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Enbumyst bumetanide .5 mg/.1mL Spray — NDC 84388-0005-06 package photo

Enbumyst bumetanide .5 mg/.1mL Spray

by Corstasis USA LLC · 6 BLISTER PACK in 1 CARTON (84388-005-06) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK / .1 mL in 1 VIAL, SINGLE-DOSE
NDC 84388-0005-06
🏷️ FDA NDC (as labeled) 84388-005-06 billing pads the product segment with a zero
This package
Contains.1 mL in 1 vial, single-dose Pack sizes2 compare ↓
Also priced by: Part D plans $108.29/unit — full pricing hub ↓
Also comes in: 1 vial 84388-0005-12
Rx only Brand Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ Data synced Sep 17, 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

⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 84388-005-06
Product NDC 84388-005
11-digit billing NDC 84388000506
NCPDP billing unit EA — each (per item)
RxCUI 2724437, 2724443
UNII 0Y2S3XUQ5H
Application # NDA219500
SPL Set ID d6f752c5-d2bd-4f77-9611-ca2110066d1f
Established class (EPC) Loop Diuretic
Physiologic effect Increased Diuresis at Loop of Henle
DEA schedule Non-controlled
Marketing category NDA
Marketing status Discontinued
FDA listing status Discontinued by firm
Marketing start 2025-09-12
Route NASAL
Dosage form SPRAY
Substance BUMETANIDE
GCN Seq No 088260
GCN 58365
HICL code 003664
Ingredient (HICL) Bumetanide
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 ENBUMYST 0.5 MG SPRAY
FDB brand name Enbumyst
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 84388-005-06 — 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 → 84388-0005-06. 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

LabelerCorstasis USA LLC
Application holderCORSTASIS THERAPEUTICS INC
FDA applicationNDA219500 (NDA)
Labeler code84388
First marketedSep 2025
Product typeHuman Prescription Drug
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 ENBUMYST 0.5 MG SPRAY Ingredient Bumetanide
📖 What it is MedlinePlus · NLM

Bumetanide nasal spray is used to treat edema (swelling caused by excess fluid in the body). Bumetanide nasal spray is in a class of medications called diuretics. It works by causing the kidneys to get rid of unneeded water and salt from the body.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Think of it as a very efficient 'water pill.' Your kidneys normally recycle most of the salt that flows through them, and water follows that salt back into your bloodstream. Bumeta...
  • What is bumetanide actually doing in my body?
  • Bumetanide works fast. If you take a tablet, you'll usually feel the urge to urinate within 30 to 60 minutes, with the strongest effect around 1 to 2 hours. Most of the diuretic ac...
  • When will I notice it working, and how long does it last?
📖 Read our full Bumetanide guide →
8
Nutrient depletion considerations

Bumetanide may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Bumetanide 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.

🧪 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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
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.

💲 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 $108.29 $64.97 / 0.6 ml
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
Enbumyst .5 mg/.1mLthis 84388-0005-06 Corstasis 1 vial — — Discontinued —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
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

🏛️
2025
First FDA approval
Sep 2025
📍
2026
Currently FDA-listed
1 year listed
🛡️
2045
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through May 2045. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Sep 12, 2025 RLD RS ⏳ ~18.6 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 12558330 — method of use (U-4279)
US 12329731 — method of use (U-4279)
US 11260038 — method of use (U-4279)
US 11123319 — drug product
2025 2027 2029 2031 2033 2035 2037 2039 2041 2043 2045
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (4)
PatentTypeUse codeExpires
US 12558330 ↗ Method of use U-4279 May 14, 2045
US 12329731 ↗ Method of use U-4279 Dec 4, 2040
US 11260038 ↗ Method of use U-4279 Dec 4, 2040
US 11123319 ↗ Drug product — Dec 4, 2040
Common questions
Is there a generic version of ENBUMYST 0.5 MG SPRAY?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for ENBUMYST 0.5 MG SPRAY. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until May 2045 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
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 Enbumyst — the program that covers self-administered drugs. 1 manufacturer.
⚠️ 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 Enbumyst. 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.
Total Part D spend
$124.6K
Claims incl. refills
69
Beneficiaries
54
Spend / beneficiary
$2,307.35
Spend / claim
$1,805.75
💵 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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Enbumyst (this brand).

