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Furosemide
Overview
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Increased Diuresis at Loop of Henle [PE] | PE | All 12 members |
| Loop Diuretic [EPC] | EPC | All 12 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 202747-001 | FUROSEMIDE | INJECTABLE | FUROSEMIDE | Prescription | AP | RS |
Therapeutic equivalence
Source: Orange BookWhat this rating means: Therapeutically equivalent — bioequivalence demonstrated (parenteral aqueous solutions)
Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 3 | Labeling | Approved | November 14, 2019 | Standard |
| Original application | 1 | Approved | January 27, 2014 | — |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260513). This is the manufacturer's labelling text, not a summary and not advice.
Boxed Warning
openFDA Drug LabelingBOXED WARNING WARNING Furosemide is a potent diuretic which, if given in excessive amounts, can lead to a profound diuresis with water and electrolyte depletion. Therefore, careful medical supervision is required and dose and dose schedule must be adjusted to the individual patient’s needs. (See DOSAGE AND ADMINISTRATION.)
Indications and Usage
openFDA Drug LabelingINDICATIONS AND USAGE Parenteral therapy should be reserved for patients unable to take oral medication or for patients in emergency clinical situations. Edema: Furosemide Injection is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide Injection is particularly useful when an agent with greater diuretic potential is desired. Furosemide Injection is indicated as adjunctive therapy in acute pulmonary edema. The intravenous administration of Furosemide Injection is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema. If gastrointestinal absorption is impaired or oral medication is not practical for any reason, Furosemide Injection is indicated by the intravenous or intramuscular route. Parenteral use should be replaced with oral furosemide as soon as practical.
Dosage and Administration
openFDA Drug LabelingDOSAGE & ADMINISTRATION Adults Parenteral therapy with Furosemide Injection, USP should be used only in patients unable to take oral medication or in emergency situations and should be replaced with oral therapy as soon as practical. Edema The usual initial dose of furosemide is 20 to 40 mg given as a single dose, injected intramuscularly or intravenously. The intravenous dose should be given slowly (1 to 2 minutes). Ordinarily a prompt diuresis ensues. If needed, another dose may be administered in the same manner 2 hours later or the dose may be increased. The dose may be raised by 20 mg and given not sooner than 2 hours after the previous dose until the desired diuretic effect has been obtained. This individually determined single dose should then be given once or twice daily. Therapy should be individualized according to patient response to gain maximal therapeutic response and to determine the minimal dose needed to maintain that response. Close medical supervision is necessary. When furosemide is given for prolonged periods, careful clinical observation and laboratory monitoring are particularly advisable (see PRECAUTIONS : Laboratory Tests). If the physician elects to use high dose parenteral therapy, add the furosemide to either Sodium Chloride Injection, USP, Lactated Ringer's Injection, USP, or Dextrose Injection 5%, USP, after pH has been adjusted to above 5.5, and administer as a controlled intravenous infusion at a rate not greater than 4 mg/min. Furosemide Injection is a buffered alkaline solution with a pH of about 9 and the drug may precipitate at pH values below 7. Care must be taken to ensure that the pH of the prepared infusion solution is in the weakly alkaline to neutral range. Acid solutions, including other parenteral medications (e.g., labetalol, ciprofloxacin, amrinone, milrinone) must not be administered concurrently in the same infusion because they may cause precipitation of the furosemide. In addition, furosemide injection should not be added to a running intravenous line containing any of these acidic products. Acute Pulmonary Edema The usual initial dose of furosemide is 40 mg injected slowly intravenously (over 1 to 2 minutes). If a satisfactory response does not occur within 1 hour, the dose may be increased to 80 mg injected slowly intravenously (over 1 to 2 minutes). If necessary, additional therapy (e.g., digitalis, oxygen) may be administered concomitantly. Geriatric patients In general, dose selection for the elderly patient should be cautious, usually starting at the low end of the dosing range (see PRECAUTIONS , Geriatric Use). Pediatric Patients Parenteral therapy should be used only in patients unable to take oral medication or in emergency situations and should be replaced with oral therapy as soon as practical. The usual initial dose of furosemide injection (intravenously or intramuscularly) in pediatric patients is 1 mg/kg body weight and should be given slowly under close medical supervision. If the diuretic response to the initial dose is not satisfactory, dosage may be increased by 1 mg/kg not sooner than 2 hours after the previous dose, until the desired diuretic effect has been obtained. Doses greater than 6 mg/kg body weight are not recommended. Literature reports suggest that the maximum dose for premature infants should not exceed 1 mg/kg/day (see WARNINGS , Pediatric Use). Furosemide Injection should be inspected visually for particulate matter and discoloration before administration. Do not use if solution is discolored. To prevent needle-stick injuries, needles should not be recapped, purposely bent, or broken by hand.
