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Indomethacin - Medication Information

Product NDC Code 63323-659
Drug Name

Indomethacin

Type Generic
Pharm Class Anti-Inflammatory Agents,
Non-Steroidal [CS],
Cyclooxygenase Inhibitors [MoA],
Nonsteroidal Anti-inflammatory Drug [EPC]
Active Ingredients
Indomethacin 1 mg/ml
Route INTRAVENOUS
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
RxCUI drug identifier 346508
Application Number NDA022536
Labeler Name Fresenius Kabi USA, LLC
Packages
Package NDC Code Description
63323-659-09 1 vial in 1 carton (63323-659-09) / 1 ml in 1 vial
63323-659-03 1 vial in 1 carton (63323-659-03) / 1 ml in 1 vial
63323-659-94 1 vial in 1 carton (63323-659-94) / 1 ml in 1 vial
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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.
6 ADVERSE REACTIONS Most common adverse reactions are bleeding problems, higher incidence of transient oliguria and elevations of serum creatinine. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience In a double-blind, placebo-controlled trial of 405 premature infants weighing less than or equal to 1,750 g with evidence of large ductal shunting, in those neonates treated with indomethacin (n=206), there was a statistically significantly greater incidence of bleeding problems, including gross or microscopic bleeding into the gastrointestinal tract, oozing from the skin after needle stick, pulmonary hemorrhage, and disseminated intravascular coagulopathy. There was no statistically significant difference between treatment groups in intracranial hemorrhage. The neonates treated with Indomethacin for Injection had a significantly higher incidence of transient oliguria and elevations of serum creatinine (greater than or equal to 1.8 mg/dL) than did the neonates treated with placebo. The incidences of retrolental fibroplasia (grades III and IV) and pneumothorax in neonates treated with Indomethacin for Injection were no greater than in placebo controls and were statistically significantly lower than in surgically-treated neonates. The following additional adverse reactions in neonates have been reported from the collaborative study, anecdotal case reports, from other studies using rectal, oral, or intravenous indomethacin for treatment of patent ductus arteriosus or in marketed use. The rates are calculated from a database that contains experience of 849 indomethacin-treated neonates reported in the medical literature, regardless of the route of administration. One year follow-up is available on 175 neonates and shows no long-term sequelae that could be attributed to indomethacin. In controlled clinical studies, only electrolyte imbalance and renal dysfunction (of the reactions listed below) occurred statistically significantly more frequently after Indomethacin for Injection than after placebo. Reactions marked with a single asterisk (*) occurred in 3 to 9 percent of indomethacin-treated neonates; those marked with a double asterisk (**) occurred in 3 to 9 percent of both indomethacin- and placebo-treated neonates. Unmarked reactions occurred in less than 3 percent of neonates. Renal: renal failure, renal dysfunction in 41 percent of neonates, including one or more of the following: reduced urinary output; reduced urine sodium, chloride, or potassium, urine osmolality, free water clearance, or glomerular filtration rate; elevated serum creatinine or BUN; uremia. Cardiovascular: intracranial bleeding**, pulmonary hypertension. Gastrointestinal: gastrointestinal bleeding*, vomiting, abdominal distention, transient ileus, gastric perforation, localized perforation(s) of the small and/or large intestine, necrotizing enterocolitis. Metabolic: hyponatremia*, elevated serum potassium*, reduction in blood sugar, including hypoglycemia, increased weight gain (fluid retention). Coagulation: decreased platelet aggregation [see Warnings and Precautions ( 5.3 )] . The following adverse reactions have also been reported in neonates treated with indomethacin, however, a causal relationship to therapy with Indomethacin for Injection has not been established: Cardiovascular: bradycardia. Respiratory: apnea, exacerbation of pre-existing pulmonary infection. Metabolic: acidosis/alkalosis. Hematologic: disseminated intravascular coagulation, thrombocytopenia. Ophthalmic: retrolental fibroplasia.** Dermatologic: drug reaction with eosinophilia and systemic symptoms (DRESS) A variety of additional adverse experiences have been reported in adults treated with oral indomethacin for moderate to severe rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute painful shoulder and acute gouty arthritis (see package insert for oral indomethacin for additional information concerning adverse reactions and other cautionary statements). Their relevance to the pre-term infant receiving indomethacin for patent ductus arteriosus is unknown, however, the possibility exists that these experiences may be associated with the use of Indomethacin for Injection in pre-term infants.

