap at notch and remove solution container. if supplemental medication is desired, follow directions below before preparing for administration. 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 or safety. the opacity will diminish gradually. to add medication prepare additive port. using aseptic technique and an additive delivery needle of appropriate length, puncture resealable additive port at target
Read more...area, inner diaphragm and inject. withdraw needle after injecting medication. the additive port may be protected by covering with an additive cap. mix container contents thoroughly. preparation for administration (use aseptic technique) close flow control clamp of administration set. remove cover from outlet port at bottom of container. insert piercing pin of administration set into port with a twisting motion until the set is firmly seated. note: see full directions on administration set carton. suspend container from hanger. squeeze and release drip chamber to establish proper fluid level in chamber. open flow control clamp and clear air from set. close clamp. attach set to venipuncture device. if device is not indwelling, prime and make venipuncture. regulate rate of administration with flow control clamp. warning: do not use flexible container in series connections. sodium-chloride-injection-1
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.
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 0.9% sodium chloride injection, usp is sterile and nonpyrogenic. it is a parenteral solution containing 0.9% sodium chloride in water for injection intended for intravenous administration. each 100 ml of 0.9% sodium chloride injection, usp 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 is 5.6. the ph range is 4.5 - 7.0. the solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only as a single-dose injection. when smaller doses are required the unused portion should be discarded. the solution is a parenteral fluid and electrolyte replenisher. sodium chloride, usp is chemically designated nacl, a white crystalline powder freely soluble in water. water for injection, usp is chemically designed h 2 o. 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 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 when administered intravenously, this solution provides 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. sodium chloride in water dissociates to provide sodium (na+) and chloride (cl-) ions. sodium (na+) is the principle cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte disturbances. chloride (cl-) 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 (cl-) are largely under the control of the kidney which maintains a balance between intake and output. water is an essential constituent of al
Read more...l 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 a 1000 ml single-dose flexible plastic container. (us manufactured ndc number 49230-300-10) (mexico manufactured dnc number 46163-300-10) store at 20° to 25°c (68° to 77°f). [see usp controlled room temperature.] protect from freezing. fresenius medical care north america waltham, ma 02451 1-800-323-5188 89-900-74 rev. 03/15
Package Label Principal Display Panel:
Package label - principal display panel - 0.9% sodium chloride injection, usp bag label fresenius bag label