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ONYDA XR Clonidine hydrochloride .1 mg/mL Suspension, Extended Release, 7 mL — NDC 24478-0148-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

ONYDA XR Clonidine hydrochloride .1 mg/mL Suspension, Extended Release, 7 mL — NDC 24478-148-01 (Billing 24478-0148-01)

by NextWave Pharmaceuticals, Inc · 7 mL in 1 BOTTLE

This is a package of 7 mL of ONYDA XR Clonidine hydrochloride .1 mg/mL Suspension, Extended Release from NextWave Pharmaceuticals, Inc, marketed since Aug 2024 and currently FDA-listed.

NDC 24478-0148-01
🏷️ FDA NDC (as labeled) 24478-148-01 billing pads the product segment with a zero
This package
Contains7 mL Pack sizes2 compare ↓
Also priced by: Part D plans $14.29/unit — full pricing hub ↓
Product page 24478-0148-03 Also comes in: 30 ml 24478-148-03
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 24478-148-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
24478 labeler · 148 product · 01 package
Package marketed since
Aug 13, 2024
Sample package
Yes — professional sample, not for sale
Listing certified through
Dec 31, 2026
Billing quantity
7 mL per package
Barcode (UPC)
0324478148010, 0324478148034
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 24478-148-01
Product NDC 24478-148
11-digit billing NDC 24478014801
NCPDP billing unit ML — per mL (volume)
RxCUI 2690727, 2690735
UNII W76I6XXF06
UPC 0324478148010, 0324478148034
Application # NDA217645
SPL Set ID 4a15c850-9da5-4bdc-a34d-7f740a6149b7
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 2024-08-13
Route ORAL
Dosage form SUSPENSION, EXTENDED RELEASE
Substance CLONIDINE HYDROCHLORIDE

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

GPI-14 6135302010G110
GCN Seq No 086166
GCN 55838
HICL code 000113
Ingredient (HICL) Clonidine Hcl
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H8
Therapeutic class — intermediate (HIC2) Psychoactive Drugs (Continued 2)
HIC3 code H8M
Therapeutic class — specific (HIC3) Tx For Adhd - Selective Alpha-2 Receptor Agonist
AHFS code 12:12.04.00
AHFS class Alpha-Adrenergic Agonists (12:12)
FDB label name ONYDA XR 0.1 MG/ML SUSPENSION
FDB brand name Onyda Xr
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 086166
  • GCN: 55838
  • GPI-14 (Medi-Span): 6135302010G110
  • HICL (First Databank): 000113
  • AHFS class code: 12:12.04.00
  • RxCUI (RxNorm): 2690727
Why two NDCs? The FDA registers this code as 24478-148-01 — 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 → 24478-0148-01. 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 ONYDA XR 0.1 MG/ML SUSPENSION Ingredient Clonidine Hcl
📖 What it is MedlinePlus · NLM

Clonidine is used alone or in combination with other medications to treat high blood pressure. Clonidine is also used alone or in combination with other medications as part of a treatment program to control symptoms of attention deficit hyperactivity disorder (ADHD; more difficulty focusing, controlling actions, and remaining still or quiet than other people who are the same age) in children 6 years of age and older. Clonidine is in a class of medications called centrally acting alpha-agonist hypotensive agents. Clonidine treats high blood pressure by decreasing your heart rate and relaxing th...

Read the full MedlinePlus article ↗
📗 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 →
1
Nutrient depletion considerations

Clonidine may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Clonidine nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

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

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $14.29 $100.04 / 7 ml
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
24478-0148-01 You're viewing this 7 mL in 1 BOTTLE Sample — — 2024-08-13 — Active
24478-0148-03 24478-148-03 Main listing 30 mL in 1 BOTTLE $13.38 / mL $401.39 2024-08-13 — Active

You're viewing the smallest of 2 pack sizes for this product.

This pack shows little to no recent Medicaid volume — the 30 ml pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package contains 7 mL — 7 ml in 1 bottle.
How does this package differ from NDC 24478-0148-03?
Both are ONYDA XR Clonidine hydrochloride .1 mg/mL Suspension, Extended Release — the drug itself is identical. This page's package is the 7 mL one, while NDC 24478-0148-03 is the 30 ml package.
What NDC number is used to bill for this package of ONYDA XR Clonidine hydrochloride .1 mg/mL Suspension, Extended Release?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Onyda Xr .1 mg/mLthis 24478-0148-01 NextWave 7 ml — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2024
First FDA approval
May 2024
📍
2026
Currently FDA-listed
2 years listed
🛡️
2041
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 2041. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved May 24, 2024 RLD RS ⏳ ~14.8 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 11918689 — method of use (U-3944)
US 12576032 — method of use (U-2357)
US 8062667 — drug product
2024 2026 2028 2030 2032 2034 2036 2038 2040
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 (3)
PatentTypeUse codeExpires
US 11918689 ↗ Method of use U-3944 Jul 28, 2041
US 12576032 ↗ Method of use U-2357 Jul 28, 2041
US 8062667 ↗ Drug product — Mar 29, 2029
Common questions
Is there a generic version of ONYDA XR 0.1 MG/ML SUSPENSION?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for ONYDA XR 0.1 MG/ML SUSPENSION. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Jul 2041 — 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.

What it looks like

Color brown
FlavorOrange
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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 XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII 32K497ZK2U
    Polyvinyl acetate is a synthetic plastic polymer derived from vinyl acetate. It acts as a binder and film-forming agent in medicines, helping to hold ingredients together and create protective coatings on tablets or capsules.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII 1699G8679Z
    A synthetic polymer that acts as a binder and helps hold tablet or capsule ingredients together. It may also be used to improve how the medicine dissolves or is absorbed in the digestive system.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • UNII XHX3C3X673
    Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

13 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

LabelerNextWave Pharmaceuticals, Inc
Application holderTRIS PHARMA INC
FDA applicationNDA217645 (NDA)
Labeler code24478
First marketedAug 2024
Product typeHuman Prescription Drug
Portfolio13 products on file

More NDCs from NextWave Pharmaceuticals, Inc labeler code 24478

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 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🍼 Nursing Mothers 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📖 Instructions for Use 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 90 words ▾

1 INDICATIONS AND USAGE ONYDA XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to central nervous system (CNS) stimulant medications in pediatric patients 6 years of age and older [see Clinical Studies ( 14 )]. ONYDA XR is a centrally acting alpha 2 -adrenergic agonist indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy or as adjunctive therapy to central nervous system (CNS) stimulant medications in pediatric patients 6 years of age and older.

