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FUROSEMIDE 10 mg/mL Injection, Solution, 1 vial — NDC 0404-9862-10 (Billing 00404-9862-10)

by Henry Schein, Inc. · 1 VIAL, GLASS in 1 BAG / 1 mL in 1 VIAL, GLASS

This is a package of 1 vial of FUROSEMIDE 10 mg/mL Injection, Solution from Henry Schein, Inc., marketed since Jan 2022 and currently FDA-listed. It is this product's only package size.

NDC 00404-9862-10
🏷️ FDA NDC (as labeled) 0404-9862-10 billing pads the labeler segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Furosemide (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 20, 2026 — CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit. (Leading Pharma, LLC) · FDA recall D-0486-2026
Class II · Jan 10, 2026 — Presence of Foreign Substance (Graviti Pharmaceuticals Private Limited) · FDA recall D-0293-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0404-9862-10
Product NDC 0404-9862
11-digit billing NDC 00404986210
RxCUI 1719286
UNII 7LXU5N7ZO5
Application # ANDA202747
SPL Set ID a9853417-0442-4f53-9543-e0749bc3c80d
Established class (EPC) Loop Diuretic
Physiologic effect Increased Diuresis at Loop of Henle
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-01-10
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance FUROSEMIDE
TE code (Orange Book) AP · RLD · RS
Quick answers
  • RxCUI (RxNorm): 1719286
Why two NDCs? The FDA registers this code as 0404-9862-10 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00404-9862-10. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Loop Diuretic class.

Pharmacologic class Loop Diuretic
Drug family (ATC) Sulfonamides, plain
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📗 Our plain-language guide HelloPharmacist
  • It helps your body get rid of extra fluid. It is used for swelling from heart failure, liver cirrhosis and kidney disease. In adults, oral forms can also treat high blood pressure.
  • Tablets and oral solution are swallowed, usually once or twice a day, or on certain days of the week if your doctor says so. Injected forms are for short-term use and are switched...
  • Dizziness, stomach upset, headache and more frequent urination can happen. Call your doctor right away for ringing in the ears, hearing loss, fainting, severe weakness, little urin...
  • What side effects are normal, and what should I call about?
📖 Read our full Furosemide guide →
9
Nutrient depletion considerations

Furosemide may be associated with lower levels of 9 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Furosemide nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.3524 $0.35 / 1 ml
Medicare Part B allowsASP · J1938 $0.018 / J1938 unit —
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Billing & reimbursement