INDOMETHACIN 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.
7 DRUG INTERACTIONS As renal function may be reduced by Indomethacin for Injection, consider reducing the dosage of those medications that rely on adequate renal function for their elimination. When used concomitantly with digoxin, monitor neonates for the development of digoxin toxicity. ( 7.1 ) Monitor prothrombin time when indomethacin is added to anticoagulants. ( 7.2 ) 7.1 Digoxin Because the half-life of digoxin (given frequently to pre-term infants with patent ductus arteriosus and associated cardiac failure) may be prolonged when given concomitantly with indomethacin, observe neonates receiving concomitant digoxin closely; frequent ECGs and serum digoxin levels may be required to prevent or detect digoxin toxicity early. 7.2 Anticoagulants Indomethacin usually does not influence the hypoprothrombinemia produced by anticoagulants. When indomethacin is added to anticoagulants, monitor prothrombin time closely. In post-marketing experience, bleeding has been reported in patients on concomitant treatment with anticoagulants and Indomethacin for Injection. 7.3 Furosemide Therapy with indomethacin may blunt the natriuretic effect of furosemide. This response has been attributed to inhibition of prostaglandin synthesis by non-steroidal anti-inflammatory drugs. In a study of 19 premature infants with patent ductus arteriosus treated with either Indomethacin for Injection alone or a combination of Indomethacin for Injection and furosemide, results showed that neonates receiving both Indomethacin for Injection and furosemide had significantly higher urinary output, higher levels of sodium and chloride excretion, and higher glomerular filtration rates than did those receiving Indomethacin for Injection alone. In this study, therapy with furosemide helped to maintain renal function in the premature infant when Indomethacin for Injection was added. 7.4 Aminoglycosides In one study of premature infants treated with Indomethacin for Injection and also receiving either gentamicin or amikacin, both peak and trough levels of these aminoglycosides were significantly elevated. 7.5 Drugs that Act on the Renin-Angiotensin System In some patients with compromised renal function, the co-administration of an NSAID and an ACE inhibitor or angiotensin II antagonist may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible.

Clinical pharmacology

Information about the clinical pharmacology and actions of the drug in humans.
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Although the exact mechanism of action through which indomethacin causes closure of a patent ductus arteriosus is not known, it is believed to be through inhibition of prostaglandin synthesis. 12.2 Pharmacodynamics Indomethacin has been shown to be a potent inhibitor of prostaglandin synthesis, both in vitro and in vivo . In human newborns with certain congenital heart malformations, PGE 1 dilates the ductus arteriosus. In fetal and newborn lambs, E type prostaglandins have also been shown to maintain the patency of the ductus, and as in human newborns, indomethacin causes its constriction. Studies in healthy young animals and in premature infants with patent ductus arteriosus indicated that, after the first dose of intravenous indomethacin, there was a transient reduction in cerebral blood flow velocity and cerebral blood flow. Similar decreases in mesenteric blood flow and velocity have been observed. The clinical significance of these effects has not been established. In double-blind, placebo-controlled studies of Indomethacin for Injection in 460 small pre-term infants, weighing 1,750 g or less, the neonates treated with placebo had a ductus closure rate after 48 hours of 25 to 30 percent, whereas those treated with Indomethacin for Injection had a 75 to 80 percent closure rate. In one of these studies, a multicenter study, involving 405 pre-term infants, later reopening of the ductus arteriosus occurred in 26 percent of neonates treated with Indomethacin for Injection however, 70 percent of these closed subsequently without the need for surgery or additional indomethacin. 12.3 Pharmacokinetics The disposition of indomethacin following intravenous administration (0.2 mg/kg) in pre-term neonates with patent ductus arteriosus has not been extensively evaluated. Even though the plasma half-life of indomethacin was variable among premature infants, it was shown to vary inversely with postnatal age and weight. In one study, of 28 neonates who could be evaluated, the plasma half-life in those less than 7 days old averaged 20 hours (range: 3 to 60 hours, n=18). In neonates older than 7 days, the mean plasma half-life of indomethacin was 12 hours (range: 4 to 38 hours, n=10). Grouping the neonates by weight, mean plasma half-life in those weighing less than 1,000 g was 21 hours (range: 9 to 60 hours, n=10); in those neonates weighing more than 1,000 g, the mean plasma half-life was 15 hours (range: 3 to 52 hours, n=18). Following intravenous administration in adults, indomethacin is eliminated via renal excretion, metabolism, and biliary excretion. Indomethacin undergoes appreciable enterohepatic circulation. The mean plasma half-life of indomethacin is 4.5 hours. In the absence of enterohepatic circulation, it is 90 minutes. Indomethacin has been found to cross the blood-brain barrier and the placenta. In adults, about 99 percent of indomethacin is bound to protein in plasma over the expected range of therapeutic plasma concentrations. The percent bound in neonates has not been studied. In controlled trials in premature infants, however, no evidence of bilirubin displacement has been observed as evidenced by increased incidence of bilirubin encephalopathy (kernicterus).