( 1 )

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Starting dosage is 0.1 mg of ONYDA XR orally once daily at bedtime with or without food. Dosage may be increased in increments of 0.1 mg per day at weekly intervals. Maximum recommended dosage is 0.4 mg once daily at bedtime.

( 2.1 ) Do not substitute ONYDA XR for other clonidine products on a mg-per-mg basis because of differing pharmacokinetic profiles. ( 2.3 ) When discontinuing, taper the dose in decrements of no more than 0.1 mg every 3 to 7 days to avoid rebound hypertension. ( 2.4 )

2.1Recommended Dosage The starting dosage of ONYDA XR is 0.1 mg orally once daily at bedtime with or without food [see Clinical Pharmacology ( 12.3 )] . Titrate the dose of ONYDA XR in increments of 0.1 mg per day at weekly intervals depending on clinical response up to the maximum recommended dosage of 0.4 mg once daily at bedtime. Doses of ONYDA XR higher than 0.4 mg once daily were not evaluated in clinical trials for ADHD and are not recommended.

When ONYDA XR is added to a CNS stimulant, adjust the dose of the CNS stimulant depending on the clinical response to ONYDA XR.

2.2Administration Instructions Instruct patients to read the “Instructions for Use” for complete administration instructions. Use the oral dosing dispenser and bottle adapter provided with ONYDA XR. Ensure that the bottle adapter is firmly inserted into the bottle before first use and keep the adapter in place for the duration of the usage of the bottle.

Gently shake ONYDA XR with a smooth up and down motion (to avoid foaming) for at least 10 seconds before each administration. For the bottles of 30 mL and 60 mL, discard any unused ONYDA XR 30 days after first opening the bottle. For the 120 mL bottle, discard any unused ONYDA XR 60 days after first opening the bottle.

2.3Switching from Other Clonidine Products For patients switching from another clonidine product, discontinue that treatment, and titrate with ONYDA XR using the titration schedule [see Dosage and Administration ( 2.1 )] . Do not substitute for other clonidine products on a milligram-per-milligram basis because of differing pharmacokinetic profiles [see Clinical Pharmacology ( 12.3 )].

2.4Discontinuation When discontinuing ONYDA XR, taper the total daily dose in decrements of no more than 0.1 mg every 3 to 7 days to avoid rebound hypertension [see Warnings and Precautions ( 5.3 )].

2.5Missed Doses If a dose of ONYDA XR is missed, skip that dose and take the next dose as scheduled. Do not take more than the prescribed total daily amount of ONYDA XR in any 24-hour period.

💊 Dosage Forms and Strengths 33 words ▾

3 DOSAGE FORMS AND STRENGTHS Extended-release oral suspension: Light beige to tan viscous suspension containing 0.1 mg clonidine hydrochloride per mL. Extended-release oral suspension: 0.1 mg clonidine hydrochloride per mL ( 3 )

⛔ Contraindications 55 words ▾

4 CONTRAINDICATIONS ONYDA XR is contraindicated in patients with a history of a hypersensitivity reaction to clonidine. Reactions have included generalized rash, urticaria, and angioedema [see Warnings and Precautions ( 5.4 ) and Adverse Reactions ( 6 )]. History of a hypersensitivity reaction to clonidine. Reactions have included generalized rash, urticaria, angioedema. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Hypotension/bradycardia: Titrate slowly and monitor vital signs frequently in patients at risk for hypotension, heart block, bradycardia, syncope, cardiovascular disease, vascular disease, cerebrovascular disease, or chronic renal failure. Measure heart rate and blood pressure prior to initiation of therapy, following dose increases, and periodically while on therapy. Avoid concomitant use of drugs with additive effects unless clinically indicated.

Advise patients to avoid becoming dehydrated or overheated. ( 5.1 ) Somnolence/Sedation: Has been observed with clonidine. Consider the potential for additive sedative effects with CNS depressant drugs.

Caution patients against operating heavy equipment or driving until they know how they respond to ONYDA XR ( 5.2 ) Cardiac Conduction Abnormalities: May worsen sinus node dysfunction and atrioventricular (AV) block, especially in patients taking other sympatholytic drugs. Titrate slowly and monitor vital signs frequently. ( 5.5 )

5.1Hypotension/Bradycardia Treatment with ONYDA XR can cause dose-related decreases in blood pressure and heart rate [see Adverse Reactions ( 6.1 )]. Measure heart rate and blood pressure prior to initiation of therapy, following dose increases, and periodically while on therapy. Titrate ONYDA XR slowly in patients with a history of hypotension, 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.

In patients who have a history of syncope or may have a condition that predisposes them to syncope, such as hypotension, orthostatic hypotension, bradycardia, or dehydration, advise patients to avoid becoming dehydrated or overheated. 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 [see Drug Interactions ( 7 )] .

5.2Sedation and Somnolence Somnolence and sedation were commonly reported adverse reactions in clinical studies with clonidine hydrochloride extended-release tablets. In patients that completed 5 weeks of therapy in a controlled, fixed dose pediatric monotherapy study, 31% of patients treated with 0.4 mg/day and 38% treated with 0.2 mg/day versus 4% of placebo treated patients reported somnolence as an adverse reaction. In patients that completed 5 weeks of therapy in a controlled flexible dose pediatric adjunctive to stimulants study, 19% of patients treated with clonidine hydrochloride extended-release tablets plus a stimulant versus 7% treated with placebo plus a stimulant reported somnolence.

Before using ONYDA XR with other centrally active depressants (such as phenothiazines, barbiturates, or benzodiazepines), consider the potential for additive sedative effects [see Drug Interactions ( 7 )] . Caution patients against operating heavy equipment or driving until they know how they respond to treatment with ONYDA XR. Advise patients to avoid use with alcohol.

