Home › NDC Lookup › Ingredients › Levetiracetam › 50474-0001-48
Keppra levetiracetam 100 mg/mL Solution, 473 mL — NDC 50474-0001-48 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Keppra levetiracetam 100 mg/mL Solution, 473 mL — NDC 50474-001-48 (Billing 50474-0001-48)

by UCB, Inc. · 473 mL in 1 BOTTLE, PLASTIC

This is a package of 473 mL of Keppra levetiracetam 100 mg/mL Solution from UCB, Inc., marketed since Oct 2003 and currently FDA-listed; retail pharmacies pay about $1.92 per mL (NADAC). It is this product's only package size.

NDC 50474-0001-48
🏷️ FDA NDC (as labeled) 50474-001-48 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 50474-001-48 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
50474 labeler · 001 product · 48 package
Package marketed since
Oct 20, 2003
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
473 mL per package
Barcode (UPC)
0350474595404
Medicaid fills, this package
9,151 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 50474-001-48
Product NDC 50474-001
11-digit billing NDC 50474000148
NCPDP billing unit ML — per mL (volume)
RxCUI 261335, 261336, 284391, 311288, 311289, 311290, 387003, 403884,
UNII 44YRR34555
UPC 0350474595404
Application # NDA021505
SPL Set ID 3ca9df05-a506-4ec8-a4fe-320f1219ab21
Physiologic effect Decreased Central Nervous System Disorganized Electrical Activity
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2003-10-20
Route ORAL
Dosage form SOLUTION
Substance LEVETIRACETAM
TE code (Orange Book) AA · RLD · RS

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

GPI-14 72600043002020
GPI class Keppra
GCN Seq No 053031
GCN 20353
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 KEPPRA 100 MG/ML ORAL SOLN
FDB brand name Keppra
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 053031
  • GCN: 20353
  • GPI-14 (Medi-Span): 72600043002020
  • HICL (First Databank): 020952
  • AHFS class code: 28:12.92.00
  • RxCUI (RxNorm): 261335
Why two NDCs? The FDA registers this code as 50474-001-48 — 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 → 50474-0001-48. 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.

Clinical

Label name KEPPRA 100 MG/ML ORAL SOLN Ingredient Levetiracetam
📗 Our plain-language guide HelloPharmacist
  • It treats seizures in epilepsy. Depending on the product, that means partial-onset seizures, and as add-on therapy, myoclonic seizures in juvenile myoclonic epilepsy and primary ge...
  • Follow your prescriber and label. Tablets and solution are usually twice daily, while extended-release tablets are once daily and must be swallowed whole. Use a calibrated device f...
  • Sleepiness, tiredness, dizziness and headache are common, especially early on. Children may become irritable or aggressive. Avoid driving until you know how it affects you.
  • Call right away for new or worsening depression, suicidal thoughts, unusual behavior, a rash, swelling of the face or throat, or trouble walking. Get emergency help for trouble bre...
📖 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.

