Home › NDC Lookup › Ingredients › Clonidine Hydrochloride Oral › 24338-0115-01
JAVADIN clonidine hydrochloride oral 20 ug/mL Solution — NDC 24338-0115-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

JAVADIN clonidine hydrochloride oral 20 ug/mL Solution — NDC 24338-115-01 (Billing 24338-0115-01)

by Azurity Pharmaceuticals, Inc. · 1 BOTTLE in 1 CARTON / 250 mL in 1 BOTTLE

This is a package of JAVADIN clonidine hydrochloride oral 20 ug/mL Solution from Azurity Pharmaceuticals, Inc., marketed since Oct 2025 and currently FDA-listed; retail pharmacies pay about $1.53 per mL (NADAC). It is this product's only package size.

NDC 24338-0115-01
🏷️ FDA NDC (as labeled) 24338-115-01 billing pads the product 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 Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 24338-115-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
24338 labeler · 115 product · 01 package
Package marketed since
Oct 23, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 2433811501 5
Medicaid fills, this package
538 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 24338-115-01
Product NDC 24338-115
11-digit billing NDC 24338011501
NCPDP billing unit ML — per mL (volume)
RxCUI 2725554, 2725561
UNII W76I6XXF06
Application # NDA220256
SPL Set ID c36d94f5-a30d-4997-b141-e79a4ea45ecf
Established class (EPC) Central alpha-2 Adrenergic Agonist
Mechanism of action Adrenergic alpha2-Agonists
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-10-23
Route ORAL
Dosage form SOLUTION
Substance CLONIDINE HYDROCHLORIDE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 36201010102060
GCN Seq No 086922
GCN 56724
HICL code 000113
Ingredient (HICL) Clonidine Hcl
HIC1 code A
Therapeutic class — broad (HIC1) Cardiovascular System
HIC2 code A4
Therapeutic class — intermediate (HIC2) Antihypertensives
HIC3 code A4B
Therapeutic class — specific (HIC3) Antihypertensives, Sympatholytic
AHFS code 24:24.00.00
AHFS class Central Alpha-Agonists
FDB label name JAVADIN 0.02 MG/ML SOLUTION
FDB brand name Javadin
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 086922
  • GCN: 56724
  • GPI-14 (Medi-Span): 36201010102060
  • HICL (First Databank): 000113
  • AHFS class code: 24:24.00.00
  • RxCUI (RxNorm): 2725554
Why two NDCs? The FDA registers this code as 24338-115-01 — 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 → 24338-0115-01. 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 Central alpha-2 Adrenergic Agonist class.

Pharmacologic class Central alpha-2 Adrenergic Agonist
Drug family (ATC) Imidazoline receptor agonists, Other antimigraine preparations, Sympathomimetics in glaucoma therapy
How it works Adrenergic alpha2-Agonists
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

Label name JAVADIN 0.02 MG/ML SOLUTION Ingredient Clonidine Hcl
📗 Our plain-language guide HelloPharmacist
  • It depends on the product. Tablets, oral solutions, Nexiclon XR and patches lower high blood pressure. Certain extended-release products treat ADHD. The epidural injection is used...
  • No. Stopping suddenly can cause rebound high blood pressure, with headache, a racing heart, nervousness and anxiety. Your doctor will lower the dose gradually.
  • Sleepiness is common. Don't drive or use heavy equipment until you know how it affects you. Avoid alcohol, and ask me before combining it with other sedating medicines.
  • No. Extended-release clonidine tablets should be swallowed whole, not crushed, chewed or broken. They can be taken with or without food.
📖 Read our full Clonidine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 $1.529 $382.33 / 250 ml
Medicaid paysCMS SDUD · 12 mo $1.64 $410.30 / 250 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per mL) — tap or hover for the price & month
Jun 2026 Jul 2026 Aug 2026 Sep 2026 $1.532 $1.529
Flat over the last 4 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
24338-0115-01 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 250 mL in 1 BOTTLE 2025-10-23 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Javadin 20 ug/mLthis 24338-0115-01 Azurity 1 bottle $1.529 — Availability likely —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2025
First FDA approval
Oct 2025
📍
2026
Currently FDA-listed
1 year listed
🛡️
2042
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

