Home › NDC Lookup › Ingredients › Desmopressin Acetate Oral Solution › 71863-0123-14
DESMODA Desmopressin Acetate Oral Solution .05 mg/mL Solution, 145 mL — NDC 71863-0123-14 package photo

DESMODA Desmopressin Acetate Oral Solution .05 mg/mL Solution, 145 mL

by Eton Pharmaceuticals, Inc. · 145 mL in 1 BOTTLE (71863-123-14)
NDC 71863-0123-14
🏷️ FDA NDC (as labeled) 71863-123-14 billing pads the product segment with a zero
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

🆔 Identity & classification

FDA NDC (as labeled) 71863-123-14
Product NDC 71863-123
11-digit billing NDC 71863012314
NCPDP billing unit ML — per mL (volume)
RxCUI 2738083, 2738090
UNII XB13HYU18U
UPC 0371863123145
Application # NDA219873
SPL Set ID 4c0e1356-d14f-cfb4-e063-6294a90acd27
Established class (EPC) Factor VIII Activator; Vasopressin Analog
Physiologic effect Increased Coagulation Factor VIII Activity; Increased Coagulation Factor VIII Concentration
Chemical class Vasopressins
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-03-02
Route ORAL
Dosage form SOLUTION
Substance DESMOPRESSIN ACETATE
GPI-14 30201010102065
GCN Seq No 088725
GCN 58877
HICL code 002841
Ingredient (HICL) Desmopressin Acetate
HIC1 code P
Therapeutic class — broad (HIC1) Endocrine System
HIC2 code P2
Therapeutic class — intermediate (HIC2) Posterior Pituitary Hormones
HIC3 code P2B
Therapeutic class — specific (HIC3) Antidiuretic And Vasopressor Hormones
AHFS code 20:28.16.00
AHFS class Hemostatics
FDB label name DESMODA 0.05 MG/ML ORAL SOLN
FDB brand name Desmoda
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 71863-123-14 — 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 → 71863-0123-14. 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 Vasopressin Analog class.

Pharmacologic class Vasopressin Analog, Factor VIII Activator
Drug family (ATC) Vasopressin and analogues
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

LabelerEton Pharmaceuticals, Inc.
Application holderETON PHARMACEUTICALS INC
FDA applicationNDA219873 (NDA)
Labeler code71863
First marketedMar 2026
Product typeHuman Prescription Drug
Portfolio16 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 DESMODA 0.05 MG/ML ORAL SOLN Ingredient Desmopressin Acetate
📗 Our plain-language guide HelloPharmacist
  • Your body normally makes a hormone that tells your kidneys to hold onto water so you don't lose too much in your urine. With central diabetes insipidus, your body isn't making enou...
  • What exactly is this medication doing for me — why do I need it?
  • This one matters more than you might think. A high-fat meal can cut the amount of desmopressin your body absorbs by a significant amount. Your prescriber will advise you on the bes...
  • Should I take it with food or on an empty stomach?
📖 Read our full Desmopressin guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

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

  • UNII 8SKN0B0MIM
    Benzoic acid is a naturally occurring organic acid used as a preservative in medicines and foods. It helps prevent bacterial and fungal growth to extend shelf life and maintain product stability.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

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

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

Inactive ingredient FAQ

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

💲 Pricing

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

Price systemPer 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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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
Desmoda .05 mg/mLthis 71863-0123-14 Eton 145 ml — — FDA listed —
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

🏛️
2026
First FDA approval
Feb 2026
📍
2026
Currently FDA-listed
listed with the FDA
🛡️
2044
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 Apr 2044. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Feb 25, 2026 RLD RS ⏳ ~17.5 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 12343372 — method of use (U-4432)
US 12214010 — drug product
2026 2028 2030 2032 2034 2036 2038 2040 2042 2044
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 (2)
PatentTypeUse codeExpires
US 12343372 ↗ Method of use U-4432 Apr 3, 2044
US 12214010 ↗ Drug product — Apr 3, 2044
Common questions
Is there a generic version of DESMODA 0.05 MG/ML ORAL SOLN?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for DESMODA 0.05 MG/ML ORAL SOLN. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Apr 2044 — 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
71863-0123-14 You're viewing this 145 mL in 1 BOTTLE (71863-123-14) 2026-03-02 Active

