HomeNDC LookupIngredientsDesmopressin Acetate › 68682-0342-05
Desmopressin Acetate .1 mg/mL Solution — NDC 68682-0342-05 package photo

Desmopressin Acetate .1 mg/mL Solution

by Oceanside Pharmaceuticals · 1 BOTTLE, PUMP in 1 CARTON (68682-342-05) / 5 mL in 1 BOTTLE, PUMP
NDC 68682-0342-05
🏷️ FDA NDC (as labeled) 68682-342-05 billing pads the product segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Aug 6, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 68682-342-05
Product NDC 68682-342
11-digit billing NDC 68682034205
NCPDP billing unit ML — per mL (volume)
RxCUI 849506
UNII XB13HYU18U
Application # ANDA074830
SPL Set ID 8034989a-45f5-436b-8b1f-42108ee2a21a
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 ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-06-01
Marketing end 2028-01-31
Route NASAL
Dosage form SOLUTION
Substance DESMOPRESSIN ACETATE
GCN Seq No 006614
GCN 26173
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 DESMOPRESSIN 0.01% SOLUTION
FDB brand name Desmopressin Acetate
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 68682-342-05 — 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 → 68682-0342-05. 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

LabelerOceanside Pharmaceuticals
Application holderBAUSCH HEALTH US LLC
FDA applicationANDA074830 (ANDA)
Labeler code68682
First marketedJun 2025
Product typeHuman Prescription Drug
Portfolio87 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 DESMOPRESSIN 0.01% SOLUTION Ingredient Desmopressin Acetate
📖 What it is MedlinePlus · NLM

Desmopressin nasal (DDAVP®) is used to control the symptoms of a certain type of diabetes insipidus ('water diabetes'; condition in which the body produces an abnormally large amount of urine). Desmopressinnasal (DDAVP®) is also used to control excessive thirst and the passage of an abnormally large amount of urine that may occur after a head injury or after certain types of surgery. Desmopressin nasal (Noctiva®) is used to control frequent nighttime urination in adults who awaken at least 2 times per night to urinate. Desmopressin nasal (Stimate®) is used to stop some types of bleeding in peo...

Read the full MedlinePlus article ↗
📗 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 →
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 HM4YQM8WRC
    Chlorobutanol is a colorless crystalline chemical used as a preservative in medicines. It prevents bacterial and fungal growth to maintain product safety and shelf life.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • 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.

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

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

Inactive ingredient FAQ

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

💲 Pricing

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

Price systemPer 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 $22.67 $113.34 / 5 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
Desmopressin Acetate 10 ug 60505-0815-00 Apotex 1 bottle $9.282 AB Availability likely
Desmopressin Acetate .1 mg/mL 24208-0342-05 Bauch 1 bottle $23.917 AB FDA listed
Desmopressin Acetate .1 mg/mLthis 68682-0342-05 Oceanside 1 bottle AB FDA listed
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2025
On the market since
Jun 2025
📍
2026
Currently FDA-listed
1 year listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

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

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

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

Medicare Part D (outpatient prescription) spending for Desmopressin Acetate — the program that covers self-administered drugs. 12 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Desmopressin Acetate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$3.68M
Claims incl. refills
49.8K
Beneficiaries
27.1K
Spend / beneficiary
$135.80
Spend / claim
$73.95
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 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 Desmopressin Acetate — the ingredient across all brands.