Mechanism of action

Information about the established mechanism(s) of the drugÕs action in humans at various levels (for example receptor, membrane, tissue, organ, whole body). If the mechanism of action is not known, this field contains a statement about the lack of information.
12.1 Mechanism of Action Although the exact mechanism of action through which indomethacin causes closure of a patent ductus arteriosus is not known, it is believed to be through inhibition of prostaglandin synthesis.

Pharmacodynamics

Information about any biochemical or physiologic pharmacologic effects of the drug or active metabolites related to the drugÕs clinical effect in preventing, diagnosing, mitigating, curing, or treating disease, or those related to adverse effects or toxicity.
12.2 Pharmacodynamics Indomethacin has been shown to be a potent inhibitor of prostaglandin synthesis, both in vitro and in vivo . In human newborns with certain congenital heart malformations, PGE 1 dilates the ductus arteriosus. In fetal and newborn lambs, E type prostaglandins have also been shown to maintain the patency of the ductus, and as in human newborns, indomethacin causes its constriction. Studies in healthy young animals and in premature infants with patent ductus arteriosus indicated that, after the first dose of intravenous indomethacin, there was a transient reduction in cerebral blood flow velocity and cerebral blood flow. Similar decreases in mesenteric blood flow and velocity have been observed. The clinical significance of these effects has not been established. In double-blind, placebo-controlled studies of Indomethacin for Injection in 460 small pre-term infants, weighing 1,750 g or less, the neonates treated with placebo had a ductus closure rate after 48 hours of 25 to 30 percent, whereas those treated with Indomethacin for Injection had a 75 to 80 percent closure rate. In one of these studies, a multicenter study, involving 405 pre-term infants, later reopening of the ductus arteriosus occurred in 26 percent of neonates treated with Indomethacin for Injection however, 70 percent of these closed subsequently without the need for surgery or additional indomethacin.

Pharmacokinetics

Information about the clinically significant pharmacokinetics of a drug or active metabolites, for instance pertinent absorption, distribution, metabolism, and excretion parameters.
12.3 Pharmacokinetics The disposition of indomethacin following intravenous administration (0.2 mg/kg) in pre-term neonates with patent ductus arteriosus has not been extensively evaluated. Even though the plasma half-life of indomethacin was variable among premature infants, it was shown to vary inversely with postnatal age and weight. In one study, of 28 neonates who could be evaluated, the plasma half-life in those less than 7 days old averaged 20 hours (range: 3 to 60 hours, n=18). In neonates older than 7 days, the mean plasma half-life of indomethacin was 12 hours (range: 4 to 38 hours, n=10). Grouping the neonates by weight, mean plasma half-life in those weighing less than 1,000 g was 21 hours (range: 9 to 60 hours, n=10); in those neonates weighing more than 1,000 g, the mean plasma half-life was 15 hours (range: 3 to 52 hours, n=18). Following intravenous administration in adults, indomethacin is eliminated via renal excretion, metabolism, and biliary excretion. Indomethacin undergoes appreciable enterohepatic circulation. The mean plasma half-life of indomethacin is 4.5 hours. In the absence of enterohepatic circulation, it is 90 minutes. Indomethacin has been found to cross the blood-brain barrier and the placenta. In adults, about 99 percent of indomethacin is bound to protein in plasma over the expected range of therapeutic plasma concentrations. The percent bound in neonates has not been studied. In controlled trials in premature infants, however, no evidence of bilirubin displacement has been observed as evidenced by increased incidence of bilirubin encephalopathy (kernicterus).

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.
4 CONTRAINDICATIONS Indomethacin for Injection is contraindicated in neonates: With proven or suspected infection that is untreated Who are bleeding, especially those with active intracranial hemorrhage or gastrointestinal bleeding With thrombocytopenia or coagulation defects With or who are suspected of having necrotizing enterocolitis With significant impairment of renal function With congenital heart disease in whom patency of the ductus arteriosus is necessary for satisfactory pulmonary or systemic blood flow (e.g., pulmonary atresia, severe tetralogy of Fallot, severe coarctation of the aorta). Indomethacin for Injection is contraindicated in neonates: With proven or suspected infection that is untreated Who are bleeding, especially those with active intracranial hemorrhage or gastrointestinal bleeding With thrombocytopenia or coagulation defects Suspected of having necrotizing enterocolitis With significant impairment of renal function With congenital heart disease in whom patency of the ductus arteriosus is necessary for satisfactory pulmonary or systemic blood flow. ( 4 )

