HomeNDC LookupIngredientsFurosemide › 69315-0117-10
Furosemide 40 mg Tablet, 1,000-count — NDC 69315-0117-10 package photo

Furosemide 40 mg Tablet, 1,000-count

by Leading Pharma, LLC · 1000 TABLET in 1 BOTTLE (69315-117-10)
NDC 69315-0117-10
🏷️ FDA NDC (as labeled) 69315-117-10 billing pads the product segment with a zero
This package
Contains1,000-count Cost per ea$0.0293 NADAC Per package$29.30 / 1000 tablets Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.1914/unit · Part D plans $0.0882/unit — full pricing hub ↓
Also comes in: 100 tablets 69315-0117-01
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 →
🚨
Active recall for this product.
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
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗
⚠️
Other active recalls for Furosemide (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
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) 69315-117-10
Product NDC 69315-117
11-digit billing NDC 69315011710
NCPDP billing unit EA — each (per item)
RxCUI 197732, 310429, 313988
UNII 7LXU5N7ZO5
Application # ANDA077293
SPL Set ID b5c6fcf4-fd37-4fee-8dac-1a3273d95ffe
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 2006-02-01
Route ORAL
Dosage form TABLET
Substance FUROSEMIDE
GPI-14 37200030000310
GPI class Furosemide
GCN Seq No 008209
GCN 34962
HICL code 003660
Ingredient (HICL) Furosemide
HIC1 code R
Therapeutic class — broad (HIC1) Kidney/Urinary Tract
HIC2 code R1
Therapeutic class — intermediate (HIC2) Affect Primarily Kidneys/Urinary Tract
HIC3 code R1M
Therapeutic class — specific (HIC3) Loop Diuretics
AHFS code 24:36.08.00
AHFS class Loop Diuretics (24:36)
FDB label name FUROSEMIDE 40 MG TABLET
FDB brand name Furosemide
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 69315-117-10 — 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 → 69315-0117-10. 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.

🏭 Manufacturer & labeler

LabelerLeading Pharma, LLC
Application holderLEADING PHARMA LLC
FDA applicationANDA077293 (ANDA)
Labeler code69315
First marketedFeb 2006
Product typeHuman Prescription Drug
Portfolio83 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

Label name FUROSEMIDE 40 MG TABLET Ingredient Furosemide
📖 What it is MedlinePlus · NLM

Furosemide is used alone or with other medications to treat high blood pressure. Furosemide is used to treat edema excess fluid held in body tissues caused by various medical problems. Furosemide is in a class of medications called diuretics ('water pills'). It works by causing the kidneys to get rid of unneeded water and salt from the body. High blood pressure is a common condition. When not treated, it can cause damage to the brain, heart, blood vessels, kidneys and other parts of the body. This damage may cause heart disease, a heart attack, heart failure, stroke, kidney failure, loss of vi...

Read the full MedlinePlus article ↗
📗 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.

