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ZTALMY ganaxolone 50 mg/mL Suspension — NDC 81583-0100-05 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

ZTALMY ganaxolone 50 mg/mL Suspension — NDC 81583-100-05 (Billing 81583-0100-05)

by Immedica Pharma US Inc · 5 BOTTLE, PLASTIC in 1 CARTON / 110 mL in 1 BOTTLE, PLASTIC

This is a package of ZTALMY ganaxolone 50 mg/mL Suspension from Immedica Pharma US Inc, no longer marketed (first marketed Jun 2022), no longer in the FDA NDC Directory.

NDC 81583-0100-05
🏷️ FDA NDC (as labeled) 81583-100-05 billing pads the product segment with a zero
This package
Contains110 mL in 1 bottle, plastic Pack sizes2 compare ↓
Product page 81583-0100-01 Also comes in: 110 mL 81583-100-01
Rx only Brand Discontinued CV ⚠ Discontinued by firm ⇄ 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

⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 81583-100-05
Product NDC 81583-100
11-digit billing NDC 81583010005
NCPDP billing unit ML — per mL (volume)
RxCUI 2604694, 2604700
UNII 98WI44OHIQ
Application # NDA215904
SPL Set ID d91612c4-b03a-4be4-a1ee-6a13e3b83d4e
Established class (EPC) Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator
Mechanism of action GABA A Receptor Positive Modulators
DEA schedule CV
Marketing category NDA
Marketing status Discontinued
FDA listing status Discontinued by firm
Marketing start 2022-06-06
Route ORAL
Dosage form SUSPENSION
Substance GANAXOLONE

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

GPI-14 72600033001820
GPI class Ztalmy
GCN Seq No 083201
GCN 52095
HICL code 047912
Ingredient (HICL) Ganaxolone
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H2
Therapeutic class — intermediate (HIC2) Psychoactive Drugs
HIC3 code H23
Therapeutic class — specific (HIC3) Neuroactive Steroid Gaba-A Receptor Modulator
AHFS code 28:12.28.00
AHFS class Gaba-Mediated Anticonvulsants
FDB label name ZTALMY 50 MG/ML SUSPENSION
FDB brand name Ztalmy
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 083201
  • GCN: 52095
  • GPI-14 (Medi-Span): 72600033001820
  • HICL (First Databank): 047912
  • AHFS class code: 28:12.28.00
  • RxCUI (RxNorm): 2604694
Why two NDCs? The FDA registers this code as 81583-100-05 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 81583-0100-05. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator class.

Pharmacologic class Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator
Drug family (ATC) Other antiepileptics
How it works GABA A Receptor Positive Modulators
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 ZTALMY 50 MG/ML SUSPENSION Ingredient Ganaxolone
📗 Our plain-language guide HelloPharmacist
  • Ztalmy is used to help control seizures in people who have CDKL5 deficiency disorder — often called CDD. CDD is a rare genetic condition that causes frequent, hard-to-treat seizure...
  • Yes — you must take Ztalmy with food every single time. This isn't just a comfort tip: food dramatically increases how much of the medication your body actually absorbs. Taking it...
  • Do I have to take it with food, and why does that matter?
  • Yes, sleepiness is the most common side effect and it's something to watch carefully. About 44% of kids in the clinical trial experienced some degree of sleepiness or sedation with...
📖 Read our full Ganaxolone guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

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

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 110 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 Marketing startMarketing endStatus
81583-0100-01 81583-100-01 Main listing 1 BOTTLE, PLASTIC in 1 CARTON / 110 mL in 1 BOTTLE, PLASTIC 2022-06-06 — Active
81583-0100-05 You're viewing this 5 BOTTLE, PLASTIC in 1 CARTON / 110 mL in 1 BOTTLE, PLASTIC 2022-06-06 — Discontinued by firm

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 5 bottle, plastic in 1 carton / 110 ml in 1 bottle, plastic.
What NDC number is used to bill for this package of ZTALMY ganaxolone 50 mg/mL Suspension?
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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ztalmy 50 mg/mLthis 81583-0100-05 Immedica 5 bottles — — Discontinued —
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

🏛️
2022
First FDA approval
Jun 2022
📍
2026
Currently FDA-listed
4 years 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 Sep 2042. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Jun 1, 2022 RLD RS ⏳ ~16 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 12144801 — method of use (U-4034)
US 8618087 — method of use (U-3374)
US 12115169 — method of use (U-3374)
US 12268696 — method of use (U-3374)
US 10603308 — method of use (U-3374)
US 9056116 — method of use (U-3374)
US 7858609 — drug product
US 8022054 — drug product
US 8367651 — drug product
US 9029355 — drug product
US 8318714 — drug product
Exclusivity D-197
Exclusivity NCE
Exclusivity ODE-395
2022 2024 2026 2028 2030 2032 2034 2036 2038 2040 2042
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 (11)
PatentTypeUse codeExpires
US 12144801 ↗ Method of use U-4034 Aug 10, 2037
US 8618087 ↗ Method of use U-3374 Nov 28, 2026
US 12115169 ↗ Method of use U-3374 Sep 30, 2042
US 12268696 ↗ Method of use U-3374 Sep 30, 2042
US 10603308 ↗ Method of use U-3374 Aug 10, 2037
US 9056116 ↗ Method of use U-3374 Nov 28, 2026
US 7858609 ↗ Drug product — Nov 28, 2026
US 8022054 ↗ Drug product — Nov 28, 2026
US 8367651 ↗ Drug product — Nov 28, 2026
US 9029355 ↗ Drug product — Nov 28, 2026
US 8318714 ↗ Drug product — Nov 28, 2031
FDA exclusivity
CodeWhat it grantsExpires
D-197Other change requiring clinical data (3-year)Oct 16, 2028
NCENew Chemical Entity (5-year)Jun 1, 2027
ODE-395Orphan Drug Exclusivity (7-year)Jun 1, 2029
Common questions
Is there a generic version of ZTALMY 50 MG/ML SUSPENSION?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for ZTALMY 50 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 Sep 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 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 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • 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 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • 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 OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • 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.
  • 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.

10 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

LabelerImmedica Pharma US Inc
Application holderIMMEDICA PHARMA AB
FDA applicationNDA215904 (NDA)
Labeler code81583
First marketedJun 2022
DEA scheduleCV
Product typeHuman Prescription Drug
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🔒 Drug Abuse and Dependence 🔒 Controlled Substance 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📖 Instructions for Use 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 67 words ▾

1 INDICATIONS AND USAGE ZTALMY is indicated for the treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients 2 years of age and older. ZTALMY is a neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive modulator indicated for the treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients 2 years of age and older. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Administer ZTALMY orally three times daily with food. ( 2.1 ) Titrate ZTALMY gradually according to the recommended schedules. See full prescribing information.

