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Stimate desmopressin acetate 1.5 mg/mL Spray, 2.5 mL — NDC 55566-3000-00 package photo
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Stimate desmopressin acetate 1.5 mg/mL Spray, 2.5 mL — NDC 55566-3000-0 (Billing 55566-3000-00)

by Ferring Pharmaceuticals Inc. · 2.5 mL in 1 BOTTLE, SPRAY

This is a package of 2.5 mL of Stimate desmopressin acetate 1.5 mg/mL Spray from Ferring Pharmaceuticals Inc., marketed since Jun 2025 and currently FDA-listed. It is this product's only package size.

NDC 55566-3000-00
🏷️ FDA NDC (as labeled) 55566-3000-0 billing pads the package segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 6, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
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NDC database record

One package, one record: these facts belong to NDC 55566-3000-0 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
55566 labeler · 3000 product · 0 package
Package marketed since
Jun 25, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 5556630000 3
FDA record last changed
Aug 6, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 55566-3000-0
Product NDC 55566-3000
11-digit billing NDC 55566300000
RxCUI 1797859, 1797861
UNII XB13HYU18U
Application # NDA020355
SPL Set ID f5ada39c-20ed-4500-9dce-1e4ab642a358
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 2025-06-25
Route NASAL
Dosage form SPRAY
Substance DESMOPRESSIN ACETATE
Quick answers
  • RxCUI (RxNorm): 1797859
Why two NDCs? The FDA registers this code as 55566-3000-0 — a 5-4-1 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 package segment → 55566-3000-00. 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.

Clinical

📖 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
  • Stimate works by signaling your body to release more of the clotting proteins it already has stored — specifically factor VIII and von Willebrand factor. In people with hemophilia...
  • What exactly does Stimate do — how does it help with my bleeding disorder?
  • This is really important and one of the first things I'd want you to understand. Stimate also tells your kidneys to hold onto water, so less urine is made. If you drink normally wh...
  • Why do I have to restrict fluids when I use Stimate?
📖 Read our full Desmopressin Nasal 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.

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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
55566-3000-00 You're viewing this Main listing 2.5 mL in 1 BOTTLE, SPRAY 2025-06-25 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Stimate 1.5 mg/mLthis 55566-3000-00 Ferring 2.5 ml — — FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
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 versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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.

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.

🧪 Avoiding an ingredient? See Desmopressin Nasal inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

  • UNII F5UM2KM3W7
    Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • 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 94255I6E2T
    Sodium phosphate dibasic dihydrate is a salt that helps control the acidity level of a medicine. It acts as a buffer and pH regulator to keep the medication stable and effective.
  • 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.

5 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.

Manufacturer & labeler

LabelerFerring Pharmaceuticals Inc.
Application holderFERRING PHARMACEUTICALS INC
FDA applicationNDA020355 (NDA)
Labeler code55566
First marketedJun 2025
Product typeHuman Prescription Drug
Portfolio17 products on file

More NDCs from Ferring Pharmaceuticals Inc. labeler code 55566

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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE STIMATE is a vasopressin analog used for: Hemophilia A - for patients with factor VIII coagulant activity levels greater than 5% to maintain hemostasis during surgical procedures and postoperatively or reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. ( 1.1 ) von Willebrand’s disease (Type I) - for patients with mild to moderate disease with factor VIII levels greater than 5% to maintain hemostasis during surgical procedures or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding.

( 1.2 ) Limitations of Use STIMATE is not indicated for: von Willebrand’s disease (severe Type I) - not indicated for the treatment of patients with severe Type I von Willebrand’s disease and when there is evidence of an abnormal molecular form of factor VIII antigen. ( 1.2 )

1.1Hemophilia A STIMATE is indicated for patients with hemophilia A with factor VIII coagulant activity levels greater than 5% without factor VIII antibodies to: Maintain hemostasis during surgical procedures and postoperatively Reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. 1.2 von Willebrand’s Disease (Type I) STIMATE is indicated for patients with mild to moderate von Willebrand’s disease (Type I) with factor VIII levels greater than 5% to: Maintain hemostasis during surgical procedures and postoperatively Reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, mucosal bleeding, or menorrhagia.