Dosage Forms and Strengths
openFDA Drug Labeling3 DOSAGE FORMS AND STRENGTHS Injection: Furosemide Injection, USP is supplied as a sterile, colorless solution as • 20 mg/2 mL (10 mg/mL) in a single-dose vial • 40 mg/4 mL (10 mg/mL) in a single-dose vial • 100 mg/10 mL (10 mg/mL) in a single-dose vial Injection: Furosemide Injection, USP is supplied as a sterile, colorless solution as • 20 mg/2 mL (10 mg/mL) in a single-dose vial ( 3 ) • 40 mg/4 mL (10 mg/mL) in a single-dose vial ( 3 ) • 100 mg/10 mL (10 mg/mL) in a single-dose vial ( 3 )
Contraindications
openFDA Drug Labeling4 CONTRAINDICATIONS • Furosemide Injection is contraindicated in patients with anuria. • Furosemide Injection is contraindicated in patients with a history of hypersensitivity to furosemide. • Anuria ( 4 ) • Hypersensitivity to furosemide ( 4 )
Warnings and Cautions
openFDA Drug Labeling5 WARNINGS AND PRECAUTIONS • Fluid, Electrolyte, and Metabolic Abnormalities : Monitor serum electrolytes, CO 2 , BUN, creatinine, glucose, and uric acid ( 5.1 ) • Worsening Renal Function : Monitor for dehydration and azotemia. ( 5.2 ) • Ototoxicity: Avoid rapid injection and higher than recommended doses. ( 5.3 , 7.1 ) • Acute Urinary Retention : Monitor patients with symptoms of urinary retention. ( 5.4 ) 5.1 Fluid, Electrolyte, and Metabolic Abnormalities Furosemide may cause fluid, electrolyte, and metabolic abnormalities such as hypovolemia, hypokalemia, azotemia, hyponatremia, hypochloremic alkalosis, hypomagnesemia, hypocalcemia, hyperglycemia, or hyperuricemia, particularly in patients receiving higher doses, patients with inadequate oral electrolyte intake, and in elderly patients. Excessive diuresis may cause dehydration and blood volume reduction with circulatory collapse and possibly vascular thrombosis and embolism, particularly in elderly patients. Serum electrolytes, CO 2 , BUN, creatinine, glucose, and uric acid should be monitored frequently during furosemide therapy. In patients with hepatic cirrhosis and ascites, sudden alterations of fluid and electrolyte balance may precipitate hepatic encephalopathy and coma. Treatment in such patients is best initiated in the hospital with small doses and careful monitoring of the patient's clinical status and electrolyte balance. 5.2 Worsening Renal Function Furosemide can cause dehydration and azotemia. If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, furosemide should be discontinued [see Clinical Pharmacology ( 12.3 )] . Furosemide use in the first year of life, especially in patients born pre-term, may precipitate nephrocalcinosis/nephrolithiasis. Therefore renal function must be monitored and renal ultrasonography performed in this age group [see Use in Specific Populations ( 8.4 )] . 5.3 Ototoxicity Cases of tinnitus and reversible or irreversible hearing impairment and deafness have been reported. Reports usually indicate that furosemide ototoxicity is associated with rapid injection, severe renal impairment, the use of higher than recommended doses, hypoproteinemia or concomitant therapy with aminoglycoside antibiotics, ethacrynic acid, or other ototoxic drugs. If the physician elects to use high-dose parenteral therapy, controlled intravenous infusion is advisable (for adults, an infusion rate not exceeding 4 mg furosemide per minute has been used) [see Drug Interactions ( 7.1 )] . Hearing loss in neonates, including premature neonates has been associated with the use of Furosemide Injection [see Use in Specific Populations ( 8.4 )]. 5.4 Acute Urinary Retention In patients with severe symptoms of urinary retention (because of bladder emptying disorders, prostatic hyperplasia, urethral narrowing), the administration of furosemide can cause acute urinary retention related to increased production and retention of urine. Thus, these patients require careful monitoring, especially during the initial stages of treatment.
Warnings
openFDA Drug LabelingWARNINGS In patients with hepatic cirrhosis and ascites, furosemide therapy is best initiated in the hospital. In hepatic coma and in states of electrolyte depletion, therapy should not be instituted until the basic condition is improved. Sudden alterations of fluid and electrolyte balance in patients with cirrhosis may precipitate hepatic coma; therefore, strict observation is necessary during the period of diuresis. Supplemental potassium chloride and, if required, an aldosterone antagonist are helpful in preventing hypokalemia and metabolic alkalosis. If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, furosemide should be discontinued. Cases of tinnitus and reversible or irreversible hearing impairment and deafness have been reported. Reports usually indicate that furosemide ototoxicity is associated with rapid injection, severe renal impairment, the use of higher than recommended doses, hypoproteinemia or concomitant therapy with aminoglycoside antibiotics, ethacrynic acid, or other ototoxic drugs. If the physician elects to use high dose parenteral therapy, controlled intravenous infusion is advisable (for adults, an infusion rate not exceeding 4 mg furosemide per minute has been used). (See PRECAUTIONS, Drug Interactions . ) Pediatric Use: In premature neonates with respiratory distress syndrome, diuretic treatment with furosemide in the first few weeks of life may increase the risk of persistent patent ductus arteriosus (PDA), possibly through a prostaglandin-E-mediated process. Literature reports indicate that premature infants with post conceptual age (gestational plus postnatal) less than 31 weeks receiving doses exceeding 1 mg/kg/24 hours may develop plasma levels which could be associated with potential toxic effects including ototoxicity. Hearing loss in neonates has been associated with the use of furosemide injection (see WARNINGS , above).
Adverse Reactions
openFDA Drug Labeling6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in the labeling: • Fluid, Electrolyte, and Metabolic Abnormalities [see Warnings and Precautions ( 5.1 )] • Ototoxicity [see Warnings and Precautions ( 5.3 )] The following adverse reactions associated with the use of furosemide were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Adverse reactions are categorized below by organ system and listed by decreasing severity. Gastrointestinal System Reactions: pancreatitis, jaundice (intrahepatic cholestatic jaundice), increased liver enzymes, anorexia, oral and gastric irritation, cramping, diarrhea, constipation, nausea, vomiting. Systemic Hypersensitivity Reactions: severe anaphylactic or anaphylactoid reactions (e.g., with shock), systemic vasculitis, interstitial nephritis, necrotizing angiitis. Central Nervous System Reactions: tinnitus and hearing loss, paresthesias, vertigo, dizziness, headache, blurred vision, xanthopsia. Hematologic Reactions: aplastic anemia, thrombocytopenia, agranulocytosis, hemolytic anemia, leukopenia, anemia, eosinophilia. Dermatologic-Hypersensitivity Reactions: toxic epidermal necrolysis, Stevens-Johnson Syndrome, erythema multiforme, drug rash with eosinophilia and systemic symptoms, acute generalized exanthematous pustulosis, exfoliative dermatitis, bullous pemphigoid, purpura, photosensitivity, rash. Cardiovascular Reactions: orthostatic hypotension, increase in cholesterol and triglyceride serum levels. Other Reactions: glycosuria, muscle spasm, weakness, restlessness, urinary bladder spasm, thrombophlebitis, transient injection site pain following intramuscular injection, fever. Most common adverse reactions are related to fluid and electrolyte imbalance ( 6 ) 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.