🧭 About this NDC listing & data coverage

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

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 71863-123-14, 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: 71863-0123-14, written without dashes as 71863012314. 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 71863-0123-14, the first segment (71863) is the labeler code FDA assigned to Eton Pharmaceuticals, Inc.; the middle segment (0123) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (14) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Eton Pharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Eton Pharmaceuticals, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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 📋 Description 💬 Medication Guide
🎯 Indications and Usage 75 words ▾

1 INDICATIONS AND USAGE DESMODA is indicated for the management of central diabetes insipidus as antidiuretic replacement therapy for adults and pediatric patients. Limitations of Use • DESMODA is not indicated for the treatment of nephrogenic diabetes insipidus. DESMODA is a vasopressin analog indicated for the management of central diabetes insipidus as antidiuretic replacement therapy for adults and pediatric patients.

Limitations of Use • DESMODA is not indicated for the treatment of nephrogenic diabetes insipidus.

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION

2.1Recommended Dosage for Central Diabetes Insipidus • Instruct patients about appropriate fluid restriction during DESMODA treatment due to risk of hyponatremia [see Warnings and Precautions (5.1)]. • Individualize the dosage of DESMODA for each patient and adjust the dosage according to the diurnal pattern of response. Estimate patient response by adequate duration of sleep and water turnover. • Recommended starting dosage of DESMODA for adults and pediatric patients is 0.05 mg orally twice daily. • Titrate the daily dosage as needed to obtain an adequate antidiuretic response. • Administer DESMODA on an empty stomach, at least 1 hour prior to or 2 hours after food. • Administer DESMODA using an oral syringe provided by the pharmacy. • Monitor response by measuring urine volume and osmolarity.

Monitoring measurements of plasma osmolarity may also be useful.

2.2Switching Patients with Central Diabetes Insipidus to DESMODA From Desmopressin Acetate Nasal Spray • For patients with central diabetes insipidus switching to DESMODA from desmopressin acetate nasal spray, wait twelve hours after the last dose. • Monitor patients closely during the initial dose titration period. Instruct patients about appropriate fluid restriction during DESMODA treatment due to risk of hyponatremia. (2.1) • Recommended starting dosage for adults and pediatric patients is 0.05 mg twice.

(2.1) • Titrate the daily dosage as needed to obtain an adequate antidiuretic response. (2.1) • Take DESMODA on an empty stomach, at least 1 hour before or 2 hours after food. (2.1) • Monitor response by measuring urine volume and osmolarity.

(2.1) • For patients with central diabetes insipidus switching to DESMODA from desmopressin acetate nasal spray, wait twelve hours after the last dose. Monitor patients closely during the initial dose titration period. (2.2)

💊 Dosage Forms and Strengths 28 words ▾

3 DOSAGE FORMS AND STRENGTHS Oral solution: 0.05 mg desmopressin acetate in 1 mL (0.05 mg/mL) Oral solution: 0.05 mg desmopressin acetate in 1 mL (0.05 mg/mL) (3)

⛔ Contraindications 98 words ▾

4 CONTRAINDICATIONS DESMODA is contraindicated in patients with: •Hyponatremia or a history of hyponatremia [see Warnings and Precautions (5.1)]. •Hypersensitivity to desmopressin acetate or any of the inactive ingredients of DESMODA.Reactions have included anaphylaxis [see Warnings and Precautions (5.3)]. •Moderate to severe renal impairment (defined as creatinine clearance (CLcr) less than 50 mL/min)[see Use in Specific Populations (8.6)]. • Hypersensitivity to desmopressin acetate or any of the inactive ingredients of DESMODA.

(4) • Patients with moderate to severe renal impairment defined as creatinine clearance below 50 mL/min. (4) • Patients with hyponatremia or a history of hyponatremia. (4)

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS

5.1Hyponatremia Excessive fluid intake when urine output is limited by the antidiuretic effect of desmopressin may lead to water intoxication with hyponatremia. Cases of hyponatremia have been reported from postmarketing experience in patients treated with desmopressin acetate. Unless properly diagnosed and treated hyponatremia can be fatal.

Observe all patients receiving DESMODA for the following signs or symptoms associated with hyponatremia: headache, nausea/vomiting, decreased serum sodium, weight gain, restlessness, fatigue, lethargy, disorientation, depressed reflexes, loss of appetite, irritability, muscle weakness, muscle spasms or cramps and abnormal mental status such as hallucinations, decreased consciousness and confusion. Severe symptoms due to an extreme decrease in serum sodium and plasma osmolality may include one or a combination of the following: seizure, coma and/or respiratory arrest.