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

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Jul 2042. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Oct 23, 2025 RLD RS ⏳ ~15.8 yr to latest listed protection

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

Patents & exclusivity — FDA Orange Book
US 12233049 — drug product
US 12440474 — drug product
2025 2027 2029 2031 2033 2035 2037 2039 2041
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

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

Listed patents (2)
PatentTypeUse codeExpires
US 12233049 ↗ Drug product — Jul 15, 2042
US 12440474 ↗ Drug product — Jul 15, 2042
Common questions
Is there a generic version of JAVADIN 0.02 MG/ML SOLUTION?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for JAVADIN 0.02 MG/ML SOLUTION. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Jul 2042 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

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 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 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII DK6Y9P42IN
    Sodium propionate is a salt derived from propionic acid. It's added to medicines as a preservative to prevent bacterial and fungal growth, helping extend shelf life.
  • UNII 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.

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

LabelerAzurity Pharmaceuticals, Inc.
Application holderAZURITY PHARMACEUTICALS INC
FDA applicationNDA220256 (NDA)
Labeler code24338
First marketedOct 2025
Product typeHuman Prescription Drug
Portfolio57 products on file

More NDCs from Azurity Pharmaceuticals, Inc. labeler code 24338

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. 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 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~2 min read ▾

1 INDICATIONS AND USAGE JAVADIN is indicated for the treatment of hypertension in adult patients, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes.

There are no controlled trials demonstrating risk reduction with JAVADIN. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals.

For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits.

The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.

Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. JAVADIN may be used alone or in combination with other antihypertensive agents.

JAVADIN is a central alpha-2 adrenergic agonist, indicated for the treatment of hypertension in adult patients to lower blood pressure. Lowering blood pressure has been shown to reduce the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1 )

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION Initial dosage is 0.1 mg orally twice daily with or without food (morning and bedtime) ( 2.1 ) Titrate in increments of 0.1 mg per day at weekly intervals if necessary until the desired response is achieved. ( 2.1 ) The therapeutic doses most commonly used have ranged from 0.2 mg to 0.6 mg per day, given in divided doses. ( 2.1 ) Maximum recommended daily dose is 2.4 mg. ( 2.1 )

2.1Recommended Dosage Dosage should be individualized based on response. The recommended initial dosage is 0.1 mg orally twice daily (morning and bedtime). Dosage can be titrated in increments of 0.1 mg per day at weekly intervals as necessary.

Doses should be taken twice a day, with either an equal or higher split dosage being given at bedtime. The therapeutic doses most commonly employed have ranged from 0.2 mg to 0.6 mg per day, given in divided doses. Maximum recommended daily dose is 2.4 mg, but doses as high as this have rarely been employed.

2.2Administration Instructions A calibrated measuring device, such as an oral dosing syringe or oral dosing cup, is recommended to measure and deliver the prescribed dose accurately. A household teaspoon or tablespoon is not an adequate measuring device. Administer JAVADIN (clonidine hydrochloride) oral solution with or without food. [see Clinical Pharmacology ( 12.3 )] JAVADIN may be administered up to 4 hours before surgery and resume as soon as possible post-operatively [see Warning and Precaution ( 5.2 )].

💊 Dosage Forms and Strengths 23 words ▾

3 DOSAGE FORMS AND STRENGTHS Oral Solution: 0.02 mg/mL clear, colorless solution, with mixed-berry flavor. • Oral Solution: 0.02 mg/mL ( 3 )

⛔ Contraindications 32 words ▾

4 CONTRAINDICATIONS JAVADIN is contraindicated in patients with known hypersensitivity to clonidine. [see Adverse Reactions ( 6 )]. • JAVADIN is contraindicated in patients with known hypersensitivity to clonidine ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Bradycardia, Cardiac Conduction Abnormalities, and Symptomatic Hypotension: Clonidine may cause bradycardia, conduction abnormalities, and hypotension. Titrate slowly in patients with syncope, heart block, or vascular disease. Monitor blood pressure and heart rate.