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.
11 DESCRIPTION Sterile Indomethacin for Injection for intravenous administration is lyophilized indomethacin for injection. Each vial of indomethacin for injection contains 1 mg indomethacin; 0.29 mg monobasic sodium phosphate, 0.41 mg dibasic sodium phosphate and not more than 0.24 mg of sodium hydroxide (used for converting indomethacin base to the sodium salt) as a white to yellow lyophilized powder or plug. Variations in the size of the lyophilized plug and the intensity of color have no relationship to the quality or amount of indomethacin present in the vial. If necessary, hydrochloric acid (q.s.) and sodium hydroxide (q.s.) are added as pH adjusters. The reconstituted solution, pH 6.0 to 7.5, is clear, slightly yellow and essentially free from visible particles. The pH of the product does not meet the USP monograph [FD&C Act Chapter V, SEC. 501. [21USC §351](b)]. Indomethacin is designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The structural formula is: Structural Formula

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.
2 DOSAGE AND ADMINISTRATION For intravenous administration only . Dosage recommendations for closure of the ductus arteriosus depend on the age of the infant at the time of therapy. A course of therapy is defined as three intravenous doses of Indomethacin for Injection given at 12 to 24 hour intervals, with careful attention to urinary output. If anuria or marked oliguria (urinary output <0.6 mL/kg/hr) is evident at the scheduled time of the second or third dose of Indomethacin for Injection, do not give additional doses until laboratory studies indicate that renal function has returned to normal [see Warnings and Precautions ( 5.7 )] . Dosage according to age is as follows: AGE at 1st dose DOSAGE (mg/kg) Less than 48 hours 1st 0.2 2nd 0.1 3rd 0.1 2 to 7 days 0.2 0.2 0.2 Over 7 days 0.2 0.25 0.25 If the ductus arteriosus closes or is significantly reduced in size after an interval of 48 hours or more from completion of the first course of Indomethacin for Injection, no further doses are necessary. If the ductus arteriosus re-opens, a second course of 1 to 3 doses may be given, each dose separated by a 12 to 24 hour interval as described above. If the neonate remains unresponsive to therapy with Indomethacin for Injection after 2 courses, surgery may be necessary for closure of the ductus arteriosus. Dosage is dependent on the age of the infant at time of therapy. A course of therapy requires intravenous doses of Indomethacin for Injection given at 12 to 24 hour intervals. AGE at 1st dose DOSAGE (mg/kg) Less than 48 hours 1st 0.2 2nd 0.1 3rd 0.1 2 to 7 days 0.2 0.2 0.2 Over 7 days 0.2 0.25 0.25 If anuria or marked oliguria (urinary output <0.6 mL/kg/hr) is evident at the scheduled time of the second or third dose of Indomethacin for Injection, do not give additional doses until laboratory studies indicate that renal function has returned to normal If the ductus arteriosus closes or is significantly reduced in size after an interval of 48 hours or more from completion of the first course of Indomethacin for Injection, no further doses are necessary If the neonate remains unresponsive to therapy with Indomethacin for Injection after 2 courses, surgery may be necessary for closure of the ductus arteriosus. ( 2.1 ) 2.1 Directions for Use Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. The reconstituted solution, pH 6.0 to 7.5, is clear, slightly yellow and essentially free from visible particles. Prepare the solution with 1 to 2 mL of preservative-free Sterile Sodium Chloride Injection, 0.9 percent or preservative-free Sterile Water for Injection. Benzyl alcohol as a preservative has been associated with toxicity in neonates. Therefore, do not use diluents that contain preservatives. If 1 mL of diluent is used, the concentration of indomethacin in the solution will equal approximately 0.1 mg/0.1 mL; if 2 mL of diluent are used, the concentration of the solution will equal approximately 0.05 mg/0.1 mL. Discard any unused portion of the solution as it does not contain a preservative. Prepare a fresh solution just prior to each administration. Once reconstituted, the indomethacin solution may be injected intravenously. While the optimal rate of injection has not been established, published literature suggests an infusion rate over 20 to 30 minutes. Further dilution with intravenous infusion solutions is not recommended.
AGE at 1st dose DOSAGE (mg/kg)
Less than 48 hours 1st 0.2 2nd 0.1 3rd 0.1
2 to 7 days 0.2 0.2 0.2
Over 7 days 0.2 0.25 0.25
AGE at 1st dose DOSAGE (mg/kg)
Less than 48 hours 1st 0.2 2nd 0.1 3rd 0.1
2 to 7 days 0.2 0.2 0.2
Over 7 days 0.2 0.25 0.25