Limitations of Use Desmopressin acetate is not indicated for the treatment of severe von Willebrand’s disease (Type I) and when there is evidence of an abnormal molecular form of factor VIII antigen [see Warnings and Precautions ( 5. 5 )].

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Instruct patients to prime pump prior to use. ( 2 ) Patients weighing at least 50 kg: 300 mcg (one spray in each nostril). ( 2.2 ) Patients weighing less than 50 kg: 150 mcg administered as a single spray ( 2.2 ) Should not be used in infants younger than 11 months. ( 2.2 ) Not indicated for patients who require less than a 150 mcg dose. ( 2.2 )

2.1Pretreatment Testing and On-Treatment Monitoring Hemophilia A Laboratory tests for assessing patient status include levels of Factor VIII coagulant, Factor VIII antigen and Factor VIII ristocetin cofactor (von Willebrand factor) as well as activated partial thromboplastin time. Factor VIII coagulant activity should be determined before giving STIMATE for hemostasis. If Factor VIII coagulant activity is present at less than 5% of normal, STIMATE should not be relied on. von Willebrand's Disease Laboratory tests for assessing patient status include levels of Factor VIII coagulant activity, VWF:RCo and VWF:Ag.

Fluid Restriction Instruct patients about appropriate fluid restriction during STIMATE treatment. Fluid restriction should be observed, and fluid intake should be limited to a minimum, from 1 hour before desmopressin administration, until at least 24 hours after administration [see Warnings and Precautions ( 5.1 )].

2.2Recommended Dosage The recommended dosage for patients weighing at least 50 kg is 300 mcg intranasal spray (one spray in each nostril). The recommended dosage for patients weighing less than 50 kg is 150 mcg administered as a single intranasal spray. The use of STIMATE is not indicated for patients who require less than a 150 mcg dose or doses that are not multiples of 150 mcg because the spray pump can only deliver doses of 150 mcg [see Indications and Usage ( 1 )] .

If other doses are required, DDAVP Injection may be used [see Warnings and Precautions ( 2.3 )] . If STIMATE is used preoperatively, it should be administered 2 hours prior to the scheduled procedure. The necessity for repeat administration of STIMATE or use of any blood products for hemostasis should be determined by laboratory response as well as the clinical condition of the patient.

The tendency toward tachyphylaxis (lessening of response) with repeated administration given more frequently than once every 48 hours should be considered in treating each patient. Must prime the spray pump prior to the first use. Instruct patients to: Prime STIMATE before initial use by releasing 6 sprays or until a fine mist appears.

When STIMATE has not been used within 3 days, re-prime the pump by pressing down on the pump twice, or until you see a fine mist. Discard STIMATE 6 months after it is opened, after 25 sprays, or by the expiration date, whichever is sooner. Pediatric Patients STIMATE should not be used in infants younger than 11 months in the treatment of hemophilia A or von Willebrand’s disease.

Use in infants and children will require careful fluid intake restriction to prevent possible hyponatremia and water intoxication [see Warnings and Precautions ( 5.1 )] .

2.3Switching Between Desmopressin Acetate Formulations Desmopressin acetate, for hemostatic use or therapeutic control of bleeding in patients with hemophilia A and mild to moderate von Willebrand’s disease (Type I), is also available as a solution for injection (DDAVP Injection). For surgical procedures, parenteral administration of desmopressin is primarily recommended. In situations where the intranasal route may be compromised, parenteral administration of desmopressin should be considered [see Warnings and Precautions ( 5.3 )] .

When switching from the parenteral form of desmopressin to STIMATE, administer a test dose of intranasal to establish that the patient shows an appropriate change in the coagulation profile [see Dosage and Administration ( 2.2 )] .