Top reported reactions

Dyspnoea1,919
Acute Kidney Injury1,396
Fatigue1,299
Death1,257
Diarrhoea1,206
Nausea1,114
Dizziness974

Age at onset

Neonate5
Infant7
Child12
Adolescent6
Adult1,171
Elderly2,329

Reporter sex

19,948 reports
Male · 45%
Female · 55%
Unknown · 0%

Serious outcomes

Hospitalization9,426
Death3,003
Life-threatening1,020
Disabling646
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,562 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
84388-0005-06 You're viewing this 6 BLISTER PACK in 1 CARTON (84388-005-06) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK / .1 mL in 1 VIAL, SINGLE-DOSE 2025-09-12 Discontinued by firm
84388-0005-12 2 CARTON in 1 CARTON (84388-005-12) / 6 PACKAGE in 1 CARTON / 1 VIAL, SINGLE-DOSE in 1 PACKAGE / .1 mL in 1 VIAL, SINGLE-DOSE 2025-09-12 Active

Pack size FAQ

What quantity is in NDC 84388-0005-06?
NDC 84388-0005-06 is listed by the FDA — 6 blister pack in 1 carton / 1 vial, single-dose in 1 blister pack / .1 ml in 1 vial, single-dose.
What NDC number is used to bill for this package of Enbumyst bumetanide .5 mg/.1mL Spray?
Bill NDC 84388-0005-06 — the 11-digit billing format is 84388000506. 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 No longer marketed (per FDA listing data)
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) — 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 — 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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 84388-005-06, 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: 84388-0005-06, written without dashes as 84388000506. 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 84388-0005-06, the first segment (84388) is the labeler code FDA assigned to Corstasis USA LLC; the middle segment (0005) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (06) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 vial (84388-0005-12). 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?
Corstasis USA 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 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 55 words ▾

1 INDICATIONS AND USAGE ENBUMYST is indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome in adults. ENBUMYST is a loop diuretic indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including nephrotic syndrome in adults. ( 1 )

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION ENBUMYST is for nasal route only. ( 2 ) Individualize dosage based on patient response. The recommended total daily dosage of ENBUMYST is 0.5 mg to 2 mg administered once daily. ( 2.1 ) ENBUMYST is not intended for chronic use; replace with oral diuretics as soon as practical. ( 2.1 )

2.1Recommended Dosage Each unit-dose nasal spray contains 0.5 mg of bumetanide. The usual total daily dosage of ENBUMYST is 0.5 mg to 2 mg once daily. The number of nasal spray devices needed for a single dose depends upon the prescribed dose.

Individualize dosage based on patient response up to a maximum dose of 2 mg/day. ENBUMYST is not intended for chronic use and should be replaced with oral diuretics as soon as practical. ENBUMYST can be substituted at approximately a 1:40 ratio to oral furosemide and a 1:20 ratio to intravenous furosemide.

2.2Administration Instructions ENBUMYST is for nasal use only. Each ENBUMYST unit is for single use and delivers 0.5 mg bumetanide upon actuation. Do not prime or attempt to reuse ENBUMYST for more than one administration.

Administer ENBUMYST directly into the nose and not against the wall of the nose. If prescribed dose requires more than one nasal spray, alternate between right and left nostrils. Refer patients and caregivers to the Instructions for Use for detailed administration instructions.