Avoid drugs affecting sinus or AV node function. ( 5.1 ) Rebound Hypertension: Abrupt discontinuation of JAVADIN may cause rebound hypertension, especially with high doses or beta-blocker use. Taper gradually over 2–4 days.

Continue administration up to 4 hours before surgery and resume promptly postoperatively; monitor blood pressure closely. ( 5.2 ) Sedation and Somnolence: Clonidine may cause sedation; caution patients who operate machinery or drive. ( 5.3 )

5.1Bradycardia, Cardiac Conduction Abnormalities, and Symptomatic Hypotension Treatment with clonidine can cause bradycardia, cardiac conduction abnormalities, and symptomatic hypotension [see Adverse Reactions ( 6.1 )] . The sympatholytic action of clonidine may worsen sinus node dysfunction and atrioventricular (AV) block, especially in patients taking other sympatholytic drugs. There have been post-marketing reports of patients with conduction abnormalities and/or taking other sympatholytic drugs who developed severe bradycardia requiring intravenous (IV) atropine, IV isoproterenol, and temporary cardiac pacing while taking clonidine.

Titrate JAVADIN slowly in patients with a history of syncope, cardiac conduction abnormalities, and those with underlying conditions that may be worsened by hypotension and bradycardia; e.g., heart block, bradycardia, cardiovascular disease, vascular disease, cerebrovascular disease, or chronic renal failure. Monitor blood pressure and heart rate and adjust dosages accordingly in patients treated concomitantly with antihypertensives or other drugs that can reduce blood pressure or heart rate or increase the risk of syncope Avoid the use of drugs that can affect the sinus node function or AV node conduction [see Drug Interactions ( 7 )].

In patients who have a history of syncope or may have a condition that predisposes them to syncope, such as symptomatic hypotension, bradycardia, or dehydration, advise patients to avoid becoming dehydrated or overheated.

5.2Rebound Hypertension Abrupt discontinuation of JAVADIN can cause rebound hypertension with elevated plasma catecholamines, especially with higher doses or concomitant beta-blocker use. Symptoms of abrupt discontinuation include tachycardia, rapid blood pressure elevation, headache, nervousness, and agitation. Serious cases of hypertensive encephalopathy, stroke, and death have been reported after abrupt clonidine discontinuation.

To reduce the risk of rebound hypertension, taper clonidine gradually over 2-4 days. If rebound hypertension occurs, reverse hypertensive crisis with oral clonidine or IV phentolamine. When discontinuing concurrent beta-blocker therapy, withdraw the beta-blocker several days before beginning clonidine taper.

Administration of JAVADIN should be continued up to 4 hours before surgery and resumed as soon as possible thereafter. Blood pressure should be carefully monitored during surgery and additional measures to control blood pressure should be available if required.

5.3Sedation and Somnolence Clonidine may cause sedation. Patients who engage in potentially hazardous activities, such as operating machinery or driving, should be advised of possible sedative effects of clonidine. Avoid use with other central nervous system (CNS) depressants, as this combination may cause excessive drowsiness or sedation [see Drug Interactions ( 7 )] .

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed elsewhere in the labeling: Bradycardia, Cardiac Conduction Abnormalities, and Symptomatic Hypotension [see Warnings and Precautions ( 5.1 )] Rebound Hypertension [see Warnings and Precautions ( 5.2 )] Sedation and Somnolence [see Warnings and Precautions ( 5.3 )] The most frequent adverse reactions are dry mouth, drowsiness, dizziness, constipation and sedation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc., at 1-800-461-7449 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Most adverse effects are mild and tend to diminish with continued therapy. The most frequent (which appear to be dose-related) are dry mouth (40%), drowsiness (33%); dizziness (16%); constipation and sedation (10%, respectively).