Pricing

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

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly $1.919 $907.64 / 473 ml
Medicaid paysCMS SDUD · 12 mo $1.85 $876.75 / 473 ml
Medicare drug plans payPart D · Q2 2026 $1.97 $929.49 / 473 ml
NADAC price history (per mL) — tap or hover for the price & month
Dec 2021 Dec 2025 Jun 2026 Sep 2026 $1.923 $1.549
▲ Up 24% over the last 10 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
50474-0001-48 You're viewing this Main listing 473 mL in 1 BOTTLE, PLASTIC 2003-10-20 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Levetiracetam 100 mg/mL 00121-0799-16 PAI 473 ml $0.030 AA Availability likely save 98%
Levetiracetam 100 mg/mL 00472-0235-16 Actavis 473 ml $0.030 AA Availability likely save 98%
levetiracetam 100 mg/mL 00904-7420-16 MAJOR 473 ml $0.030 AA Availability likely save 98%
Levetiracetam 100 mg/mL 16714-0358-01 NorthStar 473 ml $0.030 AA Availability likely save 98%
Levetiracetam 100 mg/mL 31722-0574-47 Camber 473 ml $0.030 AA Availability likely save 98%
LEVETIRACETAM solution 100 mg/mL 62135-0548-47 Chartwell 473 ml $0.030 AA Availability likely save 98%
Levetiracetam 100 mg/mL 69452-0412-88 Bionpharma 473 ml $0.030 AA Availability likely save 98%
levetiracetam 100 mg/mL 72205-0037-72 Novadoz 473 ml $0.030 AA Availability likely save 98%
Keppra 100 mg/mLthis 50474-0001-48 UCB, 473 ml $1.919 AA Availability likely —
Levetiracetam 1000 mg/10mL 00121-1598-20 PAI 10 cups — AA FDA listed —
Levetiracetam 1500 mg/15mL 00121-2397-40 PAI 10 cups — AA FDA listed —
Levetiracetam 500 mg/5mL 00121-4799-40 PAI 10 cups — AA FDA listed —
Levetiracetam 100 mg/mL 00904-7265-92 Major 10 cups — AA FDA listed —
Levetiracetam Levetiracetam 100 mg/mL 17856-0574-01 Atlantic 72 cups — AA FDA listed —
Levetiracetam 100 mg/mL 39328-0511-05 Patrin 5 ml — — FDA listed —
Levetiracetam 100 mg/mL 51672-4136-00 Sun 3785 ml — AA FDA listed —
Levetiracetam 100 mg/mL 53041-0660-06 Guardian 473 ml — AA FDA listed —
Levetiracetam 100 mg/mL 55154-4316-05 Cardinal 5 cups — AA FDA listed —
Levetiracetam 500 mg/5mL 55154-5782-05 Cardinal 5 cups — AA FDA listed —
Levetiracetam 100 mg/mL 60687-0249-67 American 10 cups — AA FDA listed —
Levetiracetam 100 mg/mL 63629-9615-01 Bryant 473 ml — — Discontinued —
Levetiracetam 100 mg/mL 63739-0158-32 McKesson 10 cups — AA Discontinued —
Levetiracetam 100 mg/mL 65162-0685-86 Amneal 118 ml — AA FDA listed —
Levetiracetam 100 mg/mL 65862-0250-05 Aurobindo 500 ml — AA FDA listed —
LEVETIRACETAM solution 100 mg/mL 68999-0548-24 Chartwell 10 cups — AA FDA listed —
Levetiracetam 100 mg/mL 69339-0157-17 Natco 40 cups — AA FDA listed —
Levetiracetam 100 mg/mL 70518-3803-00 REMEDYREPACK 10 cups — AA FDA listed —
Levetiracetam 100 mg/mL 70518-3804-00 REMEDYREPACK 10 cups — AA FDA listed —
Levetiracetam 100 mg/mL 70752-0203-02 QUAGEN 10 cups — AA FDA listed —
levetiracetam 100 mg/mL 72162-2639-02 Bryant 473 ml — AA FDA listed —
Levetiracetam 100 mg/mL 72162-2667-02 Bryant 473 ml — AA FDA listed —
Levetiracetam 100 mg/mL 81033-0013-50 Kesin 50 cups — AA FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
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

🏛️
2003
On the market since
Oct 2003
📍
2026
Currently FDA-listed
23 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

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

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color blue / yellow / orange / white
ShapeOval
Imprintucb;1000
Size19 mm
ScoringScored — splits in 2
FlavorGrape
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 23OV73Q5G9
    Acesulfame potassium is an artificial sweetener that tastes about 200 times sweeter than sugar. It's added to medicines to improve taste without adding calories or affecting blood sugar.
  • UNII 3VRD35U26C
    A natural extract from licorice root, ammonium glycyrrhizate is used as a flavoring agent and sweetener in medicines. It may also help soothe irritated tissues in the mouth or throat.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • 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 D65DG142WK
    Maltitol is a sugar alcohol made by hydrogenating maltose. It's used as a sweetener and filler in medicines to improve taste and add bulk to tablets and capsules.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII B22547B95K
    A salt derived from citric acid that helps maintain the proper acid-base balance in the medicine. It's used as a buffer to keep the product stable and at the right pH level.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

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.

Manufacturer & labeler

LabelerUCB, Inc.
Application holderUCB INC
FDA applicationNDA021505 (NDA)
Labeler code50474
First marketedOct 2003
Product typeHuman Prescription Drug
Portfolio45 products on file

More NDCs from UCB, Inc. labeler code 50474

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 154 words ▾

1 INDICATIONS AND USAGE KEPPRA is indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1 ) KEPPRA is 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 KEPPRA is indicated for the treatment of partial-onset seizures in patients 1 month of age and older.