( 2.1 ) Dosage for patients weighing 28 kg or less ( 2.1 ): the starting dosage is 2 mg/kg three times daily (6 mg/kg/day) the maximum dosage is 21 mg/kg three times daily (63 mg/kg/day). Dosage for patients weighing over 28 kg ( 2.1 ): the starting dosage is 50 mg three times daily (150 mg daily) the maximum dosage is 600 mg three times daily (1800 mg daily). Patients with severe hepatic impairment: see full prescribing information for dosage recommendation.

( 2.3 )

2.1Dosage Information ZTALMY is administered by mouth three times daily and must be taken with food [see Clinical Pharmacology (12.3) ] . The recommended titration schedule and maintenance dosage are based on body weight for patients weighing 28 kg or less. Dosage recommendations for patients weighing 28 kg or less are included in Table 1, and dosage recommendations for patients weighing more than 28 kg are included in Table 2.

Dosage should be increased based on tolerability no more frequently than every 7 days. Titration increments should not exceed those shown in Table 1 and Table 2. Table 1 ZTALMY Recommended Titration Schedule for Patients Weighing 28 kg or Less Dosage Total Daily Dose Day 2 mg/kg three times daily 6 mg/kg/day 1 to 7 4 mg/kg three times daily 12 mg/kg/day 8 to 14 8 mg/kg three times daily 24 mg/kg/day 15 to 21 14 mg/kg three times daily 42 mg/kg/day 22 to 28 21 mg/kg three times daily 63 mg/kg/day 29 and thereafter Table 2 ZTALMY Recommended Titration Schedule for Patients Weighing More Than 28 kg Dosage Total Daily Dose Day 50 mg three times daily 150 mg 1 to 7 100 mg three times daily 300 mg 8 to 14 200 mg three times daily 600 mg 15 to 21 400 mg three times daily 1,200 mg 22 to 28 600 mg three times daily 1,800 mg 29 and thereafter

2.2Administration Instructions See the Instructions for Use for complete instructions on how to properly prepare and administer ZTALMY. Shake the bottle thoroughly for at least 1 minute and then wait for 1 minute before measuring and administering each dose. Measure and administer the prescribed dose using the oral syringe(s) provided by your pharmacist.

A household teaspoon or tablespoon is not an adequate measuring device and should not be used. ZTALMY must be administered with food [see Clinical Pharmacology (12.3) ] . Discard any unused ZTALMY oral suspension after 30 days of first opening the bottle [see How Supplied/Storage and Handling (16.2) ] .

2.3Dosage in Patients with Severe Hepatic Impairment ZTALMY is administered by mouth three times daily and must be taken with food [see Clinical Pharmacology (12.3) ] . The recommended titration schedule and maintenance dosage are based on body weight for patients weighing 28 kg or less. Dosage recommendations for patients with severe hepatic impairment and weighing 28 kg or less are included in Table 3, and dosage recommendations for patients with severe hepatic impairment (Child-Pugh class C) weighing more than 28 kg are included in Table 4.

Dosage should be increased based on tolerability no more frequently than every 7 days. Titration increments should not exceed those shown in Table 3 and Table 4. No dosage adjustment is necessary in patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment.

Table 3 ZTALMY Recommended Titration Schedule for Patients with Severe Hepatic Impairment and Weighing 28 kg or Less Dosage Total Daily Dose Approximate daily dose. Days 0.66 mg/kg three times daily 2 mg/kg/day 1 to 7 1.33 mg/kg three times daily 4 mg/kg/day 8 to 14 2.66 mg/kg three times daily 8 mg/kg/day 15 to 21 4.66 mg/kg three times daily 14 mg/kg/day 22 to 28 7 mg/kg three times daily 21 mg/kg/day 29 and thereafter Table 4 ZTALMY Recommended Titration Schedule for Patients with Severe Hepatic Impairment and Weighing More Than 28 kg Dosage Tota… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 29 words ▾

3 DOSAGE FORMS AND STRENGTHS Oral suspension: 50 mg/mL ganaxolone. Each bottle contains 110 mL of white to off-white cherry flavored suspension. Oral suspension 50 mg/mL ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Somnolence and Sedation: Monitor for somnolence and sedation and advise patients not to drive or operate machinery until they have gained sufficient experience with ZTALMY. Concomitant use with other CNS depressants or alcohol could potentiate adverse effects. ( 5.1 ) Suicidal Behavior and Ideation: Monitor patients for suicidal behavior and thoughts.

( 5.2 ) Withdrawal of Antiepileptic Drugs: ZTALMY should be withdrawn gradually to minimize the risk of increased seizure frequency and status epilepticus. ( 5.3 )

5.1Somnolence and Sedation ZTALMY can cause somnolence and sedation. In Study 1 [see Clinical Studies (14) ] , the incidence of somnolence and sedation was 44% in patients treated with ZTALMY, compared with 24% in patients receiving placebo. Somnolence and sedation appeared early during treatment and were generally dose-related [see Adverse Reactions (6.1) ] .

Other central nervous system (CNS) depressants, including opioids, antidepressants, and alcohol, could potentiate somnolence and sedation in patients receiving ZTALMY [see Clinical Pharmacology (12.3) ] . Prescribers should monitor patients for somnolence and sedation, and advise patients not to drive or operate machinery until they have gained sufficient experience on ZTALMY to gauge whether it adversely affects their ability to drive or operate machinery.

5.2Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including ZTALMY, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with an AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior. Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs, that did not include ZTALMY, showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% CI:1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo.

In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated. There were 4 suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide.

The increased risk of suicidal thoughts or behavior with AEDs was observed as early as 1 week after starting drug treatment with AEDs and persisted for the duration of treatment assessed. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed. The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed.

The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. The risk did not vary substantially by age (5–100 years) in the clinical trials analyzed. Table 5 shows absolute and relative risk by indication for all evaluated AEDs.

Table 5 Risk of Suicidal Thoughts or Behaviors by Indication for Antiepileptic Drugs in the Pooled Analysis Indication Placebo Patients with Events per 1000 Patients Drug Patients with Events per 1000 Patients Relative Risk: Incidence of Events in Drug Patients/ Incidence in Placebo Patients Risk Difference: Additional Drug Patients with Events per 1000 Patients Epilepsy 1.0 3.4 3.5

2.4Psychiatric 5.7 8.5 1.5

2.9Other 1.0 1.8 1.9

0.9Total 2.4 4.3 1.8

1.9The relative risk for suicidal thoughts or behavior was higher in clinical trials in patients with epilepsy than in clinical tria… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following important adverse reactions are described elsewhere in the labeling: Somnolence and Sedation [see Warnings and Precautions (5.1) ] Suicidal Behavior and Ideation [see Warnings and Precautions (5.2) ] Withdrawal of Antiepileptic Drugs [see Warnings and Precautions (5.3) ] Most common adverse reactions (incidence of at least 5% for ZTALMY and at least twice the rate of placebo) are somnolence, pyrexia, salivary hypersecretion, and seasonal allergy. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Immedica at 1-844-627-4687 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials 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. In controlled and uncontrolled trials in patients with seizures associated with CDD, 102 patients were treated with ZTALMY, including 83 patients treated for more than 6 months, and 50 patients treated for more than 1 year. In Study 1, 50 patients received ZTALMY [see Clinical Studies (14) ] .