The following less frequent adverse experiences have also been reported in patients receiving clonidine hydrochloride tablets, but in many cases patients were receiving concomitant medication and a causal relationship has not been established. Body as a Whole: Fatigue, headache, pallor, malaise, weakness, and withdrawal syndrome. Cardiovascular: Bradycardia, congestive heart failure, electrocardiographic abnormalities (i.e., sinus node arrest, junctional bradycardia, high degree AV block and arrhythmias), orthostatic symptoms, palpitations, syncope, and tachycardia.

Central Nervous System: Agitation, anxiety, delirium, hallucinations (including visual and auditory), insomnia, mental depression, behavioral changes, paresthesia, sleep disorder, and vivid dreams or nightmares. Gastrointestinal: Anorexia, constipation, nausea, and vomiting. Hematologic: Thrombocytopenia.

Hepatobiliary: Hepatitis and transaminitis. Hypersensitivity: Angioedema, hives, pruritus, rash, and urticaria. Metabolic: Transient elevation of blood glucose or serum creatine phosphokinase, and weight gain.

Musculoskeletal: Leg cramps and muscle or joint pain. Ophthalmological: Accommodation disorder, blurred vision, burning of the eyes, decreased lacrimation, and dryness of eyes. Renal and Urinary: Difficulty in micturition, nocturia, and urinary retention.

Reproductive System and Breast Disorders: Gynecomastia. erectile dysfunction, and loss of libido. Vascular: Raynaud's phenomenon.

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS The interactions of JAVADIN with co-administration of other drugs have not been studied. The drug interaction data provided in this section is based on oral immediate-release clonidine formulations. Table 1 displays clinically important drug interactions with JAVADIN.

Table 1: Clinically Important Drug Interactions with JAVADIN. Antihypertensive drugs Clinical Implication Concomitant use of antihypertensive drugs with clonidine potentiates the hypotensive effects of clonidine [see Warnings and Precautions ( 5.1 )]. Intervention Monitor blood pressure and heart rate, and adjust dosage of JAVADIN accordingly in patients treated concomitantly with antihypertensives CNS depressants Clinical Implication Concomitant use of CNS depressants with clonidine potentiates the sedating effects [see Warnings and Precautions ( 5.3 )].

Intervention Avoid concomitant use of CNS depressants with JAVADIN. Drugs that affect sinus node function or AV node conduction (e.g., digitalis, calcium channel blockers, beta blockers) Clinical Implication Concomitant use of drugs that affect sinus node function or AV node conduction with clonidine potentiate bradycardia and risk of AV block [see Warnings and Precautions ( 5.1 )]. Intervention Avoid concomitant use of drugs that affect sinus node function or AV node conduction with JAVADIN.

Tricyclic antidepressants Clinical Implication Concomitant use of tricyclic antidepressants with clonidine can increase blood pressure and may counteract the hypotensive effects of clonidine. Intervention Monitor blood pressure and adjust dosage of JAVADIN as needed. Sedating Drugs : Clonidine may potentiate the CNS-depressive effects of alcohol, barbiturates or other sedating drugs.

( 7 ) Tricyclic Antidepressants: May reduce the hypotensive effect of clonidine. ( 7 ) Neuroleptics: May induce or exacerbate the orthostatic regulation disturbances (e.g., orthostatic hypotension, dizziness, fatigue). ( 7 ) Drugs Known to Affect Sinus Node Function or AV Nodal Conduction: Caution is warranted in patients receiving clonidine concomitantly with agents known to affect sinus node function or AV nodal conduction (e.g., digitalis, calcium channel blockers and beta-blockers) due to a potential for additive effects such as bradycardia and AV block.

( 7 )

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS Renal Impairment: Patients with renal impairment may require a lower initial dose and should be closely monitored. ( 8.6 )

8.1Pregnancy Risk Summary Prolonged experience with clonidine in pregnant women over several decades, based on published literature, including controlled trials, a retrospective cohort study and case reports, have not identified a drug associated risk of major birth defects, miscarriage, adverse maternal or fetal outcomes. In animal embryofetal studies, increased resorptions were seen in rats and mice administered oral clonidine hydrochloride from implantation through organogenesis at approximately 2 times the maximum recommended human dose (MRHD) (see Data) .