💊 Dosage Forms and Strengths 54 words ▾

3 DOSAGE FORMS AND STRENGTHS STIMATE pump delivers 150 mcg (0.1 mL) of desmopressin acetate per spray. STIMATE is available as a 2.5 mL bottle with spray pump delivering 25 sprays. Nasal Spray: 150 mcg per 0.1 mL spray, available in a 2.5 mL bottle with spray pump delivering 25 sprays ( 3 )

⛔ Contraindications 132 words ▾

4 CONTRAINDICATIONS STIMATE is contraindicated in patients with: Known hypersensitivity to desmopressin acetate or to any of the components of STIMATE. Severe allergic reactions and anaphylaxis have been reported [see Warnings and Precautions ( 5.4 )]. Hyponatremia or a history of hyponatremia [see Warnings and Precautions ( 5.1 )] .

Type IIB von Willebrand's disease [see Warnings and Precautions ( 5.5 ) Known or suspected syndrome of inappropriate antidiuretic hormone (SIADH) secretion [see Warnings and Precautions ( 5.1 )] . Known hypersensitivity to desmopressin acetate or to any of the components of STIMATE ( 4 , 5.4 ) Hyponatremia or a history of hyponatremia ( 4 , 5.1 ) Type IIB von Willebrand's disease ( 4 , 5.5 ) Known or suspected syndrome of inappropriate antidiuretic hormone (SIADH) secretion. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Hyponatremia : Excessive fluid intake when urine output is limited by the antidiuretic effect of desmopressin may lead to water intoxication with hyponatremia. ( 5.1 ) Hypotension and Hypertension : May cause hypotension with compensatory increase in heart rate or hypertension. Monitor blood pressure during STIMATE administration, especially in patients with heart disease.

( 5.2 ) Altered Absorption in Patients with Nasal Mucosa Abnormalities: changes in the nasal mucosa such as scarring, edema, or other disease may cause erratic, unreliable absorption. ( 5.3 ) Hypersensitivity Reactions : Severe reactions have occurred. Monitor for reactions during administration and interrupt if reaction occurs.

( 5.4 ) Increased Risk of Thrombosis in Patients with von Willebrand’s Disease Type IIB : Use of STIMATE in patients with Type IIB von Willebrand’s disease may cause thrombosis due to platelet aggregation. ( 5.5 )

5.1Hyponatremia Serious and fatal hyponatremia may occur with STIMATE use. STIMATE is contraindicated in patients with hyponatremia (or a history of it) and known or suspected syndrome of inappropriate antidiuretic hormone (SIADH) secretion [see Contraindications ( 4 )] . 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 post-marketing experience in patients treated with desmopressin acetate. Unless properly diagnosed and treated, hyponatremia can be fatal. Observe patients receiving STIMATE for the following signs or symptoms associated with hyponatremia: headache, nausea/vomiting, decreased serum sodium, weight gain, restlessness, malaise, 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. Advise patients to restrict fluids in order to decrease the risk of water intoxication with hyponatremia. 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 or are known to induce SIADH . 5. 2 Hypotension and Hypertension STIMATE may cause changes in blood pressure.

Changes have included elevation or reduction in blood pressure which may also cause a compensatory increase in heart rate. Monitor blood pressure and pulse more frequently if used in patients with coronary artery insufficiency and/or hypertensive cardiovascular disease. 5.

3 Altered Absorption in Patients with Nasal Mucosa Abnormalities Since STIMATE is used intranasally, changes in the nasal mucosa such as scarring, edema, or other disease may cause erratic, unreliable absorption in which case STIMATE should be discontinued until the nasal problems resolve. Avoid use of STIMATE in such patients and consider use of other formulations of desmopressin acetate given by other routes of administration [see Dosage and Administration ( 2.4 )] .

5.4Hypersensitivity Reactions STIMATE is contraindicated in patients with known hypersensitivity to desmopressin acetate or to any of the components of STIMATE [see Contraindications ( 4 )] . Severe allergic reactions, including fatal anaphylaxis, have been reported with desmopressin. It is not known whether antibodies to desmopressin acetate are produced after repeated ad… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~1 min read ▾

6 ADVERSE REACTIONS The following serious reactions are described below and elsewhere in the labeling: Hyponatremia [see Warnings and Precautions ( 5.1 )]. Hypotension and Hypertension [see Warnings and Precautions ( 5.2 )] . Altered Absorption in Patients with Changes in Nasal Mucosa [see Warnings and Precautions ( 5.3 )] .