1.2Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy KEPPRA is 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 KEPPRA is 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 Use the oral solution for pediatric patients with body weight ≤ 20 kg ( 2.1 ) For pediatric patients, use weight-based dosing for the oral solution with a calibrated measuring device (not a household teaspoon or tablespoon) ( 2.1 ) Partial-Onset Seizures (monotherapy or adjunctive therapy) 1 Month to < 6 Months: 7 mg/kg twice daily; increase by 7 mg/kg twice daily every 2 weeks to recommended dose of 21 mg/kg twice daily ( 2.2 ) 6 Months to < 4 Years: 10 mg/kg twice daily; increase by 10 mg/kg twice daily every 2 weeks to recommended dose of 25 mg/kg twice daily ( 2.2 ) 4 Years to < 16 Years: 10 mg/kg twice daily; increase by 10 mg/kg twice daily every 2 weeks to recommended dose of 30 mg/kg twice daily ( 2.2 ) Adults 16 Years and Older: 500 mg twice daily; increase by 500 mg twice daily every 2 weeks to a recommended dose of 1500 mg twice daily ( 2.2 ) Myoclonic Seizures in Adults and Pediatric Patients 12 Years and Older 500 mg twice daily; increase by 500 mg twice daily every 2 weeks to recommended dose of 1500 mg twice daily ( 2.3 ) Primary Generalized Tonic-Clonic Seizures 6 Years to < 16 Years: 10 mg/kg twice daily, increase in increments of 10 mg/kg twice daily every 2 weeks to recommended dose of 30 mg/kg twice daily ( 2.4 ) Adults 16 Years and Older: 500 mg twice daily, increase by 500 mg twice daily every 2 weeks to recommended dose of 1500 mg twice daily ( 2.4 ) Adult Patients with Impaired Renal Function Dose adjustment is recommended, based on the patient's estimated creatinine clearance ( 2.5 , 8.6 )

2.1Important Administration Instructions KEPPRA is given orally with or without food. The KEPPRA dosing regimen depends on the indication, age group, dosage form (tablets or oral solution), and renal function. Prescribe the oral solution for pediatric patients with body weight ≤ 20 kg.

Prescribe the oral solution or tablets for pediatric patients with body weight above 20 kg. When using the oral solution in pediatric patients, dosing is weight-based (mg per kg) using a calibrated measuring device (not a household teaspoon or tablespoon). KEPPRA tablets should be swallowed whole.

KEPPRA tablets should not be chewed or crushed.

2.2Dosing for Partial-Onset Seizures The recommended dosing for monotherapy and adjunctive therapy is the same; as outlined below. Adults 16 Years of Age and Older Initiate treatment with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg.

There is no evidence that doses greater than 3000 mg/day confer additional benefit. Pediatric Patients 1 Month to < 6 Months Initiate treatment with a daily dose of 14 mg/kg in 2 divided doses (7 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 14 mg/kg to the recommended daily dose of 42 mg/kg (21 mg/kg twice daily).

In the clinical trial, the mean daily dose was 35 mg/kg in this age group. 6 Months to < 4 Years: Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). Increase the daily dose in 2 weeks by an increment of 20 mg/kg to the recommended daily dose of 50 mg/kg (25 mg/kg twice daily).

If a patient cannot tolerate a daily dose of 50 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 47 mg/kg in this age group. 4 Years to < 16 Years Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily).

Increase the daily dose every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 44 mg/kg.

The maximum daily dose was 3000 mg/day. For KEPPRA tablet dosing in pediatric patients weighing 20 to 40 kg, initiate treatment with a daily dose of 500 mg given as twice daily dosing (25… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 94 words ▾

3 DOSAGE FORMS AND STRENGTHS 250 mg, 500 mg, 750 mg, and 1000 mg film-coated, scored tablets ( 3 ) 100 mg/mL solution ( 3 ) KEPPRA Tablets 250 mg: blue, oblong-shaped, scored, film-coated, and debossed with "ucb 250" on one side 500 mg: yellow, oblong-shaped, scored, film-coated, and debossed with "ucb 500" on one side 750 mg: orange, oblong-shaped, scored, film-coated, and debossed with "ucb 750" on one side 1000 mg: white, oblong-shaped, scored, film-coated, and debossed with "ucb 1000" on one side KEPPRA Oral Solution 100 mg/mL: a clear, colorless, grape-flavored liquid

⛔ Contraindications 40 words ▾

4 CONTRAINDICATIONS KEPPRA is 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 ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Behavioral abnormalities including psychotic symptoms, suicidal ideation, irritability, and aggressive behavior have been observed; monitor patients for psychiatric signs and symptoms ( 5.1 ) Suicidal Behavior and Ideation: Monitor patients for new or worsening depression, suicidal thoughts/behavior, and/or unusual 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 sufficient experience on KEPPRA ( 5.3 ) Serious Dermatological Reactions: Discontinue KEPPRA at the first sign of rash unless clearly not drug related ( 5.5 ) Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/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 KEPPRA ( 5.7 ) Withdrawal Seizures: KEPPRA must be gradually withdrawn ( 5.8 )

5.1Behavioral Abnormalities and Psychotic Symptoms KEPPRA may cause behavioral abnormalities and psychotic symptoms. Patients treated with KEPPRA should be monitored for psychiatric signs and symptoms. Behavioral abnormalities In clinical studies, 13% of adult KEPPRA-treated patients and 38% of pediatric KEPPRA-treated patients (4 to 16 years of age) compared to 6% and 19% of adult and pediatric placebo-treated patients, 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 KEPPRA as adjunctive therapy in pediatric patients (4 to 16 years of age). The results from an exploratory analysis indicated a worsening in KEPPRA-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 KEPPRA-treated patients compared to 0% of placebo-treated patients.

