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Levetiracetam 500 mg Tablet, For Suspension — NDC 66993-0101-60 package photo

Levetiracetam 500 mg Tablet, For Suspension

by Prasco Laboratories · 60 BLISTER PACK in 1 CARTON (66993-101-60) / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (66993-101-51)
NDC 66993-0101-60
🏷️ FDA NDC (as labeled) 66993-101-60 billing pads the product segment with a zero
Rx only Brand On market Non-controlled
🗂️ Data synced 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

🆔 Identity & classification

FDA NDC (as labeled) 66993-101-60
Product NDC 66993-101
11-digit billing NDC 66993010160
NCPDP billing unit EA — each (per item)
RxCUI 1736045, 1736048
UNII 44YRR34555
Application # NDA207958
SPL Set ID dd175fa3-1d7a-4542-affd-988ac5bba1db
Physiologic effect Decreased Central Nervous System Disorganized Electrical Activity
DEA schedule Non-controlled
Marketing category NDA AUTHORIZED GENERIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-01-20
Route ORAL
Dosage form TABLET, FOR SUSPENSION
Substance LEVETIRACETAM
GPI-14 7260004300G830
GCN Seq No 075620
GCN 36046
HICL code 020952
Ingredient (HICL) Levetiracetam
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H4
Therapeutic class — intermediate (HIC2) Anticonvulsants
HIC3 code H4B
Therapeutic class — specific (HIC3) Anticonvulsants
AHFS code 28:12.92.00
AHFS class Anticonvulsants, Miscellaneous
FDB label name LEVETIRACETAM 500 MG TAB SUSP
FDB brand name Levetiracetam
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 66993-101-60 — 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 → 66993-0101-60. 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 Other antiepileptics class.

Drug family (ATC) Other antiepileptics
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerPrasco Laboratories
Application holderAPRECIA PHARMACEUTICALS LLC
FDA applicationNDA207958 (NDA AUTHORIZED GENERIC)
Labeler code66993
First marketedJan 2025
Product typeHuman Prescription Drug
Portfolio106 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name LEVETIRACETAM 500 MG TAB SUSP Ingredient Levetiracetam
📗 Our plain-language guide HelloPharmacist
  • Levetiracetam is an anti-seizure medicine. Depending on the product and your age, it can be used to treat partial-onset seizures (seizures starting in one part of the brain), myocl...
  • What is levetiracetam actually used for?
  • It can, especially when you first start taking it. Drowsiness, fatigue, and dizziness are among the most common side effects and tend to be most noticeable in the first few weeks....
  • Will levetiracetam make me feel tired or foggy?
📖 Read our full Levetiracetam guide →
1
Nutrient depletion considerations

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

🧪 Full Levetiracetam 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.

💊 What it looks like

Color white
ShapeRound
Imprintcaret;symbol;over;V
Size17 mm
ScoringNot scored
FlavorSpearmint
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 REK4960K2U
    Butylated hydroxyanisole is a synthetic preservative that prevents oils and fats in medicines from spoiling or becoming rancid. It keeps the medicine stable and extends its shelf life.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • 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 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII 7T1F30V5YH
    A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
  • 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 ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII J7I2T6IV1N
    Spearmint is a plant-derived flavoring agent added to medicines to improve taste. It helps mask bitter or unpleasant flavors, making the medication easier to take.
  • 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.

9 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.