Hypersensitivity Reactions [see Warnings and Precautions ( 5.4 )] . Increased Risk of Thrombosis in Patients with von Willebrand’s Disease Type IIB [see Warnings and Precautions ( 5.5 )] . The following adverse reactions have been identified during post-approval use of desmopressin acetate intranasal formulations.

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: Cardiac disorders : Tachycardia, palpitations Eye disorders : Eye redness, eye itchiness, light sensitivity Gastrointestinal disorders : Nausea*, abdominal cramps/pain*, dyspepsia General disorders and administration site conditions : Peripheral edema*, fatigue*, chills, chest pain Immune system disorders : Hypersensitivity reactions Investigations : Weight increased* Metabolism and nutrition disorders : Hyponatremia Nervous system disorders : Headache, somnolence, dizziness, insomnia, hyponatremic convulsions Psychiatric disorders : Confusional state* Respiratory, thoracic and mediastinal disorders : Nasal congestion, rhinitis, epistaxis, sore throat, cough, upper respiratory infections Skin and subcutaneous disorders : Pruritus Vascular disorders : Hypertension, hypotension, flushing *Reported in association with hyponatremia Adverse reactions that have been identified in patients administered STIMATE are headache, eye redness, tachycardia, flushing, nasal congestion, rhinitis, epistaxis, nausea and abdominal pain.

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Ferring Pharmaceuticals Inc. at 1-888-FERRING (1-888-337-7464) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

🔄 Drug Interactions 129 words ▾

7 DRUG INTERACTIONS Other Drugs that may Increase Risk of Hyponatremia: Monitor serum sodium more frequently. ( 7.1 ) Other Vasoconstrictors: May require a reduction of the STIMATE dosage. ( 7.2 )

7.1Other Drugs that may Increase Risk of Hyponatremia The concomitant administration of STIMATE 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, 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 STIMATE with other vasoconstrictors may require a reduction of the STIMATE dosage [ see Warnings and Precautions ( 5.2 ) ] .

👥 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 Available data on the use of desmopressin 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 hemophilia A and von Willebrand’s disease 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 and 38 times, respectively, the maximum recommended human dose based on body surface area (mg/m 2 ) (see Data). The background risk of major birth defects and miscarriage for the indicated population are 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 Pregnant women with Hemophilia A or von Willebrand’s disease may be at an increased risk for bleeding diatheses and hemorrhagic events at delivery. A newborn born to a mother with Hemophilia A or von Willebrand disease may also be at risk for bleeding diatheses.

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 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 STIMATE and any potential adverse effects on the breastfed infant from STIMATE 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 desmopressin acetate. 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 The safety and effectiveness of STIMATE has been established in children between 11 months and 12 years with hemophilia A or von Willebrand’s disease. Use in infants and pediatric patients will require careful fluid intake restriction to prevent possible hyponatremia and water intoxication. Fluid restriction should be discussed with the patient and/or guardian [see Warnings and Precautions ( 5.1 )].

Th… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary Available data on the use of desmopressin 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 hemophilia A and von Willebrand’s disease 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 and 38 times, respectively, the maximum recommended human dose based on body surface area (mg/m 2 ) (see Data). The background risk of major birth defects and miscarriage for the indicated population are 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 Pregnant women with Hemophilia A or von Willebrand’s disease may be at an increased risk for bleeding diatheses and hemorrhagic events at delivery. A newborn born to a mother with Hemophilia A or von Willebrand disease may also be at risk for bleeding diatheses.

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 81 words ▾

8.4Pediatric Use The safety and effectiveness of STIMATE has been established in children between 11 months and 12 years with hemophilia A or von Willebrand’s disease. Use in infants and pediatric patients will require careful fluid intake restriction to prevent possible hyponatremia and water intoxication. Fluid restriction should be discussed with the patient and/or guardian [see Warnings and Precautions ( 5.1 )].

The safety and effectiveness of STIMATE have not been established in pediatric patients younger than 11 months old.

