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| Product NDC Code | 0264-1800 | ||||||||
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| Drug Name | Sodium chloride |
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| Type | Generic | ||||||||
| Pharm Class | Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC] |
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| Active Ingredients |
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| Route | INTRAVENOUS | ||||||||
| Dosage Form | INJECTION, SOLUTION | ||||||||
| RxCUI drug identifier | 1807630, 1807631, 1807632 |
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| Application Number | NDA017464 | ||||||||
| Labeler Name | B. Braun Medical Inc. | ||||||||
| 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 In the event of a fluid or solute overload during parenteral therapy, reevaluate the patient's condition, and institute appropriate corrective treatment.
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 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. The physician should also be alert to the possibility of adverse reactions to drug additives diluted and administered from the plastic partial fill container. Prescribing information for drug additives to be administered in this manner should be consulted. Symptoms may result from an excess or deficit of one or more of the ions present in the solution; therefore, frequent monitoring of electrolyte levels is essential. Hypernatremia may be associated with edema and exacerbation of congestive heart failure due to the retention of water, resulting in an expanded extracellular fluid volume. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.
Sodium Chloride Drug Interactions
Information about and practical guidance on preventing clinically significant drug/drug and drug/food interactions that may occur in people taking the drug.Drug Interactions Sodium-containing solutions should be administered with caution to patients receiving cortiscosteroids or corticotrophin. Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Studies have not been conducted to evaluate additional drug/drug or drug/food interactions with Sodium Chloride Injection USP.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.CLINICAL PHARMACOLOGY 0.9% Sodium Chloride Injection USP provides electrolytes and is a source of water for hydration. It is capable of inducing diuresis depending on the clinical condition of the patient. Sodium, the major cation of the extracellular fluid, functions primarily in the control of water distribution, fluid balance, and osmotic pressure of body fluids. Sodium is also associated with chloride and bicarbonate in the regulation of the acid-base equilibrium of body fluid. Chloride, the major extracellular anion, closely follows the metabolism of sodium, and changes in the acid-base balance of the body are reflected by changes in the chloride concentration.
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.CONTRAINDICATIONS This solution is contraindicated where the administration of sodium or chloride could be clinically detrimental.
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 Each mL of 0.9% Sodium Chloride Injection USP contains: Sodium Chloride USP 9 mg; Water for Injection USP qs pH adjusted with Hydrochloric Acid NF pH: 5.5 (4.5–7.0) Calculated Osmolarity: 310 mOsmol/liter Concentration of Electrolytes (mEq/100 mL): Sodium 15.4 Chloride 15.4 This solution is sterile, nonpyrogenic, isotonic and contains no bacteriostatic or antimicrobial agents. The formula of the active ingredient is: Ingredient Molecular Formula Molecular Weight Sodium Chloride USP NaCl 58.44 Not made with natural rubber latex, PVC or DEHP. The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class VI testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. These tests have shown that the container is nontoxic and biologically inert. The container/solution unit is a closed system and is not dependent upon entry of external air during administration. The container has two ports, one is for the intravenous administration set and the other is a medication addition site. Each is covered by a tamperproof barrier. Refer to the Directions for Use of the container to properly identify the ports. No vapor barrier is necessary.
| Ingredient | Molecular Formula | Molecular Weight |
|---|---|---|
| Sodium Chloride USP | NaCl | 58.44 |
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 This solution is for intravenous use only. Do not use plastic container in series connection. If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result. This solution is intended for intravenous administration using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours. Use only if solution is clear and container and seals are intact. As directed by a physician. Dosage is dependent upon the age, weight, and clinical condition of the patient as well as laboratory determinations. There is no specific pediatric dose. The dose is dependent on weight, clinical condition, and laboratory results. Follow recommendations of appropriate pediatric reference text. See PRECAUTIONS, Pediatric Use . When using this product as a diluent or vehicle for administration of drug additives, consult the prescribing information of the drug to be used. Addition of medication should be accomplished using aseptic technique in order to assure sterility. Physicochemical studies have shown that the container and solution can withstand freezing. Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
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.INDICATIONS AND USAGE This intravenous solution is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration. This product is designed for use as a diluent and delivery system for intermittent intravenous administration of compatible drug additives. Consult prescribing information for INDICATIONS AND USAGE of drug additives to be administered in this manner.