5.3Rebound Hypertension Abrupt discontinuation of ONYDA XR can cause rebound hypertension. In adults with hypertension, sudden cessation of clonidine extended-release formulation treatment in the 0.2 to 0.6 mg per day range resulted in reports of headache, tachycardia, nausea, flushing, warm feeling, brief lightheadedness, tightness in chest, and anxiety. In adults with hypertension, sudden cessation of treatment with immediate-release clonidine has, in some cases, resulted in symptoms such as nervousness, agitation, headache, and tremor accompanied or followed by a rapid rise in blood pressure and elevated catecholamine concentrations in the plasma.

Pediatric patients with gastrointestinal illnesses that lead to vomiting may result in missed doses of ONYDA XR, increasing the risk for rebound hypertension. No studies evaluating abrupt discont… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described in greater detail elsewhere in labeling: Hypotension/bradycardia [see Warnings and Precautions ( 5.1 )] Sedation and somnolence [see Warnings and Precautions ( 5.2 )] Rebound hypertension [see Warnings and Precautions ( 5.3 )] Allergic reactions [see Warnings and Precautions ( 5.4 )] Cardiac Conduction Abnormalities [see Warnings and Precautions ( 5.5 )] Most common adverse reactions (incidence at least 5% and twice the rate of placebo) as monotherapy in ADHD: somnolence, fatigue, irritability, nightmare, insomnia, constipation, dry mouth.

( 6.1 ) Most common adverse reactions (incidence at least 5% and twice the rate of placebo) as adjunct therapy to psychostimulant in ADHD: somnolence, fatigue, decreased appetite, dizziness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Tris Pharma, Inc. at (732) 940-0358 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. The safety of ONYDA XR for the treatment of ADHD in pediatric patients 6 years and older is based upon adequate and well-controlled studies of clonidine hydrochloride extended-release tablets (referred to as “clonidine hydrochloride extended-release” in this section).

The safety results of these adequate and well-controlled studies of clonidine hydrochloride extended-release tablets are presented below. Two clonidine hydrochloride extended-release ADHD clinical studies (Study 1 and Study 2) evaluated 256 patients in two 8-week placebo-controlled studies. A third clonidine hydrochloride extended-release ADHD clinical study (Study 3) evaluated 135 pediatric patients 6 to 17 years of age in a 40-week placebo-controlled randomized‑withdrawal study.

Study 1: Fixed-dose clonidine hydrochloride extended-release Monotherapy Study 1 was a short-term, multi-center, randomized, double-blind, placebo-controlled study of two fixed doses (0.2 mg/day or 0.4 mg/day) of clonidine hydrochloride extended-release in pediatric patients 6 to 17 years of age who met DSM-IV criteria for ADHD hyperactive or combined inattentive/hyperactive subtypes. Most Common Adverse Reactions (incidence of ≥ 5% and at least twice the rate of placebo): somnolence, fatigue, irritability, insomnia, nightmare, constipation, dry mouth.

Adverse Reactions Leading to Discontinuation of clonidine hydrochloride extended-release: Five patients (7%) in the low dose group (0.2 mg), 15 patients (20%) in the high dose group (0.4 mg), and 1 patient in the placebo group (1%) reported adverse reactions that led to discontinuation. The most common adverse reactions that led to discontinuation were somnolence and fatigue. Commonly observed adverse reactions (incidence of ≥2% in either active treatment group and greater than the rate on placebo) during the treatment period are listed in Table 1 .

Table 1: Common Adverse Reactions Occurring in ≥2%of Patients Treated with Clonidine Hydrochloride Extended-Release Tablets and Greater than the Rate of Placebo in the Fixed-Dose Monotherapy Trial -Treatment Period (Study 1) Preferred Term Clonidine hydrochloride extended-release tablets 0.2 mg/day N=76 (%) Clonidine hydrochloride extended-release tablets 0.4 mg/day N=78 (%) Placebo N=76 (%) PSYCHIATRIC DISORDERS Somnolence * Nightmare Emotional Disorder Aggression Tearfulness Enuresis Sleep Terror Poor Quality Sleep 38 4 4 3 1 0 3 0 31 9 4 1 3 4 0 3 4 0 1 0 0 0 0 1 NERVOUS SYSTEM DISORDERS Headache Insomnia Tremor Abnormal Sleep-Related Event 20 5 1 3 13 6 4 1 16 1 0 0 GASTRO-INTESTINAL DISORDERS Upper Abdominal Pain Nausea Constipation Dry Mouth 15 4 1 0 10 5 6 5 12 3 0 1 GENERAL DISORDERS Fatigue † Irritability 16 9 13 5 1 4 CARDIAC DISORDERS Dizziness Bradycardia 7 0… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS The interactions of ONYDA XR 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 5 displays clinically important drug interactions with ONYDA XR.

Table 5: Clinically Important Drug Interactions with ONYDA XR Antihypertensive drugs Clinical Implication Concomitant use of antihypertensive drugs with clonidine potentiates the hypotensive effects of clonidine. Intervention Monitor blood pressure and heart rate, and adjust dosage of ONYDA XR accordingly in patients treated concomitantly with antihypertensives [see Warnings and Precautions ( 5.1 )] . CNS depressants Clinical Implication Concomitant use of CNS depressants with clonidine potentiates the sedating effects [see Warnings and Precautions ( 5.2 )] .

Intervention Avoid concomitant use of CNS depressants with ONYDA XR. 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 ( 5.5 )] . Intervention Avoid concomitant use of drugs that affect sinus node function or AV node conduction with ONYDA XR.

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 ONYDA XR as needed. CNS Depressants: 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 ) Drugs Known to Affect Sinus Node Function or AV Nodal Conduction: Avoid use of ONYDA XR 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 ) Antihypertensive drugs: Use caution when coadministered with ONYDA XR.

( 7 )

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Renal Impairment: The dosage of ONYDA XR must be adjusted according to the degree of impairment, and patients should be carefully monitored. ( 8.6 , 12.3 )

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including ONYDA XR, during pregnancy. Healthcare providers are encouraged to advise patients to register by calling the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/adhd-medications/ . 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, and 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 10 and 5 times, respectively, the maximum recommended human dose (MRHD) given to adolescents on a mg/m 2 basis. No developmental effects were seen in rabbits administered oral clonidine hydrochloride during organogenesis at doses up to 3 times the 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 80 mcg/kg/day (approximately 3 times the oral maximum recommended daily dose [MRHD] of 0.4 mg/day given to adolescents on a mg/m 2 basis) produced no developmental effects.