🧓 Geriatric Use 115 words ▾

8.5Geriatric Use Clinical studies of STIMATE 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 .

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

🆘 Overdosage 72 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 STIMATE. There is no known specific antidote for desmopressin acetate.

Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Desmopressin acetate increases plasma levels of factor VIII activity in patients with hemophilia and von Willebrand’s disease Type I.

12.2Pharmacodynamics The response to STIMATE is dose-related, with maximal plasma levels of 150 to 250 percent of initial concentrations achieved for both Factor VIII and von Willebrand factor. The increase reaches a maximum at about 1.5 hours. The percentage increase of Factor VIII and von Willebrand factor levels in patients with mild hemophilia A and von Willebrand's disease was not notably different from that observed in normal healthy individuals when treated with 300 mcg of STIMATE.

In patients with von Willebrand's disease, levels of Factor VIII coagulant activity and von Willebrand factor antigen remained greater than 30 U/dL for 8 hours after a 300 mcg dose of STIMATE. After 300 mcg of STIMATE, the percentage increase of Factor VIII and von Willebrand factor levels in patients with mild hemophilia A and von Willebrand's disease was less than observed after 0.3 mcg/kg of intravenous desmopressin acetate.

12.3Pharmacokinetics Absorption Plasma concentrations of desmopressin acetate following administration of STIMATE were maximal approximately 40 to 45 minutes after dosing. The absolute bioavailability of STIMATE administered by the intranasal route as a 1.5 mg/mL solution is between 3.3 and 4.1 percent. Elimination The half-life of desmopressin acetate following administration of STIMATE is between 3.3 and 3.5 hours, over the range of intranasal doses, 150 to 450 mcg.

Specific Populations Renal Impairment: A pharmacokinetic study was conducted in subjects with normal renal function and subjects with mild, moderate, and severe renal impairment (n=24, 6 subjects each group) following administration of a single 2 mcg dose of 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 subjects with mild, moderate, and severe renal impairment, respectively. In subjects with mild, moderate and severe renal impairment, mean desmopressin area under the plasma drug concentration time curve (AUC) was 1.5-, 2.4- and 3.6-fold higher, respectively, compared to that of subjects with normal renal function.

🧬 Mechanism of Action 23 words ▾

12.1Mechanism of Action Desmopressin acetate increases plasma levels of factor VIII activity in patients with hemophilia and von Willebrand’s disease Type I.

📦 How Supplied / Storage and Handling 96 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied STIMATE is available as a 2.5 mL bottle containing an aqueous solution with the spray pump delivering 25 sprays of 150 mcg (0.1 mL) (NDC 55566-3000-0).

16.2Storage and Handling Store at Controlled Room Temperature 20ºC to 25ºC (68ºF to 77ºF) [ see USP Controlled Room Temperature]. Discard STIMATE six months after being opened. Store bottle in upright position.

16.1How Supplied STIMATE is available as a 2.5 mL bottle containing an aqueous solution with the spray pump delivering 25 sprays of 150 mcg (0.1 mL) (NDC 55566-3000-0).

📦 Storage and Handling 33 words ▾

16.2Storage and Handling Store at Controlled Room Temperature 20ºC to 25ºC (68ºF to 77ºF) [ see USP Controlled Room Temperature]. Discard STIMATE six months after being opened. Store bottle in upright position.

📋 Description 111 words ▾

11 DESCRIPTION STIMATE (desmopressin acetate) is a synthetic 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. STIMATE is an aqueous solution for intranasal use.

Each mL contains: Benzalkonium chloride solution 0.1 mg, Citric acid monohydrate 1.7 mg, Desmopressin acetate 1.5 mg, Disodium phosphate dihydrate 3 mg, Purified water to 1 mL, Sodium chloride 7.5 mg. A black text on a white background AI-generated content may be incorrect.