In order to decrease the risk of water intoxication with hyponatremia, fluid restriction is recommended. Careful fluid intake is particularly important in pediatric and geriatric patients because these patients are at greater risk of developing hyponatremia [see Use in Specific Populations (8.4, 8.5)]. More frequent monitoring of serum sodium levels is recommended in the following patients: those with conditions associated with fluid and electrolyte imbalance, such as cystic fibrosis, heart failure, renal disorders, habitual or psychogenic polydipsia or those taking concomitant drugs that may cause hyponatremia [see Drug Interactions (7.1)].

Temporarily stop treatment with DESMODA during acute intercurrent illness characterized by fluid and/or electrolyte imbalance (e.g., systemic infections, fever, recurrent vomiting or diarrhea) or under conditions of extremely hot weather, vigorous exercise or other conditions associated with increased water intake.

5.2Fluid Retention Desmopressin acetate can cause fluid retention, which can worsen underlying conditions that are susceptible to volume status. Closely monitor patients with heart failure or uncontrolled hypertension. DESMODA is not recommended in patients at risk for increased intracranial pressure or those with a history of urinary retention.

5.3Hypersensitivity Reactions Hypersensitivity reactions including anaphylaxis have been reported with intravenous and nasal administration of desmopressin acetate, including cases of fatal anaphylaxis with intravenous desmopressin acetate [see Adverse Reactions (6)]. DESMODA is contraindicated in patients with a history of hypersensitivity to desmopressin acetate or any of the inactive ingredients of DESMODA [see Contraindications (4)]. If signs or symptoms of hypersensitivity reactions occur, discontinue DESMODA and initiate appropriate supportive care.

5.4Risk of Benzyl Alcohol Toxicity in Neonates DESMODA contains 2.74 mg/mL of benzoic acid, a metabolite of benzyl alcohol. Serious adverse reactions of metabolic acidosis, including fatalities, have been reported in low-birth-weight neonates (less than 2,500 grams) and preterm neonates (gestational age less than 34 weeks) who received benzyl alcohol-containing drugs intravenously. The relationship between systemic levels of benzoic acid and toxicity is not well-characterized [see Use in Specific Populations (8.4)].

Use DESMODA with caution in low-birth-weight neonates or preterm neonates and monitor for signs and symptoms of metabolic acidosis. • Hyponatremia: Excessive fluid intake when urine output is limited by the antidiuretic effect of desmopressin may lead to water intoxication with hyponatremia. Fluid restriction is recommended. (5.1) • Fluid Retention: Desmopressin acetate may cause fluid retention.

Use with caution in patients with heart failure or uncontrolled hypertension. DESMODA is not recommended in patients at risk for increased intracranial pressure or those with a history of urinary retention. (5.2) • Hypersensitivity: Severe reactions ha…

🤒 Adverse Reactions ~1 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in the labeling: •Hyponatremia [see Warnings and Precautions (5.1)] •Fluid Retention [see Warnings and Precautions (5.2)] •Hypersensitivity [see Warnings and Precautions (5.3)] •Risk of Benzyl Alcohol Toxicity in Neonates [see Warnings and Precautions (5.4)] The following adverse reactions associated with the use of desmopressin acetate were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cardiac disorders: hypertension Gastrointestinal disorders: nausea, vomiting, diarrhea, constipation, abdominal cramps General disorders: headache, malaise, drug ineffective, edema, fatigue Hepatobiliary disorders: transient increases in AST (1.5 times the upper limit of normal) Immune system disorders: severe allergic reactions, anaphylaxis has occurred with other formulations of desmopressin Metabolism and nutrition: dehydration, hyponatremia, water intoxication with hyponatremia Nervous system disorders: hyponatremic convulsions, hyponatremic convulsions associated with concomitant use of the following medications: oxybutynin and imipramine [see Drug Interactions (7.1)], asthenia, coma, disturbance in attention, psychomotor hyperactivity, dizziness, somnolence, depressed level of consciousness, falls.