In pregnant rats, however, doses as low as 15 mcg/kg/day (1/3 the MRHD given to adolescents on a mg/m 2 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 (up to 3 times the MRHD) when treatment of the dams was restricted to gestation days 6-15. Increases in resorptions were observed in both rats and mice at 500 mcg/kg/day (10 and 5 times the MRHD in rats and mice, respectively) or higher when the animals were treated on gestation days 1-14; 500 mcg/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 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 ONYDA XR and any potential adverse effects on the breastfed child from ONYDA XR or from the underlying maternal condition. Exercise caution when ONYDA XR is administered to a nursing woman. Clinical Considerations Monitor breastfeeding infants exposed to ONYDA XR through breast milk for symptoms of hypotension and/or bradycardia such as sedation, lethargy, tachypnea, and poor feeding.

8.3Females and Males of Reproductive Potential Infertility Findings in animal studies revealed that ONYDA XR may… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including ONYDA XR, during pregnancy. Healthcare providers are encouraged to advise patients to register by calling the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/adhd-medications/ . 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, and 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 10 and 5 times, respectively, the maximum recommended human dose (MRHD) given to adolescents on a mg/m 2 basis. No developmental effects were seen in rabbits administered oral clonidine hydrochloride during organogenesis at doses up to 3 times the 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 80 mcg/kg/day (approximately 3 times the oral maximum recommended daily dose [MRHD] of 0.4 mg/day given to adolescents on a mg/m 2 basis) produced no developmental effects.

In pregnant rats, however, doses as low as 15 mcg/kg/day (1/3 the MRHD given to adolescents on a mg/m 2 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 (up to 3 times the MRHD) when treatment of the dams was restricted to gestation days 6-15. Increases in resorptions were observed in both rats and mice at 500 mcg/kg/day (10 and 5 times the MRHD in rats and mice, respectively) or higher when the animals were treated on gestation days 1-14; 500 mcg/kg/day was the lowest dose employed in this study.

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use The safety and efficacy of clonidine hydrochloride extended-release in the treatment of ADHD have been established in pediatric patients 6 to 17 years of age. Use of clonidine hydrochloride extended-release in pediatric patients 6 to 17 years of age is supported by three adequate and well-controlled studies; a short-term, placebo-controlled monotherapy trial, a short-term adjunctive therapy trial and a longer-term randomized monotherapy trial [see Clinical Studies ( 14 )]. Safety and efficacy in pediatric patients below the age of 6 years has not been established.

Juvenile Animal Data In studies in juvenile rats, clonidine hydrochloride alone or in combination with methylphenidate had an effect on bone growth at clinically relevant doses and produced a slight delay in sexual maturation in males at 3 times the maximum recommended human dose (MRHD) for clonidine and methylphenidate. In a study where juvenile rats were treated orally with clonidine hydrochloride from day 21 of age to adulthood, a slight delay in onset of preputial separation (delayed sexual maturation) was seen in males treated with 300 mcg/kg/day, which is approximately 3 times the MRHD of 0.4 mg/day on a mg/m 2 basis.

The no-effect dose was 100 mcg/kg/day, which is approximately equal to the MRHD. There was no drug effects on fertility or on other measures of sexual or neurobehavioral development. In a study where juvenile rats were treated with clonidine alone (300 mcg/kg/day) or in combination with methylphenidate (10 mg/kg/day in females and 50/30 mg/kg/day in males; the dose was lowered from 50 to 30 mg/kg/day in males due to self-injurious behavior during the first week of treatment) from day 21 of age to adulthood, decreases in bone mineral density and mineral content were observed in males treated with 300 mcg/kg/day clonidine alone and in combination with 50/30 mg/kg/day methylphenidate and a decrease in femur length was observed in males treated with the combination at the end of the treatment period.

These doses are approximately 3 times the MRHD of 0.4 mg/day clonidine and 54 mg/day methylphenidate on a mg/m 2 basis. All these effects in male were not reversed at the end of a 4-week recovery period. In addition, similar findings were seen in males treated with a lower dose of clonidine (30 mcg/kg/day) in combination with 50 mg/kg/day of methylphenidate and a decrease in femur length was observed in females treated with clonidine alone at the end of the recovery period.

These effects were accompanied by a decrease in body weight gain in treated animals during the treatment period but the effect was reversed at the end of the recovery period. A delay in preputial separation (sexual maturation) was observed in males treated with the combination treatment of 300 mcg/kg/day clonidine and 50/30 mg/kg/day methylphenidate. There was no effect on reproduction or sperm analysis in these males.

🆘 Overdosage 84 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. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Clonidine stimulates alpha 2 -adrenergic receptors in the brain. Clonidine is not a central nervous system stimulant. The mechanism of action of clonidine in ADHD is not known.

12.2Pharmacodynamics Clonidine is a known antihypertensive agent. By stimulating alpha 2 -adrenergic receptors 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.

12.3Pharmacokinetics Immediate-release clonidine hydrochloride, extended-release clonidine hydrochloride tablets, and ONYDA XR have different pharmacokinetic characteristics. Dose substitution on a milligram for milligram basis will result in differences in exposures [see Dosage and Administration ( 2.3 )] . Absorption Following a single 0.2 mg dose of ONYDA XR in 20 healthy adult subjects under fasting conditions in a crossover study, the median (range) time to peak plasma concentrations (T max ) for clonidine was 7.50 (4 –17) hours after dosing.

Peak concentration (C max ) was 95.6% of the C max of clonidine extended-release tablet 0.1 mg administered at 0 and 12 hours under fasting conditions. The relative bioavailability of ONYDA XR compared with an equal dose of clonidine extended-release tablet was 96.1%. After oral administration of 0.2 mg of ONYDA XR once daily over 5 days under fasted conditions in healthy adult subjects, the peak steady state plasma concentration (C max .ss) was 107.9%, and steady state relative bioavailability (AUC t , ss) was 97.7% compared with 0.1 mg of clonidine extended-release tablet administered twice daily under fasting conditions.