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Hyponatremia and Fluid Restriction Inform patients that STIMATE may cause severe hyponatremia, which may be life-threatening, if it is not promptly diagnosed and treated [see Warnings and Precautions ( 5.1 )] . Inform patients about the signs and symptoms associated with hyponatremia, to undergo recommended serum sodium measurements, and to inform their health care provider about new medications . [see Warnings and Precautions ( 5.1 )] Advise patients to contact a healthcare provider if symptoms of hyponatremia occur. [see Warnings and Precautions ( 5.1 )] Discuss with patients the need to adjust fluid intake and monitor urine output. [see Warnings and Precautions ( 5.1 )] Administration For pediatric patients, inform caregivers 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 3 days. Inform patients that the desmopressin nasal spray bottle delivers 25 sprays following the initial 6 priming pumps. Inform patients to discard STIMATE 6 months after it is opened, after 25 sprays, or by the expiration date, whichever is sooner.

Changes in Blood Pressure Inform patients that STIMATE may cause increases or decreases in blood pressure, sometimes accompanied by a faster heart rate. Advise patients to report symptoms such as dizziness, fainting, pounding heartbeat, or chest pain to their healthcare provider. Instruct patients with heart disease or high blood pressure to have their blood pressure and pulse checked more often while using STIMATE. [see Warnings and Precautions ( 5.2 )].

Nasal Conditions Affecting Absorption Advise patients that nasal conditions such as swelling, congestion, scarring, or injury may affect how well STIMATE is absorbed and how well it works. Inform patients to notify their healthcare provider if they have nasal congestion, infection, or other nasal problems. The healthcare provider may recommend stopping STIMATE until the nasal condition resolves or using another form of desmopressin. [see Warnings and Precautions ( 5.3 )].

Allergic Reactions Inform patients that serious allergic reactions, including anaphylaxis, have occurred with desmopressin use. Advise patients to stop using STIMATE and get medical help right away if they experience rash, itching, swelling of the face or throat, difficulty breathing, or fainting which may be symptoms of an allergic reaction. [see Warnings and Precautions ( 5.4 )]. Risk of Blood Clots in Patients with von Willebrand’s Disease Type IIB Inform patients that STIMATE should not be used if they have Type IIB von Willebrand’s disease.

Using it in these patients may cause the platelets to clump together and increase the risk of blood clots. Advise patients with von Willebrand’s disease to inform their healthcare provider of their specific disease type before starting treatment. [see Warnings and Precautions ( 5.5 )]. Manufactured for: Ferring Pharmaceuticals Inc.

Parsippany, NJ 07054 USA xxxxxxxxxx

🧬 Pharmacokinetics 176 words ▾

12.3Pharmacokinetics Absorption Plasma concentrations of desmopressin acetate following administration of STIMATE were maximal approximately 40 to 45 minutes after dosing. The absolute bioavailability of STIMATE administered by the intranasal route as a 1.5 mg/mL solution is between 3.3 and 4.1 percent. Elimination The half-life of desmopressin acetate following administration of STIMATE is between 3.3 and 3.5 hours, over the range of intranasal doses, 150 to 450 mcg.

Specific Populations Renal Impairment: A pharmacokinetic study was conducted in subjects with normal renal function and subjects with mild, moderate, and severe renal impairment (n=24, 6 subjects each group) following administration of a single 2 mcg dose of 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 subjects with mild, moderate, and severe renal impairment, respectively. In subjects with mild, moderate and severe renal impairment, mean desmopressin area under the plasma drug concentration time curve (AUC) was 1.5-, 2.4- and 3.6-fold higher, respectively, compared to that of subjects with normal renal function.

🧬 Pharmacodynamics 146 words ▾

12.2Pharmacodynamics The response to STIMATE is dose-related, with maximal plasma levels of 150 to 250 percent of initial concentrations achieved for both Factor VIII and von Willebrand factor. The increase reaches a maximum at about 1.5 hours. The percentage increase of Factor VIII and von Willebrand factor levels in patients with mild hemophilia A and von Willebrand's disease was not notably different from that observed in normal healthy individuals when treated with 300 mcg of STIMATE.

In patients with von Willebrand's disease, levels of Factor VIII coagulant activity and von Willebrand factor antigen remained greater than 30 U/dL for 8 hours after a 300 mcg dose of STIMATE. After 300 mcg of STIMATE, the percentage increase of Factor VIII and von Willebrand factor levels in patients with mild hemophilia A and von Willebrand's disease was less than observed after 0.3 mcg/kg of intravenous desmopressin acetate.