Drug Interactions
openFDA Drug Labeling7 DRUG INTERACTIONS • Aminoglycoside antibiotics : Increased potential ototoxicity of the antibiotics. Avoid combination ( 7.1 ) • Ethacrynic acid : Risk of ototoxicity. Avoid combination ( 7.1 ) • Salicylates : Risk of salicylate toxicity ( 7.1 ) • Cisplatin and nephrotoxic drugs : Risk of ototoxicity and nephrotoxicity ( 7.1 ) • Lithium : Risk of lithium toxicity ( 7.1 ) • Renin-angiotensin inhibitors : Increased risk of hypotension and renal failure ( 7.1 ) • Adrenergic blocking drugs : Risk of potentiation ( 7.1 ) • Drugs undergoing renal tubular secretion : Risk of toxicity potentiation ( 7.1 ) 7.1 Effects of Furosemide on Other Drugs Drug/Substance Class or Name Drug Interaction Effect Recommendations Aminoglycoside antibiotics Furosemide may increase the ototoxic potential of aminoglycoside antibiotics, especially in the presence of impaired renal function [see Warnings and Precautions (5.3) ] . Avoid combination except in life‐threatening situations. Ethacrynic acid Possibility of ototoxicity [see Warnings and Precautions (5.3) ] . Avoid concomitant use with ethacrynic acid. Salicylates May experience salicylate toxicity at lower doses because of competitive renal excretory sites. Monitor for symptoms of salicylate toxicity. Cisplatin There is a risk of ototoxic effects if cisplatin and furosemide are given concomitantly [see Warnings and Precautions (5.3) ] . Cisplatin and nephrotoxic drugs Nephrotoxicity Administer furosemide at lower doses and with positive fluid balance when used to achieve forced diuresis during cisplatin treatment. Monitor renal function. Paralytic agents Furosemide has a tendency to antagonize the skeletal muscle relaxing effect of tubocurarine and may potentiate the action of succinylcholine. Monitor for skeletal muscle effect. Lithium Furosemide reduces lithium’s renal clearance and add a high-risk of lithium toxicity. Avoid concomitant use with lithium. Angiotensin converting enzyme inhibitors or angiotensin II receptor blockers May lead to severe hypotension and deterioration in renal function, including renal failure. Monitor for changes in blood pressure and renal function and interrupt or reduce the dosage of furosemide, angiotensin converting enzyme inhibitors, or angiotensin receptor blockers if needed. Antihypertensive drugs Furosemide may add to or potentiate the therapeutic effect of other antihypertensive drugs. Monitor for changes in blood pressure and adjust the dose of other antihypertensive drugs if needed. Adrenergic blocking drugs or peripheral adrenergic blocking drugs Potentiation occurs. Monitor for changes in blood pressure and adjust the dose of adrenergic blocking drugs if needed. Norepinephrine Furosemide may decrease arterial responsiveness (vasoconstricting effect) to norepinephrine. Monitor blood pressure (or mean arterial pressure). Chloral hydrate In isolated cases, intravenous administration of furosemide within 24 hours of taking chloral hydrate may lead to flushing, sweating attacks, restlessness, nausea, increase in blood pressure, and tachycardia. Concomitant use with chloral hydrate is not recommended. Methotrexate and other drugs undergoing renal tubular secretion Furosemide may decrease renal elimination of other drugs that undergo tubular secretion. High‐dose treatment of furosemide may result in elevated serum levels of these drugs and may potentiate their toxicity. Monitor serum levels of drugs undergoing renal tubular secretion and adjust the dose if needed. Cephalosporin Furosemide can increase the risk of cephalosporin-induced nephrotoxicity even in the setting of minor or transient renal impairment. Monitor for changes in renal function. Cyclosporine Increased risk of gouty arthritis secondary to furosemide-induced hyperuricemia and cyclosporine impairment of renal urate excretion. Monitor serum urate levels. Thyroid hormones High-doses (> 80 mg) of furosemide may inhibit the binding of thyroid hormones to carrier proteins and result in transient inc …
Use in Specific Populations
openFDA Drug Labeling8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary Available data from published observational studies, case reports, and postmarketing reports, from decades of use, have not demonstrated a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes with furosemide use during pregnancy. Untreated congestive heart failure and cirrhosis of the liver can lead to adverse outcomes for the mother and the fetus (see Clinical Considerations ) . In animal reproduction studies, furosemide has been shown to cause unexplained maternal deaths and abortions in rabbits when administered orally during organogenesis at 4 times a human i.v. dose of 80 mg based on body surface area (BSA) and oral bioavailability corrections, presumably secondary to volume depletion (see Data ) . The estimated background risk for major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in the clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Pregnant women with congestive heart failure are at increased risk for pre-term birth. Stroke volume and heart rate increase during pregnancy, increasing cardiac output, especially during the first trimester. Clinical classification of heart disease may worsen with pregnancy and lead to maternal death and/or stillbirth. Closely monitor pregnant patients for destabilization of their heart failure. Pregnant women with symptomatic cirrhosis generally have poor outcomes including hepatic failure, variceal hemorrhage, pre-term delivery, fetal growth restriction and maternal death. Outcomes are worse with coexisting esophageal varices. Pregnant women with cirrhosis of the liver should be carefully monitored and managed accordingly. Data Animal Data The effects of furosemide on embryonic and fetal development and on pregnant dams were studied in mice, rats and rabbits. Furosemide caused unexplained maternal deaths and abortions in the rabbit at the lowest dose of 25 mg/kg (approximately 4 times a human i.v. dose of 80 mg based on BSA and oral bioavailability corrections). In another study, a dose of 50 mg/kg (approximately 7 times a human i.v. dose of 80 mg based on BSA and oral bioavailability corrections) also caused maternal deaths and abortions when administered to rabbits between Days 12 and 17 of gestation. In a third study, none of the pregnant rabbits survived an oral dose of 100 mg/kg. Data from the above studies indicate fetal lethality that can precede maternal deaths. The results of the mouse study and one of the three rabbit studies also showed an increased incidence and severity of hydronephrosis (distention of the renal pelvis and, in some cases, of the ureters) in fetuses of treated dams as compared with the incidence of fetuses from the control group. 8.2 Lactation Risk Summary The presence of furosemide has been reported in human milk. There are no data on the effects on the breastfed infant or the effects on milk production. Doses of furosemide associated with clinically significant diuresis may impair milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for furosemide and any potential adverse effects on the breastfed infant from furosemide or from the underlying maternal condition. 8.4 Pediatric Use Published reports indicate that premature infants with post conceptual age (gestational plus postnatal) less than 31 weeks receiving doses exceeding 1 mg/kg/24 hours may develop plasma levels which could be associated with potential toxic effects including ototoxicity [see Warnings and Precautions ( 5.3 )] . Furosemide in the first year of life, especially in patients born pre-term, may …
Mechanism of Action
openFDA Drug Labeling12.1 Mechanism of Action Furosemide inhibits primarily the reabsorption of sodium and chloride not only in the proximal and distal tubules but also in the loop of Henle. The high degree of efficacy is largely due to this unique site of action. The action on the distal tubule is independent of any inhibitory effect on carbonic anhydrase and aldosterone.
