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FUROSEMIDE 20 mg Tablet, 30-count — NDC 51655-0269-52 package photo

FUROSEMIDE 20 mg Tablet, 30-count

by Northwind Health Company, LLC · 30 TABLET in 1 BOTTLE, PLASTIC (51655-269-52)
NDC 51655-0269-52
🏷️ FDA NDC (as labeled) 51655-269-52 billing pads the product segment with a zero
This package
Contains30-count Pack sizes4 compare ↓
Also priced by: Part D plans $0.1154/unit — full pricing hub ↓
Also comes in: 10 tablets 51655-0269-53 60 tablets 51655-0269-25 90 tablets 51655-0269-26
Rx only Generic On market Non-controlled
🗂️ Data synced 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

FDA NDC (as labeled) 51655-269-52
Product NDC 51655-269
11-digit billing NDC 51655026952
RxCUI 310429, 313988
UNII 7LXU5N7ZO5
Application # ANDA077293
SPL Set ID 1d99e151-75ba-6a75-e063-6294a90a4360
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 2022-08-08
Route ORAL
Dosage form TABLET
Substance FUROSEMIDE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 51655-269-52 — a 5-3-2 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 product segment → 51655-0269-52. 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.

🏭 Manufacturer & labeler

LabelerNorthwind Health Company, LLC
Application holderLEADING PHARMA LLC
FDA applicationANDA077293 (ANDA)
Labeler code51655
First marketedAug 2022
Product typeHuman Prescription Drug
Portfolio578 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.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • Furosemide is a strong 'water pill' that tells your kidneys to flush out excess sodium and water through your urine. If your legs are swollen or you're short of breath from fluid b...
  • Why did my doctor prescribe furosemide — what is it actually doing for me?
  • Yes, that's exactly what furosemide is supposed to do. The whole point is to increase urine output so your body can shed excess fluid. Many people notice it kicks in within an hour...
  • I'm going to the bathroom a lot more — is that normal?
📖 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.

💊 What it looks like

Color white
ShapeRound
ImprintEP;116
Size5 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3SY5LH9PMK
    Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.

6 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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.