The duration of treatment in this trial was up to 17 weeks. Approximately 78% of these patients were female, 92% were White, and the mean age was 6.8 years (range 2 to 19 years). All patients receiving ZTALMY, except 1, were taking other AEDs.

Adverse reactions in these patients are presented below. The most common adverse reactions (an incidence of at least 5% and at least twice the rate of placebo) were somnolence, pyrexia, salivary hypersecretion, and seasonal allergy (Table 6). The adverse reactions leading to treatment discontinuation in ZTALMY-treated patients were somnolence and seizure (1 patient) and seizure (1 patient).

Twenty-two percent of ZTALMY-treated patients had dosing interrupted or reduced because of any adverse reaction, compared to 16% of placebo-treated patients. The most frequent adverse reactions leading to a dose interruption or reduction in ZTALMY-treated patients were somnolence (10%) and sedation (2%). Table 6 presents the adverse reactions that occurred in ZTALMY-treated patients with seizures associated with CDD at a rate of at least 3% and at a rate greater than in placebo-treated patients during the double-blind phase.

Table 6 Adverse Reactions that Occurred in ZTALMY-Treated Patients with Seizures Associated with CDD at a Rate of At Least 3% and Greater Than in Placebo (Study 1) Adverse Reactions ZTALMY (N=50) Placebo (N=51) % % Somnolence somnolence includes the terms lethargy and hypersomnia adverse reactions that occurred with a 21-day titration; somnolence and sedation are expected to be reduced with the recommended 28-day titration [see Dosage and Administration (2.1, 2.3)] 38 20 Pyrexia 18 8 Upper respiratory tract infection 10 6 Sedation 6 4 Salivary Hypersecretion 6 2 Seasonal allergy 6 0 Bronchitis 4 0 Influenza 4 2 Gait disturbance 4 2 Nasal congestion 4 2

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS UGT inhibitors may increase ganaxolone exposures; consider reduction of a stable ZTALMY dosage when initiating a UGT inhibitor. ( 7.1 ) Cytochrome P450 inducers will decrease ganaxolone exposure. It is recommended to avoid concomitant use with strong or moderate CYP3A4 inducers; if unavoidable, consider a dosage increase of ZTALMY, but do not exceed the maximum recommended dosage. ( 7.2 )

7.1Effect of UGT Inhibitors on ZTALMY Concomitant use of ZTALMY and UGT inhibitors (e.g., valproic acid) may increase the exposure of ganaxolone, which may increase the risk of ZTALMY associated adverse reactions in patients who have titrated to a stable ZTALMY dosage. Consider a reduction of ZTALMY maintenance dosage when initiating a UGT inhibitor [see Clinical Pharmacology (12.3) ].

7.2Effect of Strong or Moderate Cytochrome P450 Inducers on ZTALMY Coadministration of ZTALMY with CYP450 inducers, such as strong or moderate CYP3A4 inducers, will decrease ganaxolone exposure, which can lower the efficacy of ZTALMY [see Clinical Pharmacology (12.3) ] . It is recommended to avoid concomitant use of strong or moderate CYP3A4 inducers with ZTALMY. When concomitant use of strong or moderate CYP3A4 inducers is unavoidable, consider an increase in the dosage of ZTALMY; however, do not exceed the maximum daily dosage of ZTALMY [see Dosage and Administration (2.1) ] .

In patients on a stable ZTALMY dosage who are initiating or increasing the dosages of enzyme-inducing antiepileptic drugs (e.g., carbamazepine, phenytoin, phenobarbital, and primidone), the ZTALMY dosage may need to be increased; however, do not exceed the maximum daily dosage of ZTALMY [see Dosage and Administration (2.1) ] .

7.3Concomitant Use of ZTALMY with CNS Depressants and Alcohol Concomitant use of ZTALMY with CNS depressants, including alcohol, may increase the risk of somnolence and sedation [see Warnings and Precautions (5.1) ] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm. ( 8.1 )

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as ZTALMY, during pregnancy. Encourage women who are taking ZTALMY during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling the toll-free number 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. Risk Summary There are no available data on ZTALMY use in pregnant women to inform a drug-associated risk of adverse developmental outcomes.

In animal studies, adverse effects on development were observed in mice (fetal malformations) and rats (neurobehavioral and growth impairment) following exposure during organogenesis (mouse) or throughout gestation and lactation (rat) at maternal exposures lower than that in human adults at the maximum recommended human dose (MRHD) of 1800 mg. In addition, neuronal death was observed in rats exposed to ganaxolone during a period of brain development that begins during the third trimester of pregnancy in humans and continues during the first few years after birth.

In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The background risks of major birth defects and miscarriage for the indicated populations are unknown. Clinical Considerations Disease-associated Maternal and/or Embryofetal Risk Epilepsy, with or without exposure to antiepileptic drugs, has been associated with several adverse outcomes during pregnancy, including preeclampsia, preterm labor, antepartum and postpartum hemorrhage, placental abruption, poor fetal growth, prematurity, fetal death, and maternal mortality.

The risk of maternal or fetal injury may be greatest for patients with untreated or poorly controlled convulsive seizures. Women with epilepsy who become pregnant should not abruptly discontinue antiepileptic drugs, including ZTALMY, due to the risk of status epilepticus or severe seizures, which may be life-threatening [see Warnings and Precautions (5.3) ]. Data Animal Data In an embryofetal development study in mice, oral administration of ganaxolone (0, 50, 175, or 300 mg/kg/day) throughout the period of organogenesis resulted in increased incidences of fetal malformations (external and/or visceral) at all doses in the absence of maternal toxicity.

Maternal plasma drug exposures (AUC) at the low-effect dose (50 mg/kg/day) for embryofetal developmental toxicity in the mouse were approximately 10-fold lower than that in humans at the MRHD. In a combined embryofetal development and pre- and postnatal development study in rats, ganaxolone (0, 10, 20, or 40 mg/kg/day) was administered orally to females throughout gestation and lactation. There were no effects on embryofetal growth, survival, or morphology; however, adverse effects on offspring growth (delayed reflex development, decreased body weight gain) were observed during the postnatal period (prior to and after weaning) at the high dose, and neurobehavioral impairment (decreased locomotor activity) was observed in the offspring at the two highest doses.