💊 Dosage Forms and Strengths 28 words ▾

3 DOSAGE FORMS AND STRENGTHS Nasal spray: 0.5 mg bumetanide per 0.1 mL spray in a unit-dose nasal spray. Nasal spray: 0.5 mg bumetanide per 0.1 mL spray

⛔ Contraindications 47 words ▾

4 CONTRAINDICATIONS Bumetanide is contraindicated in: Patients with anuria. Patients in hepatic coma. Patients with a history of a hypersensitivity reaction to bumetanide. Reactions have included anaphylaxis and anaphylactoid reactions. Anuria. ( 4 ) Hepatic coma. ( 4 ) History of hypersensitivity to bumetanide. ( 4 )

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS Fluid, Electrolyte, and Metabolic Abnormalities: Monitor serum electrolytes, CO 2 , BUN, creatinine, glucose and uric acid. ( 5.1 ) Worsening Renal Function: Monitor for dehydration and azotemia. ( 5.2 ) Ototoxicity: Avoid higher than recommended doses.

( 5.3 ) Potential Altered Absorption in Patients with Nasal Mucosal or Structural Abnormalities: Avoid use in patients with significant nasal mucosal or structural abnormalities, such as acute episodes of rhinitis or congestion due to any cause. ( 5.4 )

5.1Fluid, Electrolyte, and Metabolic Abnormalities Bumetanide may cause fluid, electrolyte, and metabolic abnormalities such as hypovolemia, hypokalemia, azotemia, hyponatremia, hypochloremic alkalosis, hypomagnesemia, hypocalcemia, hyperglycemia, or hyperuricemia, particularly in patients receiving higher doses, patients with inadequate oral electrolyte intake, and in elderly patients. Excessive diuresis may cause dehydration and blood volume reduction with circulatory collapse and possibly vascular thrombosis and embolism, particularly in elderly patients.

Serum electrolytes, CO2, BUN, creatinine, glucose, and uric acid should be monitored frequently during bumetanide therapy.

5.2Worsening Renal Function Bumetanide can cause dehydration and azotemia. If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, discontinue bumetanide [see Clinical Pharmacology (12.3) ].

5.3Ototoxicity Tinnitus and hearing loss (usually reversible) have been reported with loop diuretics, including bumetanide. Reports indicate that 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.

5.4Potential Altered Absorption in Patients with Nasal Mucosal or Structural Abnormalities ENBUMYST has not been assessed in individuals with nasal mucosal or structural abnormalities. Avoid use in patients with significant nasal mucosal or structural abnormalities, such as acute episodes of rhinitis or congestion due to any cause. Consider alternative products or therapies in such patients.

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Fluid, electrolyte, and metabolic abnormalities [see Warnings and Precautions (5.1) ] Worsening Renal Function [see Warnings and Precautions (5.2) ] Ototoxicity [see Warnings and Precautions (5.3) ] Potential Altered Absorption in Patients with Nasal Mucosal or Structural Abnormalities [see Warnings and Precautions (5.4) ] Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of ENBUMYST is supported by clinical trials and postmarketing reports of oral bumetanide, as well as open-label, single- and repeat-dose studies of ENBUMYST in healthy subjects. Adverse Reactions in Two Clinical Pharmacology Studies with ENBUMYST in Adult Subjects In open-label studies of ENBUMYST in healthy subjects (n = 84), the most common adverse reaction that occurred with ENBUMYST was hypovolemia (4.8%) [see Warnings and Precautions (5.1) ] . Headache occurred in 3% of subjects.

There were no adverse reactions specifically associated with the nasal route of administration such as nasal irritation or pain. There was a single case of nasal dryness. Adverse Reactions in Studies with Oral Bumetanide The following adverse reactions were identified in clinical studies or postmarketing reports with the use of oral bumetanide.

Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The most frequent clinical adverse reactions considered probably or possibly related to oral bumetanide are muscle cramps (seen in 1.1% of treated patients), dizziness (1.1%), hypotension (0.8%), headache (0.6%), nausea (0.6%) and encephalopathy (in patients with pre-existing liver disease) (0.6%). One or more of these adverse reactions have been reported in approximately 4.1% of patients treated with bumetanide.