💲 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 eachPer 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 $0.1154 $3.46 / 30 tablets
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Furosemide 20 mg 00054-4297-25 Hikma 100 tablets $0.027 AB Availability likely —
Furosemide 20 mg 00054-8297-25 Hikma 100 tablets $0.027 AB Availability likely —
Furosemide 20 mg 00904-7177-61 Major 100 tablets $0.027 AB Availability likely —
Furosemide 20 mg 43547-0401-10 Solco 100 tablets $0.027 AB Availability likely —
Furosemide 20 mg 62135-0753-90 Chartwell 90 tablets $0.027 — Availability likely —
Furosemide 20 mg 64980-0562-01 Rising 100 tablets $0.027 AB Availability likely —
Furosemide 20 mg 69315-0116-01 Leading 100 tablets $0.027 AB Availability likely —
Furosemide 20 mg 83980-0002-01 Ipca 100 tablets $0.027 AB Availability likely —
Lasix 20 mg 30698-0067-01 Validus 100 tablets $0.749 — Availability likely —
Furosemide 20 mg 00615-8368-05 NCS 15 tablets — AB FDA listed —
Furosemide 20 mg 10135-0832-01 Marlex 100 tablets — AB FDA listed —
Furosemide 20 mg 17224-0178-21 Calvin 21 tablets — AB FDA listed —
Furosemide 20 mg 42291-0468-01 AvKARE 100 tablets — AB FDA listed —
Furosemide 20 mg 43063-0702-21 PD-Rx 21 tablets — AB FDA listed —
Furosemide 20 mg 43063-0849-21 PD-Rx 21 tablets — AB FDA listed —
Furosemide 20 mg 43353-0747-30 Aphena 30 tablets — AB FDA listed —
Furosemide 20 mg 50090-5429-00 A-S 30 tablets — AB FDA listed —
Furosemide 20 mg 50090-6219-00 A-S 30 tablets — AB FDA listed —
Furosemide 20 mg 50090-6642-00 A-S 30 tablets — AB FDA listed —
Furosemide 20 mg 50090-6942-00 A-S 90 tablets — AB FDA listed —
Furosemide 20 mg 50090-7706-00 A-S 30 tablets — AB FDA listed —
Furosemide 20 mg 50090-7708-00 A-S 90 tablets — AB FDA listed —
Furosemide 20 mgthis 51655-0269-52 Northwind 30 tablets — AB FDA listed —
Furosemide 20 mg 51655-0310-53 Northwind 10 tablets — AB FDA listed —
Furosemide 20 mg 51655-0481-52 Northwind 30 tablets — AB FDA listed —
Furosemide 20 mg 55154-2349-00 Cardinal 10 tablets — AB FDA listed —
Furosemide 20 mg 59651-0796-91 Aurobindo 100000 tablets — AB FDA listed —
Furosemide 20 mg 61919-0242-30 DIRECT 30 tablets — AB FDA listed —
Furosemide 20 mg 63187-0517-30 Proficient 30 tablets — AB FDA listed —
Furosemide 20 mg 63187-0739-10 Proficient 10 tablets — AB FDA listed —
Furosemide 20 mg 63561-0164-01 Granulation 100 tablets — AB FDA listed —
Furosemide 20 mg 63629-1214-01 Bryant 1000 tablets — AB FDA listed —
Furosemide 20 mg 63629-1215-01 Bryant 100 tablets — AB FDA listed —
Furosemide 20 mg 67046-0768-03 Coupler 30 tablets — AB FDA listed —
Furosemide 20 mg 67046-1589-03 Coupler 30 tablets — AB FDA listed —
Furosemide 20 mg 67296-2136-01 Redpharm 3 tablets — AB FDA listed —
Furosemide 20 mg 68071-1708-01 NuCare 100 tablets — AB FDA listed —
Furosemide 20 mg 68071-3673-03 NuCare 30 tablets — AB FDA listed —
Furosemide 20 mg 68071-4534-01 NuCare 100 tablets — AB FDA listed —
Furosemide 20 mg 68788-6948-01 Preferred 100 tablets — AB FDA listed —
Furosemide 20 mg 68788-8870-01 Prefferred 100 tablets — AB FDA listed —
Furosemide 20 mg 70518-0050-00 REMEDYREPACK 30 tablets — AB FDA listed —
Furosemide 20 mg 70518-2528-01 REMEDYREPACK 30 tablets — AB FDA listed —
Furosemide 20 mg 70518-3061-00 REMEDYREPACK 5 tablets — AB Discontinued —
Furosemide 20 mg 70518-3757-00 REMEDYREPACK 30 tablets — AB FDA listed —
Furosemide 20 mg 70518-4679-00 REMEDYREPACK 30 tablets — AB FDA listed —
Furosemide 20 mg 71335-0384-01 Bryant 30 tablets — AB Discontinued —
Furosemide 20 mg 71335-0852-01 Bryant 30 tablets — AB FDA listed —
Furosemide 20 mg 71335-2319-01 Bryant 30 tablets — AB FDA listed —
Furosemide 20 mg 71610-0096-30 Aphena 30 tablets — AB FDA listed —
Furosemide 20 mg 71610-0635-30 Aphena 30 tablets — AB FDA listed —
Furosemide 20 mg 71610-0843-30 Aphena 30 tablets — AB FDA listed —
Furosemide 20 mg 72162-1360-00 Bryant 1000 tablets — AB FDA listed —
Furosemide 20 mg 72789-0030-30 PD-Rx 30 tablets — AB FDA listed —
Furosemide 20 mg 82868-0050-30 Northwind 30 tablets — AB FDA listed —
Furosemide 20 mg 87441-0033-01 Unit 30 tablets — AB 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
Aug 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.

