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Levetiracetam 500 mg Tablet, Film Coated — NDC 55154-0288-00 package photo

Levetiracetam 500 mg Tablet, Film Coated

by Cardinal Health 107, LLC · 10 BLISTER PACK in 1 BAG (55154-0288-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK
NDC 55154-0288-00
🏷️ FDA NDC (as labeled) 55154-0288-0 billing pads the package segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Sep 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) 55154-0288-0
Product NDC 55154-0288
11-digit billing NDC 55154028800
Application # ANDA076919
SPL Set ID 100d7618-b8e6-43f5-a4e2-6fd728de9d3f
Physiologic effect Decreased Central Nervous System Disorganized Electrical Activity
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-09-11
Route ORAL
Dosage form TABLET, FILM COATED
Substance LEVETIRACETAM
Why two NDCs? The FDA registers this code as 55154-0288-0 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 55154-0288-00. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerCardinal Health 107, LLC
Application holderMYLAN PHARMACEUTICALS INC
FDA applicationANDA076919 (ANDA)
Labeler code55154
First marketedSep 2026
Product typeHuman Prescription Drug
Portfolio477 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

📗 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
ShapeOval
ImprintM;615
Size17 mm
ScoringScored — splits in 2
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 M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII 0VUT3PMY82
    Hypromellose 2910 is a plant-derived thickening agent made from cellulose. In medicines, it forms protective coatings on tablets or capsules, controls how fast the drug releases, and thickens liquid formulations.
  • UNII 1IVH67816N
    Hypromellose 2910 is a plant-derived cellulose compound used as a thickener and film-former in medicines. It helps control how quickly the medication dissolves and creates protective coatings on tablets or capsules.
  • UNII 0WZ8WG20P6
    Hypromellose 2910 is a plant-based cellulose derivative that acts as a thickener, binder, and film-coating agent. It helps control how quickly the medicine dissolves and protects the tablet or capsule from moisture and light.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 7T9FYH5QMK
    A plant-derived powder that serves as a binder and filler in tablets and capsules. It helps hold ingredients together, adds bulk, and aids in smooth tablet disintegration when swallowed.
  • UNII VH2XOU12IE
    Polydextrose is a synthetic polymer made from dextrose (sugar) that acts as a bulking agent and filler in medicines. It helps give tablets and capsules proper volume and texture while often adding slight sweetness.
  • UNII B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII Q662QK8M3B
    Polyethylene glycol 8000 is a synthetic polymer made from ethylene oxide. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and add bulk to the medicine.
  • UNII U725QWY32X
    Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the 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 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 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII XHX3C3X673
    Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.

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

🔁 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 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 66993-0101-60 Prasco 1 tablet — — 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 —
Levetiracetam 500 mgthis 55154-0288-00 Cardinal 1 tablet — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and 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

🏛️
2026
On the market since
Sep 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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
55154-0288-00 You're viewing this 10 BLISTER PACK in 1 BAG (55154-0288-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK 2026-09-11 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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 55154-0288-0, 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: 55154-0288-00, written without dashes as 55154028800. 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 55154-0288-00, the first segment (55154) is the labeler code FDA assigned to Cardinal Health 107, LLC; the middle segment (0288) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (00) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Cardinal Health 107, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Cardinal Health 107, LLC 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.

📄 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.
📄 FDA label
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 55154-0287-00 · Cardinal 55154-0289-00 · Cardinal →
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.