The following additional adverse reactions have been reported with bumetanide. Blood and Lymphatic System Disorders: Deviations in hemoglobin, prothrombin time, hematocrit, WBC and differential counts, thrombocytopenia Cardiac Disorders: Chest pain, electrocardiogram changes Ear and Labyrinth Disorders: Ear discomfort, impaired hearing, vertigo Gastrointestinal Disorders: Abdominal pain, diarrhea, dry mouth, GI upset, vomiting General Disorders and Administration Site Conditions: Fatigue, weakness Investigations: Changes in LDH, total serum bilirubin, serum proteins, SGOT, SGPT, alkaline phosphatase, cholesterol, creatinine clearance, urinary glucose, and urinary protein Metabolism and Nutrition Disorders: Dehydration Musculoskeletal and Connective Tissue Disorders: Arthritic pain, musculoskeletal pain Nervous System Disorders: Asterixis Renal and Urinary Disorders: Renal failure Reproductive System and Breast Disorders: Erectile dysfunction, nipple tenderness, premature ejaculation Respiratory, Thoracic and Mediastinal Disorders: Hyperventilation Skin and Subcutaneous Tissue Disorders: Pruritus, rash, Stevens-Johnson syndrome, sweating, toxic epidermal necrolysis Most common adverse reactions (incidence > 0.5%) are hypovolemia, headache, muscle cramps, dizziness, hypotension, nausea and encephalopathy (in patients with pre-existing liver disease).

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Corstasis Therapeutics at 1-877-300-5339 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Lithium may reduce renal clearance of bumetanide and add a high risk of lithium toxicity. ( 7 ) Probenecid reduces both the natriuresis and hyperreninemia. ( 7 ) Indomethacin blunts the increase in urine volume and sodium excretion.

( 7 ) Drugs with ototoxic potential: avoid parenteral bumetanide in patients receiving aminoglycoside antibiotics. ( 7 ) Drugs with nephrotoxic potential: the simultaneous administration of ENBUMYST with drugs of nephrotoxic potential should be avoided. ( 7 ) Antihypertensive effects may be potentiated by bumetanide.

( 7 )

7.1Effects of Other Drugs on Bumetanide Lithium Lithium should generally not be given with diuretics (such as bumetanide) because they reduce its renal clearance and add a high risk of lithium toxicity. Probenecid Probenecid should not be administered concurrently with bumetanide. Pretreatment with probenecid reduces both the natriuresis and hyperreninemia produced by bumetanide.

This antagonistic effect of probenecid on bumetanide natriuresis is not due to a direct action on sodium excretion but is probably secondary to its inhibitory effect on renal tubular secretion of bumetanide. Indomethacin Concurrent therapy with bumetanide is not recommended. Indomethacin blunts the increases in urine volume and sodium excretion seen during bumetanide treatment and inhibits the bumetanide-induced increase in plasma renin activity.

7.2Effects of Bumetanide on Other Drugs Drugs with Ototoxic Potential [ see Warnings and Precautions (5.3) ] Especially in the presence of impaired renal function, the use of parenterally administered bumetanide in patients to whom aminoglycoside antibiotics are also being given should be avoided, except in life-threatening conditions. Drugs with Nephrotoxic Potential Monitor renal function. Concomitant use may worsen renal function and increase the risk of nephrotoxicity.

Antihypertensives Bumetanide may potentiate the effect of various antihypertensive drugs, necessitating a reduction in the dosage of these drugs. Digoxin Interaction studies in humans have shown no effect on digoxin blood levels. Anticoagulants Interaction studies in humans have shown bumetanide to have no effect on warfarin metabolism or on plasma prothrombin activity.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation: A lactating woman treated with ENBUMYST should monitor her infant for excessive urine output, dehydration, and lethargy. ( 8.2 )

8.1Pregnancy Risk Summary The available data on bumetanide use in pregnant women from scientific review publications have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Untreated congestive heart failure, hepatic disease such as cirrhosis and chronic kidney disease can lead to adverse outcomes for the mother and fetus (see Clinical Considerations ). In animal reproduction studies, no malformations were observed with oral administration of bumetanide to pregnant rats and rabbits during organogenesis at doses approximately 485 times and equivalent to a human dose of 2 mg once daily, respectively (see Data ) .