Description
openFDA Drug LabelingDESCRIPTION Furosemide is a diuretic which is an anthranilic acid derivative. Chemically it is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide is a white to slightly-yellow crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. It has the following structural formula: Molecular formula: C12H11CI N2O5S Molecular weight: 330.75 Furosemide Injection, USP is a sterile solution intended for intramuscular or intravenous administration. Each mL contains furosemide 10 mg and sodium chloride sufficient to render solution isotonic in water for injection. Contains sodium hydroxide and may contain hydrochloric acid for pH adjustment. pH is 8.0 to 9.3. The plastic syringe is molded from a specially formulated polypropylene. Water permeates from inside the container at an extremely slow rate which will have an insignificant effect on solution concentration over the expected shelf life. 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 syringe material. Contains no preservative. STRUCTURE
Overdosage
openFDA Drug LabelingOVERDOSAGE The principal signs and symptoms of overdose with furosemide are dehydration, blood volume reduction, hypotension, electrolyte imbalance, hypokalemia and hypochloremic alkalosis, and are extensions of its diuretic action. The acute toxicity of furosemide has been determined in mice, rats and dogs. In all three, the oral LD50exceeded 1000 mg/kg body weight, while the intravenous LD50 ranged from 300 to 680 mg/kg. The acute intragastric toxicity in neonatal rats is 7 to 10 times that of adult rats. The concentration of furosemide in biological fluids associated with toxicity or death is not known. Treatment of overdosage is supportive and consists of replacement of excessive fluid and electrolyte losses. Serum electrolytes, carbon dioxide level and blood pressure should be determined frequently. Adequate drainage must be assured in patients with urinary bladder outlet obstruction (such as prostatic hypertrophy). Hemodialysis does not accelerate furosemide elimination.
OVERDOSAGE The principal signs and symptoms of overdose with furosemide are dehydration, blood volume reduction, hypotension, electrolyte imbalance, hypokalemia and hypochloremic alkalosis, and are extensions of its diuretic action. The acute toxicity of furosemide has been determined in mice, rats and dogs. In all three, the oral LD50exceeded 1000 mg/kg body weight, while the intravenous LD50 ranged from 300 to 680 mg/kg. The acute intragastric toxicity in neonatal rats is 7 to 10 times that of adult rats. The concentration of furosemide in biological fluids associated with toxicity or death is not known. Treatment of overdosage is supportive and consists of replacement of excessive fluid and electrolyte losses. Serum electrolytes, carbon dioxide level and blood pressure should be determined frequently. Adequate drainage must be assured in patients with urinary bladder outlet obstruction (such as prostatic hypertrophy). Hemodialysis does not accelerate furosemide elimination.
How Supplied / Storage and Handling
openFDA Drug LabelingHOW SUPPLIED Furosemide Injection, USP is clear, colorless to slightly yellow solution. Furosemide Injection USP, (10 mg/mL) NDC 23155-473-41 2 mL single dose amber colored vial (23155-473-31) packaged in boxes of 25. NDC 23155-473-42 4 mL single dose amber colored vial (23155-473-32) packaged in boxes of 25. NDC 23155-473-43 4 mL single dose amber colored vial (23155-473-32) packaged in boxes of 50. NDC 23155-473-44 10 mL single dose amber colored vial (23155-473-33) packaged in boxes of 25. NDC 23155-473-45 10 mL single dose amber colored vial (23155-473-33) packaged in boxes of 50. Do not use if solution is discolored. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature). Protect from light. Manufactured by: Emcure Pharmaceuticals Ltd., Sanand, Ahmedabad – 382110, India. Manufactured for: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901.DRUG (3784) Revised:02 /2025 OR Manufactured by: Maiva Pharma Private Limited. No. 32, Sipcot Industrial Complex, Phase -1, Hosur-635126 Tamilnadu, INDIA. Manufactured for: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901.DRUG (3784) Revised : 02 /2025 logo
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: FUROSEMIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Recalls
Source: FDA Enforcement| Classification | Reported | Firm | Reason | Status |
|---|---|---|---|---|
| Class II | May 15, 2013 | Hospira Inc. | Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. | Terminated |