💲 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 $9.82 —
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Levetiracetam 500 mg 00378-5615-05 Mylan 500 tablets $0.074 — Availability likely —
Levetiracetam 500 mg 16714-0035-01 NorthStar 120 tablets $0.074 AB Availability likely —
Levetiracetam 500 mg 65862-0246-05 Aurobindo 500 tablets $0.074 AB Availability likely —
Levetiracetam 500 mg 68001-0403-03 BluePoint 500 tablets $0.074 AB Availability likely —
Levetiracetam 500 mg 72205-0095-92 Novadoz 120 tablets $0.074 AB Availability likely —
Levetiracetam 500 mg 69102-0105-01 OWP 120 tablets $0.074 AB Availability likely —
Levetiracetam 500 mg 50228-0471-05 ScieGen 500 tablets $0.074 AB Availability likely —
Levetiracetam 500 mg 82009-0122-05 Quallent 500 tablets $0.074 AB Availability likely —
Levetiracetam 500 mg 31722-0537-05 Camber 500 tablets $0.074 AB Availability likely —
Levetiracetam 500 mg 51079-0821-20 Mylan 1 tablet $0.074 — Availability likely —
Levetiracetam 500 mg 67877-0769-05 Ascend 500 tablets $0.074 AB Availability likely —
Levetiracetam 500 mg 43547-0222-11 Solco 1000 tablets $0.074 AB Availability likely —
Levetiracetam 500 mg 60687-0657-01 American 1 tablet $0.074 AB Availability likely —
Levetiracetam 500 mg 00904-7124-61 Major 1 tablet $0.074 AB Availability likely —
Levetiracetam 500 mg 27808-0264-01 Cranbury 120 tablets $0.074 AB Availability likely —
Levetiracetam 500 mg 68180-0113-02 Lupin 500 tablets $0.074 AB Availability likely —
Levetiracetam 500 mg 13668-0015-05 Torrent 500 tablets $0.095 AB FDA listed —
Keppra 500 mg 50474-0595-40 UCB, 120 tablets $9.916 AB Availability likely —
Spritam 500 mg 43485-0102-60 Aprecia 1 tablet $10.241 — Availability likely —
Levetiracetam 500 mgthis 66993-0101-60 Prasco 1 tablet — — FDA listed —
Levetiracetam 500 mg 55111-0182-01 Dr. 100 tablets — AB FDA listed —
Levetiracetam 500 mg 76282-0247-12 Exelan 120 tablets — — FDA listed —
Levetiracetam 500 mg 76494-0529-12 Prinston 120 tablets — AB FDA listed —
Levetiracetam 500 mg 72865-0188-05 XLCare 500 tablets — AB FDA listed —
Levetiracetam 500 mg 87234-0035-01 Injecta 1 tablet — AB FDA listed —
Levetiracetam 500 mg 63187-0360-30 Proficient 30 tablets — AB FDA listed —
Levetiracetam 500 mg 65162-0529-16 Amneal 120 tablets — AB FDA listed —
Levetiracetam 500 mg 43063-0499-60 PD-Rx 60 tablets — AB FDA listed —
Levetiracetam 500 mg 43063-0617-60 PD-Rx 60 tablets — AB FDA listed —
Levetiracetam 500 mg 50090-1333-00 A-S 120 tablets — AB FDA listed —
Levetiracetam 500 mg 50090-7717-00 A-S 120 tablets — AB FDA listed —
Levetiracetam 500 mg 55154-3367-00 Cardinal 1 tablet — AB FDA listed —
Levetiracetam 500 mg 67046-2094-03 Coupler 30 tablets — AB FDA listed —
Levetiracetam 500 mg 71335-0694-01 Bryant 90 tablets — AB FDA listed —
Levetiracetam 500 mg 50090-7768-00 A-S 120 tablets — AB FDA listed —
Levetiracetam 500 mg 68788-8843-01 Preferred 100 tablets — AB FDA listed —
Levetiracetam 500 mg 50405-0301-01 SOHM, 30 tablets — AB FDA listed —
Levetiracetam 500 mg 71335-9757-01 Bryant 90 tablets — AB FDA listed —
Levetiracetam 500 mg 80425-0566-01 Advanced 120 tablets — AB FDA listed —
Levetiracetam 500 mg 51655-0325-52 Northwind 30 tablets — AB FDA listed —
Levetiracetam 500 mg 67046-0420-03 Coupler 30 tablets — AB FDA listed —
Levetiracetam 500 mg 00615-8499-05 NCS 15 tablets — AB FDA listed —
Levetiracetam 500 mg 87063-0191-12 ASCLEMED 120 tablets — AB FDA listed —
Levetiracetam 500 mg 50090-7521-00 A-S 120 tablets — AB FDA listed —
Levetiracetam 500 mg 55154-5699-00 Cardinal 1 tablet — — FDA listed —
Levetiracetam 500 mg 70010-0522-03 Granules 30 tablets — — FDA listed —
Levetiracetam 500 mg 70518-1796-00 REMEDYREPACK 30 tablets — AB Discontinued —
Levetiracetam 500 mg 70518-4301-00 REMEDYREPACK 30 tablets — AB FDA listed —
Levetiracetam 500 mg 71335-2282-01 Bryant 500 tablets — AB FDA listed —
Levetiracetam 500 mg 72189-0229-60 DIRECT 60 tablets — AB FDA listed —
Levetiracetam 500 mg 72789-0152-60 PD-Rx 60 tablets — AB FDA listed —
Levetiracetam 500 mg 43547-0881-15 Solco 120 tablets — AB FDA listed —
Levetiracetam 500 mg 48433-0052-20 Safecor 1 tablet — — FDA listed —
Levetiracetam 500 mg 50090-7820-00 A-S 120 tablets — AB FDA listed —
Levetiracetam 500 mg 64980-0605-01 Rising 100 tablets — AB FDA listed —
Levetiracetam 500 mg 80425-0565-01 Advanced 120 tablets — AB FDA listed —
Levetiracetam 500 mg 63629-4137-01 Bryant 90 tablets — AB FDA listed —
Levetiracetam 500 mg 68788-8254-01 Preferred 100 tablets — AB FDA listed —
Levetiracetam 500 mg 70518-1108-00 REMEDYREPACK 30 tablets — AB FDA listed —
Levetiracetam 500 mg 87441-0046-01 Unit 30 tablets — AB FDA listed —
Levetiracetam 500 mg 70518-1772-00 REMEDYREPACK 30 tablets — AB Discontinued —
About this product: this is an authorized generic — the brand-name product marketed without its brand name. Other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2015
First FDA approval
Jul 2015
📍
2026
Currently FDA-listed
11 years listed
🛡️
2034
Latest patent/protection listed
not a guaranteed launch date
✅Generic appears available

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

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Mar 2034. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Jul 31, 2015 RLD RS ⏳ ~7.5 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 9339489 — method of use (U-1850)
US 9339489 — method of use (U-1850)
US 9339489 — method of use (U-1850)
US 9669009 — method of use (U-2021)
US 9669009 — method of use (U-1850)
US 9669009 — method of use (U-2021)
US 9669009 — method of use (U-2022)
US 9339489 — method of use (U-1850)
US 9669009 — method of use (U-2022)
US 9669009 — method of use (U-2022)
US 9669009 — method of use (U-2021)
US 9669009 — method of use (U-1850)
US 9669009 — method of use (U-1850)
US 9669009 — method of use (U-2021)
US 9669009 — method of use (U-1850)
US 9669009 — method of use (U-2022)
US 11160786 — drug product
US 11160786 — drug product
US 11160786 — drug product
US 11160786 — drug product
2015 2017 2019 2021 2023 2025 2027 2029 2031 2033
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 (20)
PatentTypeUse codeExpires
US 9339489 ↗ Method of use U-1850 Mar 14, 2034
US 9339489 ↗ Method of use U-1850 Mar 14, 2034
US 9339489 ↗ Method of use U-1850 Mar 14, 2034
US 9669009 ↗ Method of use U-2021 Mar 14, 2034
US 9669009 ↗ Method of use U-1850 Mar 14, 2034
US 9669009 ↗ Method of use U-2021 Mar 14, 2034
US 9669009 ↗ Method of use U-2022 Mar 14, 2034
US 9339489 ↗ Method of use U-1850 Mar 14, 2034
US 9669009 ↗ Method of use U-2022 Mar 14, 2034
US 9669009 ↗ Method of use U-2022 Mar 14, 2034
US 9669009 ↗ Method of use U-2021 Mar 14, 2034
US 9669009 ↗ Method of use U-1850 Mar 14, 2034
US 9669009 ↗ Method of use U-1850 Mar 14, 2034
US 9669009 ↗ Method of use U-2021 Mar 14, 2034
US 9669009 ↗ Method of use U-1850 Mar 14, 2034
US 9669009 ↗ Method of use U-2022 Mar 14, 2034
US 11160786 ↗ Drug product — Mar 14, 2034
US 11160786 ↗ Drug product — Mar 14, 2034
US 11160786 ↗ Drug product — Mar 14, 2034
US 11160786 ↗ Drug product — Mar 14, 2034
Common questions
Is there a generic version of LEVETIRACETAM 500 MG TAB SUSP?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for LEVETIRACETAM 500 MG TAB SUSP. See the alternatives section for substitutable, lower-cost products.
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.