Top reported reactions

Hyponatraemia357
Headache268
Nausea204
Fatigue173
Vomiting155
Dizziness138
Diarrhoea117

Age at onset

Neonate5
Infant6
Child46
Adolescent61
Adult175
Elderly84

Reporter sex

3,776 reports
Male · 44%
Female · 56%
Unknown · 0%

Serious outcomes

Hospitalization1,368
Life-threatening233
Disabling74
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 256 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
68682-0342-05 You're viewing this 1 BOTTLE, PUMP in 1 CARTON (68682-342-05) / 5 mL in 1 BOTTLE, PUMP 2025-06-01 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 68682-342-05, 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: 68682-0342-05, written without dashes as 68682034205. 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 68682-0342-05, the first segment (68682) is the labeler code FDA assigned to Oceanside Pharmaceuticals; the middle segment (0342) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (05) 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 it is currently marketed — but Oceanside Pharmaceuticals has reported a marketing end date of 2028-01-31, after which this package is expected to stop being marketed. The directory data on this page refreshes weekly.
Who lists this product with the FDA?
Oceanside Pharmaceuticals 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 ~1 min read

1 INDICATIONS AND USAGE Desmopressin nasal spray solution is indicated as antidiuretic replacement therapy in the management of central diabetes insipidus in adults and pediatric patients 4 years of age and older. Limitations of Use: Desmopressin nasal spray solution is not indicated for: Treatment of nephrogenic diabetes insipidus, Treatment of primary nocturnal enuresis [ see Warnings and Precautions (5.1) ], Use in patients with conditions that compromise the intranasal route of administration (e.g., severe nasal congestion and blockage, nasal mucosa atrophy, severe atrophic rhinitis, recent nasal surgery such as transsphenoidal hypophysectomy) [see Warnings and Precautions (5.2) ], Use in patients with an impaired level of consciousness, Use in patients requiring doses less than 10 mcg or doses that are not multiples of 10 mcg [see Dosage Forms and Strengths ( 3 )] Desmopressin nasal spray solution is a vasopressin analog indicated as antidiuretic replacement therapy in the management of central diabetes insipidus for adults and pediatric patients 4 years of age and older.

( 1 ) Limitations of Use: Desmopressin nasal spray solution is not indicated for: Treatment of nephrogenic diabetes insipidus ( 1 ) Treatment of primary nocturnal enuresis ( 1 , 5.1 ) Use in patients with conditions that compromise intranasal route of administration ( 1 , 5.2 ) Use in patients with an impaired level of consciousness ( 1 ) Use in patients requiring doses less than 10 mcg or doses that are not multiples of 10 mcg ( 1 , 3 )

⏱️ Dosage and Administration ~3 min read

2 DOSAGE AND ADMINISTRATION For intranasal use only ( 2.1 ) Instruct patients to prime pump prior to use ( 2.1 ) Adults: 10 mcg to 40 mcg daily (either as a single dose or divided into two or three daily doses) ( 2.2 ) Pediatrics: 10 mcg once daily into one nostril up to 30 mcg once daily (or 30 mcg divided as 20 mcg during the morning and 10 mcg at night) ( 2.2 ) See the Full Prescribing Information for recommendations for switching between desmopressin acetate formulations ( 2.3 )

2.1Important Administration Instructions Administer desmopressin nasal spray solution by intranasal use only. Instruct patients about appropriate fluid restriction during desmopressin nasal spray solution treatment [see Warnings and Precautions (5.1) ]. Must prime the spray pump prior to the first use.

Instruct patients to: Prime pump by pressing down on pump five times (if the spray pump is not used for one week, re-prime the pump by pressing down on the pump once). Discard desmopressin nasal spray solution after 50 sprays since the amount delivered thereafter may be substantially less than the recommended dosage.

2.2Recommended Dosage The use of desmopressin nasal spray solution is not indicated for patients who require less than 10 mcg doses or doses that are not multiples of 10 mcg because the spray pump can only deliver doses of 10 mcg [see Indications and Usage ( 1 )] . If other doses are required, use another desmopressin acetate product. Individualize the dosage of desmopressin nasal spray solution for each patient with particular attention in pediatric and elderly patients and adjust according to the diurnal pattern of response to limit nocturia and to ensure fluid intake with respect to urine output is not excessive [see Warnings and Precautions (5.1) ].