| Class II | March 6, 2013 | Hospira, Inc. | Lack of Assurance of Sterility; possible loose crimp applied to fliptop vial | Terminated |
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 83634-302-02 | 83634-302 | Avenacy Inc. | 25 VIAL, SINGLE-DOSE in 1 CARTON (83634-302-02) / 2 mL in 1 VIAL, SINGLE-DOSE (83634-302-42) | March 15, 2024 |
| 83634-302-04 | 83634-302 | Avenacy Inc. | 25 VIAL, SINGLE-DOSE in 1 CARTON (83634-302-04) / 4 mL in 1 VIAL, SINGLE-DOSE (83634-302-43) | March 15, 2024 |
| 83634-302-10 | 83634-302 | Avenacy Inc. | 25 VIAL, SINGLE-DOSE in 1 CARTON (83634-302-10) / 10 mL in 1 VIAL, SINGLE-DOSE (83634-302-41) | March 15, 2024 |
| 36000-063-05 | 36000-063 | Baxter Healthcare Corporation | 5 VIAL, SINGLE-DOSE in 1 BOX (36000-063-05) / 2 mL in 1 VIAL, SINGLE-DOSE | February 6, 2014 |
| 36000-064-05 | 36000-064 | Baxter Healthcare Corporation | 5 VIAL, SINGLE-DOSE in 1 BOX (36000-064-05) / 4 mL in 1 VIAL, SINGLE-DOSE | February 6, 2014 |
| 36000-065-05 | 36000-065 | Baxter Healthcare Corporation | 5 VIAL, SINGLE-DOSE in 1 BOX (36000-065-05) / 10 mL in 1 VIAL, SINGLE-DOSE | February 6, 2014 |
| 36000-282-25 | 36000-282 | Baxter Healthcare Corporation | 25 VIAL, SINGLE-DOSE in 1 BOX (36000-282-25) / 2 mL in 1 VIAL, SINGLE-DOSE | February 6, 2014 |
| 36000-283-25 | 36000-283 | Baxter Healthcare Corporation | 25 VIAL, SINGLE-DOSE in 1 BOX (36000-283-25) / 4 mL in 1 VIAL, SINGLE-DOSE | February 6, 2014 |
| 36000-284-25 | 36000-284 | Baxter Healthcare Corporation | 25 VIAL, SINGLE-DOSE in 1 BOX (36000-284-25) / 10 mL in 1 VIAL, SINGLE-DOSE | February 6, 2014 |
| 31722-309-32 | 31722-309 | Camber Pharmaceuticals, Inc. | 25 VIAL, GLASS in 1 BOX (31722-309-32) / 2 mL in 1 VIAL, GLASS (31722-309-31) | December 13, 2024 |
| 31722-310-32 | 31722-310 | Camber Pharmaceuticals, Inc. | 25 VIAL, GLASS in 1 BOX (31722-310-32) / 4 mL in 1 VIAL, GLASS (31722-310-31) | December 13, 2024 |
| 31722-311-31 | 31722-311 | Camber Pharmaceuticals, Inc. | 25 VIAL, GLASS in 1 BOX (31722-311-31) / 10 mL in 1 VIAL, GLASS (31722-311-10) | December 13, 2024 |
| 55154-2364-5 | 55154-2364 | Cardinal Health 107, LLC | 5 VIAL in 1 BAG (55154-2364-5) / 2 mL in 1 VIAL | July 13, 2010 |
| 55154-2365-5 | 55154-2365 | Cardinal Health 107, LLC | 5 VIAL, SINGLE-USE in 1 BAG (55154-2365-5) / 4 mL in 1 VIAL, SINGLE-USE | February 28, 2005 |
| 55154-4452-5 | 55154-4452 | Cardinal Health 107, LLC | 5 VIAL, SINGLE-DOSE in 1 BAG (55154-4452-5) / 4 mL in 1 VIAL, SINGLE-DOSE | February 6, 2014 |
| 55154-9581-5 | 55154-9581 | Cardinal Health 107, LLC | 5 VIAL in 1 BAG (55154-9581-5) / 2 mL in 1 VIAL | July 12, 2000 |
| 55154-9582-5 | 55154-9582 | Cardinal Health 107, LLC | 5 VIAL in 1 BAG (55154-9582-5) / 4 mL in 1 VIAL | July 12, 2000 |
| 72572-190-25 | 72572-190 | Civica, Inc. | 25 VIAL, SINGLE-DOSE in 1 BOX (72572-190-25) / 4 mL in 1 VIAL, SINGLE-DOSE | September 23, 2022 |
| 73043-022-01 | 73043-022 | Devatis Inc. | 25 VIAL, GLASS in 1 BOX (73043-022-01) / 2 mL in 1 VIAL, GLASS | August 10, 2024 |
| 73043-023-01 | 73043-023 | Devatis Inc. | 25 VIAL, GLASS in 1 BOX (73043-023-01) / 4 mL in 1 VIAL, GLASS | August 10, 2024 |
| 73043-024-01 | 73043-024 | Devatis Inc. | 25 VIAL, GLASS in 1 BOX (73043-024-01) / 10 mL in 1 VIAL, GLASS | August 10, 2024 |
| 55150-322-25 | 55150-322 | Eugia US LLC | 25 VIAL in 1 CARTON (55150-322-25) / 2 mL in 1 VIAL (55150-322-01) | May 3, 2019 |
| 55150-323-25 | 55150-323 | Eugia US LLC | 25 VIAL in 1 CARTON (55150-323-25) / 4 mL in 1 VIAL (55150-323-01) | May 3, 2019 |
| 55150-324-25 | 55150-324 | Eugia US LLC | 25 VIAL in 1 CARTON (55150-324-25) / 10 mL in 1 VIAL (55150-324-01) | May 3, 2019 |
| 63323-280-02 | 63323-280 | Fresenius Kabi USA, LLC | 25 VIAL in 1 TRAY (63323-280-02) / 2 mL in 1 VIAL (63323-280-01) | July 12, 2000 |
| 63323-280-04 | 63323-280 | Fresenius Kabi USA, LLC | 25 VIAL in 1 TRAY (63323-280-04) / 4 mL in 1 VIAL (63323-280-03) | July 12, 2000 |
| 63323-280-10 | 63323-280 | Fresenius Kabi USA, LLC | 25 VIAL in 1 TRAY (63323-280-10) / 10 mL in 1 VIAL (63323-280-05) | July 12, 2000 |
| 63323-280-16 | 63323-280 | Fresenius Kabi USA, LLC | 25 VIAL in 1 TRAY (63323-280-16) / 2 mL in 1 VIAL (63323-280-41) | July 12, 2000 |
| 63323-280-26 | 63323-280 | Fresenius Kabi USA, LLC | 25 VIAL in 1 TRAY (63323-280-26) / 4 mL in 1 VIAL (63323-280-43) | July 12, 2000 |
| 63323-280-36 | 63323-280 | Fresenius Kabi USA, LLC | 25 VIAL in 1 TRAY (63323-280-36) / 10 mL in 1 VIAL (63323-280-45) | July 12, 2000 |
| 68083-432-05 | 68083-432 | Gland Pharma Limited | 5 VIAL, GLASS in 1 BOX (68083-432-05) / 2 mL in 1 VIAL, GLASS | July 1, 2020 |