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

Data Animal Data Oral administration of clonidine hydrochloride to pregnant rabbits during the period of embryo/fetal organogenesis at doses of up to 0.08 mg/kg/day (approximately 0.6 times the oral maximum recommended human dose [MRHD] of 2.4 mg/day) produced no developmental effects. In pregnant rats, however, doses as low as 0.015 mg/kg/day (~1/16 the oral MRHD on a mg/kg basis) were associated with increased resorptions in a study in which dams were treated continuously from 2 months prior to mating and throughout gestation.

Increased resorptions were not associated with treatment at the same or at higher dose levels when treatment of the dams was restricted to gestation days 6-15. Increases in resorptions were observed in both rats and mice at 0.5 mg/kg/day (2 and 1 times the MRHD in rats and mice, respectively) or higher when the animals were treated on gestation days 1-14; 0.5 mg/kg/day was the lowest dose employed in this study.

8.2Lactation Risk Summary Based on published lactation studies, clonidine hydrochloride is present in human milk at relative infant doses ranging from 4.1 to 8.4% of the maternal weight-adjusted dosage. Although in most cases, there were no reported adverse effects in breastfed infants exposed to clonidine, there is one case report of sedation, hypotonia, and apnea in an infant exposed to clonidine through breast milk. If an infant is exposed to clonidine hydrochloride through breastmilk, monitor for symptoms of hypotension and bradycardia, such as sedation, lethargy, tachypnea and poor feeding (see Clinical Considerations) .

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for JAVADIN and any potential adverse effects on the breastfed child from clonidine or from the underlying maternal condition. Exercise caution when JAVADIN is administered to a nursing woman. Clinical Considerations Monitor breastfeeding infants exposed to JAVADIN through breast milk for symptoms of hypotension and/or bradycardia such as sedation, lethargy, tachypnea, and poor feeding.

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.

8.6Renal Impairment The half-life of clonidine increases in patients with renal impairment [see Clinical Pharmacology (12.3)]. Patients with renal impairment may start from a lower dose. Since only a minimal amount of clonidine is removed during routine hemodialysis, there is no need to give supplemental JAVADIN following dialysis.

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary Prolonged experience with clonidine in pregnant women over several decades, based on published literature, including controlled trials, a retrospective cohort study and case reports, have not identified a drug associated risk of major birth defects, miscarriage, adverse maternal or fetal outcomes. In animal embryofetal studies, increased resorptions were seen in rats and mice administered oral clonidine hydrochloride from implantation through organogenesis at approximately 2 times the maximum recommended human dose (MRHD) (see Data) .

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

Data Animal Data Oral administration of clonidine hydrochloride to pregnant rabbits during the period of embryo/fetal organogenesis at doses of up to 0.08 mg/kg/day (approximately 0.6 times the oral maximum recommended human dose [MRHD] of 2.4 mg/day) produced no developmental effects. In pregnant rats, however, doses as low as 0.015 mg/kg/day (~1/16 the oral MRHD on a mg/kg basis) were associated with increased resorptions in a study in which dams were treated continuously from 2 months prior to mating and throughout gestation.

Increased resorptions were not associated with treatment at the same or at higher dose levels when treatment of the dams was restricted to gestation days 6-15. Increases in resorptions were observed in both rats and mice at 0.5 mg/kg/day (2 and 1 times the MRHD in rats and mice, respectively) or higher when the animals were treated on gestation days 1-14; 0.5 mg/kg/day was the lowest dose employed in this study.

🧒 Pediatric Use 13 words ▾

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🆘 Overdosage 79 words ▾

10 OVERDOSAGE Hypertension may develop early and may be followed by hypotension, bradycardia, respiratory depression, hypothermia, drowsiness, decreased or absent reflexes, weakness, irritability and miosis. The frequency of CNS depression may be higher in pediatric patients than adults. Large overdoses may result in reversible cardiac conduction defects or dysrhythmias, apnea, coma and seizures.