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;118;80
Size9 mm
ScoringScored — splits in 2
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 DailyMedingredient 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 eaPer package
Retail pharmacies payNADAC · weekly $0.029 $29.30 / 1000 tablets
Medicaid paysCMS SDUD · 12 mo $0.1914 $191.40 / 1000 tablets
Medicare drug plans payPart D · Q2 2026 $0.0882 $88.20 / 1000 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.034 $0.029
▼ Down 10% over the last 24 months.
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 40 mg 00054-4299-25 Hikma 100 tablets $0.029 AB Availability likely
Furosemide 40 mg 00054-8299-25 Hikma 100 tablets $0.029 AB Availability likely
Furosemide 40 mg 00904-7178-61 Major 100 tablets $0.029 AB Availability likely
Furosemide 40 mg 43547-0402-10 Solco 100 tablets $0.029 AB Availability likely
Furosemide 40 mg 62135-0754-90 Chartwell 90 tablets $0.029 Availability likely
Furosemide 40 mg 64980-0563-01 Rising 100 tablets $0.029 AB Availability likely
Furosemide 40 mgthis 69315-0117-10 Leading 1000 tablets $0.029 AB Availability likely
Furosemide 40 mg 83980-0003-01 Ipca 100 tablets $0.029 AB Availability likely
Lasix 40 mg 30698-0060-01 Validus 100 tablets $1.049 Availability likely +3482%
Furosemide 40 mg 00615-8369-05 NCS 15 tablets AB FDA listed
Furosemide 40 mg 10135-0833-01 Marlex 100 tablets AB FDA listed
Furosemide 40 mg 17224-0185-21 Calvin 21 tablets AB FDA listed
Furosemide 40 mg 42291-0469-01 AvKARE 100 tablets AB FDA listed
Furosemide 40 mg 42708-0123-30 QPharma 30 tablets AB FDA listed
Furosemide 40 mg 43063-0716-01 PD-Rx 100 tablets AB FDA listed
Furosemide 40 mg 43353-0069-30 Aphena 30 tablets AB FDA listed
Furosemide 40 mg 50090-3313-00 A-S 30 tablets AB FDA listed
Furosemide 40 mg 50090-5702-00 A-S 100 tablets AB FDA listed
Furosemide 40 mg 50090-6646-00 A-S 30 tablets AB FDA listed
Furosemide 40 mg 50090-6647-01 A-S 180 tablets AB FDA listed
Furosemide 40 mg 50090-6937-00 A-S 90 tablets AB FDA listed
Furosemide 40 mg 50090-7703-00 A-S 30 tablets AB FDA listed
Furosemide 40 mg 50090-7704-01 A-S 180 tablets AB FDA listed
Furosemide 40 mg 50090-7705-00 A-S 90 tablets AB FDA listed
Furosemide 40 mg 51655-0517-26 Northwind 90 tablets AB FDA listed
Furosemide 40 mg 55154-2348-00 Cardinal 10 tablets AB FDA listed
Furosemide 40 mg 59651-0797-72 Aurobindo 75000 tablets AB FDA listed
Furosemide 40 mg 60760-0858-90 St. 90 tablets AB FDA listed
Furosemide 40 mg 61919-0255-90 Direct_Rx 90 tablets AB FDA listed
Furosemide 40 mg 63187-0506-30 Proficient 30 tablets AB FDA listed
Furosemide 40 mg 63187-0790-30 Proficient 30 tablets AB FDA listed
Furosemide 40 mg 63561-0165-01 Granulation 100 tablets AB FDA listed
Furosemide 40 mg 63629-1216-01 Bryant 100 tablets AB FDA listed
Furosemide 40 mg 63629-1217-01 Bryant 1000 tablets AB FDA listed
Furosemide 40 mg 67046-1663-03 Coupler 30 tablets AB FDA listed
Furosemide 40 mg 67296-2139-03 Redpharm 30 tablets AB FDA listed
Furosemide 40 mg 68071-1809-01 NuCare 100 tablets AB FDA listed
Furosemide 40 mg 68071-2360-01 NuCare 100 tablets AB FDA listed
Furosemide 40 mg 68071-3273-03 NuCare 30 tablets AB FDA listed
Furosemide 40 mg 68071-3536-03 NuCare 30 tablets AB FDA listed
Furosemide 40 mg 68071-4445-01 NuCare 10 tablets AB FDA listed
Furosemide 40 mg 68071-4522-01 NuCare 100 tablets AB FDA listed
Furosemide 40 mg 68788-6784-01 Preferred 100 tablets AB FDA listed
Furosemide 40 mg 68788-8799-01 Preferred 100 tablets AB FDA listed
Furosemide 40 mg 70518-0251-01 REMEDYREPACK 90 tablets AB FDA listed
Furosemide 40 mg 70518-4609-00 REMEDYREPACK 50 tablets AB FDA listed
Furosemide 40 mg 71335-0842-01 Bryant 40 tablets AB FDA listed
Furosemide 40 mg 71335-2317-01 Bryant 40 tablets AB FDA listed
Furosemide 40 mg 71610-0049-30 Aphena 30 tablets AB FDA listed
Furosemide 40 mg 71610-0634-30 Aphena 30 tablets AB FDA listed
Furosemide 40 mg 71610-0951-30 Aphena 30 tablets AB FDA listed
Furosemide 40 mg 72162-1361-00 Bryant 1000 tablets AB FDA listed
Furosemide 40 mg 72789-0032-30 PD-Rx 30 tablets AB FDA listed
Furosemide 40 mg 72789-0157-01 PD-Rx 100 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