| 68083-432-25 | 68083-432 | Gland Pharma Limited | 25 VIAL, GLASS in 1 BOX (68083-432-25) / 2 mL in 1 VIAL, GLASS | July 1, 2020 |
| 68083-433-05 | 68083-433 | Gland Pharma Limited | 5 VIAL, GLASS in 1 BOX (68083-433-05) / 4 mL in 1 VIAL, GLASS | July 1, 2020 |
| 68083-433-25 | 68083-433 | Gland Pharma Limited | 25 VIAL, GLASS in 1 BOX (68083-433-25) / 4 mL in 1 VIAL, GLASS | July 1, 2020 |
| 68083-434-05 | 68083-434 | Gland Pharma Limited | 5 VIAL, GLASS in 1 BOX (68083-434-05) / 10 mL in 1 VIAL, GLASS | July 1, 2020 |
| 68083-434-25 | 68083-434 | Gland Pharma Limited | 25 VIAL, GLASS in 1 BOX (68083-434-25) / 10 mL in 1 VIAL, GLASS | July 1, 2020 |
| 51662-1226-1 | 51662-1226 | HF Acquisition Co LLC, DBA HealthFirst | 10 mL in 1 VIAL, SINGLE-USE (51662-1226-1) | September 14, 2018 |
| 51662-1226-3 | 51662-1226 | HF Acquisition Co LLC, DBA HealthFirst | 25 POUCH in 1 CASE (51662-1226-3) / 1 VIAL, SINGLE-USE in 1 POUCH (51662-1226-2) / 10 mL in 1 VIAL, SINGLE-USE | April 22, 2022 |
| 51662-1227-1 | 51662-1227 | HF Acquisition Co LLC, DBA HealthFirst | 2 mL in 1 VIAL, SINGLE-USE (51662-1227-1) | September 14, 2018 |
| 51662-1227-3 | 51662-1227 | HF Acquisition Co LLC, DBA HealthFirst | 25 POUCH in 1 CASE (51662-1227-3) / 1 mL in 1 POUCH (51662-1227-2) | October 27, 2020 |
| 51662-1336-1 | 51662-1336 | HF Acquisition Co LLC, DBA HealthFirst | 4 mL in 1 VIAL, SINGLE-USE (51662-1336-1) | November 26, 2018 |
| 51662-1336-3 | 51662-1336 | HF Acquisition Co LLC, DBA HealthFirst | 25 POUCH in 1 CASE (51662-1336-3) / 1 mL in 1 POUCH (51662-1336-2) | June 15, 2020 |
| 51662-1572-1 | 51662-1572 | HF Acquisition Co LLC, DBA HealthFirst | 2 mL in 1 VIAL (51662-1572-1) | June 28, 2021 |
| 51662-1572-3 | 51662-1572 | HF Acquisition Co LLC, DBA HealthFirst | 25 POUCH in 1 CASE (51662-1572-3) / 1 VIAL in 1 POUCH (51662-1572-2) / 2 mL in 1 VIAL | June 12, 2022 |
| 51662-1574-1 | 51662-1574 | HF Acquisition Co LLC, DBA HealthFirst | 4 mL in 1 VIAL (51662-1574-1) | June 28, 2021 |
| 51662-1574-3 | 51662-1574 | HF Acquisition Co LLC, DBA HealthFirst | 25 POUCH in 1 CASE (51662-1574-3) / 1 VIAL in 1 POUCH (51662-1574-2) / 4 mL in 1 VIAL | June 28, 2021 |
| 51662-1575-1 | 51662-1575 | HF Acquisition Co LLC, DBA HealthFirst | 10 mL in 1 VIAL (51662-1575-1) | June 28, 2021 |
| 0404-9862-10 | 0404-9862 | Henry Schein, Inc. | 1 VIAL, GLASS in 1 BAG (0404-9862-10) / 1 mL in 1 VIAL, GLASS | January 10, 2022 |
| 0404-9863-04 | 0404-9863 | Henry Schein, Inc. | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9863-04) / 4 mL in 1 VIAL, SINGLE-DOSE | January 10, 2022 |
| 0404-9864-02 | 0404-9864 | Henry Schein, Inc. | 1 VIAL in 1 BAG (0404-9864-02) / 2 mL in 1 VIAL | January 10, 2022 |
| 23155-473-41 | 23155-473 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 25 VIAL in 1 CARTON (23155-473-41) / 2 mL in 1 VIAL (23155-473-31) | September 2, 2014 |
| 23155-473-42 | 23155-473 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 25 VIAL in 1 CARTON (23155-473-42) / 4 mL in 1 VIAL (23155-473-32) | September 2, 2014 |
| 23155-473-43 | 23155-473 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 50 VIAL in 1 CARTON (23155-473-43) / 4 mL in 1 VIAL (23155-473-32) | September 2, 2014 |
| 23155-473-44 | 23155-473 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 25 VIAL in 1 CARTON (23155-473-44) / 10 mL in 1 VIAL (23155-473-33) | September 2, 2014 |
| 23155-473-45 | 23155-473 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 50 VIAL in 1 CARTON (23155-473-45) / 10 mL in 1 VIAL (23155-473-33) | September 2, 2014 |
| 0409-6102-02 | 0409-6102 | Hospira, Inc. | 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-6102-02) / 2 mL in 1 VIAL, SINGLE-DOSE (0409-6102-19) | February 28, 2005 |
| 0409-6102-04 | 0409-6102 | Hospira, Inc. | 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-6102-04) / 4 mL in 1 VIAL, SINGLE-DOSE (0409-6102-18) | February 28, 2005 |
| 0409-6102-10 | 0409-6102 | Hospira, Inc. | 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-6102-10) / 10 mL in 1 VIAL, SINGLE-DOSE (0409-6102-20) | March 31, 2005 |
| 0409-6102-25 | 0409-6102 | Hospira, Inc. | 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-6102-25) / 2 mL in 1 VIAL, SINGLE-DOSE (0409-6102-35) | November 19, 2013 |
| 0409-6102-26 | 0409-6102 | Hospira, Inc. | 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-6102-26) / 4 mL in 1 VIAL, SINGLE-DOSE (0409-6102-36) | November 19, 2013 |
| 0409-6102-27 | 0409-6102 | Hospira, Inc. | 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-6102-27) / 10 mL in 1 VIAL, SINGLE-DOSE (0409-6102-37) | November 19, 2013 |