Signs and symptoms of overdose generally occur within 30 minutes to two hours after exposure. Dialysis is not likely to significantly enhance the elimination of clonidine.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Clonidine stimulates alpha-adrenoreceptors in the brain. Clonidine is not a central nervous system stimulant. Clonidine is a known antihypertensive agent. By stimulating alpha-adrenoreceptors in the brain stem, clonidine reduces sympathetic outflow from the central nervous system and decreases peripheral resistance, renal vascular resistance, heart rate, and blood pressure.

12.2Pharmacodynamics The patient’s blood pressure declines within 30 to 60 minutes after an oral dose, the maximum decrease occurring within 2 to 4 hours. Renal blood flow and glomerular filtration rate remain essentially unchanged. Normal postural reflexes are intact; therefore, orthostatic symptoms are mild and infrequent.

The antihypertensive effect is reached at plasma concentrations between about 0.2 and 2.0 ng/mL in patients with normal excretory function. A further rise in the plasma levels will not enhance the antihypertensive effect. Clonidine hydrochloride in humans have demonstrated a moderate reduction (15% to 20%) of cardiac output in the supine position with no change in the peripheral resistance: at a 45° tilt there is a smaller reduction in cardiac output and a decrease of peripheral resistance.

During long term therapy, cardiac output tends to return to control values, while peripheral resistance remains decreased. Slowing of the pulse rate has been observed in most patients given clonidine but the drug does not alter normal hemodynamic response to exercise. Tolerance to the antihypertensive effect may develop in some patients, necessitating a reevaluation of therapy.

Other studies in patients have provided evidence of a reduction in plasma renin activity and in the excretion of aldosterone and catecholamines. The exact relationship of these pharmacologic actions to the antihypertensive effect of clonidine has not been fully elucidated.

12.3Pharmacokinetics Median time to peak clonidine plasma concentrations (C max ) occurred at approximately 2.8 hours (range: 1 to 6 hours) following 0.3 mg oral dose of JAVADIN in healthy adult subjects under fasting conditions. The pharmacokinetics of clonidine is dose-proportional in the range of 0.1 to 0.6 mg. Absorption The absolute bioavailability of clonidine on oral administration is 70% to 80%.

Effect of Food Food had no effect on plasma exposures of clonidine after administration of JAVADIN. Distribution Following intravenous administration, clonidine displays biphasic disposition with a distribution half-life of about 20 minutes. Clonidine crosses the placental barrier.

Elimination Elimination half-life ranges from 12 to 16 hours. Metabolism About 50% of the absorbed dose is metabolized in the liver. Excretion Following oral administration, about 40% to 60% of the absorbed dose is recovered in the urine as unchanged drug in 24 hours.

Specific Populations Patients with Renal Impairment The half-life increases up to 41 hours in patients with severe impairment of renal function. Clonidine is minimally removed during hemodialysis.

🧬 Mechanism of Action 52 words ▾

12.1Mechanism of Action Clonidine stimulates alpha-adrenoreceptors in the brain. Clonidine is not a central nervous system stimulant. Clonidine is a known antihypertensive agent. By stimulating alpha-adrenoreceptors in the brain stem, clonidine reduces sympathetic outflow from the central nervous system and decreases peripheral resistance, renal vascular resistance, heart rate, and blood pressure.

📦 How Supplied / Storage and Handling 76 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied JAVADIN (clonidine hydrochloride) is a clear, colorless solution supplied in a high-density polyethylene (HDPE) bottle with child-resistant closure. The 0.02 mg/mL oral solution is available in bottles of 250 mL (NDC 24338-115-01).

16.2Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86° F) (see USP Controlled Room Temperature ). Discard unused portion 60 days after first opening.

📋 Description 130 words ▾

11 DESCRIPTION JAVADIN (clonidine hydrochloride) oral solution is a central alpha-2 adrenergic agonist hypotensive agent available as a 0.02 mg/mL solution for oral administration. Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride.