The background risk for major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the background risk of major birth defects and miscarriage in the clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Pregnant women with congestive heart failure are at increased risk for pre-term birth. Stroke volume and heart rate increase during pregnancy, increasing cardiac output, especially during the first trimester. Clinical classification of heart disease may worsen with pregnancy and lead to maternal death and/or stillbirth.

Closely monitor pregnant patients for destabilization of their heart failure. Pregnant women with symptomatic cirrhosis generally have poor outcomes including hepatic failure, variceal hemorrhage, pre-term delivery, fetal growth restriction and maternal death. Outcomes are worse with coexisting esophageal varices.

Pregnant women with cirrhosis of the liver should be carefully monitored and managed accordingly. Chronic kidney disease in pregnancy increases the risk for maternal hypertension and preeclampsia, miscarriage, preterm delivery, polyhydramnios, still birth, and low birth weight infants. Data Animal Data Bumetanide has been shown to be nonteratogenic, but it has a slight embryocidal effect in rats when given at a dose approximately 485 times and in rabbits at a dose equivalent to a 2 mg/day human dose, based on body surface area (BSA).

In one study, moderate growth retardation and increased incidence of delayed ossification of sternebrae were observed in rats at oral doses of 100 mg/kg/day, approximately 485 times a 2 mg/day human dose, based on BSA. These effects were associated with maternal weight reductions noted during dosing. No such adverse effects were observed at 30 mg/kg/day (approximately 146 times a 2 mg/day human dose, based on BSA).

No fetotoxicity was observed at dose up to approximately 292 times a 2 mg/day human dose, based on BSA. In rabbits, a dose-related decrease in litter size and an increase in resorption rate were noted at oral doses of 0.1 mg/kg/day and 0.3 mg/kg/day (approximately equivalent to 3 times a 2 mg/day human dose, based on BSA). A slightly increased incidence of delayed ossification of sternebrae occurred at 0.3 mg/kg/day; however, no such adverse effects were observed at the dose of 0.03 mg/kg/day.

The sensitivity of the rabbit to bumetanide parallels the marked pharmacologic and toxicologic effects of the drug in this species. Bumetanide was not teratogenic in the hamster at an oral dose of 0.5 mg/kg/day (approximately 3 times a 2 mg/day human dose, based on BSA).

8.2Lactation Risk Summary There are no data on the presence of bumetanide in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. Because there have been no reports of adverse events in breastfed infants over decades of bumetanide use, the developmental and health benefits of breastf…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary The available data on bumetanide use in pregnant women from scientific review publications have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Untreated congestive heart failure, hepatic disease such as cirrhosis and chronic kidney disease can lead to adverse outcomes for the mother and fetus (see Clinical Considerations ). In animal reproduction studies, no malformations were observed with oral administration of bumetanide to pregnant rats and rabbits during organogenesis at doses approximately 485 times and equivalent to a human dose of 2 mg once daily, respectively (see Data ) .

The background risk for major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the background risk of major birth defects and miscarriage in the clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Pregnant women with congestive heart failure are at increased risk for pre-term birth. Stroke volume and heart rate increase during pregnancy, increasing cardiac output, especially during the first trimester. Clinical classification of heart disease may worsen with pregnancy and lead to maternal death and/or stillbirth.

Closely monitor pregnant patients for destabilization of their heart failure. Pregnant women with symptomatic cirrhosis generally have poor outcomes including hepatic failure, variceal hemorrhage, pre-term delivery, fetal growth restriction and maternal death. Outcomes are worse with coexisting esophageal varices.