Spl product data elements
Usually a list of ingredients in a drug product.Sodium Chloride Sodium Chloride SODIUM CHLORIDE SODIUM CATION CHLORIDE ION WATER HYDROCHLORIC ACID
Carcinogenesis and mutagenesis and impairment of fertility
Information about carcinogenic, mutagenic, or fertility impairment potential revealed by studies in animals. Information from human data about such potential is part of the warnings field.Carcinogenesis, Mutagenesis, Impairment of Fertility Studies with 0.9% Sodium Chloride Injection USP have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.
Laboratory tests
Information on laboratory tests helpful in following the patient’s response to the drug or in identifying possible adverse reactions. If appropriate, information may be provided on such factors as the range of normal and abnormal values expected in the particular situation and the recommended frequency with which tests should be performed before, during, and after therapy.Laboratory Tests Periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation.
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 - 25 mL Container Label LOT EXP 0.9% Sodium Chloride Injection USP NDC 0264-1800-36 REF S8004-5410 25 mL Partial Fill in 100 mL PAB ® Container Each mL contains: Sodium Chloride USP 9 mg; Water for Injection USP qs pH adjusted with Hydrochloric Acid NF pH: 5.5 (4.5-7.0) Calc. Osmolarity: 310 mOsmol/liter Electrolytes (mEq/25 mL): Sodium 3.8 Chloride 3.8 Sterile, nonpyrogenic. Single dose container. For intravenous use only. Use only if solution is clear and container and seals are intact. WARNING: Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Recommended Storage: Room temperature (25°C). Avoid excessive heat. See Package Insert. Not made with natural rubber latex, PVC or DEHP. Rx only PAB is a registered trademark of B. Braun Medical Inc. B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 Y94-003-353 LD-227-2 25 mL Container Label
PRINCIPAL DISPLAY PANEL - 50 mL Container Label LOT EXP 0.9% Sodium Chloride Injection USP NDC 0264-1800-31 REF S8004-5384 50 mL Partial Fill in 100 mL PAB ® Container Each mL contains: Sodium Chloride USP 9 mg; Water for Injection USP qs pH adjusted with Hydrochloric Acid NF pH: 5.5 (4.5-7.0) Calc. Osmolarity: 310 mOsmol/liter Electrolytes (mEq/50 mL): Sodium 7.7 Chloride 7.7 Sterile, nonpyrogenic. Single dose container. For intravenous use only. Use only if solution is clear and container and seals are intact. WARNING: Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Recommended Storage: Room temperature (25°C). Avoid excessive heat. See Package Insert. Not made with natural rubber latex, PVC or DEHP. Rx only PAB is a registered trademark of B. Braun Medical Inc. B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 Y94-003-339 LD-226-A-2 50 mL Container Label
PRINCIPAL DISPLAY PANEL - 100 mL Container Label LOT EXP 0.9% Sodium Chloride Injection USP NDC 0264-1800-32 REF S8004-5264 100 mL Partial Fill in 150 mL PAB ® Container Each mL contains: Sodium Chloride USP 9 mg Water for Injection USP qs pH adjusted with Hydrochloric Acid NF pH: 5.5 (4.5-7.0) Calc. Osmolarity: 310 mOsmol/liter Electrolytes (mEq/100 mL): Sodium 15.4; Chloride 15.4 Sterile, nonpyrogenic. Single dose container. For intravenous use only. Use only if solution is clear and container and seals are intact. WARNING: Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Recommended Storage: Room temperature (25°C). Avoid excessive heat. See Package Insert. Not made with natural rubber latex, PVC or DEHP. Rx only PAB is a registered trademark of B. Braun Medical Inc. B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 Y94-003-337 LD-225-A-2 100 mL Container 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.Partial Fill
Rx only Revised: October 2016 PAB is a registered trademark of B. Braun Medical Inc.