🏛️
2006
On the market since
Feb 2006
📍
2026
Currently FDA-listed
20 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 69315-0117-10, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
395K
Units reimbursed last 4 qtrs
17.8M
Gross reimbursed last 4 qtrs
$3.41M
Avg / prescription
$8.64
Avg / unit
$0.1914
Latest quarter Q4 2025
76KRx
Medicaid pays / ea
$0.1914
gross reimbursed
vs
NADAC / ea
$0.0293
acquisition cost
=
Spread
+$0.1621
+553% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
43% FFS 57% MCO
Fee-for-service · 168,247 Rx Managed care · 226,791 Rx
State Medicaid map
Alaska: 5,752 units · 785 per 100k residents AK Maine: 107,938 units · 7,737 per 100k residents ME Washington: 206,560 units · 2,644 per 100k residents WA Idaho: 75,847 units · 3,862 per 100k residents ID Montana: 45,262 units · 3,998 per 100k residents MT North Dakota: 50,046 units · 6,392 per 100k residents ND Minnesota: 202,088 units · 3,523 per 100k residents MN Wisconsin: 324,112 units · 5,484 per 100k residents WI Michigan: 799,385 units · 7,964 per 100k residents MI New York: 2,062,826 units · 10,540 per 100k residents NY Vermont: 13,215 units · 2,043 per 100k residents VT New Hampshire: 21,657 units · 1,545 per 100k residents NH Oregon: 98,109 units · 2,318 per 100k residents OR Nevada: 79,018 units · 2,474 per 100k residents NV Wyoming: 5,202 units · 891 per 100k residents WY South Dakota: 62,139 units · 6,762 per 100k residents SD Iowa: 158,292 units · 4,936 per 100k residents IA Illinois: 980,788 units · 7,816 per 100k residents IL Indiana: 936,529 units · 13,648 per 100k residents IN Ohio: 1,360,386 units · 11,543 per 100k residents OH Pennsylvania: 1,446,120 units · 11,157 per 100k residents PA New Jersey: 654,121 units · 7,041 per 100k residents NJ Massachusetts: 116,449 units · 1,663 per 100k residents MA California: 1,660,224 units · 4,261 per 100k residents CA Utah: 61,003 units · 1,785 per 100k residents UT Colorado: 127,516 units · 2,169 per 100k residents CO Nebraska: 76,034 units · 3,844 per 100k residents NE Missouri: 602,136 units · 9,718 per 100k residents MO Kentucky: 728,563 units · 16,097 per 100k residents KY West Virginia: 390,348 units · 22,054 per 100k residents WV Virginia: 377,868 units · 4,335 per 100k residents VA Maryland: 453,591 units · 7,340 per 100k residents MD Connecticut: 169,829 units · 4,695 per 100k residents CT Rhode Island: 36,928 units · 3,372 per 100k residents RI Arizona: 113,965 units · 1,534 per 100k residents AZ New Mexico: 78,053 units · 3,692 per 100k residents NM Kansas: 102,526 units · 3,487 per 100k residents KS Arkansas: 164,959 units · 5,379 per 100k residents AR Tennessee: 225,255 units · 3,161 per 100k residents TN North Carolina: 477,285 units · 4,405 per 100k residents NC South Carolina: 72,238 units · 1,344 per 100k residents SC Delaware: 66,767 units · 6,476 per 100k residents DE Oklahoma: 207,151 units · 5,111 per 100k residents OK Louisiana: 158,058 units · 3,456 per 100k residents LA Mississippi: 107,059 units · 3,641 per 100k residents MS Alabama: 112,387 units · 2,200 per 100k residents AL Georgia: 237,579 units · 2,154 per 100k residents GA D.C.: 89,612 units · 13,198 per 100k residents DC Hawaii: 13,057 units · 910 per 100k residents HI Texas: 427,841 units · 1,403 per 100k residents TX Florida: 260,298 units · 1,151 per 100k residents FL
Units reimbursed · per 100k residents
78522,054
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 West Virginia 22,054 /100k
2 Kentucky 16,097 /100k
3 Indiana 13,648 /100k
4 D.C. 13,198 /100k
5 Ohio 11,543 /100k
6 Pennsylvania 11,157 /100k
7 New York 10,540 /100k
8 Missouri 9,718 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1000 tablets this page69315-0117-10 395,038 Rx · $3,411,758
100 tablets69315-0117-01 10,182 Rx · $89,233
Drug total (last 4 qtrs): 405,220 Rx · 18,292,470 units · $3,500,992 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 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 Per unit Per pack Marketing startStatus
69315-0117-01 100 TABLET in 1 BOTTLE (69315-117-01) $0.0293 / ea $2.93 2016-05-15 Active
69315-0117-10 You're viewing this 1000 TABLET in 1 BOTTLE (69315-117-10) $0.0293 / ea $29.29 2016-05-15 Active

You're viewing the largest of 2 pack sizes for this product.

This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($0.0293 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 97% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 69315-0117-10?
NDC 69315-0117-10 is a 1,000-count package — 1000 tablet in 1 bottle.
What is the difference between NDC 69315-0117-10 and NDC 69315-0117-01?
Both are Furosemide 40 mg Tablet — the drug itself is identical. NDC 69315-0117-10 is the 1,000-count package, while NDC 69315-0117-01 is the 100 tablets package.
What NDC number is used to bill for this package of Furosemide 40 mg Tablet?
Bill NDC 69315-0117-10 — the 11-digit billing format is 69315011710. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 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 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 181 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.

🔄 Drug Interactions ~2 min read

Drug Interactions Furosemide tablets may increase the ototoxic potential of aminoglycoside antibiotics, especially in the presence of impaired renal function. Except in life-threatening situations, avoid this combination. Furosemide tablets should not be used concomitantly with ethacrynic acid because of the possibility of ototoxicity.