The no-effect dose (10 mg/kg/day) for pre- and postnatal developmental toxicity in rats was associated with maternal drug exposures less than that in humans at the MRHD. Oral administration of ganaxolone (0, 20, 45, or 90 mg/kg/day) to rats on postnatal day (PND) 7 resulted in widespread apoptotic neurodegeneration in the brain (cortex, thalamus, and hippocampus) at all doses; a no-effect dose was not identified. Brain development on PND 7 in rat corresponds to that beginning in humans during the third trimester of pregnancy and continuing for the first several months to years after birth [see Use in Specific Populations (8.4) ] .

8.2Lactation Risk Summary Ganaxolone is excreted… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as ZTALMY, during pregnancy. Encourage women who are taking ZTALMY during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling the toll-free number 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. Risk Summary There are no available data on ZTALMY use in pregnant women to inform a drug-associated risk of adverse developmental outcomes.

In animal studies, adverse effects on development were observed in mice (fetal malformations) and rats (neurobehavioral and growth impairment) following exposure during organogenesis (mouse) or throughout gestation and lactation (rat) at maternal exposures lower than that in human adults at the maximum recommended human dose (MRHD) of 1800 mg. In addition, neuronal death was observed in rats exposed to ganaxolone during a period of brain development that begins during the third trimester of pregnancy in humans and continues during the first few years after birth.

In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The background risks of major birth defects and miscarriage for the indicated populations are unknown. Clinical Considerations Disease-associated Maternal and/or Embryofetal Risk Epilepsy, with or without exposure to antiepileptic drugs, has been associated with several adverse outcomes during pregnancy, including preeclampsia, preterm labor, antepartum and postpartum hemorrhage, placental abruption, poor fetal growth, prematurity, fetal death, and maternal mortality.

The risk of maternal or fetal injury may be greatest for patients with untreated or poorly controlled convulsive seizures. Women with epilepsy who become pregnant should not abruptly discontinue antiepileptic drugs, including ZTALMY, due to the risk of status epilepticus or severe seizures, which may be life-threatening [see Warnings and Precautions (5.3) ]. Data Animal Data In an embryofetal development study in mice, oral administration of ganaxolone (0, 50, 175, or 300 mg/kg/day) throughout the period of organogenesis resulted in increased incidences of fetal malformations (external and/or visceral) at all doses in the absence of maternal toxicity.

Maternal plasma drug exposures (AUC) at the low-effect dose (50 mg/kg/day) for embryofetal developmental toxicity in the mouse were approximately 10-fold lower than that in humans at the MRHD. In a combined embryofetal development and pre- and postnatal development study in rats, ganaxolone (0, 10, 20, or 40 mg/kg/day) was administered orally to females throughout gestation and lactation. There were no effects on embryofetal growth, survival, or morphology; however, adverse effects on offspring growth (delayed reflex development, decreased body weight gain) were observed during the postnatal period (prior to and after weaning) at the high dose, and neurobehavioral impairment (decreased locomotor activity) was observed in the offspring at the two highest doses.

The no-effect dose (10 mg/kg/day) for pre- and postnatal developmental toxicity in rats was associated with maternal drug exposures less than that in humans at the MRHD. Oral administration of ganaxolone (0, 20, 45, or 90 mg/kg/day) to rats on postnatal day (PND) 7 resulted in widespread apoptotic neurodegeneration in the brain (cortex, thalamus, and hippocampus) at all doses; a no-effect dose was not identified. Brain development on PND 7 in rat corresponds to that beginning in humans during the third trimester of pregnancy and continuing for the first several months to years after birth [see Use in Specific Populations (8.4) ] .

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use The safety and effectiveness of ZTALMY for the treatment of seizures associated with CDD have been established in pediatric patients 2 years of age and older. The use of ZTALMY for the treatment of seizures associated with CDD in patients 2 years of age and older is supported by a randomized, double-blind, placebo-controlled trial that included 99 pediatric patients 2 to less than 18 years of age [see Clinical Studies (14) ] . Safety and effectiveness of ZTALMY in pediatric patients below 2 years of age have not been established.

Juvenile Animal Data Oral administration of ganaxolone (0, 20, 45, 90/150/250/500 mg/kg/day) to juvenile rats from postnatal day (PND) 7 through PND 91 resulted in deaths associated with sedation and decreased male reproductive organ weights at the mid and high doses, and delayed female sexual maturation and decreased brain weights at all doses. There were no adverse effects on neurobehavioral (locomotor activity, auditory startle response, learning and memory) or reproductive function. A no-effect dose was not established.

The lowest dose producing developmental toxicity in juvenile rats (20 mg/kg/day) was associated with plasma drug exposures (AUC) less than that in pediatric patients at the maximum recommended human dose (MRHD) of 1800 mg. Oral administration of ganaxolone (0, 10, 45, or 90 mg/kg/day) to rats on postnatal day (PND) 7 resulted in widespread neuronal death in multiple brain regions, including cortex, thalamus, and hippocampus, at all doses. The pattern and extent of neuronal death was similar to that produced by intraperitoneal injection of the positive control, the NMDA receptor antagonist MK-801 (1 mg/kg).

The hippocampus, in particular, is recognized to have an important role in learning and memory. Effects of ganaxolone and MK-801 on neurobehavioral function were not assessed in this study. Brain development on PND 7 in rat corresponds to that beginning in humans during the third trimester of pregnancy and continuing for the first several months to years after birth.

At the lowest-effect dose for neuronal death, plasma drug exposure in the neonatal rat was less than that in pediatric patients at the MRHD. Oral administration of M2 (0, 15, 30, or 60 mg/kg/day), a human-specific metabolite of ganaxolone, to juvenile rats from PNDs 7 to 70 resulted in adverse effects on reproductive system development in both sexes at all doses. Effects in females included decreased corpora lutea and follicular cysts in the ovary at the high dose and signs of precocious puberty and estrous cycle disruption at all doses.

Female reproductive tract changes indicative of estrous cycle disruption persisted after a 5-week recovery period at the high dose. In males, effects consisted of delayed sexual maturation and decreased epididymis and prostate weights at the high dose, seminal vesicle atrophy at mid and high doses, and decreased seminal vesicle weights at all doses. Plasma exposures (AUC) of M2 at the highest dose were 2 times those in humans at the ganaxalone MRHD of 1,800 mg, while exposures at the mid and low doses were below those in humans at the ganaxolone MRHD.

🧓 Geriatric Use 28 words ▾

8.5Geriatric Use CDD is largely a disease of pediatric and young adult patients. Clinical studies of ZTALMY did not include patients 65 years of age and older.

🆘 Overdosage 88 words ▾

10 OVERDOSAGE There is limited clinical trial experience regarding overdose with ZTALMY. Unintentional overdose has been reported in 1 pediatric patient. This patient received ten times the prescribed dose.