In clinical studies, 1.7% of adult KEPPRA-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 KEPPRA-treated patients and in 0.5% of placebo-treated patients. Overall, 11% of KEPPRA-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 KEPPRA-treated adult patients, 2% of KEPPRA-treated pediatric patients 4 to 16 years of age, and 17% of KEPPRA-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 a controlled study that assessed the neurocognitive and behavioral effects of KEPPRA in pediatric patients 4 to 16 years of age, 1.6% of KEPPRA-treated patients experienced paranoia, compared to 0% of placebo-treated patients.

In the same study, 3.1% of KEPPRA-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%) KEPPRA-treated adult patients were hospitalized and their treatment was discontinued due to psychosis. Both events, reported as psychosis, developed within the first week of treatment and resolved within 1 to 2 weeks following treatment discontinuation.

There was no difference between drug and placebo-treated patients in the incidence of the pediatric patients who discontinued treatment due to psychotic and non-psychotic… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in more details in other sections of labeling: Behavior 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: Adult patients: somnolence, asthenia, infection and dizziness ( 6.1 ) Pediatric patients: fatigue, aggression, nasal congestion, decreased appetite, and irritability ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact UCB, Inc. at 1-844-599-2273 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 KEPPRA 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 KEPPRA. Table 3 lists adverse reactions that occurred in at least 1% of adult epilepsy patients receiving KEPPRA in placebo-controlled studies and were numerically more common than in patients treated with placebo. In these studies, either KEPPRA or placebo was added to concurrent AED therapy.

Table 3: Adverse Reactions in Pooled Placebo-Controlled, Adjunctive Studies in Adults Experiencing Partial-Onset Seizures KEPPRA (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 KEPPRA and 12% receiving placebo either discontinued or had a dose reduction as a result of an adverse reaction.

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

The most common adverse reactions in pediatric patients receiving KEPPRA in combination with other AEDs, for events with rates greater than placebo, were fatigue, aggression, nasal congestion, decreased appetite, and irritability. Table 5 lists adverse reactions from the pooled pediatric controlled studies (4 to 16 years of age) that occurred in at least 2% of pediatric KEPPRA-treated patients and were numerically more comm… [Excerpted — this section continues on DailyMed.]

👥 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 KEPPRA, during pregnancy. Encourage women who are taking KEPPRA 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 KEPPRA 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).

8.2Lactatio… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), including KEPPRA, during pregnancy. Encourage women who are taking KEPPRA 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 KEPPRA 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 The safety and effectiveness of KEPPRA for the treatment of partial-onset seizures in patients 1 month to 16 years of age have been established [see Clinical Pharmacology (12.3) and Clinical Studies (14.1) ] . The dosing recommendation in these pediatric patients varies according to age group and is weight-based [see Dosage and Administration (2.2) ] . The safety and effectiveness of KEPPRA as adjunctive therapy for the treatment of myoclonic seizures in adolescents 12 years of age and older with juvenile myoclonic epilepsy have been established [see Clinical Studies (14.2) ] .

The safety and effectiveness of KEPPRA as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in pediatric patients 6 years of age and older with idiopathic generalized epilepsy have been established [see Clinical Studies (14.3) ] . Safety and effectiveness for the treatment of partial-onset seizures in pediatric patients below the age of 1 month; adjunctive therapy for the treatment of myoclonic seizures in pediatric patients below the age of 12 years; and adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in pediatric patients below the age of 6 years have not been established.

A 3-month, randomized, double-blind, placebo-controlled study was performed to assess the neurocognitive and behavioral effects of KEPPRA as adjunctive therapy in 98 (KEPPRA N=64, placebo N=34) pediatric patients, ages 4 to 16 years old, 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 KEPPRA-treated patients in aggressive behavior, one of the eight syndrome scores [see Warnings and Precautions (5.1) ] .

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 113 words ▾

8.5Geriatric Use There were 347 subjects in clinical studies of KEPPRA 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 KEPPRA 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 impaired renal function. 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 195 words ▾

10 OVERDOSAGE

10.1Signs, Symptoms and Laboratory Findings of Acute Overdosage in Humans The highest known dose of KEPPRA 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 KEPPRA overdoses in postmarketing use.