FDA NDC (as labeled)0404-9862-10
11-digit billing NDC00404-9862-10
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ1938
Descriptor1 MG
Billing units / pkg100 units
How the units are derivedThis package is 10; the HCPCS unit is 1 MG, so one package = 100 billing units.
Medicare Part B spend (2026 (Q1))$4,213 · 5,781 claims · $0.73 per claim (all NDCs under J1938)
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00404-9862-10 You're viewing this Main listing 1 VIAL, GLASS in 1 BAG / 1 mL in 1 VIAL, GLASS 2022-01-10 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Furosemide 10 mg/mL 00143-9157-10 Hikma 10 vials $0.253 AP Availability likely —
Furosemide 10 mg/mL 72572-0190-25 Civica, 25 vials $0.253 AP Availability likely —
Furosemide 10 mg/mL 31722-0310-32 Camber 25 vials $0.253 AP Availability likely —
Furosemide 10 mg/mL 72603-0251-25 NorthStar 25 vials $0.253 AP Availability likely —
Furosemide 10 mg/mL 36000-0283-25 Baxter 25 vials $0.253 AP Availability likely —
Furosemide 10 mg/mL 73043-0023-01 Devatis 25 vials $0.253 AP Availability likely —
Furosemide 10 mg/mL 16729-0502-43 Accord 10 vials $0.342 AP Availability likely —
Furosemide 10 mg/mL 00409-6102-02 Hospira, 25 vials $0.490 AP Availability likely —
Furosemide 10 mg/mL 23155-0473-41 Heritage 25 vials $0.490 AP Availability likely —
Furosemide 10 mg/mL 25021-0311-02 Sagent 25 vials $0.490 AP Availability likely —
Furosemide 10 mg/mL 25021-0320-02 Sagent 25 vials $0.490 AP Availability likely —
Furosemide 10 mg/mL 63323-0280-02 Fresenius 25 vials $0.490 AP Availability likely —
Furosemide 10 mg/mL 71288-0203-03 Meitheal 25 vials $0.490 AP Availability likely —
Furosemide 10 mg/mL 83634-0302-02 Avenacy 25 vials $0.490 AP Availability likely —
Furosemide 10 mg/mL 72603-0133-25 NorthStar 25 vials $0.490 AP Availability likely —
Furosemide 10 mg/mL 36000-0282-25 Baxter 25 vials $0.490 AP Availability likely —
Furosemide 10 mg/mL 31722-0309-32 Camber 25 vials $0.490 AP Availability likely —
Furosemide 10 mg/mL 73043-0022-01 Devatis 25 vials $0.490 AP Availability likely —
Furosemide 10 mg/mLthis 00404-9862-10 Henry 1 vial — AP FDA listed —
Furosemide 10 mg/mL 31722-0311-31 Camber 25 vials — AP FDA listed —
Furosemide 10 mg/mL 36000-0065-05 Baxter 5 vials — AP FDA listed —
Furosemide 10 mg/mL 36000-0284-25 Baxter 25 vials — AP FDA listed —
Furosemide 100 mg/10mL 42571-0438-85 Micro 25 vials — AP FDA listed —
Furosemide 10 mg/mL 51662-1226-01 HF 10 ml — AP FDA listed —
Furosemide 10 mg/mL 51662-1575-01 HF 10 ml — AP FDA listed —
Furosemide 100 mg/10mL 55150-0324-25 Eugia 25 vials — AP FDA listed —
Furosemide 10 mg/mL 68083-0434-05 Gland 5 vials — AP FDA listed —
Furosemide 100 mg/10mL 70121-1076-05 Amneal 25 vials — — Discontinued —
Furosemide 10 mg/mL 70756-0620-10 Lifestar 10 vials — AP FDA listed —
Furosemide 10 mg/mL 71872-7308-01 Medical 1 vial — AP FDA listed —
Furosemide 10 mg/mL 71872-7350-01 Medical 1 vial — AP FDA listed —
Furosemide 10 mg/mL 72603-0474-25 NorthStar 25 vials — AP FDA listed —
Furosemide 10 mg/mL 73043-0024-01 Devatis 25 vials — AP FDA listed —
Furosemide 10 mg/mL 73542-0103-25 Maiva 25 vials — AP FDA listed —
Furosemide 10 mg/mL 84549-0474-25 ProPharma 10 ml — AP FDA listed —
Furosemide 10 mg/mL 70756-0618-05 Lifestar 5 vials — AP FDA listed —
Furosemide 10 mg/mL 70756-0619-05 Lifestar 5 vials — AP FDA listed —
Furosemide 10 mg/mL 71872-7059-01 Medical 1 vial — AP FDA listed —
Furosemide 10 mg/mL 71872-7127-01 Medical 1 vial — AP FDA listed —
Furosemide 10 mg/mL 71872-7295-01 Medical 1 vial — AP FDA listed —
Furosemide 10 mg/mL 71872-7314-01 Medical 1 vial — AP FDA listed —
Furosemide 10 mg/mL 84549-0251-25 ProPharma 4 ml — AP FDA listed —
Furosemide 10 mg/mL 36000-0064-05 Baxter 5 vials — AP FDA listed —
Furosemide 10 mg/mL 36000-0063-05 Baxter 5 vials — AP FDA listed —
Furosemide 10 mg/mL 70518-4444-00 REMEDYREPACK 25 vials — AP FDA listed —
Furosemide 10 mg/mL 00404-9863-04 Henry 1 vial — AP FDA listed —
Furosemide 10 mg/mL 73542-0102-25 Maiva 25 vials — AP FDA listed —
Furosemide 10 mg/mL 55154-4452-05 Cardinal 5 vials — AP FDA listed —
Furosemide 10 mg/mL 73542-0101-25 Maiva 25 vials — AP FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2022
On the market since
Jan 2022
📍
2026
Currently FDA-listed
4 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerHenry Schein, Inc.
Application holderBAXTER HEALTHCARE CORP
FDA applicationANDA202747 (ANDA)
Labeler code00404
First marketedJan 2022
Product typeHuman Prescription Drug
Portfolio172 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 47 words ▾

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 131 words ▾

INDICATIONS AND USAGE Parenteral therapy should be reserved for patients unable to take oral medication or for patients in emergency clinical situations. Edema : Furosemide 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 is particularly useful when an agent with greater diuretic potential is desired.

Furosemide is indicated as adjunctive therapy in acute pulmonary edema. The intravenous administration of furosemide 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 is indicated by the intravenous or intramuscular route.