The patient was hospitalized for evaluation, including an electrocardiogram (ECG) and blood tests, and recovered. Patients who overdose should be closely monitored and receive standard supportive care. No specific information is available regarding treatment of overdose.

In the event of overdose, a certified poison control center should be contacted for updated information on the management of overdose with ZTALMY.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The precise mechanism by which ganaxolone exerts its therapeutic effects in the treatment of seizures associated with CDD is unknown, but its anticonvulsant effects are thought to result from positive allosteric modulation of the gamma-aminobutyric acid type A (GABA A ) receptor in the CNS.

12.2Pharmacodynamics Cardiac Electrophysiology At therapeutic exposures, ZTALMY does not prolong the QTc interval. QT effects of ZTALMY at high clinical exposure scenarios have not been evaluated.

12.3Pharmacokinetics Absorption Following oral administration of ZTALMY, ganaxolone is absorbed with a time to maximum plasma concentration (T max ) of 2 to 3 hours. Effect of Food When ZTALMY was administered with a high-fat meal, the C max and AUC increased by 3- and 2-fold, respectively, when compared to administration under fasted conditions. ZTALMY was administered with food in the clinical efficacy study, Study 1 [see Dosage and Administration (2.1) ] .

The efficacy of ZTALMY when administered in the fasted state is unknown. Distribution Ganaxolone is approximately 99% protein-bound in serum. Elimination The terminal half-life for ganaxolone is 34 hours.

Metabolism Ganaxolone is metabolized by CYP3A4/5, CYP2B6, CYP2C19, CYP2D6, UGT1A3, UGT1A6, UGT1A9, UGT2B7, and UGT2B15. Excretion Following a single oral dose of 300 mg [ 14 C]-ganaxolone to healthy male subjects, 55% of the total radioactivity was recovered in feces (2% as unchanged ganaxolone) and 18% of the total radioactivity dose was recovered in urine (undetected as unchanged ganaxolone). Specific Populations Age, sex, and race are not expected to have a clinically-relevant effect on ganaxolone pharmacokinetics, after accounting for body weight.

Pediatric Patients After accounting for body weight, the observed pharmacokinetic exposures in patients in Study 1 [see Clinical Studies (14) ] were comparable across the age groups 2 to less than 6 years of age (n=45), 6 to less than 12 years of age (n=28), and 12 to less than 18 years of age (n=16). Patients with Renal Impairment Following oral administration of a single 300 mg dose of ZTALMY in subjects with severe renal impairment (creatine clearance between 15 and 30 mL/min as estimated by Cockcroft-Gault formula), the AUC 0-INF of ganaxolone decreased 8% and C max decreased 11% as compared to that in subjects with normal renal function (creatinine clearance ≥ 90 mL/min as estimated by Cockcroft-Gault formula).

The changes in ganaxolone exposures when administered in patients with impaired renal function (creatinine clearance <90 mL/min) are not expected to be clinically significant. Patients with Hepatic Impairment The influence of hepatic impairment on the pharmacokinetics of ganaxolone was studied following a single oral dose of ZTALMY 300 mg. In subjects with mild hepatic impairment (Child-Pugh class A), C max and AUC last increased by 38% and 8%, respectively, compared to subjects with normal hepatic function.

In subjects with moderate hepatic impairment (Child-Pugh class B), C max and AUC last increased by 45% and 50%, respectively, compared to subjects with normal hepatic function. In subjects with severe hepatic impairment (Child-Pugh class C), C max and AUC last increased by 148% and 269%, respectively, compared to subjects with normal hepatic function [see Dosage and Administration (2.3) and Use in Specific Populations (8.6) ] . Drug Interaction Studies Clinical Studies CYP3A4 Inducers Coadministration of ZTALMY with rifampin, a strong inducer of CYP2C19 and CYP3A4, and a moderate inducer of CYP2B6, decreased C max and AUC of ganaxolone by 57% and 68%, respectively, in healthy subjects [see Drug Interactions (7.2) ] .

No dedicated drug-interaction studies were conducted with moderate or weak CYP3A4 inducers. CYP3A4 Inhibitors Coadministration of ZTALMY with itraconazole, a strong CYP3A4 inhibitor, increased the AUC of ganaxolone by 17% in healthy subjects (C max was unchanged).… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 49 words ▾

12.1Mechanism of Action The precise mechanism by which ganaxolone exerts its therapeutic effects in the treatment of seizures associated with CDD is unknown, but its anticonvulsant effects are thought to result from positive allosteric modulation of the gamma-aminobutyric acid type A (GABA A ) receptor in the CNS.

📦 How Supplied / Storage and Handling 113 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied ZTALMY (ganaxolone) oral suspension (50 mg/mL) is a cherry flavored white to off-white suspension supplied in a 4 fl. oz (135 mL) round natural high density polyethylene (HDPE) bottle with a propylene child-resistant cap containing 110 mL of ZTALMY oral suspension. ZTALMY is packaged in a carton with 1 bottle (NDC 81583-100-01).

16.2Storage and Handling Store ZTALMY in its original bottle in an upright position at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep the cap tightly closed. Use within 30 days of first opening the bottle, then discard any remainder.

📦 Storage and Handling 53 words ▾

16.2Storage and Handling Store ZTALMY in its original bottle in an upright position at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep the cap tightly closed. Use within 30 days of first opening the bottle, then discard any remainder.

📋 Description 148 words ▾

11 DESCRIPTION ZTALMY (ganaxolone) oral suspension contains ganaxolone, a neuroactive steroid gamma-aminobutyric acid A (GABA A ) receptor positive modulator. Ganaxolone (1-[(3R, 5S, 8R, 9S, 10S, 13S, 14S, 17S)-3-hydroxy-3, 10, 13-trimethyl-1, 2, 4, 5, 6, 7, 8, 9, 11, 12, 14, 15, 16, 17-tetradecahydrocyclopenta[a]phenanthren-17-yl]ethanone) is a methyl-substituted (at the 3β position) analog of the endogenous neurosteroid allopregnanolone, a derivative of progesterone. Its empirical formula is C 22 H 36 O 2 , and the molecular weight is 332.53 g/mol.

The chemical structure is: Ganaxolone is a white to off-white crystalline powder that only exists in one crystal form and has low aqueous solubility. ZTALMY is an oral suspension of ganaxolone. Each mL of oral suspension contains 50 mg of ganaxolone.

Inactive ingredients include artificial cherry flavor, citric acid, hypromellose, methylparaben, polyvinyl alcohol, propylparaben, purified water, simethicone emulsion, sodium benzoate, sodium citrate, sodium lauryl sulfate, and sucralose. Chemical Structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Somnolence and Sedation Caution patients about operating hazardous machinery, including motor vehicles, until they are reasonably certain that ZTALMY does not affect them adversely (e.g., impair judgment, thinking, or motor skills) [see Warnings and Precautions (5.1) ] . Suicidal Thinking and Behavior Counsel patients, their caregivers, and their families that antiepileptic drugs, including ZTALMY, may increase the risk of suicidal thoughts and behavior and advise them to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts of self-harm.