Monitor continued response to desmopressin nasal spray solution by urine volume and osmolality to ensure adequate diuresis to limit the risk of hyponatremia, and include measurements of serum sodium and plasma osmolality as needed. Adults The recommended dosage in adults is 10 mcg once daily into one nostril up to 40 mcg once daily (or 40 mcg divided into two or three daily doses). If administered more than once a day, adjust for an adequate diurnal rhythm of urine output.

Pediatric Patients For pediatric patients requiring doses less than 10 mcg, desmopressin nasal spray solution is not indicated. For pediatric patients 4 years of age and older, the recommended starting dosage of desmopressin nasal spray solution is 10 mcg once daily into one nostril. The dose can be titrated up to 30 mcg once daily (or 30 mcg divided into two daily doses, typically with 20 mcg given in the morning and 10 mcg given at nighttime).

If administered more than once a day, adjust for an adequate diurnal rhythm of urine output. Because administration of desmopressin acetate can be associated with decreased responsiveness with prolonged use, consider increasing the dosage of desmopressin nasal spray solution if patients demonstrate decreased response over a long period of time.

2.3Switching Between Desmopressin Acetate Formulations When switching from the desmopressin acetate injection to desmopressin nasal spray solution, administer 10 times the amount of desmopressin acetate, rounding down to the nearest 10 mcg. When switching from the desmopressin acetate tablets to desmopressin nasal spray solution, individual dose titration is required because intranasal desmopressin is approximately 10 to 40 fold more potent than oral (tablet) desmopressin.

💊 Dosage Forms and Strengths 62 words

3 DOSAGE FORMS AND STRENGTHS Desmopressin Nasal Spray Solution, USP pump delivers 10 mcg (0.1 mL) of desmopressin acetate per spray. Desmopressin Nasal Spray Solution, USP is available as a 5 mL bottle with spray pump delivering 50 sprays. Nasal Spray: 10 mcg per 0.1 mL spray, available in a 5 mL bottle with spray pump delivering 50 sprays ( 3 )

Contraindications 128 words

4 CONTRAINDICATIONS Desmopressin nasal spray solution is contraindicated in patients with: Known hypersensitivity to desmopressin acetate or to any of the components of desmopressin nasal spray solution. Severe allergic reactions and anaphylaxis have been reported [see Adverse Reactions ( 6 )]. Renal impairment defined as estimated creatinine clearance (CLcr) by Cockcroft-Gault equation less than 50 mL/min [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3) ] .

Hyponatremia or a history of hyponatremia [see Warnings and Precautions (5.1) ] . Known hypersensitivity to desmopressin acetate or to any of the components of desmopressin nasal spray solution ( 4 , 6 ) Patients with renal impairment (creatinine clearance below 50 mL/min) ( 4 , 8.6 , 12.3 ) Hyponatremia or a history of hyponatremia ( 4, 5.1 )

⚠️ Warnings and Cautions ~2 min read

5 WARNINGS AND PRECAUTIONS Hyponatremia: Instruct patients about proper fluid restriction and monitor serum sodium as needed ( 2.1 , 5.1 ) Altered Absorption in Patients with Nasal Mucosa Abnormalities: May occur with chronic administration, and require use of other formulations instead ( 5.2 )

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.

All patients receiving desmopressin nasal spray solution should be observed for the following signs or symptoms associated with hyponatremia: headache, nausea/vomiting, decreased serum sodium, weight gain, restlessness, fatigue, lethargy, disorientation, depressed reflexes, loss 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 restriction 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) ].

Desmopressin nasal spray solution is not an indicated formulation for the treatment of primary nocturnal enuresis due to a higher risk of hyponatremia and hyponatremic convulsions with the use of the nasal spray formulation compared to desmopressin tablets seen in postmarketing reports [see Indications and Usage ( 1 )].

5.2Altered Absorption in Patients with Nasal Mucosa Abnormalities Chronic administration of desmopressin nasal spray solution may result in changes to nasal mucosa. Nasal mucosa abnormalities (such as scarring and edema) due to chronic administration, or due to other causes (nasal blockage, nasal mucosal atrophy, severe atrophic rhinitis, recent nasal surgery such as transsphenoidal hypophysectomy) may cause erratic, unreliable absorption. Avoid use of desmopressin nasal spray solution in such patients [see Indications and Usage ( 1 )] and consider use of other formulations of desmopressin acetate given by other routes of administration.