Psychiatric disorders: confusional state, abnormal behavior, emotional disorder, depression, hallucination, insomnia Renal and urinary disorders: bladder and urethral symptoms, including urinary retention, urine flow decreased, dysuria Skin and subcutaneous tissue disorders: rash, dermatitis allergic, sweating, flushing, urticaria Respiratory, thoracic and mediastinal disorders: dyspnea, epistaxis In long-term clinical studies in which patients with diabetes insipidus were followed for periods up to 44 months of desmopressin acetate oral therapy, transient increases in AST (SGOT) no higher than 1.5 times the upper limit of normal were occasionally observed.

Elevated AST (SGOT) returned to the normal range despite the continued use of desmopressin acetate oral therapy. Most common adverse reactions include: headache, dizziness, nausea, abdominal pain, hypertension, and diarrhea. (6) To report SUSPECTED ADVERSE REACTIONS, contact Eton Pharmaceuticals, Inc. at 1-855-224-0233 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 142 words ▾

7 DRUG INTERACTIONS

7.1Other Drugs that may Increase Risk of Hyponatremia Concomitant administration of DESMODA with other drugs that may increase the risk of water intoxication with hyponatremia, (e.g., tricyclic antidepressants, selective serotonin re-uptake inhibitors, chlorpromazine, opiate analgesics, thiazide diuretics, NSAIDs, lamotrigine, sulfonylureas, particularly chlorpropamide, oxybutynin and carbamazepine). Monitor serum sodium more frequently in patients taking DESMODA concomitantly with these drugs and when doses of these drugs are increased [see Warnings and Precautions (5.1), Adverse Reactions (6)].

7.2Other Vasoconstrictors Desmopressin acetate can elevate blood pressure. Use of large doses of DESMODA with other vasoconstrictors may require a reduction of the DESMODA dosage [see Adverse Reactions (6)]. • Drugs that may Increase Risk of Hyponatremia: Requires more frequent monitoring of serum sodium. (7.1) • Other Vasoconstrictors : Concomitant use may elevate blood pressure and require a reduction in DESMODA dosage. (7.2)

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS • Pediatric Use: Use requires careful fluid restriction to prevent hyponatremia with water intoxication. (5.1, 8.4) • Geriatric Use: Carefully select dose and monitor renal function; restrict fluid intake to prevent hyponatremia with water intoxication. (5.1, 8.5) • Renal Impairment : The risk of adverse reactions may be greater in patients with renal impairment, compared to patients with normal renal function.

(8.6) See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. Revised: 02/2026

8.1Pregnancy Risk Summary Available data on the use of desmopressin acetate during pregnancy over decades of use have not identified a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks associated with untreated central diabetes insipidus during pregnancy (see Clinical Considerations). In vitro studies with human placenta demonstrate poor placental transfer of desmopressin.

No adverse developmental outcomes were observed in animal reproduction studies with administration of desmopressin during organogenesis to pregnant rats and rabbits at doses approximately <1 to 38 times, respectively, the maximum recommended human dose based on body surface areas (mg/m2) (see Data). The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease Associated Maternal and Embryo-Fetal Risk There are risks associated with untreated central diabetes insipidus during pregnancy such as dehydration, preterm birth and oligohydramnios. Pregnant patients with diabetes insipidus should be monitored for electrolyte imbalance, maternal hypotension, and low amniotic fluid levels.

Data Animal Data In a developmental toxicity study in rats, desmopressin acetate was administered intravenously at doses of 9.68, 48.4, or 241 mcg/kg/day during the period of organogenesis (gestations days 7 to 17). Laparohysterectomy for fetal examinations were conducted on gestation day 20 for twenty females in each group; the remaining 10 females were allowed to litter in order to determine any postnatal effects that might be attributable to pre-natal treatment. No effects were seen on maternal and fetal survival, growth and morphology or post-natal offspring survival, growth, development, behavior and reproductive performance up to 241 mcg/kg/day (4 times a 0.6 mg dose received by a 60 kg patient based on body surface area).

In an embryo-fetal development study and a pre- and postnatal development study in rabbits, desmopressin acetate was administered subcutaneously at doses of 2, 20 or 200 mcg/kg/day (embryo-fetal development) and 0.1, 1 or 10 mcg/kg/day (pre- and postnatal development) during the period of organogenesis (gestation days 6 to 18). No effects on maternal and fetal survival or morphology were observed in both studies at doses of up to 200 mcg/kg/day (6.5 times a 0.6 mg dose received by a 60 kg patient based on body surface area) nor were there effects in the pre- and postnatal development study on parturition, postnatal survival, growth, development or behavior, up to the highest dose tested of 10 mcg/kg/day (0.3 times a 0.6 mg dose received by a 60 kg patient, based on body surface area).