🧪 Nonclinical Toxicology 39 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Studies with desmopressin acetate have not been performed to evaluate carcinogenic potential or effects on fertility. Desmopressin acetate was negative in vitro in Ames and mouse lymphoma cell mutation tests.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 36 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Studies with desmopressin acetate have not been performed to evaluate carcinogenic potential or effects on fertility. Desmopressin acetate was negative in vitro in Ames and mouse lymphoma cell mutation tests.

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION STIMATE ® (stim-ate) (desmopressin acetate) nasal spray What is STIMATE? STIMATE is a prescription medicine used to treat people with: Certain types of Hemophilia A to: control bleeding during and after surgery reduce bleeding episodes caused by spontaneous or traumatic injuries in the joints, muscles, and in mucous membranes such as the nose, mouth, throat, stomach, intestines, and rectum. von Willebrand’s Disease (Type 1) to: control bleeding during and after surgery reduce bleeding episodes caused by spontaneous or traumatic injuries in the joints, muscles, and in mucous membranes such as the nose, mouth, throat, stomach, intestines, and rectum, and to reduce heavy menstrual bleeding.

Desmopressin acetate is not used for the treatment of severe von Willebrand’s disease (Type 1) and when there is an abnormal factor VIII protein. It is not known if STIMATE is safe and effective in children younger than 11 months old. STIMATE should not be used in children younger than 11 months old in the treatment of hemophilia A or von Willebrand’s disease.

Do not use STIMATE if you: are allergic to desmopressin acetate or any of the ingredients in STIMATE (see “What are the possible side effects of STIMATE?”). See the end of this Patient Information for a complete list of ingredients in STIMATE. have or have had low levels of sodium in your blood (hyponatremia) have type IIB von Willibrand’s disease have or may have a condition called syndrome of inappropriate antidiuretic hormone (SIADH) secretion Ask your healthcare provider if you are not sure you have any of these conditions.

Before using STIMATE, tell your healthcare provider about all your medical conditions including if you: have or have had nasal sores, nasal surgery, nasal injury, or have problems such as a stuffy nose or trouble breathing through your nose. have a condition that causes fluid or water imbalance problems such as cystic fibrosis, heart failure or kidney problems. have a condition that causes you to be very thirsty have heart, blood circulation, or blood pressure problems are pregnant or plan to become pregnant. It is not known if STIMATE will harm your unborn baby. are breastfeeding or plan to breastfeed.

It is not known if STIMATE passes into your breast milk. You and your healthcare provider should decide if you will use STIMATE. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

STIMATE and other medicines may affect each other causing side effects. STIMATE may affect the way other medicines work, and other medicines may affect how STIMATE works. How should I use STIMATE?

STIMATE is for use in the nose only. See the Instructions for Use that comes with STIMATE for information about the right way to use STIMATE. Use STIMATE exactly as your healthcare provider tells you to use it.

An adult should watch a child use STIMATE to make sure the child receives the prescribed dose. If you use STIMATE before a surgery, you should use STIMATE 2 hours before the scheduled surgery. The STIMATE bottle must be primed before the first use and again if not used for more than 3 days.

The STIMATE bottle delivers 25 sprays after the first 6 priming pumps. Your healthcare provider may change your dose of STIMATE if needed. If you take too much STIMATE, call your healthcare provider or Poison Help line at 1-800-222-1222 right away.

What are the possible side effects of STIMATE? STIMATE may cause serious side effects including: low salt (sodium) levels in the blood (hyponatremia). STIMATE may cause low sodium levels in the blood that can be serious, which may be life-threatening, and can lead to death.

People using STIMATE are at risk for low sodium levels in the blood, water intoxication, and fluid overload. Children and the elderly are at higher risk for developing hyponatremia. Your healthcare provide will check your sodium levels during treatment with STIMATE as… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

INSTRUCTIONS FOR USE STIMATE ® (stim-ate) (desmopressin acetate) nasal spray Read this Instructions for Use before using STIMATE and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

Before you use the STIMATE, make sure your healthcare provider shows you the right way to use it. The parts of your STIMATE bottle (see Figure A ) : Figure A Important Information You Need to Know Before using STIMATE: For use in the nose only. Do not spray in the eyes.