🤒 Adverse Reactions 183 words

6 ADVERSE REACTIONS The following serious reactions are described below and elsewhere in the labeling: Hyponatremia [see Warnings and Precautions (5.1) ]. Altered Absorption in Patients with Changes in Nasal Mucosa [see Warnings and Precautions (5.2) ] . The following adverse reactions have been identified during post-approval use of desmopressin acetate.

Because these reactions are 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: Increase in blood pressure, headache, nasal congestion, rhinitis, nosebleed, sore throat, cough, upper respiratory infections, nausea, flushing, and abdominal cramps. Water intoxication with hyponatremia. Hyponatremic convulsions associated with concomitant use of the following medications: oxybutynin and imipramine [see Drug Interactions (7.1) ] .

Severe allergic reactions and anaphylaxis [see Contraindications (4) ]. Adverse reactions that have been identified in patients administered desmopressin nasal spray solution are headache, nasal congestion, rhinitis, nosebleed, sore throat, cough, upper respiratory infections, nausea, flushing, and mild abdominal cramps. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Oceanside Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 142 words

7 DRUG INTERACTIONS Drugs that 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 desmopressin acetate nasal spray solution dosage ( 7.2 )

7.1Other Drugs that may Increase Risk of Hyponatremia The concomitant administration of desmopressin nasal spray solution 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, NSAIDs, lamotrigine, oxybutynin and carbamazepine) requires more frequent serum sodium monitoring [see Warnings and Precautions (5.1) and Adverse Reactions ( 6 )] .

7.2Other Vasoconstrictors Desmopressin acetate can elevate blood pressure. Use of large doses of desmopressin nasal spray solution with other vasoconstrictors may require a reduction of the desmopressin nasal spray solution dosage [see Adverse Reactions ( 6 )].

👥 Use in Specific Populations ~3 min read

8 USE IN SPECIFIC POPULATIONS Pediatric Use: Use requires careful fluid intake restriction to prevent hyponatremia with water intoxication ( 5.1 , 8.4 ) Geriatric Use : Carefully monitor renal function; restrict fluid intake to prevent hyponatremia with water intoxication ( 5.1 , 8.5 )

8.1Pregnancy Risk Summary Prolonged experience with desmopressin in pregnant women over several decades, based on the available published data and case reports, did not identify a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In addition, 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 and 38 times, respectively, the maximum recommended human dose based on body surface area (mg/m 2 ) (see Data).

The estimated background risk of major birth defects and miscarriage for the indicated population are unknown. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data Desmopressin acetate at up to 50 ng/kg/day was given by subcutaneous injection to pregnant rats, from gestation day 1 to 20 during the period of early embryonic development and organogenesis without teratogenic effects.

Desmopressin acetate at up to 10 mcg/kg/day was given to pregnant rabbits by subcutaneous injection from gestation day 6 to 18 during fetal organogenesis without teratogenic effects. These doses of desmopressin acetate represent approximately <1 times (rat) and 38 times (rabbit) the maximum recommended human dose based on body surface area (mg/m 2 ).

8.2Lactation Risk Summary Breastfeeding is not expected to result in clinically relevant exposure of the infant to desmopressin following maternal intranasal administration. Desmopressin is poorly 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 desmopressin nasal spray solution and any potential adverse effects on the breastfed infant from desmopressin nasal spray solution or from the underlying maternal condition. Data A trial was conducted in six healthy lactating women, at greater than 4 months postpartum, to evaluate intranasal administration of 300 mcg single dose of another desmopressin product (7.5 times the recommended adult dose of desmopressin nasal spray solution).