10.2Management of Overdose There is no specific antidote for overdose with KEPPRA. 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 KEPPRA.

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 KEPPRA on QTc prolongation was evaluated in a randomized, double-blind, positive-controlled (moxifloxacin 400 mg) and placebo-controlled crossover study of KEPPRA (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 Absorption of levetiracetam is rapid, with peak plasma concentrations occurring in about an hour following oral administration in fasted subjects. 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 with renal impairment [see Use in Specific Populations (8.6) and Dosage and Administration (2.5) ] . Specific Populations Elderly Pharmacokinetics of levetiracetam were evaluated in 16 elderly subjects (age 61-88 years) with creatinine clearance ranging from 30 to 74 mL/min. Following oral administration of twice-daily dosing for 10 days, total body clearance decreased by 38% and the half-life was 2.5 hours longer in the elderly comp… [Excerpted — this section continues on DailyMed.]

🧬 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 156 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied KEPPRA Tablets 250 mg: blue, oblong-shaped, scored, film-coated tablets debossed with "ucb 250" on one side. They are supplied in white HDPE bottles containing 120 tablets (NDC 50474-594-40). 500 mg: yellow, oblong-shaped, scored, film-coated tablets debossed with "ucb 500" on one side.

They are supplied in white HDPE bottles containing 120 tablets (NDC 50474-595-40). 750 mg: orange, oblong-shaped, scored, film-coated tablets debossed with "ucb 750" on one side. They are supplied in white HDPE bottles containing 120 tablets (NDC 50474-596-40).

1000 mg: white, oblong-shaped, scored, film-coated tablets debossed with "ucb 1000" on one side. They are supplied in white HDPE bottles containing 60 tablets (NDC 50474-597-66). KEPPRA Oral Solution 100 mg/mL: a clear, colorless, grape-flavored liquid.

It is supplied in 16 fl. oz. white HDPE bottles (NDC 50474-001-48).

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].

📦 Storage and Handling 20 words ▾

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 KEPPRA is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets and as a clear, colorless, grape-flavored liquid (100 mg/mL) for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs).

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.) KEPPRA tablets contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, polyethylene glycol 3350, polyethylene glycol 6000, polyvinyl alcohol, talc, titanium dioxide, and additional agents listed below: 250 mg tablets: FD&C Blue #2/indigo carmine aluminum lake 500 mg tablets: iron oxide yellow 750 mg tablets: FD&C yellow #6/sunset yellow FCF aluminum lake, iron oxide red KEPPRA oral solution contains 100 mg of levetiracetam per mL.

Inactive ingredients: ammonium glycyrrhizinate, citric acid monohydrate, glycerin, maltitol solution, methylparaben, potassium acesulfame, propylparaben, purified water, sodium citrate dihydrate and natural and artificial flavor. Chemical Structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). The Medication Guide accompanies the product and can also be accessed on www.keppra.com or by calling 1-844-599-2273. Psychiatric Reactions and Changes in Behavior Advise patients that KEPPRA 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 KEPPRA, 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 KEPPRA may cause dizziness and somnolence. Inform patients not to drive or operate machinery until they have gained sufficient experience on KEPPRA 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 KEPPRA 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 KEPPRA 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.

KEPPRA should be discontinued immediately if a serious hypersensitivity reaction is suspected [see Warnings and Precautions (5.6) ]. Withdrawal of KEPPRA Advise patients and caregivers not to discontinue use of KEPPRA without consulting with their healthcare provider. KEPPRA 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 KEPPRA 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) ] .

💬 Medication Guide ~3 min read ▾

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 3/2024 MEDICATION GUIDE KEPPRA ® (KEPP-ruh ) (levetiracetam) tablets, for oral use, and oral solution Read this Medication Guide before you start taking KEPPRA and each time you get a refill.

There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. What is the most important information I should know about KEPPRA?

Like other antiepileptic drugs, KEPPRA 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 attempts to commit suicide new or worse depression new or worse anxiety feeling agitated or restless panic attacks trouble sleeping (insomnia) new or worse irritability acting aggressive, being angry, or violent acting on dangerous impulses an extreme increase in activity and talking (mania) other unusual changes in behavior or mood Do not stop KEPPRA without first talking to a healthcare provider .

Stopping KEPPRA 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 KEPPRA? KEPPRA is a prescription medicine taken by mouth that is used to treat partial-onset seizures in people 1 month of age and older.

KEPPRA is 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 KEPPRA is safe or effective in children under: 1 month 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 Before taking your medicine, make sure you have received the correct medicine.