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

Medicare Part D (outpatient prescription) spending for Levetiracetam — the program that covers self-administered drugs. 30 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Levetiracetam. 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
$42.44M
Claims incl. refills
1.2M
Beneficiaries
606K
Spend / beneficiary
$70.03
Spend / claim
$35.28
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 Levetiracetam — the ingredient across all brands.

Top reported reactions

Seizure15,978
Fatigue5,591
Somnolence4,177
Epilepsy4,136
Convulsion4,085
Fall3,756
Headache3,734

Reporter sex

0 reports

Serious outcomes

Hospitalization49,182
Death11,940
Life-threatening8,185
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 9,966 4,886
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
66993-0101-60 You're viewing this 60 BLISTER PACK in 1 CARTON (66993-101-60) / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (66993-101-51) 2026-01-16 Active

🧭 About this NDC listing & data coverage

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

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 66993-101-60, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 66993-0101-60, written without dashes as 66993010160. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 66993-0101-60, the first segment (66993) is the labeler code FDA assigned to Prasco Laboratories; the middle segment (0101) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (60) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
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📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🎯 Indications and Usage 184 words ▾

1 INDICATIONS AND USAGE Levetiracetam tablets for oral suspension are indicated for the treatment of partial-onset seizures in patients 4 years of age and older weighing more than 20 kg ( 1.1 ) Levetiracetam tablets for oral suspension are indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ( 1.2 ) Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ( 1.3 )

1.1Partial-Onset Seizures Levetiracetam tablets for oral suspension are indicated for the treatment of partial-onset seizures in patients 4 years of age and older weighing more than 20 kg.

1.2Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy Levetiracetam tablets for oral suspension are indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy.

1.3Primary Generalized Tonic-Clonic Seizures Levetiracetam tablets for oral suspension are indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Levetiracetam tablets for oral suspension are intended to disintegrate in the mouth when taken with a sip of liquid. Swallow only after the tablet disintegrates. Do not swallow tablet(s) intact.

Partial tablet(s) should not be administered ( 2.1 ) Alternately, add whole Levetiracetam tablet(s) for oral suspension to a small volume of liquid in a cup (one tablespoon or enough to cover the medicine). Allow the tablet(s) to disperse prior to consuming entire contents immediately ( 2.1 ) Levetiracetam tablets for oral suspension may also be administered via nasogastric or gastrostomy feeding tubes ( 2.1 ) Recommended dosage ( 2.2 ): Age and Body Weight Initial Dosage Titration Regimen Maximum or Recommended Dosage Adults and pediatric patients weighing over 40 kg 500 mg twice daily Increase by 500 mg twice daily every 2 weeks Partial-Onset Seizures Maximum dosage of 1,500 mg twice daily Myoclonic ± and PGTC ± Recommended dosage of 1,500 mg twice daily Pediatric patients weighing 20 kg to 40 kg 250 mg twice daily Increase by 250 mg twice daily every 2 weeks Maximum 750 mg twice daily Adult Patients with Renal Impairment Dose adjustment is recommended based on creatinine clearance ( 2.3 , 8.6 )

2.1Important Preparation and Administration Instructions The Levetiracetam tablets for oral suspension dosing regimen depends on the indication, age group, and renal function. Administer Levetiracetam tablets for oral suspension with or without food. Do not administer partial tablets.

Patients should be instructed not to push the tablet through the foil. The foil should be peeled away from the blister by bending up and lifting the peel tab around the blister seal. Oral Administration Levetiracetam tablets for oral suspension are intended to disintegrate in the mouth when taken with a sip of liquid, one tablet at a time.

As a primary method of administration, place one tablet on the tongue with a dry hand, follow with a sip of liquid and swallow only after the tablet disintegrates. Repeat this step, if needed, until the full dose has been administered. Do not swallow tablet(s) intact.

Levetiracetam tablets for oral suspension disintegrate in a mean time of 11 seconds (ranging from 2 to 27 seconds) in the mouth when taken with a sip of liquid. Alternately, add whole Levetiracetam tablet(s) for oral suspension to a small volume of liquid in a cup (one tablespoon or enough liquid to cover the medicine). Allow the tablet(s) to fully disperse, then immediately consume the entire contents by mouth using the cup or an oral syringe.

After administration of the suspension, re-suspend any residue by adding an additional small volume of liquid to the cup, swirl, then swallow the entire contents. Nasogastric Tube (NG Tube) or Gastrostomy Tube (G-Tube) Administration For patients who have a NG tube or G tube (French size 10 to 14) in place, administer Levetiracetam tablets for oral suspension as follows: Place the number of whole tablets needed for the prescribed dose in a small dosing cup, Add approximately 10 mL of room temperature water. Gently swirl the cup until the tablet(s) disperse.

Draw up the mixture into a 10 mL oral catheter-tip syringe, hold the syringe in a vertical position, and administer immediately via feeding tube. After administration, flush the feeding tube twice, as follows: Add another 10 mL of room temperature water to the dosing cup that contained the dispersion. Swirl the cup to re-suspend any tablet residue.

Draw up the mixture into the same oral syringe and immediately push through the feeding tube.