| 70756-618-05 | 70756-618 | Lifestar Pharma LLC | 5 VIAL in 1 CARTON (70756-618-05) / 2 mL in 1 VIAL (70756-618-82) | December 17, 2022 |
| 70756-618-25 | 70756-618 | Lifestar Pharma LLC | 25 VIAL in 1 CARTON (70756-618-25) / 2 mL in 1 VIAL (70756-618-82) | December 17, 2022 |
| 70756-619-05 | 70756-619 | Lifestar Pharma LLC | 5 VIAL in 1 CARTON (70756-619-05) / 4 mL in 1 VIAL (70756-619-85) | December 17, 2022 |
| 70756-619-10 | 70756-619 | Lifestar Pharma LLC | 10 VIAL in 1 CARTON (70756-619-10) / 4 mL in 1 VIAL (70756-619-85) | December 17, 2022 |
| 70756-619-25 | 70756-619 | Lifestar Pharma LLC | 25 VIAL in 1 CARTON (70756-619-25) / 4 mL in 1 VIAL (70756-619-85) | December 17, 2022 |
| 70756-620-10 | 70756-620 | Lifestar Pharma LLC | 10 VIAL in 1 CARTON (70756-620-10) / 10 mL in 1 VIAL (70756-620-86) | December 17, 2022 |
| 70756-620-25 | 70756-620 | Lifestar Pharma LLC | 25 VIAL in 1 CARTON (70756-620-25) / 10 mL in 1 VIAL (70756-620-86) | December 17, 2022 |
| 71872-7059-1 | 71872-7059 | Medical Purchasing Solutions, LLC | 1 VIAL, GLASS in 1 BAG (71872-7059-1) / 2 mL in 1 VIAL, GLASS | March 2, 2018 |
| 71872-7127-1 | 71872-7127 | Medical Purchasing Solutions, LLC | 1 VIAL, GLASS in 1 BAG (71872-7127-1) / 4 mL in 1 VIAL, GLASS | March 30, 2018 |
| 71872-7236-1 | 71872-7236 | Medical Purchasing Solutions, LLC | 1 VIAL in 1 BAG (71872-7236-1) / 2 mL in 1 VIAL | December 15, 2020 |
| 71872-7295-1 | 71872-7295 | Medical Purchasing Solutions, LLC | 1 VIAL in 1 BAG (71872-7295-1) / 2 mL in 1 VIAL | July 25, 2022 |
| 71872-7308-1 | 71872-7308 | Medical Purchasing Solutions, LLC | 1 VIAL in 1 BAG (71872-7308-1) / 10 mL in 1 VIAL | August 31, 2023 |
| 71872-7314-1 | 71872-7314 | Medical Purchasing Solutions, LLC | 1 VIAL in 1 BAG (71872-7314-1) / 4 mL in 1 VIAL | October 6, 2023 |
| 71872-7380-1 | 71872-7380 | Medical Purchasing Solutions, LLC | 1 VIAL, SINGLE-DOSE in 1 BAG (71872-7380-1) / 10 mL in 1 VIAL, SINGLE-DOSE | August 11, 2026 |
| 71288-203-03 | 71288-203 | Meitheal Pharmaceuticals Inc. | 25 VIAL, SINGLE-DOSE in 1 CARTON (71288-203-03) / 2 mL in 1 VIAL, SINGLE-DOSE (71288-203-02) | January 27, 2022 |
| 71288-203-05 | 71288-203 | Meitheal Pharmaceuticals Inc. | 25 VIAL, SINGLE-DOSE in 1 CARTON (71288-203-05) / 4 mL in 1 VIAL, SINGLE-DOSE (71288-203-04) | January 27, 2022 |
| 71288-203-11 | 71288-203 | Meitheal Pharmaceuticals Inc. | 25 VIAL, SINGLE-DOSE in 1 CARTON (71288-203-11) / 10 mL in 1 VIAL, SINGLE-DOSE (71288-203-10) | January 27, 2022 |
| 71288-203-92 | 71288-203 | Meitheal Pharmaceuticals Inc. | 25 VIAL, SINGLE-DOSE in 1 CARTON (71288-203-92) / 2 mL in 1 VIAL, SINGLE-DOSE (71288-203-91) | January 27, 2022 |
| 71288-203-94 | 71288-203 | Meitheal Pharmaceuticals Inc. | 25 VIAL, SINGLE-DOSE in 1 CARTON (71288-203-94) / 10 mL in 1 VIAL, SINGLE-DOSE (71288-203-93) | January 27, 2022 |
| 72603-133-25 | 72603-133 | NorthStar Rx LLC | 25 VIAL in 1 CARTON (72603-133-25) / 2 mL in 1 VIAL (72603-133-01) | February 1, 2023 |
| 72603-251-25 | 72603-251 | NorthStar Rx LLC | 25 VIAL in 1 CARTON (72603-251-25) / 4 mL in 1 VIAL (72603-251-01) | February 1, 2023 |
| 72603-474-25 | 72603-474 | NorthStar Rx LLC | 25 VIAL in 1 CARTON (72603-474-25) / 10 mL in 1 VIAL (72603-474-01) | February 1, 2023 |
| 81565-201-02 | 81565-201 | Phlow Corporation | 25 VIAL in 1 TRAY (81565-201-02) / 2 mL in 1 VIAL (81565-201-01) | February 1, 2022 |
| 84549-251-25 | 84549-251 | ProPharma Distribution | 4 mL in 1 VIAL (84549-251-25) | August 27, 2025 |
| 84549-474-25 | 84549-474 | ProPharma Distribution | 10 mL in 1 VIAL (84549-474-25) | October 10, 2025 |
| 70518-4444-0 | 70518-4444 | REMEDYREPACK INC. | 25 VIAL, GLASS in 1 BOX (70518-4444-0) / 4 mL in 1 VIAL, GLASS (70518-4444-1) | August 15, 2025 |
| 25021-311-02 | 25021-311 | Sagent Pharmaceuticals | 25 VIAL in 1 CARTON (25021-311-02) / 2 mL in 1 VIAL | March 15, 2021 |
| 25021-311-04 | 25021-311 | Sagent Pharmaceuticals | 25 VIAL in 1 CARTON (25021-311-04) / 4 mL in 1 VIAL | March 15, 2021 |
| 25021-311-10 | 25021-311 | Sagent Pharmaceuticals | 25 VIAL in 1 CARTON (25021-311-10) / 10 mL in 1 VIAL | March 15, 2021 |
| 25021-320-02 | 25021-320 | Sagent Pharmaceuticals | 25 VIAL in 1 CARTON (25021-320-02) / 2 mL in 1 VIAL | July 15, 2025 |
| 25021-320-04 | 25021-320 | Sagent Pharmaceuticals | 25 VIAL in 1 CARTON (25021-320-04) / 4 mL in 1 VIAL | July 15, 2025 |
| 25021-320-10 | 25021-320 | Sagent Pharmaceuticals | 25 VIAL in 1 CARTON (25021-320-10) / 10 mL in 1 VIAL | July 15, 2025 |
| 83634-302 | 83634-302 | Avenacy Inc. | — | March 15, 2024 |