The minimum concentration at steady state (Cmin,ss) of ONYDA XR was about 26% lower than that of the equal dose of clonidine extended-release tablet. Following oral administration of an immediate release formulation in healthy adult subjects, plasma clonidine concentration peaks in approximately 3 to 5 hours. A comparison across studies suggests that the C max is 50% lower for clonidine hydrochloride extended-release tablets compared to immediate-release clonidine hydrochloride.

Effect of Food Food had no effect on plasma exposures of clonidine after administration of ONYDA XR (see Figure 1 ). Figure 1: Mean Clonidine Concentration-Time Profiles After Single Dose Administration Elimination The plasma half-life of immediate-release clonidine ranges from 12 to 16 hours. The half-life increases up to 41 hours in patients with severe impairment of renal function.

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. Although studies of the effect of renal impairment and studies of clonidine excretion have not been performed with ONYDA XR, results are expected to be similar to those of the immediate-release formulation.

Specific Populations Pediatric patients Plasma clonidine concentrations in pediatric patients 6 to 17 years (0.1 mg twice daily and 0.2 mg twice daily of clonidine hydrochloride extended-release tablets) with ADHD are greater than those of adults with hypertension, with pediatric patients 6 to 17 years receiving higher doses on a mg/kg basis. Body weight normalized clearance (CL/F) in pediatric patients aged 6 to 17 years was higher than CL/F observed in adults with hypertension. Clonidine concentrations in plasma increased with increases in dose over the dose range of 0.2 to 0.4 mg/day.

Clonidine CL/F was independent of dose administered over the 0.2 to 0.4 mg/day dose range. Clonidine CL/F appeared to decrease slightly with increases in age over the range of 6 to 17 years, and females had a 23% lower CL/F than males. The incidence of "sedation-like" events (somnolence and fatigue) appeared to be independent of clonidine dose or concentration within the studied dose range in the titration… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 32 words ▾

12.1Mechanism of Action Clonidine stimulates alpha 2 -adrenergic receptors in the brain. Clonidine is not a central nervous system stimulant. The mechanism of action of clonidine in ADHD is not known.

📦 How Supplied / Storage and Handling 192 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied ONYDA XR (clonidine hydrochloride) extended-release oral suspension 0.1 mg/mL is a light beige to tan viscous suspension. ONYDA XR is supplied in a carton. Each carton contains one bottle with a child resistant closure, an oral dosing dispenser(s), and a press in bottle adapter(s).

Bottle of 30 mL NDC 24478-148-03 One (1) oral dosing dispenser and one (1) press in bottle adapter Bottle of 60 mL NDC 24478-148-04 One (1) oral dosing dispenser and one (1) press in bottle adapter Bottle of 120 mL NDC 24478-148-02 Two (2) oral dosing dispensers and two (2) press in bottle adapters Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light. Store and dispense ONYDA XR in the original bottle.

Dispense with bottle adapter and oral dosing dispenser supplied in the carton. For the bottles of 30 mL and 60 mL, discard any unused ONYDA XR 30 days after first opening the bottle. For the 120 mL bottle, discard any unused ONYDA XR 60 days after first opening the bottle.

📋 Description 177 words ▾

11 DESCRIPTION ONYDA XR contains clonidine hydrochloride, a centrally acting alpha 2 -adrenergic agonist. Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-[(2,6-dichlorophenyl)imino]imidazolidine hydrochloride.

The following is the structural formula: The molecular formula of clonidine hydrochloride is C 9 H 9 C l2 N 3 •HCl and the molecular weight is 266.5. The pKa is 8.05. Clonidine hydrochloride is an odorless, bitter, white to almost white, crystalline powder soluble in water and alcohol.

The pH of a 5% solution in water is between 3.5 and 5.5. ONYDA XR is an extended-release suspension for oral administration. Each mL of ONYDA XR contains 0.09 mg clonidine equivalent to 0.1 mg clonidine hydrochloride (0.095 mg clonidine hydrochloride complexed with sodium polystyrene sulfonate and 0.005 mg clonidine hydrochloride).

The pH of ONYDA XR is between 2.8 and 4. The inactive ingredients are anhydrous citric acid, edetate disodium, glycerin, modified starch, methylparaben, orange flavor, polyvinyl acetate dispersion 30%, povidone, polysorbate 80, propylparaben, purified water, sucrose, sodium polystyrene sulfonate, triacetin, xanthan gum. Chem Draw Structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Patient Information and Instructions for Use ). Dosage and Administration Advise patients that ONYDA XR may be taken with or without food. When initiating treatment, provide titration instructions [see Dosage and Administration ( 2.1 )].

Administration Instructions Instruct patients to read the “Instructions for Use” for complete administration instructions [see Dosage and Administration ( 2.2 )] . Advise patients to: firmly insert the bottle adapter into the bottle and do not remove the bottle adapter once inserted. Use the oral dispenser provided with ONYDA XR. gently shake ONYDA XR with a smooth up and down motion (to avoid foaming) for at least 10 seconds before each administration.

For the bottles of 30 mL and 60 mL, discard any unused ONYDA XR 30 days after first opening the bottle. For the 120 mL bottle, discard any unused ONYDA XR 60 days after first opening the bottle. Missed Dose If patients miss a dose of ONYDA XR, advise them to skip the dose and take the next dose as scheduled and not to take more than the prescribed total daily amount of ONYDA XR in any 24‑hour period [see Dosage and Administration ( 2.5 )].

Hypotension/Bradycardia Advise patients who have a history of syncope or may have a condition that predisposes them to syncope, such as hypotension, orthostatic hypotension, bradycardia, or dehydration, to avoid becoming dehydrated or overheated [see Warnings and Precautions ( 5.1 ) ]. Sedation and Somnolence Instruct patients to use caution when driving a car or operating heavy equipment until they know how they will respond to treatment with ONYDA XR. Also advise patients to avoid the use of ONYDA XR with other centrally active depressants and with alcohol [see Warnings and Precautions ( 5.2 )].

Rebound Hypertension Advise patients not to discontinue ONYDA XR abruptly. Inform patients and caregivers that pediatric patients with gastrointestinal illnesses that lead to vomiting may be at increased risk for rebound hypertension [see Warnings and Precautions ( 5.3 )]. Allergic Reactions Advise patients to discontinue ONYDA XR and seek immediate medical attention if any signs or symptoms of a hypersensitivity reaction occur, such as generalized rash, urticaria, or angioedema [see Warnings and Precautions ( 5.4 )].