Compare the name above with the name on your bottle and the appearance of your medicine with the description of KEPPRA provided below. Tell your pharmacist immediately if you think you have been given the wrong medicine. Who should not take KEPPRA?

Do not take KEPPRA if you are allergic to levetiracetam. What should I tell my healthcare provider before starting KEPPRA? Before taking KEPPRA, 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 KEPPRA will harm your unborn baby. You and your healthcare provider will have to decide if you should take KEPPRA while you are pregnant. If you become pregnant while taking KEPPRA, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry.

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

It is not known if the KEPPRA that passes into your breast milk can harm your baby. Talk to your doctor about the best way to fe… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~3 min read ▾

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 Absorption of levetiracetam is rapid, with peak plasma concentrations occurring in about an hour following oral administration in fasted subjects. 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 with renal impairment [see Use in Specific Populations (8.6) and Dosage and Administration (2.5) ] . Specific Populations Elderly Pharmacokinetics of levetiracetam were evaluated in 16 elderly subjects (age 61-88 years) with creatinine clearance ranging from 30 to 74 mL/min. Following oral administration of twice-daily dosing for 10 days, total body clearance decreased by 38% and the half-life was 2.5 hours longer in the elderly compared to healthy adults.

This is most likely due to the decrease in renal function in these subjects. Pediatric Patients Pharmacokinetics of levetiracetam were evaluated in 24 pediatric patients (age 6-12 years) after single dose (20 mg/kg). The body weight adjusted apparent clearance of levetiracetam was approximately 40% higher than in adults.

A repeat dose pharmacokinetic study was conducted in pediatric patients (age 4-12 years) at doses of 20 mg/kg/day, 40 mg/kg/day, and 60 mg/kg/day. The evaluation of the pharmacokinetic profile of levetiracetam and its metabolite (ucb L057) in 14 pediatric patients demonstrated rapid absorption of levetiracetam at all doses with a T max of about 1 hour and a t 1/2 of 5 hours across the three dosing levels. The pharmacokinetics of levetiracetam in children was linear between 20 to 60 mg/kg/day.

The potential interaction of levetiracetam with other AEDs was also evaluated in these patients. Levetiracetam had no significant effect on the plasma concentrations of carbamazepine, valproic acid, topiramate or lamotrigine. However, there was about a 22% increase of apparent clearance of levetiracetam when it was co-administered with an enzyme-inducing AED (e.g. carbamazepine).

Following single dose administration (20 mg/kg) of a 10% oral solution… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 68 words ▾

12.2Pharmacodynamics Effects on QTc Interval The effect of KEPPRA on QTc prolongation was evaluated in a randomized, double-blind, positive-controlled (moxifloxacin 400 mg) and placebo-controlled crossover study of KEPPRA (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.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Partial-Onset Seizures Effectiveness in Partial-Onset Seizures in Adults The effectiveness of KEPPRA for the treatment of partial-onset seizures in adults was established in three multicenter, randomized, double-blind, placebo-controlled clinical studies in patients who had refractory partial-onset seizures with or without secondary generalization. The tablet formulation was used in all these studies. In these studies, 904 patients were randomized to placebo, 1000 mg, 2000 mg, or 3000 mg/day.

Patients enrolled in Study 1 or Study 2 had refractory partial-onset seizures for at least two years and had taken two or more classical AEDs. Patients enrolled in Study 3 had refractory partial-onset seizures for at least 1 year and had taken one classical AED. At the time of the study, patients were taking a stable dose regimen of at least one and could take a maximum of two AEDs.

During the baseline period, patients had to have experienced at least two partial- onset seizures during each 4-week period. Study 1 Study 1 was a double-blind, placebo-controlled, parallel-group study conducted at 41 sites in the United States comparing KEPPRA 1000 mg/day (N=97), KEPPRA 3000 mg/day (N=101), and placebo (N=95) given in equally divided doses twice daily. After a prospective baseline period of 12 weeks, patients were randomized to one of the three treatment groups described above.

The 18-week treatment period consisted of a 6-week titration period, followed by a 12-week fixed dose evaluation period, during which concomitant AED regimens were held constant. The primary measure of effectiveness was a between group comparison of the percent reduction in weekly partial seizure frequency relative to placebo over the entire randomized treatment period (titration + evaluation period). Secondary outcome variables included the responder rate (incidence of patients with ≥50% reduction from baseline in partial-onset seizure frequency).

