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| Product NDC Code | 65282-1505 | ||||
|---|---|---|---|---|---|
| Drug Name | Sodium chloride |
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| Type | Generic | ||||
| Active Ingredients |
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| Route | INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | ||||
| Dosage Form | INJECTION, SOLUTION | ||||
| RxCUI drug identifier | 1807637, 1807646 |
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| Application Number | ANDA206171 | ||||
| Labeler Name | Spectra Medical Deviecs, LLC | ||||
| Packages |
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Overdosage of Sodium Chloride
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.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 .
Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.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.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.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 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.
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.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.
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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 .
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.INDICATION 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.
Spl product data elements
Usually a list of ingredients in a drug product.Sodium Chloride Sodium Chloride SODIUM CHLORIDE CHLORIDE ION Sodium Chloride Sodium Chloride SODIUM CHLORIDE CHLORIDE ION
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.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. FOR USE AS A STERILE DILUENT Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°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, LLC. WILMINGTON, MA. 01887 BY: HUONS. CO., LTD. Jecheon, Korea 27159 sodium_5_case
Principal Display Panel - 5 mL Ampule Label NDC 65282-1505-1 5 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, LLC. Wilmington, MA 01887 By: Huons. 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 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. LOT No.: XXX000 EXP.: YYYY/MM sodium_5_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 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°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, LLC. WILMINGTON, MA.01887 BY : HUONS CO., LTD. Jecheon, Korea 27159 sodium_10_case
Principal Display Panel - 10 mL Ampule Label NDC 62582-1510-1 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, LLC Wilmington, MA 01887 By: Huons 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 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. LOT No.: XX0000 EXP.: YYYY/MM sodium_10_label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.0.9% Sodium Chloride Injection, USP Rx only
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.HOW SUPPLIED 0.9% Sodium Chloride Injection, USP is supplied in the following: Size Container NDC 5 mL Glass ampules packed in carton of 25 each 65282-1505-1 10 mL Glass ampules packed in carton of 25 each 65282-1510-1 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Manufactured for: Spectra Medical Devices, LLC Wilmington, MA 01887 (978) 657-0889 By: Huons Co., Ltd. 100 Bio valley-ro Jecheon-si Chungcheongbuk-do, 27159 Republic of Korea XX#### Rev. # MM/YY
| Size | Container | NDC |
| 5 mL | Glass ampules packed in carton of 25 each | 65282-1505-1 |
| 10 mL | Glass ampules packed in carton of 25 each | 65282-1510-1 |
Precautions
Information about any special care to be exercised for safe and effective use of the drug.PRECAUTIONS Consult the manufacturer's instructions for choice of vehicle, appropriate dilution or volume for dissolving the drugs to be injected, including the route and rate of injection. Inspect reconstituted (diluted or dissolved) drugs for clarity (if soluble) and freedom from unexpected precipitation or discoloration prior to administration. 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 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. 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.
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