📊 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
51655-0269-25 60 TABLET in 1 BOTTLE, PLASTIC (51655-269-25) 2023-02-09 Active
51655-0269-26 90 TABLET in 1 BOTTLE, PLASTIC (51655-269-26) 2022-09-06 Active
51655-0269-52 You're viewing this 30 TABLET in 1 BOTTLE, PLASTIC (51655-269-52) 2022-08-08 Active
51655-0269-53 10 TABLET in 1 BOTTLE, PLASTIC (51655-269-53) 2023-02-09 Active

You're viewing one of 4 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 51655-0269-52?
NDC 51655-0269-52 is a 30-count package — 30 tablet in 1 bottle, plastic.
What is the difference between NDC 51655-0269-52 and NDC 51655-0269-53?
Both are FUROSEMIDE 20 mg Tablet — the drug itself is identical. NDC 51655-0269-52 is the 30-count package, while NDC 51655-0269-53 is the 10 tablets package.
What NDC number is used to bill for this package of FUROSEMIDE 20 mg Tablet?
Bill NDC 51655-0269-52 — the 11-digit billing format is 51655026952. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 ✓ Available
Inactive ingredients (structured) ✓ 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 — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
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 FDA registers it as 51655-269-52, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 51655-0269-52, written without dashes as 51655026952. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 51655-0269-52, the first segment (51655) is the labeler code FDA assigned to Northwind Health Company, LLC; the middle segment (0269) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (52) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Northwind Health Company, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 10 tablets (51655-0269-53), 60 tablets (51655-0269-25), 90 tablets (51655-0269-26). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Northwind Health Company, LLC 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.
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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 90 words ▾

INDICATIONS AND USAGE Edema Furosemide tablets are 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 tablets are particularly useful when an agent with greater diuretic potential is desired. Hypertension Oral Furosemide tablets may be used in adults for the treatment of hypertension alone or in combination with other antihypertensive agents.

Hypertensive patients who cannot be adequately controlled with thiazides will probably also not be adequately controlled with Furosemide tablets alone.

⏱️ Dosage and Administration ~2 min read ▾

DOSAGE AND ADMINISTRATION Edema Therapy should be individualized according to patient response to gain maximal therapeutic response and to determine the minimal dose needed to maintain that response. Adults The usual initial dose of Furosemide tablets is 20 to 80 mg given as a single dose. Ordinarily a prompt diuresis ensues.

If needed, the same dose can be administered 6 to 8 hours later or the dose may be increased. The dose may be raised by 20 or 40 mg and given not sooner than 6 to 8 hours after the previous dose until the desired diuretic effect has been obtained. The individually determined single dose should then be given once or twice daily (eg, at 8 am and 2 pm).

The dose of Furosemide tablets may be carefully titrated up to 600 mg/day in patients with clinically severe edematous states. Edema may be most efficiently and safely mobilized by giving Furosemide tablets on 2 to 4 consecutive days each week. When doses exceeding 80 mg/day are given for prolonged periods, careful clinical observation and laboratory monitoring are particularly advisable.

(See PRECAUTIONS: LABORATORY TESTS ) 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 The usual initial dose of oral Furosemide tablets in pediatric patients is 2 mg/kg body weight, given as a single dose. If the diuretic response is not satisfactory after the initial dose, dosage may be increased by 1 or 2 mg/kg no sooner than 6 to 8 hours after the previous dose.

Doses greater than 6 mg/kg body weight are not recommended. For maintenance therapy in pediatric patients, the dose should be adjusted to the minimum effective level. Hypertension Therapy should be individualized according to the patient's response to gain maximal therapeutic response and to determine the minimal dose needed to maintain the therapeutic response.

Adults The usual initial dose of Furosemide tablets for hypertension is 80 mg, usually divided into 40 mg twice a day. Dosage should then be adjusted according to response. If response is not satisfactory, add other antihypertensive agents.