The results of the analysis of Study 1 are displayed in Table 10. Table 10: Reduction in Mean Over Placebo in Weekly Frequency of Partial-Onset Seizures in Study 1 Placebo (N=95) KEPPRA 1000 mg/day (N=97) KEPPRA 3000 mg/day (N=101) Percent reduction in partial seizure frequency over placebo – 26.1% statistically significant versus placebo 30.1% The percentage of patients (y-axis) who achieved ≥50% reduction in weekly seizure rates from baseline in partial-onset seizure frequency over the entire randomized treatment period (titration + evaluation period) within the three treatment groups (x-axis) is presented in Figure 1.

Figure 1: Responder Rate (≥50% Reduction from Baseline) in Study 1 *statistically significant versus placebo Figure 1 Study 2 Study 2 was a double-blind, placebo-controlled, crossover study conducted at 62 centers in Europe comparing KEPPRA 1000 mg/day (N=106), KEPPRA 2000 mg/day (N=105), and placebo (N=111) given in equally divided doses twice daily. The first period of the study (Period A) was designed to be analyzed as a parallel-group study. After a prospective baseline period of up to 12 weeks, patients were randomized to one of the three treatment groups described above.

The 16-week treatment period consisted of the 4-week titration period followed by a 12-week fixed dose evaluation period, during which concomitant AED regimens were held constant. The primary measure of effectiveness was a between group comparison of the percent reduction in weekly partial seizure frequency relative to placebo over the entire randomized treatment period (titration + evaluation period). Secondary outcome variables included the responder rate (incidence of patients with ≥50% reduction from baseline in partial-onset seizure frequency).

The results of the analysis of Period A are displayed in Table 11. Table 11: Reduction in Mean Over Placebo in Weekly Frequency of Partial-Onset Seizures in Study 2: Period A Placebo (N=111) KEPPRA 1000 mg/day (N=106) KEPPRA 2000 mg/day (N=105) Percent reduction in… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 205 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Rats were dosed with levetiracetam in the diet for 104 weeks at doses of 50, 300, and 1800 mg/kg/day. Plasma exposure (AUC) at the highest dose was approximately 6 times that in humans at the maximum recommended daily human dose (MRHD) of 3000 mg. There was no evidence of carcinogenicity.

In mice, oral administration of levetiracetam for 80 weeks (doses up to 960 mg/kg/day) or 2 years (doses up to 4000 mg/kg/day, lowered to 3000 mg/kg/day after 45 weeks due to intolerability) was not associated with an increase in tumors. The highest dose tested in mice for 2 years (3000 mg/kg/day) is approximately 5 times the MRHD on a body surface area (mg/m 2 ) basis. Mutagenesis Levetiracetam was negative in in vitro (Ames, chromosomal aberration in mammalian cells) and in vivo (mouse micronucleus) assays.

The major human metabolite of levetiracetam (ucb L057) was negative in in vitro (Ames, mouse lymphoma) assays. Impairment of Fertility No adverse effects on male or female fertility or reproductive performance were observed in rats at oral doses up to 1800 mg/kg/day, which were associated with plasma exposures (AUC) up to approximately 6 times that in humans at the MRHD.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 202 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Rats were dosed with levetiracetam in the diet for 104 weeks at doses of 50, 300, and 1800 mg/kg/day. Plasma exposure (AUC) at the highest dose was approximately 6 times that in humans at the maximum recommended daily human dose (MRHD) of 3000 mg. There was no evidence of carcinogenicity.

In mice, oral administration of levetiracetam for 80 weeks (doses up to 960 mg/kg/day) or 2 years (doses up to 4000 mg/kg/day, lowered to 3000 mg/kg/day after 45 weeks due to intolerability) was not associated with an increase in tumors. The highest dose tested in mice for 2 years (3000 mg/kg/day) is approximately 5 times the MRHD on a body surface area (mg/m 2 ) basis. Mutagenesis Levetiracetam was negative in in vitro (Ames, chromosomal aberration in mammalian cells) and in vivo (mouse micronucleus) assays.

The major human metabolite of levetiracetam (ucb L057) was negative in in vitro (Ames, mouse lymphoma) assays. Impairment of Fertility No adverse effects on male or female fertility or reproductive performance were observed in rats at oral doses up to 1800 mg/kg/day, which were associated with plasma exposures (AUC) up to approximately 6 times that in humans at the MRHD.