Instruct patients, caregivers, and families to report behaviors of concern immediately to healthcare providers [see Warnings and Precautions (5.2) ] . Withdrawal of Antiepileptic Drugs (AEDs) Advise patients not to discontinue use of ZTALMY without consulting with their healthcare provider. ZTALMY should normally be gradually withdrawn to reduce the potential for increased seizure frequency and status epilepticus [see Dosage and Administration (2.4) and Warnings and Precautions (5.3) ] .

Administration information Advise patients who are prescribed ZTALMY to use the adapter and oral dosing syringes provided by their pharmacist [see Dosage and Administration (2.2) and Instructions for Use ] . Instruct patients to take ZTALMY with food [see Dosage and Administration (2.1) ] . Instruct patients to shake ZTALMY thoroughly for at least 1 minute and then wait for 1 minute before measuring and administering each dose [see Dosage and Administration (2.2) and Instructions for Use ] .

Instruct patients to discard any unused ZTALMY oral suspension after 30 days of first opening the bottle [see Dosage and Administration (2.2) and How Supplied/Storage and Handling (16.2) ] . Pregnancy Registry Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during ZTALMY therapy. Encourage women who are taking ZTALMY to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant.

This registry is collecting information about the safety of antiepileptic drugs during pregnancy [see Use in Specific Populations (8.1) ] . Potential for Abuse Advise patients that ZTALMY can be abused or lead to dependence [see Drug Abuse and Dependence (9) ] .

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE ZTALMY ® (zuh tal' mee) (ganaxolone) oral suspension, CV This Medication Guide has been approved by the U.S. Food and Drug Administration Issued: Issued: 11/2025 What is the most important information I should know about ZTALMY? ZTALMY can cause serious side effects, including: ZTALMY may cause sleepiness.

Taking ZTALMY with central nervous system (CNS) depressants including alcohol may increase sleepiness. Do not drive, operate heavy machinery, or do other dangerous activities until you know how ZTALMY affects you or your child. Like other antiepileptic drugs, ZTALMY may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.

Call a healthcare provider right away if you or your child have any of these symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying attempt to commit suicide new or worse depression new or worse anxiety feeling agitated or restless panic attacks trouble sleeping (insomnia) new or worse irritability acting aggressive, being angry, or violent acting on dangerous impulses an extreme increase in activity and talking (mania) other unusual changes in behavior or mood How can I watch for early symptoms of suicidal thoughts and actions?

Pay attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings. Keep all follow-up visits with your healthcare provider as scheduled. Do not stop taking ZTALMY without first talking to your healthcare provider.

Stopping a seizure medicine such as ZTALMY suddenly can cause you or your child to have seizures more often or seizures that do not stop (status epilepticus). Call your healthcare provider between visits as needed, especially if you are worried about symptoms. WHAT IS ZTALMY?

ZTALMY is a prescription medicine that is used to treat seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in people 2 years of age and older. ZTALMY is a federally controlled substance (CV) because it contains ganaxolone that can be abused and lead to dependence. Keep ZTALMY in a safe place to prevent misuse and abuse.

Selling or giving away ZTALMY may harm others and is against the law. Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs. It is not known if ZTALMY is safe and effective in children under 2 years of age.

Before taking ZTALMY, tell your healthcare provider about all of your or your child's medical conditions, including if you or your child: drink alcohol. have or have had depression, mood problems, or suicidal thoughts or behavior. have abused or been dependent on prescription medicines, street drugs, or alcohol. have liver problems. are pregnant or plan to become pregnant. Tell your healthcare provider right away if you or your child become pregnant while taking ZTALMY. You and your healthcare provider will decide if you or your child should take ZTALMY while pregnant. if you or your child become pregnant while taking ZTALMY, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry.

You can enroll in this registry by calling 1-888-233-2334 or go to http://www.aedpregnancyregistry.org/. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy. are breastfeeding or plan to breastfeed. ZTALMY may pass into breast milk.

Talk to your healthcare provider about the best way to feed your or your child's baby while taking ZTALMY. Tell your healthcare provider about all the medicines you or your child take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ZTALMY may affect the way other medicines work, and other medicines may affect how ZTALMY works.

Do not stop or start taking other medicines without talking to your healthcare provider. Especially tell your healthcare provider if you or your child take: alco… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Absorption Following oral administration of ZTALMY, ganaxolone is absorbed with a time to maximum plasma concentration (T max ) of 2 to 3 hours. Effect of Food When ZTALMY was administered with a high-fat meal, the C max and AUC increased by 3- and 2-fold, respectively, when compared to administration under fasted conditions. ZTALMY was administered with food in the clinical efficacy study, Study 1 [see Dosage and Administration (2.1) ] .

The efficacy of ZTALMY when administered in the fasted state is unknown. Distribution Ganaxolone is approximately 99% protein-bound in serum. Elimination The terminal half-life for ganaxolone is 34 hours.

Metabolism Ganaxolone is metabolized by CYP3A4/5, CYP2B6, CYP2C19, CYP2D6, UGT1A3, UGT1A6, UGT1A9, UGT2B7, and UGT2B15. Excretion Following a single oral dose of 300 mg [ 14 C]-ganaxolone to healthy male subjects, 55% of the total radioactivity was recovered in feces (2% as unchanged ganaxolone) and 18% of the total radioactivity dose was recovered in urine (undetected as unchanged ganaxolone). Specific Populations Age, sex, and race are not expected to have a clinically-relevant effect on ganaxolone pharmacokinetics, after accounting for body weight.

Pediatric Patients After accounting for body weight, the observed pharmacokinetic exposures in patients in Study 1 [see Clinical Studies (14) ] were comparable across the age groups 2 to less than 6 years of age (n=45), 6 to less than 12 years of age (n=28), and 12 to less than 18 years of age (n=16). Patients with Renal Impairment Following oral administration of a single 300 mg dose of ZTALMY in subjects with severe renal impairment (creatine clearance between 15 and 30 mL/min as estimated by Cockcroft-Gault formula), the AUC 0-INF of ganaxolone decreased 8% and C max decreased 11% as compared to that in subjects with normal renal function (creatinine clearance ≥ 90 mL/min as estimated by Cockcroft-Gault formula).

The changes in ganaxolone exposures when administered in patients with impaired renal function (creatinine clearance <90 mL/min) are not expected to be clinically significant. Patients with Hepatic Impairment The influence of hepatic impairment on the pharmacokinetics of ganaxolone was studied following a single oral dose of ZTALMY 300 mg. In subjects with mild hepatic impairment (Child-Pugh class A), C max and AUC last increased by 38% and 8%, respectively, compared to subjects with normal hepatic function.