Samples of maternal plasma and breastmilk were obtained at 0, 30, 60, 120, 240, 360 and 480 min after the drug administration. At 8 hours after dose intake, the levels in the milk ranged between 4.16 and 101 pg/ml, and the plasma levels ranged between 40 and 242 pg/ml. The total amount of desmopressin present in the milk over the 8 hours ranged between 491 pg and 16 ng, which corresponds to 0.0001 - 0.005% of the administered dose to the breastfeeding mother.

8.4Pediatric Use Desmopressin nasal spray solution is indicated as antidiuretic replacement therapy in the management of central diabetes insipidus in pediatric patients 4 years of age and older. Desmopressin nasal spray solution is not indicated in pediatric patients less than 4 years of age. Use of desmopressin nasal spray solution in pediatric patients 4 years of age and older is supported by evidence from adults and pediatric patients with central diabetes insipidus.

Use in pediatric patients requires careful fluid intake restriction to prevent possible water intoxication with hyponatremia [see Warnings and Precautions (5.1 )].

8.5Geriatric Use Clinical studies of desmopressin nasal spray solution did not include sufficient numbers of subjects aged 65 a…

🤰 Pregnancy ~1 min read

8.1Pregnancy Risk Summary Prolonged experience with desmopressin in pregnant women over several decades, based on the available published data and case reports, did not identify a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In addition, 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 and 38 times, respectively, the maximum recommended human dose based on body surface area (mg/m 2 ) (see Data).

The estimated background risk of major birth defects and miscarriage for the indicated population are unknown. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data Desmopressin acetate at up to 50 ng/kg/day was given by subcutaneous injection to pregnant rats, from gestation day 1 to 20 during the period of early embryonic development and organogenesis without teratogenic effects.

Desmopressin acetate at up to 10 mcg/kg/day was given to pregnant rabbits by subcutaneous injection from gestation day 6 to 18 during fetal organogenesis without teratogenic effects. These doses of desmopressin acetate represent approximately <1 times (rat) and 38 times (rabbit) the maximum recommended human dose based on body surface area (mg/m 2 ).

🧒 Pediatric Use 95 words

8.4Pediatric Use Desmopressin nasal spray solution is indicated as antidiuretic replacement therapy in the management of central diabetes insipidus in pediatric patients 4 years of age and older. Desmopressin nasal spray solution is not indicated in pediatric patients less than 4 years of age. Use of desmopressin nasal spray solution in pediatric patients 4 years of age and older is supported by evidence from adults and pediatric patients with central diabetes insipidus.

Use in pediatric patients requires careful fluid intake restriction to prevent possible water intoxication with hyponatremia [see Warnings and Precautions (5.1 )].

🧓 Geriatric Use 129 words

8.5Geriatric Use Clinical studies of desmopressin nasal spray solution did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at a low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or drug therapy. Because elderly patients are more likely to have renal impairment, care should be taken in dose selection, and monitoring renal function is recommended [see Contraindications (4) , Use in Specific Populations (8.6) ].

Use of desmopressin nasal spray solution in geriatric patients requires careful fluid intake restriction to prevent possible water intoxication with hyponatremia [see Warnings and Precautions (5.1) ].

🆘 Overdosage 58 words

10 OVERDOSAGE Signs of desmopressin acetate overdosage 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 desmopressin nasal spray solution. There is no known specific antidote for desmopressin acetate.

🧬 Clinical Pharmacology ~1 min read

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The antidiuretic effects of desmopressin are mediated by stimulation of vasopressin 2 (V2) receptors, thereby increasing water re-absorption in the kidney, and hence reducing urine production. Desmopressin is a replacement hormone for antidiuretic hormone in the treatment of central diabetes insipidus. The change in structure of arginine vasopressin to desmopressin acetate resulted in a decreased vasopressor action and decreased actions on visceral smooth muscle relative to the enhanced antidiuretic activity, so that clinically effective antidiuretic doses were usually below threshold levels for effects on vascular or visceral smooth muscle.