📄 Recent Major Changes 7 words ▾

Warnings and Precautions ( 5.6 ) 3/2024

📄 Package Label / Principal Display Panel 187 words ▾

PRINCIPAL DISPLAY PANEL - 250 mg Tablet Bottle Label NDC 50474-594-40 120 tablets Keppra ® (levetiracetam) 250 mg tablets Dispense accompanying Medication Guide to each patient. Rx only PRINCIPAL DISPLAY PANEL - 250 mg Tablet Bottle Label

PRINCIPAL DISPLAY PANEL - 500 mg Tablet Bottle Label NDC 50474-595-40 120 tablets Keppra ® (levetiracetam) 500 mg tablets Dispense accompanying Medication Guide to each patient. Rx only PRINCIPAL DISPLAY PANEL - 500 mg Tablet Bottle Label

PRINCIPAL DISPLAY PANEL - 750 mg Tablet Bottle Label NDC 50474-596-40 120 tablets Keppra ® (levetiracetam) 750 mg tablets Dispense accompanying Medication Guide to each patient. Rx only PRINCIPAL DISPLAY PANEL - 750 mg Tablet Bottle Label

PRINCIPAL DISPLAY PANEL - 1000 mg Tablet Bottle Label NDC 50474-597-66 60 tablets Keppra ® (levetiracetam) 1000 mg tablets Dispense accompanying Medication Guide to each patient. Rx only PRINCIPAL DISPLAY PANEL - 1000 mg Tablet Bottle Label

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label NDC 50474-001-48 Keppra ® (levetiracetam) 100 mg/mL oral solution Dispense accompanying Medication Guide to each patient. Rx only 16 fl oz (473 mL) PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
9.2K
Units reimbursed last 4 qtrs
6.3M
Gross reimbursed last 4 qtrs
$11.71M
Avg / prescription
$1,279.33
Avg / unit
$1.8536
Latest quarter Q1 2026
2.1KRx
Medicaid pays / mL
$1.8536
gross reimbursed
vs
NADAC / mL
$1.9189
acquisition cost
=
Spread
−$0.0653
-3% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
39% FFS 61% MCO
Fee-for-service · 3,610 Rx Managed care · 5,541 Rx
State Medicaid map
Alaska: no data reported AK Maine: 76,008 units · 5,449 per 100k residents ME Washington: 64,911 units · 831 per 100k residents WA Idaho: 7,600 units · 387 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 15,399 units · 268 per 100k residents MN Wisconsin: 149,082 units · 2,523 per 100k residents WI Michigan: 89,360 units · 890 per 100k residents MI New York: 553,277 units · 2,827 per 100k residents NY Vermont: no data reported VT New Hampshire: 47,168 units · 3,364 per 100k residents NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 51,019 units · 1,591 per 100k residents IA Illinois: 36,198 units · 288 per 100k residents IL Indiana: 82,149 units · 1,197 per 100k residents IN Ohio: 159,847 units · 1,356 per 100k residents OH Pennsylvania: 462,072 units · 3,565 per 100k residents PA New Jersey: 287,589 units · 3,096 per 100k residents NJ Massachusetts: 159,958 units · 2,285 per 100k residents MA California: 364,997 units · 937 per 100k residents CA Utah: no data reported UT Colorado: 119,228 units · 2,028 per 100k residents CO Nebraska: no data reported NE Missouri: 44,461 units · 718 per 100k residents MO Kentucky: 10,892 units · 241 per 100k residents KY West Virginia: 13,891 units · 785 per 100k residents WV Virginia: 143,565 units · 1,647 per 100k residents VA Maryland: 63,502 units · 1,028 per 100k residents MD Connecticut: 130,939 units · 3,620 per 100k residents CT Rhode Island: no data reported RI Arizona: 142,365 units · 1,916 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: 26,466 units · 863 per 100k residents AR Tennessee: 102,107 units · 1,433 per 100k residents TN North Carolina: 887,006 units · 8,186 per 100k residents NC South Carolina: 88,176 units · 1,641 per 100k residents SC Delaware: 155,695 units · 15,101 per 100k residents DE Oklahoma: no data reported OK Louisiana: 68,819 units · 1,505 per 100k residents LA Mississippi: no data reported MS Alabama: 4,020 units · 78.7 per 100k residents AL Georgia: 151,525 units · 1,374 per 100k residents GA D.C.: no data reported DC Hawaii: 32,260 units · 2,248 per 100k residents HI Texas: 857,456 units · 2,811 per 100k residents TX Florida: 500,470 units · 2,213 per 100k residents FL
Units reimbursed · per 100k residents
78.715,101
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Delaware 15,101 /100k
2 North Carolina 8,186 /100k
3 Maine 5,449 /100k
4 Connecticut 3,620 /100k
5 Pennsylvania 3,565 /100k
6 New Hampshire 3,364 /100k
7 New Jersey 3,096 /100k
8 New York 2,827 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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

Medicare Part D (outpatient prescription) spending for Keppra — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Keppra. 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
$15.35M
Claims incl. refills
8.5K
Beneficiaries
4K
Spend / beneficiary
$3,881.47
Spend / claim
$1,797.36
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.
← 50473-0936-00 · MSD 50474-0002-63 · UCB, →
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.