Sodium Chloride

Spectra Medical Devices, Llc
Human Prescription Drug
NDC 65282-1510

Sodium Chloride is a human prescription drug labeled by 'Spectra Medical Devices, Llc'. National Drug Code (NDC) number for Sodium Chloride is 65282-1510. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Sodium Chloride drug includes Sodium Chloride - 9 mg/mL . The currest status of Sodium Chloride drug is Active.

Drug Information:

Drug NDC:	65282-1510
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:	Spectra Medical Devices, Llc
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 mg/mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
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:	21 Jul, 2017
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	18 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:	ANDA206171
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:	Spectra Medical Devices, LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	1807637 1807646
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.
UPC:	0365282150516 0365282151018
UPC stands for Universal Product Code.
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
65282-1510-1	5 TRAY in 1 CARTON (65282-1510-1) / 5 AMPULE in 1 TRAY / 10 mL in 1 AMPULE	21 Jul, 2017	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.

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Product Elements:

Sodium chloride sodium chloride sodium chloride chloride ion sodium chloride sodium chloride sodium chloride chloride ion

Drug Interactions:

Drug interactions some drugs for injection may be incompatible in a given vehicle, or when combined in the same vehicle or in a vehicle containing benzyl alcohol. consult with pharmacist, if available. use aseptic technique for single or multiple entry and withdrawal from all containers. when diluting or dissolving drugs, mix thoroughly and use promptly. do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute. do not use unless the solution is clear and seal intact. do not reuse single-dose containers, discard unused portion.

Indications and Usage:

Indications and usage this parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.

Dosage and Administration:

Dosage and administration the volume of the preparation to be used for diluting or dissolving any drug for injection, is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer. this parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. see precautions .

Adverse Reactions:

Adverse reactions reactions which may occur because of this solution, added drugs or the technique of reconstitution or administration include febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasation. if an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate countermeasures, and if possible, retrieve and save the remainder of the unused vehicle for examination.

Drug Interactions:

Use in Pregnancy:

Pregnancy category c animal reproduction studies have not been conducted with 0.9% sodium chloride injection, usp. it is also not known whether sodium chloride injection containing additives can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. sodium chloride injection containing additives should be given to a pregnant woman only if clearly needed.

Pediatric Use:

Pediatric use the safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations. in neonates or very small infants the volume of fluid may affect fluid and electrolyte balance.

Overdosage:

Overdosage use only as a diluent or solvent. this parenteral preparation is unlikely to pose a threat of carbohydrate, sodium chloride or fluid overload except possibly in neonates or very small infants. in the event these should occur, re-evaluate the patient and institute appropriate corrective measures. see precautions and adverse reactions .

Description:

Description this preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection. 0.9% sodium chloride injection, usp is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection. each ml contains sodium chloride 9 mg. it contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection. 0.308 mosmol/ml (calc.). 0.9% sodium chloride injection, usp contains no preservatives. the solution may contain hydrochloric acid and/or sodium hydroxide for ph adjustment. the ph range is 4.5 to 7.0. the glass ampules made up of type i glass are used as a primary container for the drug product. sodium chloride, usp is chemically designated nacl, a white crystalline compound freely soluble in water.

Clinical Pharmacology:

Clinical pharmacology sodium chloride in water dissociates to provide sodium (na + ) and chloride (cl - ) ions. these ions are normal constituents of the body fluids (principally extracellular) and are essential for maintaining electrolyte balance. 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. the small volume of fluid and amount of sodium chloride provided by 0.9% sodium chloride injection, usp when used only as an isotonic vehicle for parenteral injection of drugs, is unlikely to exert a significant effect on fluid and electrolyte balance except possibly in neonates and very small infants. 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 bal Read more...