Use STIMATE exactly as your healthcare provider tells you. Do not use more STIMATE or take it more often than your healthcare provider tells you to. You should limit fluid intake 1 hour before using STIMATE and until at least 24 hours after using STIMATE.

If you use STIMATE before a surgery, you should use STIMATE 2 hours before the scheduled surgery. An adult should watch a child use STIMATE to make sure the child receives the prescribed dose. Your STIMATE bottle must be primed before the first use and again if not used for more than 3 days (see Priming your STIMATE bottle ).

After your STIMATE bottle is primed, it will spray 150 micrograms (mcg) of medicine each time it is used. Priming your STIMATE bottle: Step 1. Remove the protective cap (see Figure B ).

Figure B Step 2. Hold the bottle upright with 2 fingers on the shoulders of the STIMATE bottle and put your thumb on the bottom of the bottle. Hold the spray tip away from your face and eye.

Press down on the shoulders at the top of your STIMATE bottle 6 times, or until you see a fine mist (see Figure C ). Figure C When you see the fine mist of medicine, the STIMATE bottle is ready for use. Using your STIMATE: Step 1.

Remove the protective cap. Step 2. Put the spray nozzle tip of your STIMATE into 1 nostril and press the shoulders down to spray STIMATE.

(see Figure D ). If your dose is 1 spray (150 mcg), skip to Step 3 below. If your dose is 2 sprays (300 mcg), repeat Step 2 in the other nostril.

Your STIMATE bottle delivers 25 sprays after the first 6 priming pumps. If any medicine is left in your STIMATE bottle after 25 sprays, do not use it. You may not get the correct dose.

(see Throwing away (disposing of) the STIMATE bottle ). Figure D Step 3. Put the protective cap back on the spray nozzle tip when you finish using your STIMATE.

How should I store STIMATE bottle? Store STIMATE bottle at room temperature between 68ºF to 77ºF (20ºC to 25ºC). Store STIMATE bottle standing up straight.

Keep the STIMATE bottle and all medicines out of the reach of children. Keep track of the number of sprays that you use. Throwing away (disposing of) the STIMATE bottle: Throw away the STIMATE bottle 6 months after first opening, after 25 sprays, or by the expiration date, whichever is sooner.

Throw away your STIMATE bottle after 25 sprays. Do not use it even if medicine remains in the bottle after 25 sprays. Do not try to remove any medicine from your STIMATE bottle and place it in another bottle.

This Instructions for Use has been approved by the U.S. Food and Drug Administration. Manufactured for: Ferring Pharmaceuticals Inc.

Parsippany, NJ 07054 USA Approved: 07/2026 Image Figure B Figure C Figure D

📄 Package Label / Principal Display Panel 45 words ▾

PRINCIPAL DISPLAY PANEL NDC 55566-3000-0 STIMATE® (desmopressin acetate) Nasal Spray 150 mcg/spray (0.1 mL) For Intranasal Use Only. Read the enclosed Instructions for Use prior to use. 1 x 2.5 mL bottle containing 25 sprays of 150 mcg each. Rx only FERRING PHARMACEUTICALS Stimate PDP

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

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

Medicare Part D (outpatient prescription) spending for Desmopressin Acetate (matched by generic name) — 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. CMS lists 2 products for this generic; we show the highest-spend one. 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 Stimate (this brand).

Top reported reactions

Hyponatraemia236
Headache173
Nausea122
Fatigue101
Vomiting93
Dizziness77
Flushing66

Reporter sex

2,393 reports
Male · 43%
Female · 56%
Unknown · 0%

Serious outcomes

Death150
Life-threatening136
Disabling44
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 173 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.

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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Ferring Pharmaceuticals Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Ferring 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.
← 55566-2800-01 · Ferring 55566-6500-03 · Ferring →
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.