Furosemide - Hospira, Inc. | Pfizer Healthcare India Private Limited

Manufacturer
Hospira, Inc. | Pfizer Healthcare India Private Limited
Effective date
2026-05-13
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
33
Source
full-release
Hydrated at
2026-05-31 22:19:45

Label at a glance#

ProductFurosemide
Active ingredientFUROSEMIDE
Label structure21 sections

Indications and uses

Furosemide Injection is indicated in adults and pediatric patients for the treatment of edema associated with heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide Injection is indicated as adjunctive therapy in acute pulmonary edema.

Dosage and administration

Inspect Furosemide Injection visually for particulate matter and discoloration before administration. Edema Individualize therapy according to patient response. The usual initial dose of furosemide is 20 mg to 40 mg given as a single-dose, injected intramuscularly or intravenously. Give the intravenous dose slowly (over 1 minute to 2 minutes). If needed, administer another dose in the same manner 2 hours later or ...

Storage and handling

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.] Protect from light. Furosemide Injection, USP is a sterile, colorless solution for injection, available as a single-dose vial that contains 10 mg/mL of furosemide, and is supplied as follows: Unit of Sale Presentations Concentration NDC 0409-6102-02 Tray of 25 amber glass single-dose vi...

Label contents#

Full prescribing information#

1 INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

1.1 Edema

SPL UNCLASSIFIED SECTION

Furosemide Injection is indicated in adults and pediatric patients for the treatment of edema associated with heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome.

1.2 Acute Pulmonary Edema

SPL UNCLASSIFIED SECTION

Furosemide Injection is indicated as adjunctive therapy in acute pulmonary edema.

2 DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

2.1 General Considerations

SPL UNCLASSIFIED SECTION

Inspect Furosemide Injection visually for particulate matter and discoloration before administration.

3 DOSAGE FORMS AND STRENGTHS

DOSAGE FORMS & STRENGTHS SECTION

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

4 CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

  • Furosemide Injection is contraindicated in patients with anuria.
  • Furosemide Injection is contraindicated in patients with a history of hypersensitivity to furosemide.

5 WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

5.1 Fluid, Electrolyte, and Metabolic Abnormalities

SPL UNCLASSIFIED SECTION

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, CO2, 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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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.

6 ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

The following adverse reactions are described elsewhere in the labeling:

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.

7 DRUG INTERACTIONS

DRUG INTERACTIONS SECTION

7.1 Effects of Furosemide on Other Drugs

SPL UNCLASSIFIED SECTION

Drug/Substance Class or NameDrug Interaction EffectRecommendations

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 postitive 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 increase in free thyroid hormones, followed by an overall decrease in total thyroid hormone levels.

Monitor the total thyroid hormone levels.

7.2 Effects of Other Drugs on Furosemide

SPL UNCLASSIFIED SECTION

Drug/Substance Class or NameDrug Interaction EffectRecommendations

Phenytoin

Interferes directly with renal action of furosemide.

Monitor diuretic effects of furosemide and adjust the dose of furosemide if needed.

Methotrexate and other drugs undergoing renal tubular secretion

May reduce the effect of furosemide. High-dose treatment of methotrexate and these other drugs may result in elevated serum levels of furosemide and may potentiate the toxicity of furosemide.

Monitor for enhanced toxicity of furosemide.

Indomethacin

Coadministration of indomethacin may reduce the natriuretic and antihypertensive effects of furosemide in some patients by inhibiting prostaglandin synthesis. Indomethacin may also affect plasma renin levels, aldosterone excretion, and renin profile evaluation.

Patients receiving both indomethacin and furosemide should be observed closely to determine if the desired diuretic and/or antihypertensive effect of furosemide is achieved.

8 USE IN SPECIFIC POPULATIONS

USE IN SPECIFIC POPULATIONS SECTION

8.1 Pregnancy

PREGNANCY SECTION

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

Clinical Considerations

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

Data

SPL UNCLASSIFIED SECTION

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

LACTATION SECTION

SPL UNCLASSIFIED SECTION

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

PEDIATRIC USE SECTION

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 precipitate nephrocalcinosis/nephrolithiasis [see Warnings and Precautions (5.2)].

8.5 Geriatric Use

GERIATRIC USE SECTION

Controlled clinical studies of furosemide did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for the 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 to this drug 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 [see Clinical Pharmacology (12.3)].

10 OVERDOSAGE

OVERDOSAGE SECTION

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 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.