Pregnancy Registry Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in patients exposed to ONYDA XR during pregnancy [see Use in Specific Populations ( 8.1 )]. Lactation Advise breastfeeding women using ONYDA XR to monitor infants for excess sedation, decreased muscle tone, and respiratory depression and to seek medical care if they notice these signs [see Use in Specific Populations ( 8.2 )]. Fertility Advise females and males of reproductive potential that ONYDA XR may impair fertility [see Use in Specific Populations ( 8.3 ) and Nonclinical Toxicology ( 13.1 )].

Manufactured by/Distributed by: Tris Pharma, Inc. Monmouth Junction, NJ 08852 www.trispharma.com LB8735 Rev. 05

🍼 Nursing Mothers 32 words ▾

8.3Females and Males of Reproductive Potential Infertility Findings in animal studies revealed that ONYDA XR may impair fertility in females and males of reproductive potential [see Nonclinical Toxicology ( 13.1 )].

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Immediate-release clonidine hydrochloride, extended-release clonidine hydrochloride tablets, and ONYDA XR have different pharmacokinetic characteristics. Dose substitution on a milligram for milligram basis will result in differences in exposures [see Dosage and Administration ( 2.3 )] . Absorption Following a single 0.2 mg dose of ONYDA XR in 20 healthy adult subjects under fasting conditions in a crossover study, the median (range) time to peak plasma concentrations (T max ) for clonidine was 7.50 (4 –17) hours after dosing.

Peak concentration (C max ) was 95.6% of the C max of clonidine extended-release tablet 0.1 mg administered at 0 and 12 hours under fasting conditions. The relative bioavailability of ONYDA XR compared with an equal dose of clonidine extended-release tablet was 96.1%. After oral administration of 0.2 mg of ONYDA XR once daily over 5 days under fasted conditions in healthy adult subjects, the peak steady state plasma concentration (C max .ss) was 107.9%, and steady state relative bioavailability (AUC t , ss) was 97.7% compared with 0.1 mg of clonidine extended-release tablet administered twice daily under fasting conditions.

The minimum concentration at steady state (Cmin,ss) of ONYDA XR was about 26% lower than that of the equal dose of clonidine extended-release tablet. Following oral administration of an immediate release formulation in healthy adult subjects, plasma clonidine concentration peaks in approximately 3 to 5 hours. A comparison across studies suggests that the C max is 50% lower for clonidine hydrochloride extended-release tablets compared to immediate-release clonidine hydrochloride.

Effect of Food Food had no effect on plasma exposures of clonidine after administration of ONYDA XR (see Figure 1 ). Figure 1: Mean Clonidine Concentration-Time Profiles After Single Dose Administration Elimination The plasma half-life of immediate-release clonidine ranges from 12 to 16 hours. The half-life increases up to 41 hours in patients with severe impairment of renal function.

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. Although studies of the effect of renal impairment and studies of clonidine excretion have not been performed with ONYDA XR, results are expected to be similar to those of the immediate-release formulation.

Specific Populations Pediatric patients Plasma clonidine concentrations in pediatric patients 6 to 17 years (0.1 mg twice daily and 0.2 mg twice daily of clonidine hydrochloride extended-release tablets) with ADHD are greater than those of adults with hypertension, with pediatric patients 6 to 17 years receiving higher doses on a mg/kg basis. Body weight normalized clearance (CL/F) in pediatric patients aged 6 to 17 years was higher than CL/F observed in adults with hypertension. Clonidine concentrations in plasma increased with increases in dose over the dose range of 0.2 to 0.4 mg/day.

Clonidine CL/F was independent of dose administered over the 0.2 to 0.4 mg/day dose range. Clonidine CL/F appeared to decrease slightly with increases in age over the range of 6 to 17 years, and females had a 23% lower CL/F than males. The incidence of "sedation-like" events (somnolence and fatigue) appeared to be independent of clonidine dose or concentration within the studied dose range in the titration study.

Results from the add-on study showed that clonidine CL/F was 11% higher in patients who were receiving methylphenidate and 44% lower in those receiving amphetamine compared to subjects not on adjunctive therapy. Drug Interaction Studies Alcohol: In an in vitro alcohol-induced dose dumping study, a significantly faster and more variable ONYDA XR drug release was observed in the presence of 20% alcohol, but not with 5% or 10% alcohol, when compared to 0% alcohol. Figure 1

🧬 Pharmacodynamics 39 words ▾

12.2Pharmacodynamics Clonidine is a known antihypertensive agent. By stimulating alpha 2 -adrenergic receptors 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.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES The efficacy of ONYDA XR for the treatment of ADHD in pediatric patients 6 years of age and older is based upon adequate and well-controlled studies of clonidine hydrochloride extended-release tablets (referred to as “clonidine hydrochloride extended-release” in this section). The efficacy results of these adequate and well-controlled studies of clonidine hydrochloride extended-release tablets are presented below. Efficacy of clonidine hydrochloride extended-release in the treatment of ADHD was established in pediatric patients 6 to 17 years in: One short-term, placebo-controlled monotherapy trial (Study 1) One short-term adjunctive therapy to psychostimulants trial (Study 2) One randomized withdrawal trial as monotherapy (Study 3) Short-term Monotherapy and Adjunctive Therapy to Psychostimulant Studies for ADHD The efficacy of clonidine hydrochloride extended-release in the treatment of ADHD was established in 2 (one monotherapy and one adjunctive therapy) placebo-controlled trials in pediatric patients aged 6 to 17 years, who met DSM-IV criteria of ADHD hyperactive or combined hyperactive/inattentive subtypes.

Signs and symptoms of ADHD were evaluated using the investigator administered and scored ADHD Rating Scale-IV-Parent Version (ADHDRS-IV) total score including hyperactive/impulsivity and inattentive subscales. Study 1 was an 8-week randomized, double-blind, placebo-controlled, fixed dose study of pediatric patients 6 to 17 years (N=236) with a 5-week primary efficacy endpoint. Patients were randomly assigned to one of the following three treatment groups: clonidine hydrochloride extended-release 0.2 mg/day (N=78), clonidine hydrochloride extended-release 0.4 mg/day (N=80), or placebo (N=78).