Parenteral use should be replaced with oral furosemide as soon as practical.

⏱️ Dosage and Administration ~2 min read ▾

DOSAGE AND ADMINISTRATION Adults : Parenteral therapy with Furosemide Injection 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 (5%) Injection 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 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.

⛔ Contraindications 18 words ▾

CONTRAINDICATIONS Furosemide is contraindicated in patients with anuria and in patients with a history of hypersensitivity to furosemide.

⚠️ Warnings ~1 min read ▾

WARNINGS 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 161 words ▾

ADVERSE REACTIONS Adverse reactions are categorized below by organ system and listed by decreasing severity. Gastrointestinal System Reactions 1.Hepatic encephalopathy in patients with hepatocellular insufficiency 2.Pancreatitis 3.Jaundice (intrahepatic cholestatic jaundice) 4.Increased liver enzymes 5.Anorexia 6.Oral and gastric irritation 7.Cramping 8.Diarrhea 9.Constipation 10.Nausea 11.Vomiting Systemic Hypersensitivity Reactions 1.Severe anaphylactic or anaphylactoid reactions (e.g. with shock) 2.Systemic vasculitis 3.Interstitial nephritis 4.Necrotizing angiitis Central Nervous System Reactions 1.Tinnitus and hearing loss 2.Paresthesias 3.Vertigo 4.Dizziness 5.Headache 6.Blurred vision 7.Xanthopsia Hematologic Reactions 1.Aplastic anemia 2.Thrombocytopenia 3.Agranulocytosis 4.Hemolytic anemia 5.Leukopenia 6.Anemia 7.Eosinophilia Dermatologic-Hypersensitivity Reactions 1.Exfoliative dermatitis 2.Bullous pemphigoid 3.Erythema multiforme 4.Purpura 5.Photosensitivity 6.Urticaria 7.Rash 8.Pruritus 9.Stevens-Johnson Syndrome 10.Toxic epidermal necrolysis Cardiovascular Reaction 1.Orthostatic hypotension may occur and be aggravated by alcohol, barbiturates or narcotics.

2.Increase in cholesterol and triglyceride serum levels. Other Reactions 1.Hyperglycemia 2.Glycosuria 3.Hyperuricemia 4.Muscle spasm 5.Weakness 6.Restlessness 7.Urinary bladder spasm 8.Thrombophlebitis 9.Transient injection site pain following intramuscular injection 10.Fever Whenever adverse reactions are moderate or severe, furosemide dosage should be reduced or therapy withdrawn.

🆘 Overdosage ~1 min read ▾

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.

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.

🧬 Clinical Pharmacology ~2 min read ▾

CLINICAL PHARMACOLOGY Investigations into the mode of action of furosemide have utilized micropuncture studies is rats, stop flow experiments in dogs and various clearance studies in both humans and experimental animals. It has been demonstrated that 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. Recent evidence suggests that furosemide glucuronide is the only or at least the major biotransformation product of furosemide in man. Furosemide is extensively bound to plasma proteins, mainly to albumin.

Plasma concentrations ranging from 1 to 400 μg/mL are 91 to 99% bound in healthy individuals. The unbound fraction averages 2.3 to 4.1% at therapeutic concentrations. 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. In fasted normal men, the mean bioavailability of furosemide from furosemide tablets and furosemide oral solution is 64 % and 60%, respectively, of that from an intravenous injection of the drug.

Although furosemide is more rapidly absorbed from the oral solution (50 minutes) than from the tablet (87 minutes), peak plasma levels and area under the plasma concentration-time curves do not differ significantly. Peak plasma concentrations increase with increasing dose but times-to-peak do not differ among doses. The terminal half-life of furosemide is approximately 2 hours.

Significantly more furosemide is excreted in urine following the intravenous injection than after the tablet or oral solution. There are no significant differences between the two oral formulations in the amount of unchanged drug excreted in urine. Geriatric Population 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 (60-70 years of age) is statistically significantly smaller than in younger healthy male subjects (20-35 years of age). The intial diuretic effect of furosemide in older subjects is decreased relative to younger subjects.

(See PRECAUTIONS: Geriatric Use .)