Its molecular formula is C 9 H 9 Cl 2 N 3 , HCl which corresponds to a molecular weight of 266.5. The following is the structural formula: Clonidine hydrochloride USP is a white or almost white crystalline powder. It is soluble in water, and ethanol and slightly soluble in Chloroform.

JAVADIN is a clear colorless oral solution. Each mL contains 0.02 mg of clonidine hydrochloride (equivalent to 0.0173 mg of clonidine). The inactive ingredients are: mixed berry flavor, purified water, sodium chloride, sodium propionate, sucralose.

Clonidine Structure

💬 Information for Patients 202 words ▾

17 PATIENT COUNSELING INFORMATION Sedation and Somnolence Advise patients not to interrupt JAVADIN therapy without consulting their physician. They should be cautious of potential sedative effects, dizziness, or accommodation issues and avoid activities such as driving or operating machinery. Additionally, advise patients that the sedative effects may be increased by the use of alcohol, barbiturates, or other sedating drugs. [see Drug Interactions ( 7 ) and Warnings and Precautions ( 5.3 )].

Rebound Hypertension Advise patients not to discontinue Clonidine therapy without consulting their physician, as sudden cessation can cause symptoms like tachycardia, rapid blood pressure elevation, headache, nervousness and agitation. The risk is higher with higher doses or ongoing beta-blocker use. [see Warnings and Precautions ( 5.2 )] . Bradycardia, cardiac conduction abnormalities, and symptomatic hypotension Advise patients who have a history of syncope or may have a condition that predisposes them to syncope, such as symptomatic hypotension, bradycardia, or dehydration, to avoid becoming dehydrated or overheated.

Administration Information Instruct patients or caregivers to use an oral dosing syringe or oral dosing cup to correctly measure the prescribed amount of medication. Inform patients that oral dosing syringes may be obtained from their pharmacy. Manufactured for: Azurity Pharmaceuticals, Inc.

Woburn, MA 01801

🧬 Pharmacokinetics 171 words ▾

12.3Pharmacokinetics Median time to peak clonidine plasma concentrations (C max ) occurred at approximately 2.8 hours (range: 1 to 6 hours) following 0.3 mg oral dose of JAVADIN in healthy adult subjects under fasting conditions. The pharmacokinetics of clonidine is dose-proportional in the range of 0.1 to 0.6 mg. Absorption The absolute bioavailability of clonidine on oral administration is 70% to 80%.

Effect of Food Food had no effect on plasma exposures of clonidine after administration of JAVADIN. Distribution Following intravenous administration, clonidine displays biphasic disposition with a distribution half-life of about 20 minutes. Clonidine crosses the placental barrier.

Elimination Elimination half-life ranges from 12 to 16 hours. Metabolism About 50% of the absorbed dose is metabolized in the liver. Excretion Following oral administration, about 40% to 60% of the absorbed dose is recovered in the urine as unchanged drug in 24 hours.

Specific Populations Patients with Renal Impairment The half-life increases up to 41 hours in patients with severe impairment of renal function. Clonidine is minimally removed during hemodialysis.

🧬 Pharmacodynamics 220 words ▾

12.2Pharmacodynamics The patient’s blood pressure declines within 30 to 60 minutes after an oral dose, the maximum decrease occurring within 2 to 4 hours. Renal blood flow and glomerular filtration rate remain essentially unchanged. Normal postural reflexes are intact; therefore, orthostatic symptoms are mild and infrequent.

The antihypertensive effect is reached at plasma concentrations between about 0.2 and 2.0 ng/mL in patients with normal excretory function. A further rise in the plasma levels will not enhance the antihypertensive effect. Clonidine hydrochloride in humans have demonstrated a moderate reduction (15% to 20%) of cardiac output in the supine position with no change in the peripheral resistance: at a 45° tilt there is a smaller reduction in cardiac output and a decrease of peripheral resistance.

During long term therapy, cardiac output tends to return to control values, while peripheral resistance remains decreased. Slowing of the pulse rate has been observed in most patients given clonidine but the drug does not alter normal hemodynamic response to exercise. Tolerance to the antihypertensive effect may develop in some patients, necessitating a reevaluation of therapy.