2.2Recommended Dosage See Table 1 for the recommended dosage for patients with partial-onset seizures, myoclonic seizures with juvenile myoclonic epilepsy, and primary generalized tonic-clonic seizures. Table 1: Recommended Dosage for Patients with: Partial-Onset Seizures (4 years age and older)*, Myoclonic Seizures (12 years of age and older), and Primary Generalized Tonic-Clonic Seizures (PGTC) (6 year…

💊 Dosage Forms and Strengths 53 words ▾

3 DOSAGE FORMS AND STRENGTHS Tablet(s) for oral suspension: 250 mg: round, white to off-white, spearmint-flavored, marked with " " on one side 500 mg: round, white to off-white, spearmint-flavored, marked with " " on one side Tablets for oral suspension: 250 mg and 500 mg ( 3 ) Imprint Marking Imprint Marking

⛔ Contraindications 43 words ▾

4 CONTRAINDICATIONS Levetiracetam tablets for oral suspension are contraindicated in patients with a hypersensitivity to levetiracetam. Reactions have included anaphylaxis and angioedema [see Warnings and Precautions (5.4) ] . Known hypersensitivity to levetiracetam; angioedema and anaphylaxis have occurred ( 4 , 5.4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Behavioral Abnormalities: Psychotic symptoms, irritability, and aggressive behavior have been observed: Monitor for signs and symptoms ( 5.1 ) Suicidal Behavior and Ideation: Monitor for new or worsening depression, suicidal thoughts/behavior, and/or changes in mood or behavior ( 5.2 ) Monitor for somnolence and fatigue and advise patients not to drive or operate machinery until they have gained experience on Levetiracetam tablets for oral suspension ( 5.3 ) Serious Dermatological Reactions: Discontinue Levetiracetam tablets for oral suspension at the first sign of rash unless clearly not drug related ( 5.5 ) Drug Reaction with Eosinophilia and Systemic Symptoms/Multiorgan Hypersensitivity: Discontinue if no alternative etiology ( 5.6 ) Coordination Difficulties: Monitor for ataxia, abnormal gait, and incoordination.

Advise patients to not drive or operate machinery until they have gained experience on Levetiracetam tablets for oral suspension ( 5.7 ) Withdrawal Seizures: Levetiracetam tablets for oral suspension must be gradually withdrawn ( 5.8 )

5.1Behavioral Abnormalities and Psychotic Symptoms Levetiracetam tablets for oral suspension may cause behavioral abnormalities and psychotic symptoms. Patients treated with Levetiracetam tablets for oral suspension should be monitored for psychiatric signs and symptoms. Behavioral Abnormalities In clinical studies, 13% of adult levetiracetam-treated patients and 38% of pediatric levetiracetam-treated patients (4 to 16 years of age), compared to 6% and 19% of adult and pediatric placebo-treated patients, respectively, experienced non-psychotic behavioral symptoms (reported as aggression, agitation, anger, anxiety, apathy, depersonalization, depression, emotional lability, hostility, hyperkinesias, irritability, nervousness, neurosis, and personality disorder).

A randomized double-blind, placebo-controlled study was performed to assess the neurocognitive and behavioral effects of levetiracetam as adjunctive therapy in pediatric patients (4 to 16 years of age). The results from an exploratory analysis indicated a worsening in levetiracetam-treated patients on aggressive behavior (one of eight behavior dimensions) as measured in a standardized and systematic way using a validated instrument, the Achenbach Child Behavior Checklist (CBCL/6-18). In clinical studies in pediatric patients 1 month to < 4 years of age, irritability was reported in 12% of the levetiracetam-treated patients compared to 0% of placebo-treated patients.

In clinical studies, 1.7% of adult levetiracetam-treated patients discontinued treatment due to behavioral adverse reactions, compared to 0.2% of placebo-treated patients. The treatment dose was reduced in 0.8% of adult levetiracetam-treated patients and in 0.5% of placebo-treated patients. Overall, 11% of levetiracetam-treated pediatric patients experienced behavioral symptoms associated with discontinuation or dose reduction, compared to 6% of placebo-treated patients.

Psychotic Symptoms In clinical studies, 1% of levetiracetam-treated adult patients, 2% of levetiracetam-treated pediatric patients 4 to 16 years of age, and 17% of levetiracetam-treated pediatric patients 1 month to < 4 years of age experienced psychotic symptoms, compared to 0.2%, 2%, and 5% in the corresponding age groups treated with placebo. In the controlled study that assessed the neurocognitive and behavioral effects of levetiracetam in pediatric patients 4 to 16 years of age, 1.6% of levetiracetam-treated patients experienced paranoia, compared to 0% of placebo-treated patients.

In the same study, 3.1% of levetiracetam-treated patients experienced confusional state, compared to 0% of placebo-treated patients [see Use in Specific Populations (8.4) ] . In clinical studies, two (0.3%) levetiracetam-treated adult patients were hospitalized and their treatment was discontinued due to psychosis. Both events, reported as psychosis, developed within the first week of tre…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in the labeling: Behavioral Abnormalities and Psychotic Symptoms [see Warnings and Precautions (5.1) ] Suicidal Behavior and Ideation [see Warnings and Precautions (5.2) ] Somnolence and Fatigue [see Warnings and Precautions (5.3) ] Anaphylaxis and Angioedema [ see Warnings and Precautions (5.4) ] Serious Dermatological Reactions [see Warnings and Precautions (5.5) ] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity [see Warnings and Precautions (5.6) ] Coordination Difficulties [see Warnings and Precautions (5.7) ] Hematologic Abnormalities [see Warnings and Precautions (5.9) ] Increase in Blood Pressure [see Warnings and Precautions (5.10) ] Most common adverse reactions (incidence ≥ 5% more than placebo) include: Adults: somnolence, asthenia, infection, and dizziness ( 6.1 ) Pediatrics: fatigue, aggression, nasal congestion, decreased appetite, and irritability ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Aprecia Pharmaceuticals, LLC at 1-844-882-7732 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. Partial-Onset Seizures Adults In controlled clinical studies in adults with partial-onset seizures [see Clinical Studies (14.1) ] , the most common adverse reactions in patients receiving levetiracetam in combination with other AEDs, for events with rates greater than placebo, were somnolence, asthenia, infection, and dizziness.

Of the most common adverse reactions in adults experiencing partial-onset seizures, asthenia, somnolence, and dizziness occurred predominantly during the first 4 weeks of treatment with levetiracetam. Table 4 lists adverse reactions that occurred in at least 1% of adult epilepsy patients receiving levetiracetam in placebo-controlled studies and were numerically more common than in patients treated with placebo. In these studies, either levetiracetam or placebo was added to concurrent AED therapy.