Pregnant women with cirrhosis of the liver should be carefully monitored and managed accordingly. Chronic kidney disease in pregnancy increases the risk for maternal hypertension and preeclampsia, miscarriage, preterm delivery, polyhydramnios, still birth, and low birth weight infants. Data Animal Data Bumetanide has been shown to be nonteratogenic, but it has a slight embryocidal effect in rats when given at a dose approximately 485 times and in rabbits at a dose equivalent to a 2 mg/day human dose, based on body surface area (BSA).

In one study, moderate growth retardation and increased incidence of delayed ossification of sternebrae were observed in rats at oral doses of 100 mg/kg/day, approximately 485 times a 2 mg/day human dose, based on BSA. These effects were associated with maternal weight reductions noted during dosing. No such adverse effects were observed at 30 mg/kg/day (approximately 146 times a 2 mg/day human dose, based on BSA).

No fetotoxicity was observed at dose up to approximately 292 times a 2 mg/day human dose, based on BSA. In rabbits, a dose-related decrease in litter size and an increase in resorption rate were noted at oral doses of 0.1 mg/kg/day and 0.3 mg/kg/day (approximately equivalent to 3 times a 2 mg/day human dose, based on BSA). A slightly increased incidence of delayed ossification of sternebrae occurred at 0.3 mg/kg/day; however, no such adverse effects were observed at the dose of 0.03 mg/kg/day.

The sensitivity of the rabbit to bumetanide parallels the marked pharmacologic and toxicologic effects of the drug in this species. Bumetanide was not teratogenic in the hamster at an oral dose of 0.5 mg/kg/day (approximately 3 times a 2 mg/day human dose, based on BSA).

🧒 Pediatric Use 74 words ▾

8.4Pediatric Use The safety and effectiveness of ENBUMYST (bumetanide nasal spray) have not been established in pediatric patients. In vitro studies using pooled sera from critically ill neonates have shown bumetanide to be a potent displacer of bilirubin. The administration of bumetanide could present a particular concern if given to critically ill or jaundiced neonates at risk for kernicterus.

ENBUMYST (bumetanide nasal spray) is not approved for use in pediatric patients, including neonates.

🧓 Geriatric Use 140 words ▾

8.5Geriatric Use Clinical studies of bumetanide did not include sufficient numbers of subjects aged 65 and over to determine whether they responded 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 an 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 .

🆘 Overdosage 68 words ▾

10 OVERDOSAGE Overdosage can lead to acute profound water loss, volume and electrolyte depletion, dehydration, reduction of blood volume and circulatory collapse with a possibility of vascular thrombosis and embolism. Electrolyte depletion may be manifested by weakness, dizziness, mental confusion, anorexia, lethargy, vomiting and cramps. Treatment consists of replacement of fluid and electrolyte losses by careful monitoring of the urine and electrolyte output and serum electrolyte levels .

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Bumetanide primarily inhibits the reabsorption of sodium and chloride in the proximal and distal tubules and in the loop of Henle. The high degree of diuresis 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.

12.2Pharmacodynamics Following administration of ENBUMYST, the onset of diuresis occurs in less than 60 minutes. Peak activity is reached between 0.75 and 1.5 hours. At a maximum dose of 2 mg, diuresis is largely complete within 4 hours.

Bumetanide decreases uric acid excretion and increases serum uric acid. In a study in 68 healthy adults, the effect of 2 mg ENBUMYST on diuresis, natriuresis and potassium urine excretion over 0 to 8 hours and 0 to 24 hours was similar to that of 2 mg bumetanide oral tablet and 2 mg bumetanide IV injection.

12.3Pharmacokinetics In a study in healthy adults, the exposure (C max and AUC) of 2 mg ENBUMYST was similar to that of 2 mg bumetanide oral tablet. The exposure of 2 mg ENBUMYST was approximately 11% (C max ) and 65-67% (AUC) relative to that of 2 mg bumetanide IV injection. Absorption Bumetanide median time to maximum concentration (T max ) is 1.0 hour following nasal administration of ENBUMYST.