📦 How Supplied / Storage and Handling 156 words ▾

HOW SUPPLIED Furosemide Injection, USP (10 mg/mL) 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. Baxter Manufactured for: Baxter Healthcare Corporation Deerfield, IL 60015 USA Manufactured by: Baxter Pharmaceuticals India Private Ltd Ahmedabad 382213, India Issue date: 2018-10-27 1400007271 Product repackaged by: Henry Schein, Inc., Bastian, VA 24314 From Original Manufacturer/Distributor's NDC and Unit of Sale To Henry Schein Repackaged Product NDC and Unit of Sale Total Strength/Total Volume (Concentration) per unit NDC 36000-284-25 10 mL single dose amber colored vials Boxes of 25 NDC 0404-9862-10 1 10 mL single dose vial in a bag (Vial bears NDC 36000-284-25) 10 mg/mL NDC 36000-283-25 4 mL single dose amber colored vials Boxes of 25 NDC 0404-9863-04 1 4 mL single dose vial in a bag (Vial bears NDC 36000-283-25) 10 mg/mL Image1.jpg

📋 Description 97 words ▾

DESCRIPTION Furosemide is a diuretic which is an anthranilic acid derivative. Chemically, it is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide Injection 10 mg/mL is a sterile, non-pyrogenic solution in vials for intravenous and intramuscular injection.

Furosemide is a white to off-white odorless 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: Each mL contains: Furosemide 10 mg, Water for Injection q.s., Sodium Chloride for isotonicity, Sodium Hydroxide and, if necessary, Hydrochloric Acid to adjust pH between 8.0 and 9.3.

Formula1.jpg

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General : Excessive diuresis may cause dehydration and blood volume reduction with circulatory collapse and possibly vascular thrombosis and embolism, particularly in elderly patients. As with any effective diuretic, electrolyte depletion may occur during furosemide therapy, especially in patients receiving higher doses and a restricted salt intake. Hypokalemia may develop with furosemide, especially with brisk diuresis, inadequate oral electrolyte intake, when cirrhosis is present, or during concomitant use of corticosteroids, ACTH, licorice in large amounts, or prolonged use of laxatives.

Digitalis therapy may exaggerate metabolic effects of hypokalemia, especially myocardial effects. All patients receiving furosemide therapy should be observed for these signs or symptoms of fluid or electrolyte imbalance (hyponatremia, hypochloremic alkalosis, hypokalemia, hypomagnesemia or hypocalcemia): dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia, arrhythmia or gastrointestinal disturbances such as nausea and vomiting.

Increases in blood glucose and alterations in glucose tolerance tests (with abnormalities of the fasting and 2-hour postprandial sugar) have been observed, and rarely, precipitation of diabetes mellitus has been reported. 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.

In patients at high risk for radiocontrast nephropathy, furosemide can lead to a higher incidence of deterioration in renal function after receiving radiocontrast compared to high-risk patients who received only intravenous hydration prior to receiving radiocontrast. In patients with hypoproteinemia (e.g., associated with nephrotic syndrome) the effect of furosemide may be weakened and its ototoxicity potentiated. Asymptomatic hyperuricemia can occur and gout may rarely be precipitated.

Patients allergic to sulfonamides may also be allergic to furosemide. The possibility exists of exacerbation or activation of systemic lupus erythematosus. As with many other drugs, patients should be observed regularly for the possible occurrence of blood dyscrasias, liver or kidney damage, or other idiosyncratic reactions.

Information for Patients : Patients receiving furosemide should be advised 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.

Patients with diabetes mellitus should be told that furosemide may increase blood glucose levels and thereby affect urine glucose tests. The skin of some patients may be more sensitive to the effects of sunlight while taking furosemide. Hypertensive patients should avoid medications that may increase blood pressure, including over-the-counter products for appetite suppression and cold symptoms.

Laboratory Tests : Serum electrolytes, (particularly potassium), CO 2 , creatinine and BUN should be determined frequently during the first few months of furosemide therapy and periodically thereafter. Serum and urine electrolyte determinations are particularly important when the patient is vomiting profusely or receiving parenteral fluids. Abnormalities should be corrected or the drug temporarily withdrawn.

Other medications may also influence serum electrolytes. Reversible elevations of BUN may occur and are associated with dehydration, which should be avoided, particularly in patients with renal insufficiency. Urine and blood glucose should be checked periodically in diabetics receiving furosemide, even in… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 4 words ▾

SAMPLE PACKAGE LABEL Label1.jpg

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Furosemide — the program that covers self-administered drugs. 22 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Furosemide. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$31.03M
Claims incl. refills
5.6M
Beneficiaries
3.6M
Spend / beneficiary
$8.60
Spend / claim
$5.52
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Henry Schein, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Henry Schein, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J1938 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 00404-9860-05 · Henry 00404-9863-04 · Henry →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.