Other studies in patients have provided evidence of a reduction in plasma renin activity and in the excretion of aldosterone and catecholamines. The exact relationship of these pharmacologic actions to the antihypertensive effect of clonidine has not been fully elucidated.

🧪 Nonclinical Toxicology 125 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Chronic dietary administration of clonidine was not carcinogenic to rats (132 weeks) or mice (78 weeks) dosed, respectively, at up to 10 or 15 times the maximum recommended daily human dose as mg/kg (2 or 1 times the MRDHD on a mg/m 2 basis). Mutagenicity There was no evidence of genotoxicity in the Ames test for mutagenicity or mouse micronucleus test for clastogenicity. Impairment of Fertility In a reproduction study fertility of female rats appeared to be adversely affected at dose levels of 0.5 and 2.0 mg/kg/day (2 and 8 times the MRHD on a mg/m 2 basis).

Lower doses have not been adequately evaluated and a no adverse effect level could not be established.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 122 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Chronic dietary administration of clonidine was not carcinogenic to rats (132 weeks) or mice (78 weeks) dosed, respectively, at up to 10 or 15 times the maximum recommended daily human dose as mg/kg (2 or 1 times the MRDHD on a mg/m 2 basis). Mutagenicity There was no evidence of genotoxicity in the Ames test for mutagenicity or mouse micronucleus test for clastogenicity. Impairment of Fertility In a reproduction study fertility of female rats appeared to be adversely affected at dose levels of 0.5 and 2.0 mg/kg/day (2 and 8 times the MRHD on a mg/m 2 basis).

Lower doses have not been adequately evaluated and a no adverse effect level could not be established.

📄 Package Label / Principal Display Panel 30 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 24338-115-01 JAVADIN TM (clonidine HCl) Oral Solution - Carton Label 0.02 mg/mL JAVADIN TM (clonidine HCl) Oral Solution - Container Label 0.02 mg/mL carton-label bottle-label

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q4 2025 – Q1 2026 · 2 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
538
Units reimbursed last 4 qtrs
108.8K
Gross reimbursed last 4 qtrs
$178.6K
Avg / prescription
$331.90
Avg / unit
$1.6412
Latest quarter Q1 2026
538Rx
Medicaid pays / mL
$1.6412
gross reimbursed
vs
NADAC / mL
$1.5293
acquisition cost
=
Spread
+$0.1119
+7% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
89% FFS
Fee-for-service · 478 Rx Managed care · 60 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: 70,412 units · 1,191 per 100k residents WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 2,837 units · 88.5 per 100k residents IA Illinois: no data reported IL Indiana: 4,538 units · 66.1 per 100k residents IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: 1,289 units · 21.9 per 100k residents CO Nebraska: no data reported NE Missouri: 10,122 units · 163 per 100k residents MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: 2,773 units · 76.7 per 100k residents CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 2,388 units · 33.5 per 100k residents TN North Carolina: 11,008 units · 102 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 3,430 units · 11.2 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
11.21,191
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Wisconsin 1,191 /100k
2 Missouri 163 /100k
3 North Carolina 102 /100k
4 Iowa 88.5 /100k
5 Connecticut 76.7 /100k
6 Indiana 66.1 /100k
7 Tennessee 33.5 /100k
8 Colorado 21.9 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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

Medicare Part D (outpatient prescription) spending for Javadin — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Javadin. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Total Part D spend
$6.4K
Claims incl. refills
14
Beneficiaries
—
Spend / beneficiary
—
Spend / claim
$454.85
💵 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 JAVADIN (this brand).

Top reported reactions

Death1
Product Prescribing Issue1
Product Primary Packaging Issue1
Product Taste Abnormal1

Reporter sex

3 reports
Male · 100%

Serious outcomes

Death1
Reports over time (by year) — tap or hover for the count & year
2025 2026 3 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.
← 24338-0110-03 · Azurity 24338-0119-45 · Azurity →
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.