Distribution Bumetanide exhibits high plasma protein binding in the range of 94% to 96%. Elimination Bumetanide is eliminated rapidly in humans following both oral and parenteral (intravenous or intramuscular) administration, with a half-life of 1 to 1.5 hours. ENBUMYST demonstrated a half-life of approximately 3 hours in healthy adult subjects.

Metabolism Mass balance studies using carbon-14 labeled bumetanide in healthy adults identified metabolites formed by oxidation of the N-butyl side chain. These metabolites were detected in both urine and bile. Excretion Following oral administration of carbon-14 labeled bumetanide to healthy adults, 81% of the administered radioactivity was recovered in urine, with 45% excreted as unchanged drug.

Biliary excretion accounted for 2% of the administered dose. Specific Populations Geriatric Patients In a group of ten geriatric subjects between the ages of 65 and 73 years, total bumetanide clearance was significantly lower (1.8 ± 0.3 mL/min*kg) compared with younger subjects (2.9 ± 0.2 mL/min*kg) after a single oral bumetanide 0.5 mg dose. Maximum plasma concentrations were higher in geriatric subjects (16.9 ± 1.8 ng/mL) compared with younger subjects (10.3 ± 1.5 ng/mL).

Urine flow rate and total excretion of sodium and potassium were increased less in the geriatric subjects compared with younger subjects, although potassium excretion and fractional sodium excretion were similar between the two age groups. Nonrenal clearance, bioavailability, and volume of distribution were not significantly different between the two groups.

🧬 Mechanism of Action 56 words ▾

12.1Mechanism of Action Bumetanide primarily inhibits the reabsorption of sodium and chloride in the proximal and distal tubules and in the loop of Henle. The high degree of diuresis 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.

📦 How Supplied / Storage and Handling 95 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied ENBUMYST is a clear, colorless solution, supplied as a 12-pack carton containing unit-dose nasal sprays as shown in Table 1. Each unit-dose nasal spray delivers 0.5 mg bumetanide. Table 1: Available Packaging Configurations Description Package Configuration NDC 12-pack carton Two (2) 6-pack cartons containing twelve (12) blister packages each with a unit-dose nasal spray NDC 84388-005-12 Storage and Handling Store at room temperature 59°F to 77°F (15°C to 25°C).

Short-term excursions permitted between 39°F to 104°F (4°C to 40°C). Do not freeze. Dispense in the original sealed carton.

📦 Storage and Handling 32 words ▾

Storage and Handling Store at room temperature 59°F to 77°F (15°C to 25°C). Short-term excursions permitted between 39°F to 104°F (4°C to 40°C). Do not freeze. Dispense in the original sealed carton.

📋 Description 93 words ▾

11 DESCRIPTION ENBUMYST contains bumetanide, a loop diuretic. Chemically, bumetanide is 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoic acid. It is a practically white powder with a calculated molecular weight of 364.42 g/mol, and the following structural formula: ENBUMYST is supplied as a unit-dose nasal spray containing 0.5 mg of bumetanide (equivalent to about 0.554 mg of potassium salt of bumetanide) per 0.1 mL.

ENBUMYST contains the following inactive ingredients: benzyl alcohol (0.5 mg per 0.1 mL spray), carboxymethylcellulose sodium (viscosity control agent), mannitol, potassium hydroxide (pH modifier), hydrochloric acid (to adjust pH) and water for injection. Chemical Structure

💬 Information for Patients 88 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Administration Advise patients on appropriate administration, including the number of devices to use [see Dosage and Administration (2) ]. Lactation Advise lactating women treated with ENBUMYST to monitor their breastfed infant for excessive urine output, dehydration, and lethargy [see Use in Specific Populations (8.2) ] .

Manufactured for Corstasis Therapeutics Inc., 3891 Ranchero Drive, Suite 150, Ann Arbor, MI 48108 Copyright © 2025 Corstasis Therapeutics Inc. All rights reserved

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 84387-0008-01 · ALLIED 84389-0000-00 · Privi →
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