In subjects with moderate hepatic impairment (Child-Pugh class B), C max and AUC last increased by 45% and 50%, respectively, compared to subjects with normal hepatic function. In subjects with severe hepatic impairment (Child-Pugh class C), C max and AUC last increased by 148% and 269%, respectively, compared to subjects with normal hepatic function [see Dosage and Administration (2.3) and Use in Specific Populations (8.6) ] . Drug Interaction Studies Clinical Studies CYP3A4 Inducers Coadministration of ZTALMY with rifampin, a strong inducer of CYP2C19 and CYP3A4, and a moderate inducer of CYP2B6, decreased C max and AUC of ganaxolone by 57% and 68%, respectively, in healthy subjects [see Drug Interactions (7.2) ] .

No dedicated drug-interaction studies were conducted with moderate or weak CYP3A4 inducers. CYP3A4 Inhibitors Coadministration of ZTALMY with itraconazole, a strong CYP3A4 inhibitor, increased the AUC of ganaxolone by 17% in healthy subjects (C max was unchanged). Changes in ganaxolone exposures when coadministered with strong, moderate, or weak CYP3A4 inhibitors are not expected to be clinically significant.

CYP3A4 Substrates Coadministration of ganaxolone at steady state (400 mg twice daily; 0.44 times the maximum recommended dosage) with midazolam, a sensitive CYP3A4 substrate, did not result in clinically relevant changes in exposures of the substrate in healthy subjects. In Vitro Studies CYP450 Enzymes Ganaxolone does not inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, or CYP3A4/5… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 27 words ▾

12.2Pharmacodynamics Cardiac Electrophysiology At therapeutic exposures, ZTALMY does not prolong the QTc interval. QT effects of ZTALMY at high clinical exposure scenarios have not been evaluated.

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES The effectiveness of ZTALMY for the treatment of seizures associated with CDD in patients 2 years of age and older was established in a single, double-blind, randomized, placebo-controlled study in patients 2 to 19 years of age (Study 1, NCT03572933). Patients enrolled in Study 1 (N=50 for ZTALMY; N=51 for placebo) had molecular confirmation of a pathogenic or likely pathogenic mutation in the CDKL5 gene, seizures inadequately controlled by at least 2 previous treatment regimens, and a minimum of 16 major motor seizures (i.e., bilateral tonic, generalized tonic-clonic, bilateral clonic, atonic, focal to bilateral tonic-clonic) per 28 days during a retrospective 2-month period prior to screening.

Patients were randomized in a 1:1 ratio to receive either ZTALMY or placebo. Following a titration period, patients in the ZTALMY arm weighing 28 kg or less received a maintenance dosage of 21 mg/kg three times daily (with a maximum daily dose of 1800 mg) while patients in the ZTALMY arm weighing more than 28 kg received a maintenance dosage of 600 mg three times daily [see Dosage and Administration (2.1) ]. Ninety-six percent of patients were taking between 1 to 4 concomitant AEDs.

The most frequently used concomitant AEDs (in at least 20% of patients) were valproate (34%), levetiracetam (26%), clobazam (25%), and vigabatrin (22%). The primary efficacy endpoint was the percentage change in the 28-day frequency of major motor seizures (defined similarly as in the 2-month period prior to screening) from a 6-week prospective baseline phase during the 17-week double-blind phase. Patients treated with ZTALMY had a significantly greater reduction in the 28-day frequency of major motor seizures compared to patients receiving placebo (see Table 7 ).

Table 7 Change in Frequency of Major Motor Seizures per 28 days in Patients with CDD (Study 1) Frequency of Major Motor Seizures (per 28 days) Placebo (N=51) ZTALMY (N=49) Prospective Baseline Phase Median Seizure Frequency 49 54 Median Percent Change from Baseline During Treatment -7 -31 p-value compared to placebo Obtained from a Wilcoxon rank-sum test 0.0036 Figure 1 displays the percentage of patients by category of reduction from baseline in the 28-day frequency of major motor seizures during the 17-week double-blind phase.

Figure 1 Proportion of Patients by Category of Seizure Response for ZTALMY and Placebo in Patients with CDD (Study 1) Figure 1

🔒 Drug Abuse and Dependence ~1 min read ▾

9 DRUG ABUSE AND DEPENDENCE

9.1Controlled Substance ZTALMY contains ganaxolone, a Schedule V controlled substance (CV).

9.2Abuse Ganaxolone has potential for abuse. Abuse is the intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physiological effect. In a human abuse potential study, 400, 800, and 2000 mg oral doses of ZTALMY were compared to a 6 mg oral dose of lorazepam and placebo.

On positive subjective measures of "drug liking", "overall drug liking", "high", "good drug effects", and "take drug again", the 400 and 800 mg doses of ZTALMY produced mean scores that were within or just outside of the acceptable placebo range and were not statistically significantly different than placebo. The 2000 mg dose of ZTALMY produced responses on these positive subjective measures that were slightly greater than the acceptable placebo range and were statistically significantly greater than placebo. Scores on these positive subjective measures for all three doses of ZTALMY were statistically significantly lower than those produced by lorazepam.

9.3Dependence Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. During clinical studies with ZTALMY, it was not possible to assess physical dependence because abrupt discontinuation of an antiepileptic medication in patients with epilepsy presents a serious safety concern. It is recommended that ZTALMY be tapered according to the dosage recommendations, unless symptoms warrant immediate discontinuation [see Dosage and Administration (2.4) and Warnings and Precautions (5.1) ] .

🔒 Controlled Substance 12 words ▾

9.1Controlled Substance ZTALMY contains ganaxolone, a Schedule V controlled substance (CV).

🧪 Nonclinical Toxicology 190 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Oral administration of ganaxolone (150, 500, and 1000 mg/kg/day in males and 100, 300, and 1000 mg/kg/day in females) to Tg.rasH2 mice for up to 26 weeks did not result in an increase in tumors. No carcinogenicity studies have been conducted with ganaxolone in rats. Mutagenesis Ganaxolone was negative for genotoxicity in in vitro (Ames and mouse lymphoma) and in vivo (rat bone marrow micronucleus) assays.

The major circulating human metabolite, oxy-dehydro-ganaxolone, was negative for mutagenicity in the in vitro Ames assay but positive for clastogenicity in an in vitro mammalian chromosomal aberration test in human peripheral blood lymphocytes. Impairment of Fertility Oral administration of ganaxolone (0, 10, 20 or 40 mg/kg/day) to male and female rats prior to and throughout mating and continuing in females during early gestation resulted in alterations in estrous cyclicity at the high dose. There were no effects on spermatogenesis, reproductive performance and fertility, or early embryonic development.