Dosage forms and strengths

Information about all available dosage forms and strengths for the drug product to which the labeling applies. This field may contain descriptions of product appearance.
3 DOSAGE FORMS AND STRENGTHS Indomethacin for Injection is supplied in single dose vials containing 1 mg of indomethacin as a sterile lyophilized powder or plug for reconstitution. Single dose vials of 1 mg indomethacin as a sterile, lyophilized powder or plug for reconstitution. ( 3 )

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.
1 INDICATIONS AND USAGE Indomethacin for Injection is indicated to close a hemodynamically significant patent ductus arteriosus in premature infants weighing between 500 and 1,750 g when 48 hours usual medical management (e.g., fluid restriction, diuretics, digitalis, respiratory support, etc.) is ineffective. Clear-cut clinical evidence of a hemodynamically significant patent ductus arteriosus should be present, such as respiratory distress, a continuous murmur, a hyperactive precordium, cardiomegaly, or pulmonary plethora on chest x-ray. Indomethacin for Injection is a cardiovascular drug indicated: To close a hemodynamically significant patent ductus arteriosus in premature infants weighing between 500 and 1,750 g. ( 1 )

Spl product data elements

Usually a list of ingredients in a drug product.
Indomethacin INDOMETHACIN INDOMETHACIN INDOMETHACIN SODIUM PHOSPHATE, MONOBASIC SODIUM PHOSPHATE, DIBASIC SODIUM HYDROXIDE

Nonclinical toxicology

Information about toxicology in non-human subjects.
13 NONCLINICAL TOXICOLOGY In rats and mice, oral indomethacin 4 mg/kg/day given during the last three days of gestation caused a decrease in maternal weight gain and some maternal and fetal deaths. An increased incidence of neuronal necrosis in the diencephalon in the live-born fetuses was observed. At 2 mg/kg/day, no increase in neuronal necrosis was observed as compared to the control groups. Administration of 0.5 or 4 mg/kg/day during the first three days of life did not cause an increase in neuronal necrosis at either dose level. Pregnant rats, given 2 mg/kg/day and 4 mg/kg/day during the last trimester of gestation, delivered offspring whose pulmonary blood vessels were both reduced in number and excessively muscularized. These findings are similar to those observed in the syndrome of persistent pulmonary hypertension of the neonate.

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.
PACKAGE LABEL - PRINCIPAL DISPLAY - Indomethacin for Injection 1 mg Vial Label NDC 63323-659-09 NP605903 Indomethacin For Injection 1 mg per vial FOR THE PREPARATION OF INTRAVENOUS SOLUTIONS Sterile Rx only Single Dose Vial - Discard unused portion vial PACKAGE LABEL - PRINCIPAL DISPLAY - Indomethacin for Injection 1 mg Carton Panel NDC 63323-659-09 NP605903 Indomethacin For Injection 1 mg per vial For Intravenous Use Only FOR THE PREPARATION OF INTRAVENOUS SOLUTIONS Rx only One vial Single Dose Vial - Discard any unused portion immediately. carton

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.
Manufactured by: Fresenius Kabi Lake Zurich, IL 60047 www.fresenius-kabi.com/us 451358B novoplus

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.
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Sterile Indomethacin for Injection is a lyophilized white to yellow powder or plug supplied as single dose vials containing indomethacin for injection, equivalent to 1 mg indomethacin. Product No. NDC No. NP605903 63323-659-09 1 mg per vial, Packaged individually. The container closure is not made with natural rubber latex. 16.2 Storage Store at 25°C (77°F) with excursions permitted to 15° to 30°C (59° to 86°F). Protect from light. Store container in carton until contents have been used. Novaplus is a registered trademark of Vizient, Inc. 16.1 How Supplied Sterile Indomethacin for Injection is a lyophilized white to yellow powder or plug supplied as single dose vials containing indomethacin for injection, equivalent to 1 mg indomethacin. Product No. NDC No. NP605903 63323-659-09 1 mg per vial, Packaged individually. The container closure is not made with natural rubber latex.
Product No. NDC No.
NP605903 63323-659-09 1 mg per vial, Packaged individually.
Product No. NDC No.
NP605903 63323-659-09 1 mg per vial, Packaged individually.

Storage and handling

Information about safe storage and handling of the drug product.
16.2 Storage Store at 25°C (77°F) with excursions permitted to 15° to 30°C (59° to 86°F). Protect from light. Store container in carton until contents have been used. Novaplus is a registered trademark of Vizient, Inc.

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