11 DESCRIPTION

DESCRIPTION SECTION

Furosemide Injection contains furosemide as the active pharmaceutical ingredient. Furosemide is a loop diuretic which is an anthranilic acid derivative. Furosemide chemical name 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.

The structural formula is as follows:

Chemical StructureChemical Structure

Molecular formula: C12H11CIN2O5S

Molecular weight: 330.74

Furosemide Injection, USP 10 mg/mL is a sterile, non-pyrogenic solution, available in single-dose vials for intravenous and intramuscular injection. Each mL of Furosemide Injection contains: 10 mg of Furosemide, 7.5 mg of Sodium Chloride for isotonicity, 1.34 mg of Sodium Hydroxide, Hydrochloric Acid and Sodium Hydroxide as pH adjusters, in Water for Injection. Furosemide Injection solution pH is between 8.0 and 9.3. It contains no preservative.

12 CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

12.1 Mechanism of Action

MECHANISM OF ACTION SECTION

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.

12.2 Pharmacodynamics

PHARMACODYNAMICS SECTION

The onset of diuresis following intravenous administration is within 5 minutes and somewhat later after intramuscular administration. The peak effect occurs within the first half hour. The duration of diuretic effect is approximately 2 hours.

12.3 Pharmacokinetics

PHARMACOKINETICS SECTION

SPL UNCLASSIFIED SECTION

Distribution

Furosemide is extensively bound to plasma proteins, mainly to albumin.

Plasma concentrations ranging from 1 to 400 mcg/mL are 91 to 99% bound in healthy individuals. The unbound fraction averages 2.3 to 4.1% at therapeutic concentrations.

SPL UNCLASSIFIED SECTION

Elimination

The terminal half-life of furosemide is approximately 2 hours.

SPL UNCLASSIFIED SECTION

Metabolism

Recent evidence suggests that furosemide glucuronide is the only or at least the major biotransformation product of furosemide in man.

SPL UNCLASSIFIED SECTION

Excretion

Significantly more furosemide is excreted in urine following the intravenous injection than after the tablet or oral solution.

SPL UNCLASSIFIED SECTION

Specific Populations

Geriatric Patients

SPL UNCLASSIFIED SECTION

Furosemide binding to albumin may be reduced in elderly patients. Furosemide is predominantly excreted unchanged in the urine. The renal clearance of furosemide after intravenous administration in older healthy male subjects (60 to 70 years of age) is statistically significantly smaller than in younger healthy male subjects (20 to 35 years of age). The initial diuretic effect of furosemide in older subjects is decreased relative to younger subjects [see Use in Specific Populations (8.5)].

Pediatric Patients

SPL UNCLASSIFIED SECTION

Based on PK results obtained from 51 premature infants (23-29 weeks gestational age (GA)) receiving repeated doses up to 4 times the maximum recommended total daily dose for intravenous (IV) administration (or 8 times the maximum recommended total daily dose for enteral administration), body weight and postnatal age were found to have an impact on furosemide clearance. Median clearance (normalized by dosing weight) was observed to increase from 8.9 (range: 2.1-21.2) ml/h/kg in infants with postnatal age (PNA) <30 days to 25.3 (range: 8.3 to 44.2) ml/h/kg in infants with PNA ≥30 days. In addition, higher clearance was observed in infants with higher body weight. Bioavailability of enteral dose compared to IV dose was estimated to be around 79%.

Patients with Renal Impairment

SPL UNCLASSIFIED SECTION

One study in six subjects demonstrated that the combination of furosemide and acetylsalicylic acid temporarily reduced creatinine clearance in patients with chronic renal insufficiency. There are case reports of patients who developed increased BUN, serum creatinine and serum potassium levels, and weight gain when furosemide was used in conjunction with NSAIDs.

13 NONCLINICAL TOXICOLOGY

NONCLINICAL TOXICOLOGY SECTION

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

SPL UNCLASSIFIED SECTION

Carcinogenesis

Furosemide was tested for carcinogenicity by oral administration in one strain of mice and one strain of rats. A small but significantly increased incidence of mammary gland carcinomas occurred in female mice at a dose approximately 8 times a human i.v. dose of 80 mg based on BSA and oral bioavailability corrections. There were marginal increases in uncommon tumors in male rats at a dose of 15 mg/kg but not at 30 mg/kg.