Changes in blood pressure must be carefully monitored when Furosemide tablets are used with other antihypertensive drugs, especially during initial therapy. To prevent excessive drop in blood pressure, the dosage of other agents should be reduced by at least 50% when Furosemide tablets are added to the regimen. As the blood pressure falls under the potentiating effect of Furosemide tablets, a further reduction in dosage or even discontinuation of other antihypertensive drugs may be necessary.

Geriatric patients In general, dose selection and dose adjustment for the elderly patient should be cautious, usually starting at the low end of the dosing range (see PRECAUTIONS: GERIATRIC USE ).

⛔ Contraindications 19 words ▾

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

⚠️ Warnings 182 words ▾

WARNINGS In patients with hepatic cirrhosis and ascites, Furosemide tablets 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 tablets should be discontinued. Cases of tinnitus and reversible or irreversible hearing impairment and deafness have been reported.

Reports usually indicate that Furosemide tablets 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 tablets per minute has been used). (See PRECAUTIONS: DRUG INTERACTIONS )

🤒 Adverse Reactions 191 words ▾

ADVERSE REACTIONS Adverse reactions are categorized below by organ system and listed by decreasing severity. Gastrointestinal System Reactions hepatic encephalopathy in patients with hepato-cellular insufficiency 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 pruritis urticaria Cardiovascular Reaction Orthostatic hypotension may occur and be aggravated by alcohol, barbiturates or narcotics.

Increase in cholesterol and triglyceride serum levels Other Reactions hyperglycemia glycosuria hyperuricemia muscle spasm weakness restlessness urinary bladder spasm thrombophlebitis fever Whenever adverse reactions are moderate or severe, Furosemide tablets dosage should be reduced or therapy withdrawn. CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO THE FDA AT 1-800-FDA-1088 OR LEADING PHARMA, LLC AT 1-844-740-7500.

🆘 Overdosage 144 words ▾

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 LD50 exceeded 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 tablets 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 tablets have utilized micropuncture studies in rats, stop flow experiments in dogs and various clearance studies in both humans and experimental animals. It has been demonstrated that Furosemide tablets inhibits primarily the absorption 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 the 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 oral administration is within 1 hour.

The peak effect occurs within the first or second hour. The duration of diuretic effect is 6 to 8 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 IV 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 initial diuretic effect of furosemide in older subjects is decreased relative to younger subjects.

(See PRECAUTIONS: GERIATRIC USE .)

📦 How Supplied / Storage and Handling 146 words ▾

HOW SUPPLIED Furosemide tablets 20 mg are supplied as white to off-white, round, flat face beveled edge, compressed tablets, debossed "EP" and "116" on one side and plain on the other side in bottles of 10 (NDC 51655-269-53), 30 (NDC 51655-269-52), 60 (NDC 51655-269-25) and 90 (NDC 51655-269-26). Furosemide tables 40 mg are supplied as white to off-white, round, flat face beveled edge, bisected compressed tablets, debossed "EP" above bisect and "117" below bisect on one side, and "40" on the other side in bottles of 30 (NDC 51655-517-52) and 90 (NDC 51655-517-26).

Note: Dispense in well-closed, light-resistant containers. Exposure to light might cause a slight discoloration. Discolored tablets should not be dispensed.

Meets USP Dissolution Test 2 Store at 20° -25° C (68° -77° F) [ See USP Controlled Room Temperature]. Protect from light. Manufactured by: Leading Pharma, LLC Fairfield, NJ 07004 Rev.

09 10/22

📋 Description 113 words ▾

DESCRIPTION Furosemide tablets are a diuretic which is an anthranilic acid derivative. Furosemide tablets for oral administration contain furosemide as the active ingredient and the following inactive ingredients: corn starch, lactose anhydrous, magnesium stearate, pregelatinized starch, microcrystalline cellulose, sodium starch glycolate, and colloidal silicon dioxide. Chemically, it is 4-chloro-N-furfuryl- 5-sulfamoylanthranilic acid.

Furosemide tablets are available as white tablets for oral administration in dosage strengths of 20, 40 and 80 mg. 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 CAS Registry Number is 54-31-9. The structural formula is as follows: Structure

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