Table 4: Adverse Reactions in Pooled Placebo-Controlled, Adjunctive Studies in Adults with Partial- Onset Seizures Adverse Reaction Levetiracetam (N=769) % Placebo (N=439) % Asthenia 15 9 Somnolence 15 8 Headache 14 13 Infection 13 8 Dizziness 9 4 Pain 7 6 Pharyngitis 6 4 Depression 4 2 Nervousness 4 2 Rhinitis 4 3 Anorexia 3 2 Ataxia 3 1 Vertigo 3 1 Amnesia 2 1 Anxiety 2 1 Cough Increased 2 1 Diplopia 2 1 Emotional Lability 2 0 Hostility 2 1 Paresthesia 2 1 Sinusitis 2 1 In controlled adult clinical studies, 15% of patients receiving levetiracetam and 12% receiving placebo either discontinued or had a dose reduction as a result of an adverse reaction.

Table 5 lists the most common (> 1%) adverse reactions that resulted in discontinuation or dose reduction and that occurred more frequently in levetiracetam-treated patients than in placebo-treated patients. Table 5: Adverse Reactions that Resulted in Discontinuation or Dose Reduction in Pooled Placebo- Controlled Studies in Adults with Partial-Onset Seizures Adverse Reaction Levetiracetam (N=769) % Placebo (N=439) % Somnolence 4 2 Dizziness 1 0 Pediatric Patients 4 Years to Less Than 16 Years of Age The adverse reaction data presented below was obtained from a pooled analysis of two controlled clinical studies in pediatric patients 4 to less than 16 years of age with partial-onset seizures.

The most common adverse reactions in pediatric patients 4 to less than 16 years of age receiving levetiracetam in combination with other AEDs, for events with rates greater than placebo, were fatigue, aggression, nasal congestion, decreased appetite, and irritability. Table 6 lists adverse reactions from the pooled pediatric controlled studies…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: Plasma levels of levetiracetam may be decreased and therefore need to be monitored closely during pregnancy; based on animal data, may cause fetal harm ( 5.11 , 8.1 )

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), including Levetiracetam tablets for oral suspension, during pregnancy. Encourage women who are taking Levetiracetam tablets for oral suspension during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) pregnancy registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/ . Risk Summary Prolonged experience with levetiracetam in pregnant women has not identified a drug-associated risk of major birth defects or miscarriage, based on published literature, which includes data from pregnancy registries and reflects experience over two decades [see Human Data ] .

In animal studies, levetiracetam produced developmental toxicity (increased embryofetal and offspring mortality, increased incidences of fetal structural abnormalities, decreased embryofetal and offspring growth, neurobehavioral alterations in offspring) at doses similar to human therapeutic doses [see Animal Data ] . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown.

Clinical Considerations Levetiracetam blood levels may decrease during pregnancy [see Warnings and Precautions (5.11) ] . Physiological changes during pregnancy may affect levetiracetam concentration. Decrease in levetiracetam plasma concentrations has been observed during pregnancy.

This decrease is more pronounced during the third trimester. Dose adjustments may be necessary to maintain clinical response. Data Human Data While available studies cannot definitively establish the absence of risk, data from the published literature and pregnancy registries have not established an association with levetiracetam use during pregnancy and major birth defects or miscarriage.

Animal Data When levetiracetam (0, 400, 1200, or 3600 mg/kg/day) was administered orally to pregnant rats during the period of organogenesis, reduced fetal weights and increased incidence of fetal skeletal variations were observed at the highest dose tested. There was no evidence of maternal toxicity. The no-effect dose for adverse effects on embryofetal developmental in rats (1200/mg/kg/day) is approximately 4 times the maximum recommended human dose (MRHD) of 3000 mg on a body surface area (mg/m 2 ) basis.

Oral administration of levetiracetam (0, 200, 600, or 1800 mg/kg/day) to pregnant rabbits during the period of organogenesis resulted in increased embryofetal mortality and incidence of fetal skeletal variations at the mid and high dose and decreased fetal weights and increased incidence of fetal malformations at the high dose, which was associated with maternal toxicity. The no-effect dose for adverse effects on embryofetal development in rabbits (200 mg/kg/day) is approximately equivalent to the MRHD on a mg/m 2 basis.

Oral administration of levetiracetam (0, 70, 350, or 1800 mg/kg/day) to female rats throughout pregnancy and lactation led to an increased incidence of fetal skeletal variations, reduced fetal body weight, and decreased growth in offspring at the mid and high doses and increased pup mortality and neurobehavioral alterations in offspring at the highest dose tested. There was no evidence of maternal toxicity. The no-effect dose for adverse effects on pre- and postnatal development in rats (70 mg/kg/day) is less than the MRHD on a mg/m 2 basis.

Oral administration of levetiracetam to rats during the latter part of gestation and throughout lactation produced no adverse developmental or maternal effects at do…

🤰 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), including Levetiracetam tablets for oral suspension, during pregnancy. Encourage women who are taking Levetiracetam tablets for oral suspension during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) pregnancy registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/ . Risk Summary Prolonged experience with levetiracetam in pregnant women has not identified a drug-associated risk of major birth defects or miscarriage, based on published literature, which includes data from pregnancy registries and reflects experience over two decades [see Human Data ] .

In animal studies, levetiracetam produced developmental toxicity (increased embryofetal and offspring mortality, increased incidences of fetal structural abnormalities, decreased embryofetal and offspring growth, neurobehavioral alterations in offspring) at doses similar to human therapeutic doses [see Animal Data ] . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown.

Clinical Considerations Levetiracetam blood levels may decrease during pregnancy [see Warnings and Precautions (5.11) ] . Physiological changes during pregnancy may affect levetiracetam concentration. Decrease in levetiracetam plasma concentrations has been observed during pregnancy.

This decrease is more pronounced during the third trimester. Dose adjustments may be necessary to maintain clinical response. Data Human Data While available studies cannot definitively establish the absence of risk, data from the published literature and pregnancy registries have not established an association with levetiracetam use during pregnancy and major birth defects or miscarriage.