SPL UNCLASSIFIED SECTION

Mutagenesis

Furosemide was devoid of mutagenic activity in various strains of Salmonella typhimurium when tested in the presence or absence of an in vitro metabolic activation system, and questionably positive for gene mutation in mouse lymphoma cells in the presence of rat liver S9 at the highest dose tested. Furosemide did not induce sister chromatid exchange in human cells in vitro, but other studies on chromosomal aberrations in human cells in vitro gave conflicting results. In Chinese hamster cells it induced chromosomal damage but was questionably positive for sister chromatid exchange. Studies on the induction by furosemide of chromosomal aberrations in mice were inconclusive. The urine of rats treated with this drug did not induce gene conversion in Saccharomyces cerevisiae.

SPL UNCLASSIFIED SECTION

Impairment of Fertility

Furosemide produced no impairment of fertility in male or female rats, at 100 mg/kg/day (the maximum effective diuretic dose in the rat), approximately 7 times a human i.v. dose of 80 mg based on BSA and oral bioavailability corrections.

16 HOW SUPPLIED/STORAGE AND HANDLING

HOW SUPPLIED SECTION

STORAGE AND HANDLING SECTION

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.]
Protect from light.

Furosemide Injection, USP is a sterile, colorless solution for injection, available as a single-dose vial that contains 10 mg/mL of furosemide, and is supplied as follows:

Unit of SalePresentationsConcentration

NDC 0409-6102-02

Tray of 25 amber glass single-dose vials

20 mg/2 mL
(10 mg/mL)

NDC 0409-6102-04

Tray of 25 amber glass single-dose vials

40 mg/4 mL
(10 mg/mL)

NDC 0409-6102-10

Tray of 25 amber glass single-dose vials

100 mg/10 mL
(10 mg/mL)

Discard unused portion. Do not use if solution is discolored or contains particulate.

17 PATIENT COUNSELING INFORMATION

INFORMATION FOR PATIENTS SECTION

SPL UNCLASSIFIED SECTION

Fluid, Electrolyte, and Metabolic Abnormalities

Advise patients that they may experience symptoms from excessive fluid and/or electrolyte losses. The postural hypotension that sometimes occurs can usually be managed by getting up slowly. Potassium supplements and/or dietary measures may be needed to control or avoid hypokalemia [see Warnings and Precautions (5.1)].

Advise patients that furosemide may increase blood glucose levels and thereby affect urine glucose tests [see Warnings and Precautions (5.1)].

SPL UNCLASSIFIED SECTION

Photosensitivity

The skin of some patients may be more sensitive to the effects of sunlight while taking furosemide [see Adverse Reactions (6)].

Advise hypertensive patients to avoid medications that may increase blood pressure, including over-the-counter products for appetite suppression and cold symptoms [see Drug Interactions (7.1)].

SPL UNCLASSIFIED SECTION

This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

For Medical Information about Furosemide Injection, please visit www.pfizermedicalinformation.com or call 1‑800‑438‑1985.

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Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

LAB-1025-7.0

PRINCIPAL DISPLAY PANEL - 2 mL Vial Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2 mL
NDC 0409-6102-19
Rx only

Furosemide Inj., USP

20 mg/2 mL
(10 mg/mL)

Hospira

Distributed by Hospira, Inc.
Lake Forest, IL 60045 USA

PRINCIPAL DISPLAY PANEL - 2 mL Vial Label
PRINCIPAL DISPLAY PANEL - 2 mL Vial Label

PRINCIPAL DISPLAY PANEL - 2 mL Vial Tray

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2 mL Single-Dose Vials - Discard unused portion

Rx only

NDC 0409-6102-02
Contains 25 of NDC 0409-6102-19

Furosemide Injection, USP

20 mg/2 mL (10 mg/mL)

For INTRAVENOUS or INTRAMUSCULAR use.

Hospira

PRINCIPAL DISPLAY PANEL - 2 mL Vial Tray
PRINCIPAL DISPLAY PANEL - 2 mL Vial Tray

PRINCIPAL DISPLAY PANEL - 4 mL Vial Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4 mL Single-Dose Vial

Furosemide
Injection, USP

40 mg/4 mL (10 mg/mL)

Distributed by Hospira, Inc.
Lake Forest, IL 60045 USA

Hospira

PRINCIPAL DISPLAY PANEL - 4 mL Vial Label
PRINCIPAL DISPLAY PANEL - 4 mL Vial Label

PRINCIPAL DISPLAY PANEL - 4 mL Vial Tray

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4 mL Single-Dose Vials - Discard unused portion
NDC 0409-6102-04
Contains 25 of NDC 0409-6102-18

Rx only

Furosemide Injection, USP

40 mg/4 mL (10 mg/mL)

FOR INTRAVENOUS or INTRAMUSCULAR USE.