ance 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: size container ndc 5 ml glass ampules packaged in carton of 25 each 65282-1505-1 10 ml glass ampules packaged in carton of 25 each 65282-1510-1 store at 20Â° to 25Â°c (68Â° to 77Â°f); excursions permitted between 15Â° to 30Â°c (59Â° to 86Â°f) [see usp controlled room temperature]. manufactured for: spectra medical devices, inc. 260-f fordham road wilmington, ma 01887 by: kwang myung pharm co., ltd 957, wangam-dong jechon chungbuk 27159 republic of korea xx#### rev. # mm/yy

Package Label Principal Display Panel:

Principal display panel - 5 ml carton label rx only 25 single-dose ampules each single-dose ampule contains 5 ml ndc 65282-1505-1 0.9% sodium chloride injection, usp each ml contains sodium chloride, 9 mg in water for injection. the solution may contain hydrochloric acid and/or sodium hydroxide for ph adjustment. the ph range is 4.5 to 7.0. 0.308 mosmol/ml (calc). for use as a sterile diluent for additional information, see package insert. store at 20Â° to 25Â°c (68Â° to 77Â°f); excursions permitted between 15Â° to 30Â°c (59Â° to 86Â°f) [see usp controlled room temperature], preservative-free to open ampules, using gauze, place thumb and forefinger on color line, break at constriction. product code: xxxx-y manufactured for: spectra medical devices, inc. wilmington, ma. 01887 by: k.m. pharm. co., ltd. jecheon, korea 27159 principal display panel - 5 ml carton label

Principal display panel - 5 ml ampule label ndc 65282-1505-1 5ml ampule 0.9% sodium chloride injection, usp 0.308 mosmol/ml (calc) rx only single-dose for use as a sterile diluent preservative-free each ml contains sodium chloride, 9 mg. the solution may contain hydrochloric acid and/or sodium hydroxide for ph adjustment. the ph range is 4.5 to 7.0. manufactured for: spectra medical devices, inc. wilmington, ma 01887 by: k.m. pharm. co., ltd. jecheon, korea 27159 to open ampules, using gauze, place thumb and forefinger on color line, break at constriction. product code: xxxx-y store at 20Â° to 25Â°c (68Â° to 77Â°f); excursions permitted between 15Â° to 30Â°c (59Â° to 86Â°f) [see usp controlled room temperature]. lot no.: kxxxxxxx exp.: mm/yyyy principal display panel - 5 ml ampule label

Principal display panel - 10 ml carton label rx only 25 single-dose ampules each single-dose ampule contains 10 ml ndc 65282-1510-1 0.9% sodium chloride injection, usp each ml contains sodium chloride, 9 mg in water for injection. the solution may contain hydrochloric acid and/or sodium hydroxide for ph adjustment. the ph range is 4.5 to 7.0. 0.308 mosmol/ml (calc). for use as a sterile diluent for additional information, see package insert. store at 20Â° to 25Â°c (68Â° to 77Â°f); excursions permitted between 15Â° to 30Â°c (59Â° to 86Â°f) [see usp controlled room temperature]. preservative-free to open ampules, using gauze, place thumb and forefinger on color line, break at constriction. product code: xxxx-y manufactured for: spectra medical devices, inc. wilmington, ma. 01887 by : k.m. pharm. co., ltd. jecheon, korea 27159 principal display panel - 10 ml carton label

Principal display panel - 10 ml ampule label ndc 65282-1510-1 10 ml ampule 0.9% sodium chloride injection, usp 0.308 mosmol/ml (calc) rx only single-dose for use as a sterile diluent preservative-free each ml contains sodium chloride, 9 mg. the solution may contain hydrochloric acid and/or sodium hydroxide for ph adjustment. the ph range is 4.5 to 7.0. manufactured for: spectra medical devices, inc. wilmington, ma 01887 by: k.m. pharm. co., ltd. jecheon, korea 27159 to open ampules, using gauze, place thumb and forefinger on color line, break at constriction. product code: xxxx-y store at 20Â° to 25Â°c (68Â° to 77Â°f); excursions permitted between 15Â° to 30Â°c (59Â° to 86Â°f) [see usp controlled room temperature]. lot no.: kxxxxxxx exp.: mm/yyyy principal display panel - 10 ml ampule label

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