Animal Data When levetiracetam (0, 400, 1200, or 3600 mg/kg/day) was administered orally to pregnant rats during the period of organogenesis, reduced fetal weights and increased incidence of fetal skeletal variations were observed at the highest dose tested. There was no evidence of maternal toxicity. The no-effect dose for adverse effects on embryofetal developmental in rats (1200/mg/kg/day) is approximately 4 times the maximum recommended human dose (MRHD) of 3000 mg on a body surface area (mg/m 2 ) basis.

Oral administration of levetiracetam (0, 200, 600, or 1800 mg/kg/day) to pregnant rabbits during the period of organogenesis resulted in increased embryofetal mortality and incidence of fetal skeletal variations at the mid and high dose and decreased fetal weights and increased incidence of fetal malformations at the high dose, which was associated with maternal toxicity. The no-effect dose for adverse effects on embryofetal development in rabbits (200 mg/kg/day) is approximately equivalent to the MRHD on a mg/m 2 basis.

Oral administration of levetiracetam (0, 70, 350, or 1800 mg/kg/day) to female rats throughout pregnancy and lactation led to an increased incidence of fetal skeletal variations, reduced fetal body weight, and decreased growth in offspring at the mid and high doses and increased pup mortality and neurobehavioral alterations in offspring at the highest dose tested. There was no evidence of maternal toxicity. The no-effect dose for adverse effects on pre- and postnatal development in rats (70 mg/kg/day) is less than the MRHD on a mg/m 2 basis.

Oral administration of levetiracetam to rats during the latter part of gestation and throughout lactation produced no adverse developmental or maternal effects at doses of up to 1800 mg/kg/day (6 times the MRHD on a mg/m 2 basis).

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use Levetiracetam tablets for oral suspension are not recommended for pediatric patients that weigh 20 kg or less. The following sections describe age appropriate indications. Partial-Onset Seizures The safety and effectiveness of Levetiracetam tablets for oral suspension have been established for the treatment of partial-onset seizures in pediatric patients 4 years of age and older.

Use is based on controlled studies in adult patients and efficacy data in 198 pediatric patients 4 to 16 years of age treated with levetiracetam with partial-onset seizures [see Clinical Pharmacology (12.3) and Clinical Studies (14.1) ]. Safety and effectiveness for the treatment of partial-onset seizures in pediatric patients below the age of 4 years have not been established. A 3-month, randomized, double-blind, placebo-controlled study was conducted to assess the neurocognitive and behavioral effects of levetiracetam as adjunctive therapy in 98 (levetiracetam N=64, placebo N=34) pediatric patients, 4 to 16 years of age, with partial seizures that were inadequately controlled.

The target dose was 60 mg/kg/day. Neurocognitive effects were measured by the Leiter-R Attention and Memory (AM) Battery, which measures various aspects of a child's memory and attention. Although no substantive differences were observed between the placebo and drug treated groups in the median change from baseline in this battery, the study was not adequate to assess formal statistical non-inferiority of the drug and placebo.

The Achenbach Child Behavior Checklist (CBCL/6-18), a standardized validated tool used to assess a child's competencies and behavioral/emotional problems, was also assessed in this study. An analysis of the CBCL/6-18 indicated on average a worsening in levetiracetam-treated patients in aggressive behavior, one of the eight syndrome scores [see Warnings and Precautions (5.1) ] . Myoclonic Seizures The safety and effectiveness of Levetiracetam tablets for oral suspension have been established as adjunctive treatment of myoclonic seizures in pediatric patients 12 years of age and older with juvenile myoclonic epilepsy.

Use is based on one controlled study that included 113 adult and pediatric patients as young as 12 years of age treated with levetiracetam with juvenile myoclonic epilepsy [see Clinical Studies (14.2) ] . Safety and effectiveness as adjunctive therapy for the treatment of myoclonic seizures in pediatric patients below the age of 12 years have not been established. Primary Generalized Tonic-Clonic Seizures The safety and effectiveness of Levetiracetam tablets for oral suspension have been established as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in pediatric patients 6 years of age and older with idiopathic generalized epilepsy.

Use is based on one controlled study that included 164 adult and pediatric patients treated with levetiracetam with generalized tonic-clonic seizures [see Clinical Studies (14.3) ] . Safety and effectiveness as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in pediatric patients below the age of 6 years have not been established. Juvenile Animal Toxicity Data Studies of levetiracetam in juvenile rats (dosed on postnatal days 4 through 52) and dogs (dosed from postnatal weeks 3 through 7) at doses of up to 1800 mg/kg/day (approximately 7 and 24 times, respectively, the maximum recommended pediatric dose of 60 mg/kg/day on a mg/m 2 basis) did not demonstrate adverse effects on postnatal development.

🧓 Geriatric Use 112 words ▾

8.5Geriatric Use There were 347 subjects in clinical studies of levetiracetam that were 65 and over. No overall differences in safety were observed between these subjects and younger subjects. There were insufficient numbers of elderly subjects in controlled trials of epilepsy to adequately assess the effectiveness of levetiracetam in these patients.

Levetiracetam is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with renal impairment. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see Clinical Pharmacology (12.3) ] .

🆘 Overdosage 203 words ▾

10 OVERDOSAGE

10.1Signs, Symptoms and Laboratory Findings of Acute Overdosage in Humans The highest known dose of levetiracetam received in the clinical development program was 6000 mg/day. Other than drowsiness, there were no adverse reactions in the few known cases of overdose in clinical trials. Cases of somnolence, agitation, aggression, depressed level of consciousness, respiratory depression and coma were observed with levetiracetam overdoses in postmarketing use.

10.2Management of Overdose There is no specific antidote for overdose with Levetiracetam tablets for oral suspension. If indicated, elimination of unabsorbed drug should be attempted by emesis or gastric lavage; usual precautions should be observed to maintain airway. General supportive care of the patient is indicated including monitoring of vital signs and observation of the patient's clinical status.

A Certified Poison Control Center should be contacted for up to date information on the management of overdose with Levetiracetam tablets for oral suspension.