Hospira

PRINCIPAL DISPLAY PANEL - 4 mL Vial Tray
PRINCIPAL DISPLAY PANEL - 4 mL Vial Tray

PRINCIPAL DISPLAY PANEL - 10 mL Vial Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

10 mL Single-Dose Vial

Furosemide
Injection, USP

100 mg/10 mL
(10 mg/mL)

Distributed by Hospira Inc.,
Lake Forest, IL 60045 USA

Hospira

PRINCIPAL DISPLAY PANEL - 10 mL Vial Label
PRINCIPAL DISPLAY PANEL - 10 mL Vial Label

PRINCIPAL DISPLAY PANEL - 10 mL Vial Tray

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

10 mL Single-Dose Vials - Discard unused portion

Rx only

NDC 0409-6102-10
Contains 25 of NDC 0409-6102-20

Furosemide Injection, USP

100 mg/10 mL (10 mg/mL)

For INTRAVENOUS or INTRAMUSCULAR use.

Hospira

PRINCIPAL DISPLAY PANEL - 10 mL Vial Tray
PRINCIPAL DISPLAY PANEL - 10 mL Vial Tray

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1719286furosemide 100 MG in 10 ML InjectionPSN33
1719290furosemide 20 MG in 2 ML InjectionPSN33
1719291furosemide 40 MG in 4 ML InjectionPSN33
171928610 ML furosemide 10 MG/ML InjectionSCD33
17192902 ML furosemide 10 MG/ML InjectionSCD33
17192914 ML furosemide 10 MG/ML InjectionSCD33
1719286furosemide 100 MG per 10 ML InjectionSY33
1719290furosemide 20 MG per 2 ML InjectionSY33
1719291furosemide 40 MG per 4 ML InjectionSY33

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
FUROSEMIDE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeDataBar Limited(01)00304096102199GTIN-14: 00304096102199
GTIN-12: 304096102199
UPC-A: 304096102199
EAN-13: 0304096102199
GTIN storage (14 digits): 00304096102199
furosemide-03.jpg
BarcodeDataBar Limited(01)00304096102205GTIN-14: 00304096102205
GTIN-12: 304096102205
UPC-A: 304096102205
EAN-13: 0304096102205
GTIN storage (14 digits): 00304096102205
furosemide-07.jpg
BarcodeDataBar Stacked(01)00304096102182GTIN-14: 00304096102182
GTIN-12: 304096102182
UPC-A: 304096102182
EAN-13: 0304096102182
GTIN storage (14 digits): 00304096102182
furosemide-05.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d80d3aff-3a63-4d7b-a2be-fd9388b04330Product name920250806
9061e89f-9c86-4196-b34b-886fc1673cc4Product name120140821

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-6102-02Furosemide25 in 1 TRAYINJECTION, SOLUTION2533
0409-6102-04Furosemide25 in 1 TRAYINJECTION, SOLUTION2533
0409-6102-10Furosemide25 in 1 TRAYINJECTION, SOLUTION2533
0409-6102-18Furosemide4 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION433
0409-6102-19Furosemide2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION233
0409-6102-20Furosemide10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION1033

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-6102-02ML - Milliliter0409-6102417c9737-6a24-4c24-9a3f-7fec57c8f03712012-07-24
0409-6102-04ML - Milliliter0409-6102217afd0d-7f27-4283-9a1d-b606747fd1f112012-07-24
0409-6102-10ML - Milliliter0409-61026c2bba85-6eff-4131-9b42-ee2c810966db12012-07-24
0409-6102-18ML - Milliliter0409-61022572bd0d-55a9-438d-9c6e-97a851c3e7a312016-11-08
0409-6102-19ML - Milliliter0409-610201613d0d-fa9f-425c-8c3c-8cd8da61e8da12016-11-08
0409-6102-20ML - Milliliter0409-61020a1887ed-29c3-487a-aac8-cd35e75e0a8712017-03-06
0409-6102-25ML - Milliliter0409-61027a73ea99-1411-4f9c-9f7b-28229ea52c3e12014-04-03
0409-6102-27ML - Milliliter0409-6102c706a294-295c-46e9-a970-e1d5beed013012014-04-03
0409-6102-35ML - Milliliter0409-6102e54dba2d-b1ef-4c41-b7eb-2d91dc8853b812017-07-07
0409-6102-36ML - Milliliter0409-6102f6792d6a-78e7-44fb-bfce-61126420881a12017-07-07
0409-6102-37ML - Milliliter0409-61028a809bc1-0c6d-442e-8931-e17e9f36d05412017-07-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
FUROSEMIDEACTIVE INGREDIENT7LXU5N7ZO515
FUROSEMIDEACTIVE MOIETY7LXU5N7ZO515
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CB15
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8X15
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I15
WATERINACTIVE INGREDIENT059QF0KO0R15