Dosing for the clonidine hydrochloride extended-release groups started at 0.1 mg/day and was titrated in increments of 0.1 mg/week to their respective dose (as divided doses). Patients were maintained at their dose for a minimum of 2 weeks before being gradually tapered down to 0.1 mg/day at the last week of treatment. At both doses, improvements in ADHD symptoms were statistically significantly superior in clonidine hydrochloride extended-release-treated patients compared with placebo-treated patients at the end of 5 weeks as measured by the ADHDRS-IV total score ( Table 6 ).

Study 2 was an 8-week randomized, double-blind, placebo-controlled, flexible dose study in pediatric patients 6 to 17 years (N=198) with a 5-week primary efficacy end point. Patients had been treated with a psychostimulant (methylphenidate or amphetamine) for four weeks with inadequate response. Patients were randomly assigned to one of two treatment groups: clonidine hydrochloride extended-release adjunct to a psychostimulant (N=102) or psychostimulant alone (N=96).

The clonidine hydrochloride extended-release dose was initiated at 0.1 mg/day and doses were titrated in increments of 0.1 mg/week up to 0.4 mg/day, as divided doses, over a 3-week period based on tolerability and clinical response. The dose was maintained for a minimum of 2 weeks before being gradually tapered to 0.1 mg/day at the last week of treatment. ADHD symptoms were statistically significantly improved in clonidine hydrochloride extended-release plus stimulant group compared with the stimulant alone group at the end of 5 weeks as measured by the ADHDRS-IV total score ( Table 6 ).

Table 6: Short-Term Trials Study Number Treatment Group Primary Efficacy Measure: ADHDRS-IV Total Score Mean Baseline Score (SD) LS Mean Change from Baseline (SE) Placebo-subtracted Difference a (95% CI) Study 1 Clonidine hydrochloride extended-release tablets (0.2 mg/day) 43.8 (7.47) -15.0 (1.38) -8.5 (-12.2, -4.8) Clonidine hydrochloride extended-release tablets (0.4 mg/day) 44.6 (7.73) -15.6 (1.33) -9.1 (-12.8, -5.5) Placebo 45.0 (8.53) -6.5 (1.35) ---------- Study 2 Clonidine hydrochloride extended-release tablets (0.4 mg/day) + Psychostimulant 38.9 (6.95) -15.8 (1.18) -4.5 (-7.8, -1.1) Ps… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 145 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis and Impairment of Fertility Carcinogenesis Clonidine hydrochloride was not carcinogenic when administered in the diet of rats (for up to 132 weeks) or mice (for up to 78 weeks) at doses of up to 1,620 (male rats), 2,040 (female rats), or 2,500 (mice) mcg/kg/day. These doses are approximately 20, 25, and 15 times, respectively, the maximum recommended human dose (MRHD) of 0.4 mg/day on a mg/m 2 basis. Mutagenesis 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 500 and 2,000 mcg/kg/day (10 and 40 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 142 words ▾

13.1Carcinogenesis, Mutagenesis and Impairment of Fertility Carcinogenesis Clonidine hydrochloride was not carcinogenic when administered in the diet of rats (for up to 132 weeks) or mice (for up to 78 weeks) at doses of up to 1,620 (male rats), 2,040 (female rats), or 2,500 (mice) mcg/kg/day. These doses are approximately 20, 25, and 15 times, respectively, the maximum recommended human dose (MRHD) of 0.4 mg/day on a mg/m 2 basis. Mutagenesis 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 500 and 2,000 mcg/kg/day (10 and 40 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.

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION ONYDA TM XR (oh-nee-dah) (clonidine hydrochloride) extended-release oral suspension What is ONYDA XR? ONYDA XR is a prescription medicine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) alone or with certain other ADHD medicines in children 6 years of age and older. It is not known if ONYDA XR is safe and effective in children under 6 years of age.

Who should not take ONYDA XR? Do not take ONYDA XR if you are allergic to clonidine. See the end of this Patient Information for a complete list of ingredients in ONYDA XR.

Before taking ONYDA XR, tell your healthcare provider about all of your medical conditions, including if you: have kidney problems have low or high blood pressure have a history of passing out (syncope) have heart problems, including slow heart rate or other heart rhythm problems had a stroke or have stroke symptoms had an allergic reaction after taking clonidine through your skin in a transdermal system (patch) are pregnant or plan to become pregnant. It is not known if ONYDA XR will harm the unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.

There is a pregnancy registry for females who are exposed to ADHD medications, including ONYDA XR, during pregnancy. The purpose of the registry is to collect information about the health of females exposed to ONYDA XR and their baby. If you become pregnant during treatment with ONYDA XR, talk to your healthcare provider about registering with the National Pregnancy Registry of ADHD Medications at 1-866-961-2388 or visit online at https://womensmentalhealth.org/adhdmedications/ are breastfeeding or plan to breastfeed.

ONYDA XR passes into the breast milk. Babies who are breastfed during treatment with ONYDA XR may become very sleepy, develop relaxed or floppy muscles, and develop trouble breathing. Call the baby’s healthcare provider if the baby is breastfed during treatment with ONYDA XR and develops any of these symptoms.

Talk to your healthcare provider about the best way to feed your baby if you take ONYDA XR. Tell your healthcare provider about all of the medicines that you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ONYDA XR and certain other medicines may affect each other causing serious side effects.

Especially tell your healthcare provider if you take: • anti-depression medicines • other medicines for ADHD • heart or blood pressure medicines • medicines that cause sleepiness (sedation) • other medicines that contain clonidine Ask your healthcare provider or pharmacist if you are not sure if your medicine is listed above. Know the medicines that you take. Keep a list of your medicines with you to show your healthcare provider and pharmacist when you get a new medicine.

How should I take ONYDA XR? Take ONYDA XR 1 time daily at bedtime with or without food. Take ONYDA XR exactly as your healthcare provider tells you.

Your healthcare provider may change your dose of ONYDA XR. Do not change your dose of ONYDA XR without talking to your healthcare provider. If you are taking another clonidine medicine , stop taking it before you start treatment with ONYDA XR.

The dose of ONYDA XR is not the same as other clonidine medicines. Do not change between ONYDA XR and other clonidine medicines unless your healthcare provider tells you. Do not stop taking ONYDA XR without talking to your healthcare provider.