10.3Hemodialysis Standard hemodialysis procedures result in significant clearance of levetiracetam (approximately 50% in 4 hours) and should be considered in cases of overdose. Although hemodialysis has not been performed in the few known cases of overdose, it may be indicated by the patient's clinical state or in patients with significant renal impairment.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The precise mechanism(s) by which levetiracetam exerts its antiepileptic effect is unknown. A saturable and stereoselective neuronal binding site in rat brain tissue has been described for levetiracetam. Experimental data indicate that this binding site is the synaptic vesicle protein SV2A, thought to be involved in the regulation of vesicle exocytosis.

Although the molecular significance of levetiracetam binding to SV2A is not understood, levetiracetam and related analogs showed a rank order of affinity for SV2A which correlated with the potency of their antiseizure activity in audiogenic seizure-prone mice. These findings suggest that the interaction of levetiracetam with the SV2A protein may contribute to the antiepileptic mechanism of action of the drug.

12.2Pharmacodynamics Effects on QTc Interval The effect of levetiracetam on QTc prolongation was evaluated in a randomized, double-blind, positive-controlled (moxifloxacin 400 mg) and placebo-controlled crossover study of levetiracetam (1000 mg or 5000 mg) in 52 healthy subjects. The upper bound of the 90% confidence interval for the largest placebo-adjusted, baseline-corrected QTc was below 10 milliseconds. Therefore, there was no evidence of significant QTc prolongation in this study.

12.3Pharmacokinetics The pharmacokinetics of levetiracetam are similar when used as monotherapy or as adjunctive therapy for the treatment of partial-onset seizures. Absorption and Distribution Peak plasma concentrations of levetiracetam occurred in about an hour following oral administration in fasted subjects. In a crossover study in healthy volunteers, Levetiracetam tablets for oral suspension, administered with a sip of water, were shown to have equivalent rate and extent of absorption to levetiracetam immediate release tablets, administered with a glass of water under fasting conditions.

High fat meal does not affect the extent of absorption of Levetiracetam tablets for oral suspension but it decreases C max by 36% and delays t max by 3.4 hours. The oral bioavailability of levetiracetam tablets is 100% and the tablets and oral solution are bioequivalent in rate and extent of absorption. Food does not affect the extent of absorption of levetiracetam but it decreases C max by 20% and delays t max by 1.5 hours.

The pharmacokinetics of levetiracetam are linear over the dose range of 500-5000 mg. Steady state is achieved after 2 days of multiple twice-daily dosing. Levetiracetam and its major metabolite are less than 10% bound to plasma proteins; clinically significant interactions with other drugs through competition for protein binding sites are therefore unlikely.

Metabolism Levetiracetam is not extensively metabolized in humans. The major metabolic pathway is the enzymatic hydrolysis of the acetamide group, which produces the carboxylic acid metabolite, ucb L057 (24% of dose) and is not dependent on any liver cytochrome P450 isoenzymes. The major metabolite is inactive in animal seizure models.

Two minor metabolites were identified as the product of hydroxylation of the 2-oxo-pyrrolidine ring (2% of dose) and opening of the 2‑oxo‑pyrrolidine ring in position 5 (1% of dose). There is no enantiomeric interconversion of levetiracetam or its major metabolite. Elimination Levetiracetam plasma half-life in adults is 7 ± 1 hour and is unaffected by either dose or repeated administration.

Levetiracetam is eliminated from the systemic circulation by renal excretion as unchanged drug which represents 66% of administered dose. The total body clearance is 0.96 mL/min/kg and the renal clearance is 0.6 mL/min/kg. The mechanism of excretion is glomerular filtration with subsequent partial tubular reabsorption.

The metabolite ucb L057 is excreted by glomerular filtration and active tubular secretion with a renal clearance of 4 mL/min/kg. Levetiracetam elimination is correlated to creatinine clearance. Levetiracetam clearance is reduced in patients wit…

🧬 Mechanism of Action 115 words ▾

12.1Mechanism of Action The precise mechanism(s) by which levetiracetam exerts its antiepileptic effect is unknown. A saturable and stereoselective neuronal binding site in rat brain tissue has been described for levetiracetam. Experimental data indicate that this binding site is the synaptic vesicle protein SV2A, thought to be involved in the regulation of vesicle exocytosis.

Although the molecular significance of levetiracetam binding to SV2A is not understood, levetiracetam and related analogs showed a rank order of affinity for SV2A which correlated with the potency of their antiseizure activity in audiogenic seizure-prone mice. These findings suggest that the interaction of levetiracetam with the SV2A protein may contribute to the antiepileptic mechanism of action of the drug.

📦 How Supplied / Storage and Handling 120 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Levetiracetam tablet(s) for oral suspension are supplied in child-resistant blisters as follows: 250 mg: round, white to off-white, spearmint-flavored tablets, marked with “ ” on one side Commercial Use: 60 tablets per carton (6 tablets per blister card x 10 cards) (NDC 66993-100-60) Institutional Use: 6 tablets per carton (6 tablets per blister card x 1 card) (NDC 66993-100-06) 500 mg: round, white to off-white, spearmint-flavored tablets, marked with “ ” on one side Commercial Use: 60 tablets per carton (6 tablets per blister card x 10 cards) (NDC 66993-101-60) 11 12

16.2Storage Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

📋 Description ~1 min read ▾

11 DESCRIPTION Levetiracetam tablets for oral suspension are an antiepileptic drug available as 250 mg and 500 mg, round, white to off-white, spearmint-flavored tablets for oral suspension. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8 H 14 N 2 O 2 and its molecular weight is 170.21. It has the following structural formula: Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste.

It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent).

Levetiracetam tablets for oral suspension contain 250 mg and 500 mg levetiracetam. Each tablet also contains the following inactive ingredients: colloidal silicon dioxide, glycerin, mannitol, microcrystalline cellulose, polysorbate 20, povidone, sucralose, butylated hydroxyanisole, and natural and artificial spearmint flavor. Levetiracetam tablets for oral suspension are unitary porous structures produced by a three-dimensional printing process that binds the powders without compression.