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0409-61020409-6102-19, 0409-6102-02, 0409-6102-18, 0409-6102-04, 0409-6102-20, 0409-6102-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 42 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRAVENOUS78 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, SOLUTION / INTRAVENOUS1037 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRAVENOUS78 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRAMUSCULAR1486 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRAMUSCULAR78 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRAMUSCULAR78 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, SOLUTION / INTRAMUSCULAR1037 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, SOLUTION / INTRAVENOUS1037 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRAVENOUS2916 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRAMUSCULAR1486 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRAMUSCULAR78 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, SOLUTION / INTRAMUSCULAR1037 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRAVENOUS78 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRAVENOUS78 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRAVENOUS78 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRAMUSCULAR1486 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRAMUSCULAR78 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, SOLUTION / INTRAVENOUS1037 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRAMUSCULAR1486 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, SOLUTION / INTRAMUSCULAR1037 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, SOLUTION / INTRAVENOUS1037 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, SOLUTION / INTRAVENOUS1037 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, SOLUTION / INTRAMUSCULAR1037 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRAVENOUS2916 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRAVENOUS2916 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRAVENOUS2916 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, SOLUTION / INTRAVENOUS1037 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, SOLUTION / INTRAVENOUS1037 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRAMUSCULAR1486 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRAMUSCULAR78 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRAVENOUS78 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRAVENOUS2916 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRAMUSCULAR78 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, SOLUTION / INTRAMUSCULAR1037 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, SOLUTION / INTRAMUSCULAR1037 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRAVENOUS2916 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRAMUSCULAR1486 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, SOLUTION / INTRAMUSCULAR1037 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRAVENOUS2916 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRAMUSCULAR78 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRAVENOUS78 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRAMUSCULAR1486 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018667-001FUROSEMIDEFUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N018667-001AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-2884e616aacf4f…
2026-08-18 06:07:402026-07N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-2887673890dc5c…
2021-03-12 10:30 UTC2021-03N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-283f01610625f2…
2019-09-15 20:21 UTC2019-09N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-28b00525d2431f…
2019-07-19 19:46 UTC2019-07N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-283f0d92c62455…
2023-05-13 08:27 UTC2023-05N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-28053a50430f4f…
2023-01-26 05:58 UTC2023-01N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018667-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1982-05-28f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N018667-001AP184e616aacf4f…
2026-08-18 06:07:402026-07N018667-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018667-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018667-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N018667-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018667-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018667-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018667-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018667-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018667-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018667-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018667-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018667-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018667-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018667-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018667-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018667-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018667-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018667-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018667-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018667-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018667-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018667-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03N018667-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018667-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018667-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018667-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09N018667-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07N018667-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018667-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018667-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018667-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018667-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018667-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018667-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018667-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05N018667-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01N018667-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018667-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018667-001AP1f41ea6bd6efb…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FurosemideFUROSEMIDEHospira, Inc.39fd32f2-6bb7-4a65-d298-e48d26bc80c72026-05-13Warnings, Adverse reactionsExact identifier
ndc (package): 0409-6102-10
ndc (package): 0409-6102-18
ndc (package): 0409-6102-02
ndc (package): 0409-6102-20
ndc (package): 0409-6102-19
ndc (package): 0409-6102-04
ndc (product): 0409-6102
ndc11 (package): 00409610204
ndc11 (package): 00409610218
ndc11 (package): 00409610220
ndc11 (package): 00409610210
ndc11 (package): 00409610202
ndc11 (package): 00409610219
spl id: 981d5143-60cd-4987-9b47-dec24c10de42
spl set id: 39fd32f2-6bb7-4a65-d298-e48d26bc80c7
FUROSEMIDEFUROSEMIDEHospira, Inc.aaced7a8-c3d7-4d66-8c07-aa407b8b3f352026-05-13Warnings, Adverse reactionsExact identifier
ndc (product): 0409-6102

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.