Patients receiving high doses of salicylates concomitantly with Furosemide tablets, as in rheumatic disease, may experience salicylate toxicity at lower doses because of competitive renal excretory sites. There is a risk of ototoxic effects if cisplatin and Furosemide tablets are given concomitantly. In addition, nephrotoxicity of nephrotoxic drugs such as cisplatin may be enhanced if Furosemide tablets are not given in lower doses and with positive fluid balance when used to achieve forced diuresis during cisplatin treatment.

Furosemide tablets have a tendency to antagonize the skeletal muscle relaxing effect of tubocurarine and may potentiate the action of succinylcholine. Lithium generally should not be given with diuretics because they reduce lithium’s renal clearance and add a high risk of lithium toxicity. Furosemide tablets combined with angiotensin converting enzyme inhibitors or angiotensin II receptor blockers may lead to severe hypotension and deterioration in renal function, including renal failure.

An interruption or reduction in the dosage of Furosemide tablets, angiotensin converting enzyme inhibitors, or angiotensin receptor blockers may be necessary. Potentiation occurs with ganglionic or peripheral adrenergic blocking drugs. Furosemide tablets may decrease arterial responsiveness to norepinephrine.

However, norepinephrine may still be used effectively. Simultaneous administration of sucralfate and Furosemide tablets may reduce the natriuretic and antihypertensive effects of Furosemide tablets. Patients receiving both drugs should be observed closely to determine if the desired diuretic and/or antihypertensive effect of Furosemide tablets is achieved.

The intake of Furosemide tablets and sucralfate should be separated by at least two hours. In isolated cases, intravenous administration of Furosemide tablets within 24 hours of taking chloral hydrate may lead to flushing, sweating attacks, restlessness, nausea, increase in blood pressure, and tachycardia. Use of Furosemide tablets concomitantly with chloral hydrate is, therefore, not recommended.

Phenytoin interferes directly with renal action of Furosemide tablets. There is evidence that treatment with phenytoin leads to decrease intestinal absorption of Furosemide tablets, and consequently to lower peak serum furosemide concentrations. Methotrexate and other drugs that, like Furosemide tablets, undergo significant renal tubular secretion may reduce the effect of Furosemide tablets.

Conversely, Furosemide tablets may decrease renal elimination of other drugs that undergo tubular secretion. High-dose treatment of both Furosemide tablets and these other drugs may result in elevated serum levels of these drugs and may potentiate their toxicity as well as the toxicity of Furosemide tablets. Furosemide tablets can increase the risk of cephalosporin-induced nephrotoxicity even in the setting of minor or transient renal impairment.

Concomitant use of cyclosporine and Furosemide tablets is associated with increased risk of gouty arthritis secondary to Furosemide tablets-induced hyperurecemia and cyclosporine impairment of renal urate excretion. High doses (>80mg) 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. 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 pota…

🤰 Pregnancy ~1 min read

Pregnancy Furosemide has been shown to cause unexplained maternal deaths and abortions in rabbits at 2, 4 and 8 times the maximal recommended human dose. There are no adequate and well-controlled studies in pregnant women. Furosemide tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Treatment during pregnancy requires monitoring of fetal growth because of the potential for higher birth weights. 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 (2 times the maximal recommended human dose of 600 mg/day).

In another study, a dose of 50 mg/kg (4 times the maximal recommended human dose of 600 mg/day) 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 a 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 derived from the treated dams as compared with the incidence in fetuses from the control group.

🧒 Pediatric Use 76 words

Pediatric Use In premature infants Furosemide tablets may precipitate nephrocalcinosis/nephrolithiasis. Nephrocalcinosis/ nephrolithiasis has also been observed in children under 4 years of age with no history of prematurity who have been treated chronically with Furosemide tablets. Monitor renal function, and renal ultrasonography should be considered, in pediatric patients receiving Furosemide tablets.

If Furosemide tablets are administered to premature infants during the first weeks of life, it may increase the risk of persistence of patent ductus arteriosus.

🧓 Geriatric Use 147 words

Geriatric Use Controlled clinical studies of Furosemide tablets 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 PRECAUTIONS: General and DOSAGE AND ADMINISTRATION .)

🆘 Overdosage 146 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 LD 50 exceeded 1000 mg/kg body weight, while the intravenous LD 50 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 185 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 100 (NDC 69315-116-01), and 1000 (NDC 69315-116-10). 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 100 (NDC 69315-117-01) and 1000 (NDC 69315-117-10).

Furosemide tablets 80 mg are supplied as white to off-white, round, flat face beveled edge, bisected compressed tablets, debossed "EP" above bisect and "118" below bisect on one side, and "80" on the other side in bottles of 100 (NDC 69315-118-01) and 500 (NDC 69315-118-05). 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 114 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: furosemide structure

💬 Information for Patients 104 words

Information For Patients Patients receiving Furosemide tablets 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.

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