If you miss a dose of ONYDA XR, skip the missed dose and take the next dose at their regular scheduled time. Do not take more ONYDA XR in a 24-hour period than your healthcare provider prescribed for your daily dose. For the bottles of 30 mL and 60 mL, throw away (discard of) any remaining ONYDA XR if you have not used it 30 days after first opening the bottle.

For the 120 mL bottle, throw away (discard of) any remaining ONYDA XR if you have not used it 60 days after first opening the bottle. See the detailed Instructions for Use for info… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

INSTRUCTIONS FOR USE ONYDA TM XR (oh-nee-dah) (clonidine hydrochloride) extended-release oral suspension This Instructions for Use contains information on how to take ONYDA XR. Important Information You Need to Know Before Taking ONYDA XR: ONYDA XR is for oral use only (taken by mouth). Take ONYDA XR with or without food.

Use only the oral dosing syringe and bottle adapter that come with ONYDA XR to measure and take a dose of ONYDA XR. Shake the ONYDA XR bottle gently. Check the expiration date (EXP) on the carton label.

Do not take ONYDA XR after the expiration date has passed. Call your healthcare provider or pharmacist if your medicine is expired. For the bottles of 30 mL and 60 mL, throw away (discard of) any remaining ONYDA XR if you have not used it 30 days after first opening the bottle.

For the 120 mL bottle, throw away (discard of) any remaining ONYDA XR if you have not used it 60 days after first opening the bottle. Supplies included in the ONYDA XR carton: 1 bottle of ONYDA XR Dosing Syringe(s) Bottle Adapter(s) 30 mL bottle 1 1 60 mL bottle 1 1 120 mL bottle 2 2 Figure A Figure A Step 1: Preparing to take ONYDA XR: Wash and dry your hands (see Figure B). Remove the ONYDA XR bottle, 1 oral dosing syringe, and 1 bottle adapter from the carton.

Tell your pharmacist right away if you are missing any supplies from the carton. Figure B Step 2: Place the ONYDA XR bottle on a flat surface like a table or countertop and remove the child resistant cap by pressing down and turning counterclockwise (see Figure C). Insert the bottle adapter (first time use only).

Hold the bottle firmly and insert the ridged end of the bottle adapter into the neck of the bottle. Firmly push the bottle adapter all the way down with your thumb until the top of the adapter is aligned and flat (flush) with the top of the bottle (See Figure D). Do not remove the bottle adapter once it has been inserted into the bottle.

Figure C Figure D Step 3: Put the cap back on the bottle and close it tightly by turning the cap clockwise (see Figure E). Shake the bottle gently with a smooth up and down motion to avoid foaming (see Figure F). Shake the bottle gently for at least 10 seconds before you take each dose.

Figure E Figure F Step 4: Place the ONYDA XR bottle upright on the table or countertop. Open the cap again by pressing down and turn counterclockwise to remove the cap (see Figure G). Figure G Step 5: Check the ONYDA XR oral dosing syringe to find the right dose in milliliters (mL) that has been prescribed by the healthcare provider (see Figure H).

Make sure the oral dosing syringe is dry. Figure H Step 6: Insert the tip of the oral dosing syringe through the adapter into the bottle (see Figure I). Push the plunger all the way down (see Figure J).

Figure I Figure J Step 7: Measuring the dose of ONYDA XR: With the tip of the oral dosing syringe in place in the adapter, hold the ONYDA XR bottle with 1 hand and turn the bottle upside down. Pull the plunger down until the white end of the plunger reaches the number of mL you need for the prescribed dose (see Figure K). Push and pull the plunger a few times to make sure that there are no air bubbles.

Tap the barrel of the oral dosing syringe if needed to get rid of any air bubbles (see Figure L). Figure K Figure L Step 8: Turn the bottle over and place it upright on a table or countertop, then remove the oral dosing syringe from the bottle adapter (see Figure M). Figure M Step 9: Check that the correct dose in mL was pulled up into the oral dosing syringe (see Figure N).

If the dose is not correct: Insert the oral syringe tip back into the bottle and fully push in the plunger to the bottom of the syringe barrel so that all of the oral suspension flows back into the bottle. Repeat Steps 6 through 8. Figure N Step 10: Taking the dose of ONYDA XR: The child should be in a seated position before taking ONYDA XR.

Tilt the head slightly upwards. Place the oral dosing syringe into the mouth and point it toward the… [Excerpted — this section continues on DailyMed.]

📄 Recent Major Changes 10 words ▾

RECENT MAJOR CHANGES Warnings and Precautions ( 5.3 ) 04/2025

📄 Package Label / Principal Display Panel 96 words ▾

PRINCIPAL DISPLAY PANEL NDC 24478-148-01 ONYDA TM XR (clonidine hydrochloride) extended-release oral suspension 0.1 mg Shake Gently Before Use 7 mL Rx only 7mLlabel

PRINCIPAL DISPLAY PANEL NDC 24478-148-01 ONYDA TM XR (clonidine hydrochloride) extended-release oral suspension 0.1 mg Shake Gently Before Use 7 mL Rx only 7mLcarton

PRINCIPAL DISPLAY PANEL NDC 24478-148-03 ONYDA TM XR (clonidine hydrochloride) extended-release oral suspension 0.1 mg Shake Gently Before Use 30 mL Rx only 30mLlabel

PRINCIPAL DISPLAY PANEL NDC 24478-148-03 ONYDA TM XR (clonidine hydrochloride) extended-release oral suspension 0.1 mg Shake Gently Before Use 30 mL Rx only 30mLcarton

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

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
30 ml24478-0148-03 41,614 Rx · $29,007,077
7 ml this page24478-0148-01 No Medicaid data
Drug total (last 4 qtrs): 41,614 Rx · 2,214,639 units · $29,007,077 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Onyda XR — 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 Onyda XR. 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
$38.3K
Claims incl. refills
43
Beneficiaries
24
Spend / beneficiary
$1,595.98
Spend / claim
$890.78
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.

About this NDC listing & data coverage

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

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The 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 NextWave Pharmaceuticals, Inc. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 30 ml (24478-0148-03). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
NextWave 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.
← 24478-0110-01 · NextWave 24478-0321-02 · NextWave →
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.