8.2Lactation Risk Summary Breastfeeding is not expected to result in clinically relevant exposure of the infant to desmopressin following maternal administration. Desmopressin is transferred into human breastmilk at negligible amounts (see Data). There is no information on the effects of desmopressin on the breastfed infant or on milk production.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Available data on the use of desmopressin acetate during pregnancy over decades of use have not identified a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks associated with untreated central diabetes insipidus during pregnancy (see Clinical Considerations). In vitro studies with human placenta demonstrate poor placental transfer of desmopressin.

No adverse developmental outcomes were observed in animal reproduction studies with administration of desmopressin during organogenesis to pregnant rats and rabbits at doses approximately <1 to 38 times, respectively, the maximum recommended human dose based on body surface areas (mg/m2) (see Data). The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease Associated Maternal and Embryo-Fetal Risk There are risks associated with untreated central diabetes insipidus during pregnancy such as dehydration, preterm birth and oligohydramnios. Pregnant patients with diabetes insipidus should be monitored for electrolyte imbalance, maternal hypotension, and low amniotic fluid levels.

Data Animal Data In a developmental toxicity study in rats, desmopressin acetate was administered intravenously at doses of 9.68, 48.4, or 241 mcg/kg/day during the period of organogenesis (gestations days 7 to 17). Laparohysterectomy for fetal examinations were conducted on gestation day 20 for twenty females in each group; the remaining 10 females were allowed to litter in order to determine any postnatal effects that might be attributable to pre-natal treatment. No effects were seen on maternal and fetal survival, growth and morphology or post-natal offspring survival, growth, development, behavior and reproductive performance up to 241 mcg/kg/day (4 times a 0.6 mg dose received by a 60 kg patient based on body surface area).

In an embryo-fetal development study and a pre- and postnatal development study in rabbits, desmopressin acetate was administered subcutaneously at doses of 2, 20 or 200 mcg/kg/day (embryo-fetal development) and 0.1, 1 or 10 mcg/kg/day (pre- and postnatal development) during the period of organogenesis (gestation days 6 to 18). No effects on maternal and fetal survival or morphology were observed in both studies at doses of up to 200 mcg/kg/day (6.5 times a 0.6 mg dose received by a 60 kg patient based on body surface area) nor were there effects in the pre- and postnatal development study on parturition, postnatal survival, growth, development or behavior, up to the highest dose tested of 10 mcg/kg/day (0.3 times a 0.6 mg dose received by a 60 kg patient, based on body surface area).

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use Desmopressin acetate is indicated for the management of central diabetes insipidus as antidiuretic replacement therapy in pediatric patients. Use in pediatric patients requires careful fluid intake restriction to prevent possible water intoxication with hyponatremia. In younger pediatric patients, the dose must be individually adjusted to prevent an excessive decrease in plasma osmolality leading to hyponatremia and possible convulsions.

Fluid restriction should be discussed with the patient and/or guardian [see Warnings and Precautions (5.2)]. DESMODA contains benzoic acid, a metabolite of benzyl alcohol. Serious adverse reactions, including fatal reactions, of new onset or worsening metabolic acidosis that progressed to neurotoxicity, and in some cases gasping syndrome, have been reported in low-birth weight neonates and preterm neonates who received benzyl alcohol-containing drugs intravenously (DESMODA is not approved for intravenous use [see Dosage and Administration (2.1)]).

Gasping syndrome is a life-threatening condition in neonates caused by benzyl alcohol toxicity that is characterized by new onset or worsening metabolic acidosis with gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and kidney failure, hypotension, bradycardia, and gasping respirations followed by death. In reported cases, benzyl alcohol in amounts of 99 to 234 mg/kg/day produced blood BA levels of 6.6 to 14.9 mg/dL, but the minimum amount of benzyl alcohol at which gasping syndrome may occur in neonates is not known [see Warnings and Precautions (5.4)].

The rate at which benzyl alcohol is metabolized to benzoic acid cannot be reliably predicted, and the relationship between systemic levels of benzoic acid and toxicity is not well-characterized. DESMODA contains 2.74 mg of benzoic acid per mL [see Warnings and Precautions (5.4)].