12.2Pharmacodynamics The use of desmopressin nasal spray solution in patients with central diabetes insipidus reduces urinary output, increases urine osmolality, and decreases plasma osmolality.

12.3Pharmacokinetics Absorption: Desmopressin acetate is absorbed through the nasal mucosa. Elimination: Desmopressin acetate exhibits a biphasic elimination profile, with half-lives of 7.8 and 75.5 minutes for the initial and terminal phases, respectively. Specific Populations Renal Impairment : Desmopressin acetate is mainly excreted in the urine.

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 2 mcg dose of desmopressin acetate injection (this results in approximately 20 times the exposure of 10 mcg of desmopressin nasal spray solution). The terminal half-life was 2.8 hours in subjects with normal renal function, 4.0 hours in mild renal impairment, 6.6 hours in moderate renal impairment and 8.7 hours in severe renal impairment.

In patients with mild, moderate and severe renal impairment, mean desmopressin exposure was 1.5 fold, 2.4 fold and 3.6 fold higher, respectively compared to that of subjects with normal renal function [see Contraindications (4) , Use in Specific Populations (8.6) ].

🧬 Mechanism of Action 93 words

12.1Mechanism of Action The antidiuretic effects of desmopressin are mediated by stimulation of vasopressin 2 (V2) receptors, thereby increasing water re-absorption in the kidney, and hence reducing urine production. Desmopressin is a replacement hormone for antidiuretic hormone in the treatment of central diabetes insipidus. The change in structure of arginine vasopressin to desmopressin acetate resulted in a decreased vasopressor action and decreased actions on visceral smooth muscle relative to the enhanced antidiuretic activity, so that clinically effective antidiuretic doses were usually below threshold levels for effects on vascular or visceral smooth muscle.

📦 How Supplied / Storage and Handling 73 words

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Desmopressin Nasal Spray Solution, USP is available as a 5 mL bottle containing an aqueous solution with the spray pump delivering 50 sprays of 10 mcg (0.1 mL) (NDC 68682-342-05). Storage and Handling Store in refrigerator at 2° to 8°C (36° to 46°F). When traveling, product will maintain stability for up to 3 weeks when stored at room temperature, 22°C (72°F). STORE BOTTLE IN UPRIGHT POSITION.

📋 Description 105 words

11 DESCRIPTION Desmopressin Nasal Spray Solution, USP is a vasopressin analogue of the natural pituitary hormone 8-arginine vasopressin (ADH), an antidiuretic hormone affecting renal water conservation. It is chemically defined as follows: Molecular weight: 1183.34 Empirical formula: C 46 H 64 N 14 O 12 S 2 •C 2 H 4 O 2 •3H 2 O 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate. Desmopressin Nasal Spray Solution, USP is an aqueous solution for intranasal use.

Each mL contains: ACTIVE: Desmopressin Acetate 0.1 mg (0.01%); INACTIVES: Purified Water and Sodium Chloride. Hydrochloric Acid may be added to adjust pH (3.5 - 6.0). PRESERVATIVE ADDED: Chlorobutanol 0.5%. chemstructure

💬 Information for Patients 177 words

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Administration Inform caregivers for pediatric patients that administration should be supervised to ensure the patient receives the prescribed dose. Inform patients that the pump must be primed prior to first use and again if not used for greater than one week.

Inform patients that the desmopressin nasal spray solution bottle delivers 50 sprays of 10 mcg each following the initial 5 priming pumps. Inform patients to discard any solution remaining after 50 sprays since the amount delivered thereafter may be substantially less than 10 mcg of drug. Monitoring Educate patients about the signs and symptoms of hyponatremia and advise them to contact a healthcare provider if such symptoms occur.

Discuss downward adjustment of fluid intake and monitoring of urine output with patients. Distributed by: Oceanside Pharmaceuticals, a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA Manufactured by: Bausch Health Companies Inc. Laval, Quebec H7L 4A8, Canada © 2025 Bausch Health Companies Inc. or its affiliates 90005300

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.