B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 Y36-002-925 LD-224-5
Spl patient package insert
Information necessary for patients to use the drug safely and effectively.Directions For Use of PAB® Container Partial Additive Bag Aseptic technique is required. Caution: Before use, perform the following checks: Read the label. Ensure solution is the one ordered and is within the expiration date. Inspect the solution in good light for cloudiness, haze or particulate matter; check the container for leakage or damage. Any container which is suspect should not be used. Use only if solution is clear and container and seals are intact. Single dose container. Discard unused portion. Consult Package Insert for complete product information. The physician should also be alert to the possibility of adverse reactions to drug additives diluted and administered from the plastic partial fill container. Prescribing information for drug additives to be administered in this manner should be consulted. Do not use plastic container in series connection. This solution is intended for intravenous administration using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours. Physicochemical studies have shown that the container and solution can withstand freezing. 1. Identify Two Ports (See Figure A). 2. To Add Medication Remove additive port closure: hold container below additive port and grasp cap between thumb and forefinger then flip cap upward (See Figure B). Swab exposed additive port. Using a syringe with 18 gauge or smaller needle, insert cannula through resealable additive port and add desired drug. Mix thoroughly. Note: Partial fill bags have been designed to accept an overfill of up to 50 mL. 3. To Attach Administration Set To aseptically remove the set port closure: hold container below the set port and grasp the foil tab between the thumb and forefinger then pull the tab in two steps as shown in Figure C Steps 1 and 2. 4. Push spike through the diaphragm of the port (See Figure D) . Hang container using hole on the lower flap. Prime set in accordance with the Directions for Use provided with the set in use. When the container is to be used as a diluent and delivery system for intermittent intravenous administration of compatible drug additives, consult prescribing information for INDICATIONS AND USAGE of drug additives to be administered in this manner. Warning: Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. PAB® containers can be safely transported in a standard 6-inch carrier through a pneumatic tube system that is well maintained and running properly. Figure A Figure B Figure C Figure D
Geriatric use
Information about any limitations on any geriatric indications, needs for specific monitoring, hazards associated with use of the drug in the geriatric population.Geriatric Use An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Labor and delivery
Information about the drug’s use during labor or delivery, whether or not the use is stated in the indications section of the labeling, including the effect of the drug on the mother and fetus, on the duration of labor or delivery, on the possibility of delivery-related interventions, and the effect of the drug on the later growth, development, and functional maturation of the child.Labor and Delivery Studies have not been conducted to evaluate the effects of Sodium Chloride Injection USP on labor and delivery. As reported in the literature, sodium chloride solutions have been administered during labor and delivery. Caution should be exercised, and the fluid balance, glucose and electrolyte concentrations and acid-base balance, of both mother and fetus should be evaluated periodically or whenever warranted by the condition of the patient or fetus.
Nursing mothers
Information about excretion of the drug in human milk and effects on the nursing infant, including pertinent adverse effects observed in animal offspring.Nursing Mothers Because many drugs are excreted in human milk, caution should be exercised when 0.9% Sodium Chloride Injection USP is administered to a nursing woman.
Pediatric use
Information about any limitations on any pediatric indications, needs for specific monitoring, hazards associated with use of the drug in any subsets of the pediatric population (such as neonates, infants, children, or adolescents), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug.Pediatric Use Safety and effectiveness of sodium chloride injections in pediatric patients have not been established by adequate and well controlled trials, however, the use of Sodium Chloride solutions in the pediatric population is referenced in the medical literature. All Warnings, Precautions and Adverse Reactions described in this label apply to pediatric patients.
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)Pregnancy Teratogenic Effects Pregnancy Category C Animal reproduction studies have not been conducted with 0.9% Sodium Chloride Injection USP. It is also not known whether 0.9% Sodium Chloride Injection USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 0.9% Sodium Chloride Injection USP should be given to a pregnant woman only if clearly needed.
Teratogenic effects
Pregnancy category A: Adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in the first trimester of pregnancy, and there is no evidence of a risk in later trimesters. Pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women. Pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus, there are no adequate and well-controlled studies in humans, and the benefits from the use of the drug in pregnant women may be acceptable despite its potential risks. Pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks (for example, if the drug is needed in a life-threatening situation or serious disease for which safer drugs cannot be used or are ineffective). Pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities or there is positive evidence of fetal risk based on adverse reaction reports from investigational or marketing experience, or both, and the risk of the use of the drug in a pregnant woman clearly outweighs any possible benefit (for example, safer drugs or other forms of therapy are available).Teratogenic Effects Pregnancy Category C Animal reproduction studies have not been conducted with 0.9% Sodium Chloride Injection USP. It is also not known whether 0.9% Sodium Chloride Injection USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 0.9% Sodium Chloride Injection USP should be given to a pregnant woman only if clearly needed.