🧓 Geriatric Use 54 words ▾

8.5Geriatric Use Because geriatric patients are more likely to have decreased renal function, care should be taken in dose selection and monitoring renal function is recommended [see Clinical Pharmacology (12.3)]. Use of DESMODA in geriatric patients requires careful fluid intake restriction to prevent possible water intoxication with hyponatremia [see Warnings and Precautions (5.1)].

🆘 Overdosage 64 words ▾

10 OVERDOSAGE Signs of overdose may include confusion, drowsiness, continuing headache, problems with passing urine and rapid weight gain due to fluid retention [see Warnings and Precautions (5.1)]. In case of overdosage, reduce the dosage, decrease the frequency of administration, or discontinue the DESMODA. There is no known specific antidote for desmopressin acetate. The patient should be observed and treated with appropriate symptomatic therapy.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY -

12.1Mechanism of Action Desmopressin acetate’s primary pharmacodynamic action involves its binding to vasopressin 2 (V2) receptors. V2 receptors are primarily located in the distal convoluted tubule and collecting ducts of the nephron in the kidneys. These receptors play a crucial role in regulating water reabsorption and urine concentration.

By influencing the permeability of the renal tubules, V2 receptors help maintain the body’s water balance and overall homeostasis.

12.2Pharmacodynamics Dose response studies in patients with diabetes insipidus following desmopressin acetate tablets 0.025 mg to 0.4 mg produced clinically significant antidiuretic effects. In most patients, doses of 0.1 mg to 0.2 mg produced optimal antidiuretic effects lasting up to eight hours. With doses of 0.4 mg, antidiuretic effects were observed for up to 12 hours; measurements beyond 12 hours were not recorded.

Following administration of desmopressin acetate tablets, the onset of antidiuretic effect occurs at around 1 hour, and it reaches a maximum at about 4 to 7 hours based on the measurement of increased urine osmolality.

12.3Pharmacokinetics Following a single oral administration of DESMODA in healthy subjects at 0.6 mg, mean maximum concentration (SD) is 82 (33) pg/mL, and mean total systemic exposure (SD) is 314 (138) (hrs∙pg/mL). Absorption Desmopressin absolute oral bioavailability is 0.16%. Desmopressin area under the plasma drug concentration time curve (AUC) is reduced by 95% following administration of the oral solution compared to the intranasal formulation.

Effect of Food DESMODA Cmax was decreased 72% and the AUC was decreased 64% following administration of 0.6 mg DESMODA with a high-fat meal (1000 calories, 50% fat). Distribution DESMODA mean apparent (oral) volume of distribution (SD) is 11717 (5086) L. Elimination Desmopressin is mainly excreted in the urine.

Desmopressin estimated elimination half-life is 3.6 hours. DESMODA mean apparent (oral) clearance (SD) is 2264 (940) L/hr. Specific Populations Renal Impairment A pharmacokinetic study was conducted in subjects with normal renal function and patients with mild, moderate, and severe renal impairment (n=24, 6 subjects each group) with a single dose of 2 mcg desmopressin acetate intravenous injection.

The geometric mean terminal half-life was 2.8 hours in subjects with normal renal function, and 4, 6.6, and 8.7 hours in patients with mild, moderate, and severe renal impairment, respectively. In patients with mild, moderate and severe renal impairment, mean desmopressin AUC was 1.5-fold, 2.4-fold and 3.6-fold higher, respectively, compared to that of subjects with normal renal function.

🧬 Mechanism of Action 68 words ▾

12.1Mechanism of Action Desmopressin acetate’s primary pharmacodynamic action involves its binding to vasopressin 2 (V2) receptors. V2 receptors are primarily located in the distal convoluted tubule and collecting ducts of the nephron in the kidneys. These receptors play a crucial role in regulating water reabsorption and urine concentration.

By influencing the permeability of the renal tubules, V2 receptors help maintain the body’s water balance and overall homeostasis.

📦 How Supplied / Storage and Handling 77 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied DESMODA (desmopressin acetate) oral solution is a clear, colorless to slightly yellow colored solution supplied in an amber glass bottle: Strength Volume in Bottle NDC 0.05 mg/mL 145 mL 71863-123-14 Storage and Handling Store at 2°C to 25°C (36°F to 77°F). Excursions permitted to 30°C (86°F) [see USP refrigerated and controlled room temperature]. Do not freeze.