Levetiracetam tablets for oral suspension disintegrate in a mean time of 11 seconds (ranging from 2 to 27 seconds) in the mouth, when taken with a sip of liquid, to produce small particles that may be swallowed. Chemical Structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Psychiatric Reactions and Changes in Behavior Advise patients that Levetiracetam tablets for oral suspension may cause changes in behavior (e.g. aggression, agitation, anger, anxiety, apathy, depression, hostility, and irritability) and psychotic symptoms [see Warnings and Precautions (5.1) ]. Suicidal Behavior and Ideation Counsel patients, their caregivers, and/or families that antiepileptic drugs (AEDs), including Levetiracetam tablets for oral suspension, may increase the risk of suicidal thoughts and behavior and advise patients to be alert for the emergence or worsening of symptoms of depression; unusual changes in mood or behavior; or suicidal thoughts, behavior, or thoughts about self-harm.

Advise patients, their caregivers, and/or families to immediately report behaviors of concern to a healthcare provider [see Warnings and Precautions (5.2) ]. Effects on Driving or Operating Machinery Inform patients that Levetiracetam tablets for oral suspension may cause dizziness and somnolence. Inform patients not to drive or operate machinery until they have gained sufficient experience on Levetiracetam tablets for oral suspension to gauge whether it adversely affects their ability to drive or operate machinery [see Warnings and Precautions (5.3) ].

Anaphylaxis and Angioedema Advise patients to discontinue Levetiracetam tablets for oral suspension and seek medical care if they develop signs and symptoms of anaphylaxis or angioedema [see Warnings and Precautions (5.4) ]. Dermatological Adverse Reactions Advise patients that serious dermatological adverse reactions have occurred in patients treated with Levetiracetam tablets for oral suspension and instruct them to call their physician immediately if a rash develops [see Warnings and Precautions (5.5) ]. DRESS/Multiorgan Hypersensitivity Instruct patients and caregivers that a fever or rash associated with signs of other organ system involvement (e.g., lymphadenopathy, hepatic dysfunction) may be drug-related and should be reported to their healthcare provider immediately.

Levetiracetam tablets for oral suspension should be discontinued immediately if a serious hypersensitivity reaction is suspected [see Warnings and Precautions (5.6) ] . Withdrawal of Levetiracetam Tablets for Oral Suspension Advise patients and caregivers not to discontinue use of Levetiracetam tablets for oral suspension without consulting with their healthcare provider. Levetiracetam tablets for oral suspension should normally be gradually withdrawn to reduce the potential of increased seizure frequency and status epilepticus [see Warnings and Precautions (5.8) ] .

Pregnancy Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during Levetiracetam tablets for oral suspension therapy. Encourage patients to enroll in the North American Antiepileptic Drug (NAAED) pregnancy registry if they become pregnant [see Use in Specific Populations (8.1) ] . Preparation and Administration Information Instruct patients to administer Levetiracetam tablets for oral suspension with or without food, and not to administer partial tablets [see Dosage and Administration (2.1) ].

Instruct patients to peel the foil from the blister by bending up and lifting the peel tab around the blister seal. Instruct patients on the appropriate method of administration: Place tablet on the tongue with a dry hand, follow with a sip of liquid and swallow only after the tablet disintegrates. Advise patients not to swallow Levetiracetam tablets for oral suspension intact; or Alternately, add whole Levetiracetam tablet(s) for oral suspension to a small volume of liquid in a cup (one tablespoon or enough to cover the medicine).

Advise patients to allow the tablet(s) to fully disperse, and then immediately consume the entire contents by mouth using the cup or oral syringe. After administr…

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Levetiracetam Tablets for Oral Suspension (lee" ve tye ra' se tam) What is the most important information I should know about Levetiracetam tablets for oral suspension? Like other antiepileptic drugs, Levetiracetam tablets for oral suspension may cause suicidal thoughts or actions in a very small number of people, about 1 in 500 people taking it. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying new or worse depression feeling agitated or restless trouble sleeping (insomnia) acting aggressive, being angry, or violent an extreme increase in activity or talking (mania) attempts to commit suicide new or worse anxiety panic attacks new or worse irritability acting on dangerous impulses other unusual changes in behavior or mood Do not stop Levetiracetam tablets for oral suspension without first talking to a healthcare provider.

Stopping Levetiracetam tablets for oral suspension suddenly can cause serious problems. Stopping a seizure medicine suddenly can cause seizures that will not stop (status epilepticus). Suicidal thoughts or actions can be caused by things other than medicines.

If you have suicidal thoughts or actions, your healthcare provider may check for other causes. 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. Call your healthcare provider between visits as needed, especially if you are worried about symptoms. What is Levetiracetam tablets for oral suspension?

Levetiracetam tablets for oral suspension are a prescription medicine taken by mouth that is used to treat partial-onset seizures in people 4 years of age and older weighing more than 44 pounds (20 kilograms). Levetiracetam tablets for oral suspension are a prescription medicine taken by mouth that is used with other medicines to treat: myoclonic seizures in people 12 years of age and older with juvenile myoclonic epilepsy. primary generalized tonic-clonic seizures in people 6 years of age and older with certain types of generalized epilepsy.

It is not known if Levetiracetam tablets for oral suspension are safe or effective in children under: 4 years of age to treat partial-onset seizures 12 years of age to treat myoclonic seizures 6 years of age to treat primary generalized tonic-clonic seizures Levetiracetam tablets for oral suspension are not recommended for children that weigh 44 pounds (20 kilograms) or less. Before taking your medicine, make sure you have received the correct medicine. Compare the name above with the name on your carton (box).

Tell your pharmacist immediately if you think you have been given the wrong medicine. Who should not take Levetiracetam tablets for oral suspension? Do not take Levetiracetam tablets for oral suspension if you are allergic to levetiracetam.

What should I tell my healthcare provider before starting Levetiracetam tablets for oral suspension? Before taking Levetiracetam tablets for oral suspension, tell your healthcare provider about all of your medical conditions, including if you: have or have had depression, mood problems or suicidal thoughts or behavior. have kidney problems. are pregnant or planning to become pregnant. It is not known if Levetiracetam tablets for oral suspension will harm your unborn baby.

You and your healthcare provider will have to decide if you should take Levetiracetam tablets for oral suspension while you are pregnant. If you become pregnant while taking Levetiracetam tablets for oral suspension, 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 the registry is to collect information about the safety of Leve…

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