| 36000-063 | 36000-063 | Baxter Healthcare Corporation | — | February 6, 2014 |
| 36000-064 | 36000-064 | Baxter Healthcare Corporation | — | February 6, 2014 |
| 36000-065 | 36000-065 | Baxter Healthcare Corporation | — | February 6, 2014 |
| 36000-282 | 36000-282 | Baxter Healthcare Corporation | — | February 6, 2014 |
| 36000-283 | 36000-283 | Baxter Healthcare Corporation | — | February 6, 2014 |
| 36000-284 | 36000-284 | Baxter Healthcare Corporation | — | February 6, 2014 |
| 31722-309 | 31722-309 | Camber Pharmaceuticals, Inc. | — | December 13, 2024 |
| 31722-310 | 31722-310 | Camber Pharmaceuticals, Inc. | — | December 13, 2024 |
| 31722-311 | 31722-311 | Camber Pharmaceuticals, Inc. | — | December 13, 2024 |
| 55154-2364 | 55154-2364 | Cardinal Health 107, LLC | — | July 13, 2010 |
| 55154-2365 | 55154-2365 | Cardinal Health 107, LLC | — | February 28, 2005 |
| 55154-4452 | 55154-4452 | Cardinal Health 107, LLC | — | February 6, 2014 |
| 55154-9581 | 55154-9581 | Cardinal Health 107, LLC | — | July 12, 2000 |
| 55154-9582 | 55154-9582 | Cardinal Health 107, LLC | — | July 12, 2000 |
| 72572-190 | 72572-190 | Civica, Inc. | — | September 23, 2022 |
| 73043-022 | 73043-022 | Devatis Inc. | — | August 10, 2024 |
| 73043-023 | 73043-023 | Devatis Inc. | — | August 10, 2024 |
| 73043-024 | 73043-024 | Devatis Inc. | — | August 10, 2024 |
| 55150-322 | 55150-322 | Eugia US LLC | — | May 3, 2019 |
| 55150-323 | 55150-323 | Eugia US LLC | — | May 3, 2019 |
| 55150-324 | 55150-324 | Eugia US LLC | — | May 3, 2019 |
| 63323-280 | 63323-280 | Fresenius Kabi USA, LLC | — | July 12, 2000 |
| 68083-432 | 68083-432 | Gland Pharma Limited | — | July 1, 2020 |
| 68083-433 | 68083-433 | Gland Pharma Limited | — | July 1, 2020 |
| 68083-434 | 68083-434 | Gland Pharma Limited | — | July 1, 2020 |
| 51662-1226 | 51662-1226 | HF Acquisition Co LLC, DBA HealthFirst | — | September 14, 2018 |
| 51662-1227 | 51662-1227 | HF Acquisition Co LLC, DBA HealthFirst | — | September 14, 2018 |
| 51662-1336 | 51662-1336 | HF Acquisition Co LLC, DBA HealthFirst | — | November 26, 2018 |
| 51662-1572 | 51662-1572 | HF Acquisition Co LLC, DBA HealthFirst | — | June 28, 2021 |
| 51662-1574 | 51662-1574 | HF Acquisition Co LLC, DBA HealthFirst | — | June 28, 2021 |
| 51662-1575 | 51662-1575 | HF Acquisition Co LLC, DBA HealthFirst | — | June 28, 2021 |
| 0404-9862 | 0404-9862 | Henry Schein, Inc. | — | January 10, 2022 |
| 0404-9863 | 0404-9863 | Henry Schein, Inc. | — | January 10, 2022 |
| 0404-9864 | 0404-9864 | Henry Schein, Inc. | — | January 10, 2022 |
| 23155-473 | 23155-473 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | — | September 2, 2014 |
| 0409-6102 | 0409-6102 | Hospira, Inc. | — | November 19, 2013 |
| 70756-618 | 70756-618 | Lifestar Pharma LLC | — | December 17, 2022 |
| 70756-619 | 70756-619 | Lifestar Pharma LLC | — | December 17, 2022 |
| 70756-620 | 70756-620 | Lifestar Pharma LLC | — | December 17, 2022 |
| 71872-7059 | 71872-7059 | Medical Purchasing Solutions, LLC | — | February 6, 2014 |
| 71872-7127 | 71872-7127 | Medical Purchasing Solutions, LLC | — | February 6, 2014 |
| 71872-7236 | 71872-7236 | Medical Purchasing Solutions, LLC | — | May 3, 2019 |
| 71872-7295 | 71872-7295 | Medical Purchasing Solutions, LLC | — | September 2, 2014 |
| 71872-7308 | 71872-7308 | Medical Purchasing Solutions, LLC | — | September 2, 2014 |
| 71872-7314 | 71872-7314 | Medical Purchasing Solutions, LLC | — | September 2, 2014 |
| 71872-7380 | 71872-7380 | Medical Purchasing Solutions, LLC | — | February 28, 2005 |
| 71288-203 | 71288-203 | Meitheal Pharmaceuticals Inc. | — | January 27, 2022 |
| 72603-133 | 72603-133 | NorthStar Rx LLC | — | February 1, 2023 |
| 72603-251 | 72603-251 | NorthStar Rx LLC | — | February 1, 2023 |
| 72603-474 | 72603-474 | NorthStar Rx LLC | — | February 1, 2023 |
| 81565-201 | 81565-201 | Phlow Corporation | — | February 1, 2022 |
| 84549-251 | 84549-251 | ProPharma Distribution | — | February 1, 2023 |
| 84549-474 | 84549-474 | ProPharma Distribution | — | February 1, 2023 |
| 70518-4444 | 70518-4444 | REMEDYREPACK INC. | — | August 15, 2025 |
| 25021-311 | 25021-311 | Sagent Pharmaceuticals | — | March 15, 2021 |
| 25021-320 | 25021-320 | Sagent Pharmaceuticals | — | July 15, 2025 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Orange Book | FDA | Therapeutic equivalence codes, reference drug flags, patents, exclusivity |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
| Enforcement | FDA | Recall records |
Generated September 25, 2026 · 13 sections on this page.