Discard any unused DESMODA oral solution after 120 days after first opening the bottle.

📋 Description 132 words ▾

11 DESCRIPTION DESMODA oral solution contains active moiety desmopressin, an analog of natural pituitary hormone 8-arginine vasopressin (antidiuretic hormone), in the form of acetate salt. The chemical name of desmopressin acetate is 1-desamino-8-D-arginine vasopressin acetate. Desmopressin acetate has a molecular weight of 1129.30 g/mol, an empirical formula of C 46 H 64 N 14 O 12 S 2 ·C 2 H 4 O 2 , and structural formula: Desmopressin acetate is white amorphous powder and is soluble in water.

DESMODA oral solution: Each mL contains 0.05 mg of desmopressin acetate (equivalent to 0.047 mg of desmopressin free base) as active ingredient. The inactive ingredients include benzoic acid and sodium benzoate as buffering agents and antimicrobial agents, and purified water. The pH of the oral solution is 4.8 to 5.2.

Desmoda Structural Formula

💬 Medication Guide ~3 min read ▾

Medication Guide DESMODA TM (des-MOH-duh) (desmopressin acetate) oral solution What is the most important information I should know about DESMODA? DESMODA may cause serious side effects, including: Low levels of salt (sodium) in the blood (hyponatremia). Hyponatremia has happened in people taking desmopressin acetate, an ingredient in DESMODA.

Drinking excessive fluids during treatment with DESMODA may lead to water toxicity with hyponatremia. Hyponatremia can lead to death if not treated. Talk to your healthcare provider about fluid limits during treatment with DESMODA. • Do not drink more than you need to satisfy your thirst.

You can have serious side effects such as seizures, coma, and death from drinking too much fluid. • Children and the elderly are at higher risk for these problems and should follow their healthcare provider’s limits on drinking fluids. • Tell your healthcare provider if you have any of the following signs or symptoms: • headache • restlessness • loss of appetite • nausea or vomiting • tiredness • irritability • decreased sodium levels in the blood • lack of energy • muscle weakness • weight gain • disorientation • muscle spasms or cramps • abnormal mental status (hallucinations, decreased consciousness, or confusion) • weakened reflexes Your healthcare provider will change the dose of DESMODA depending on your response.

Tell your healthcare provider if you cannot swallow medicines by mouth. People who have taken desmopressin acetate nasal spray previously should start taking the oral solution twelve hours after the last nasal spray dose. Your healthcare provider should monitor you closely during this period.

Your healthcare provider may monitor your sodium levels during your treatment with DESMODA. See “What are the possible side effects of DESMODA?” for more information about side effects. What is DESMODA?

DESMODA is a prescription medicine that contains the medicine desmopressin acetate. Desmopressin acetate is an antidiuretic, also known as vasopressin. DESMODA (desmopressin acetate) is a man-made (synthetic) prescription drug used to replace the body’s antidiuretic hormone to manage central diabetes insipidus in adults and children.

DESMODA is not effective in the treatment of diabetes insipidus related to kidney disease (nephrogenic diabetes insipidus). Who should not take DESMODA? Do not take DESMODA if you: • have or have had low levels of sodium in the blood. • are allergic to desmopressin acetate or any of the ingredients in DESMODA.

See the end of this Medication Guide for a complete list of ingredients in DESMODA. • have moderate to severe kidney problems. Before you take DESMODA, tell your healthcare provider about all of your medical conditions, including if you: • have heart failure or blood circulation problems. • are thirsty much of the time and drink excessive amounts of fluids (polydipsia). • have or have had low levels of sodium in your blood. • have high blood pressure that is not controlled. • have increased pressure in your brain (increased intracranial pressure). • have had problems with emptying your bladder (urinary retention). • are pregnant or plan to become pregnant.

It is not known if DESMODA will harm your unborn baby. • are breastfeeding or plan to breastfeed. DESMODA can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take DESMODA.

Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines, food and drink can affect the way that DESMODA works and may mean that your healthcare provider needs to change the prescribed dose of DESMODA. How should I take DESMODA? • Take DESMODA exactly as your healthcare provider tells you to take it. • Take DESMODA by mouth on an empty stomach, at least 1 hour before or 2 hours after food. • Take DESMODA using the oral syringe provided by the pharmacy. • Do not stop taking DESMO…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 71863-0122-60 · Eton 71863-0124-25 · Eton →
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.