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 sterile and nonpyrogenic in partial fill polyolefin containers. The 100/150 mL product is packaged 64 per case. The 50/100 mL product is packaged 84 per case. The 25/100 mL product is packaged 116 per case. NDC REF Fill/Container (mL) 0.9% Sodium Chloride Injection USP 0264-1800-36 S8004-5410 25/100 0264-1800-31 S8004-5384 50/100 0264-1800-32 S8004-5264 100/150 Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.
| NDC | REF | Fill/Container (mL) |
|---|---|---|
| 0.9% Sodium Chloride Injection USP | ||
| 0264-1800-36 | S8004-5410 | 25/100 |
| 0264-1800-31 | S8004-5384 | 50/100 |
| 0264-1800-32 | S8004-5264 | 100/150 |
General precautions
Information about any special care to be exercised for safe and effective use of the drug.General Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation. Significant deviations from normal concentrations may require tailoring of the electrolyte pattern, in this or an alternative solution(s). Sodium-containing solutions should be administered with caution to patients receiving corticosteroids or corticotropin, or to other salt-retaining patients. Care should be exercised in administering solutions containing sodium to patients with renal or cardiovascular insufficiency, with or without congestive heart failure, particularly if they are postoperative or elderly. See PRECAUTIONS, Geriatric Use . To minimize the risk of possible incompatibilities arising from mixing this solution with other additives that may be prescribed, the final infusate should be inspected for cloudiness or precipitation immediately after mixing, prior to administration, and periodically during administration.
Precautions
Information about any special care to be exercised for safe and effective use of the drug.PRECAUTIONS General Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation. Significant deviations from normal concentrations may require tailoring of the electrolyte pattern, in this or an alternative solution(s). Sodium-containing solutions should be administered with caution to patients receiving corticosteroids or corticotropin, or to other salt-retaining patients. Care should be exercised in administering solutions containing sodium to patients with renal or cardiovascular insufficiency, with or without congestive heart failure, particularly if they are postoperative or elderly. See PRECAUTIONS, Geriatric Use . To minimize the risk of possible incompatibilities arising from mixing this solution with other additives that may be prescribed, the final infusate should be inspected for cloudiness or precipitation immediately after mixing, prior to administration, and periodically during administration. Laboratory Tests Periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation. Drug Interactions Sodium-containing solutions should be administered with caution to patients receiving cortiscosteroids or corticotrophin. Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Studies have not been conducted to evaluate additional drug/drug or drug/food interactions with Sodium Chloride Injection USP. Carcinogenesis, Mutagenesis, Impairment of Fertility Studies with 0.9% Sodium Chloride Injection USP have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility. Pregnancy Teratogenic Effects Pregnancy Category C Animal reproduction studies have not been conducted with 0.9% Sodium Chloride Injection USP. It is also not known whether 0.9% Sodium Chloride Injection USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 0.9% Sodium Chloride Injection USP should be given to a pregnant woman only if clearly needed. Labor and Delivery Studies have not been conducted to evaluate the effects of Sodium Chloride Injection USP on labor and delivery. As reported in the literature, sodium chloride solutions have been administered during labor and delivery. Caution should be exercised, and the fluid balance, glucose and electrolyte concentrations and acid-base balance, of both mother and fetus should be evaluated periodically or whenever warranted by the condition of the patient or fetus. Nursing Mothers Because many drugs are excreted in human milk, caution should be exercised when 0.9% Sodium Chloride Injection USP is administered to a nursing woman. Pediatric Use Safety and effectiveness of sodium chloride injections in pediatric patients have not been established by adequate and well controlled trials, however, the use of Sodium Chloride solutions in the pediatric population is referenced in the medical literature. All Warnings, Precautions and Adverse Reactions described in this label apply to pediatric patients. Geriatric Use An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.WARNINGS Solutions containing sodium ions 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 is sodium retention with edema. In patients with diminished renal function, administration of solutions containing sodium ions may result in sodium retention.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API