The highest dose tested (40 mg/kg/day) was associated with plasma exposures (AUC) less than that in adult humans at the maximum recommended human dose of 1800 mg.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 187 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Oral administration of ganaxolone (150, 500, and 1000 mg/kg/day in males and 100, 300, and 1000 mg/kg/day in females) to Tg.rasH2 mice for up to 26 weeks did not result in an increase in tumors. No carcinogenicity studies have been conducted with ganaxolone in rats. Mutagenesis Ganaxolone was negative for genotoxicity in in vitro (Ames and mouse lymphoma) and in vivo (rat bone marrow micronucleus) assays.

The major circulating human metabolite, oxy-dehydro-ganaxolone, was negative for mutagenicity in the in vitro Ames assay but positive for clastogenicity in an in vitro mammalian chromosomal aberration test in human peripheral blood lymphocytes. Impairment of Fertility Oral administration of ganaxolone (0, 10, 20 or 40 mg/kg/day) to male and female rats prior to and throughout mating and continuing in females during early gestation resulted in alterations in estrous cyclicity at the high dose. There were no effects on spermatogenesis, reproductive performance and fertility, or early embryonic development.

The highest dose tested (40 mg/kg/day) was associated with plasma exposures (AUC) less than that in adult humans at the maximum recommended human dose of 1800 mg.

📖 Instructions for Use ~3 min read ▾

INSTRUCTIONS FOR USE ZTALMY ® ( zuh-tal' mee ) (ganaxolone) oral suspension, CV 50 mg/mL Be sure that you read, understand, and follow these instructions carefully to ensure proper dosing of the oral suspension. Important: Follow your healthcare provider's instructions for how to take or give ZTALMY. ZTALMY should always be given with food.

Ask your healthcare provider or pharmacist if you are not sure how to prepare, take, or give the prescribed dose of ZTALMY. Always use the oral syringe provided by your pharmacist to make sure you measure the right amount of ZTALMY. Do not use ZTALMY after the expiration date on the package and each bottle.

Use ZTALMY within 30 days of first opening the bottle. After 30 days of first opening the bottle, safely throw away (dispose of) any ZTALMY that has not been used. Each package contains: 1 bottle of ZTALMY with a child resistant cap: Supplies not included in the package: press-in bottle adapter oral syringe You can get a press-in bottle adapter and oral syringes from your pharmacy.

Your pharmacist can help you choose the right press-in bottle adapter and oral syringe to use with ZTALMY. Call your pharmacist right away if you do not have a press-in bottle adapter and the right sized oral syringe to use with your medicine. Note: If you lose or damage an oral syringe, or cannot read the markings, contact your pharmacist for a new oral syringe.

Follow the instructions below to use the press-in bottle adapter and oral syringe to measure and take or give ZTALMY. Prepare the bottle Hold the bottle in your hand and shake it up and down well for 1 minute. Always shake the bottle well for 1 minute then let the bottle stand for 1 minute so that any foam build up during shaking can settle before measuring and giving each dose of ZTALMY.

This helps you measure the correct amount of medicine. Note: This step is for each dose of the medicine. Remove the child-resistant cap by pushing down while turning the cap to the left (counter-clockwise).

Puncture and peel off the induction seal from the bottle. Note: This step is only for the first use of the bottle. Push the press-in-bottle adapter firmly into the bottle.

Firmly grasp the bottle in one hand and insert the press-in bottle adapter all the way in the bottle with the other hand using constant pressure. Make sure the press-in bottle adaptor is fully inserted. If not fully inserted, small parts such as the press-in bottle adaptor may become a choking hazard for children and pets.

Note : Do not remove the press-in bottle adapter from the bottle after it is inserted. Prepare the dose Your healthcare provider will tell you how much ZTALMY to take or give. Gather the oral syringe, push the plunger all the way down then insert the tip of the oral syringe fully into the press-in bottle adapter.

With the oral syringe in place, turn the bottle upside down. Slowly pull the plunger of the oral syringe to withdraw the dose of ZTALMY needed. Line up the end of the plunger with the marking for your dose of ZTALMY.

What to do if you see air bubbles : If there are air bubbles in the oral syringe, keep the bottle upside down and slowly push the plunger so that all of the liquid flows back into the bottle. Repeat step 6 until air bubbles are gone. When you have measured the correct amount of ZTALMY, leave the oral syringe in the press-in bottle adapter and turn the bottle right side up.

Carefully remove the oral syringe from the press-in bottle adapter. Take or give ZTALMY Place the tip of the oral syringe against the inside of the cheek and gently push the plunger until all of the ZTALMY in the oral syringe is taken or given. Do not forcefully push the plunger.

Do not direct the medicine to the back of the mouth or throat. This may cause choking. Screw the child-resistant cap back on the bottle tightly by turning the cap to the right (clockwise).

Do not remove the press-in bottle adapter. The child-resistant cap will fit over it. How should I store ZTALMY?

Store ZTALM… [Excerpted — this section continues on DailyMed.]

📄 Recent Major Changes 9 words ▾

Dosage and Administration ( 2.1 , 2.3 ) 10/2025

📄 Package Label / Principal Display Panel 105 words ▾

PRINCIPAL DISPLAY PANEL - 50 mg/mL Bottle Label NDC 81583-100-01 Rx Only Ztalmy ® (ganaxolone) oral suspension 50 mg/mL CV For Oral Administration Only Recommended Dosage: See prescribing information. Administer with the provided syringe. Date of first opening _____/_____/_____. Discard unused portion 30 days after first opening. PRINCIPAL DISPLAY PANEL - 50 mg/mL Bottle Label

PRINCIPAL DISPLAY PANEL - 50 mg/mL Bottle Carton Rx Only NDC 81583-100-01 Ztalmy ® (ganaxolone) oral suspension 50 mg/mL CV For Oral Administration Only Read enclosed instructions before using this product. Pharmacist: Dispense the enclosed Medication guide to each patient. 110 mL PRINCIPAL DISPLAY PANEL - 50 mg/mL Bottle Carton

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.
1 bottle81583-0100-01 1,122 Rx · $19,538,729
5 bottles this page81583-0100-05 No Medicaid data
Drug total (last 4 qtrs): 1,122 Rx · 786,280 units · $19,538,729 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 Ztalmy — 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 Ztalmy. 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
$737.3K
Claims incl. refills
32
Beneficiaries
11
Spend / beneficiary
$67,030.24
Spend / claim
$23,041.65
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for ZTALMY (this brand).

Top reported reactions

Seizure201
Somnolence52
Change In Seizure Presentation43
Pneumonia30
Vomiting24
Fatigue15
Illness15

Age at onset

Adolescent1

Reporter sex

648 reports
Male · 22%
Female · 78%

Serious outcomes

Hospitalization107
Death16
Life-threatening3
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 278 2
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 bottle (81583-0100-01). 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?
Immedica Pharma US 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.
← 81574-0004-01 · Skinlycious 81583-0102-01 · Immedica →
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.