Quick answers
- What is Levetiracetam used for?
- The FDA-approved label (Keppra, UCB, Inc., January 28, 2026) says: “KEPPRA is indicated for the treatment of partial-onset seizures in patients 1 month of age and older KEPPRA is indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy 1.1 Partial-Onset Seizures KEPPRA is indicated …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Levetiracetam have a boxed warning?
- No. None of the 159 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Levetiracetam?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Levetiracetam been recalled?
- FDA enforcement reports list 10 recalls of products of this medicine; the newest started March 13, 2025 (Class I). A recall usually concerns specific lots, not every product.
- Who makes Levetiracetam?
- 86 companies list prescription products of Levetiracetam in the FDA NDC Directory, including Bryant Ranch Prepack, A-S Medication Solutions and Remedyrepack Inc..
What Levetiracetam is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
KEPPRA is indicated for the treatment of partial-onset seizures in patients 1 month of age and older KEPPRA is indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy 1.1 Partial-Onset Seizures KEPPRA is indicated …
— FDA label: Keppra, UCB, Inc., effective January 28, 2026. Read the full label on DailyMed →
The FDA has 159 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 159 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Injection · Tablet · Solution · Tablet, film coated, extended release · Injection, solution · Tablet, extended release · Injection, solution, concentrate · Tablet, for suspension |
|---|---|
| Route | Oral · Intravenous |
| Prescription products | 301 in the FDA NDC Directory |
| Brand names | Keppra, Spritam, Keppra XR, Elepsia XR 1000 Mg, Roweepra, Elepsia XR 1500 Mg |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| levetiracetam 100 mg/mL solution | Generic | $0.0299 per mL |
| levetiracetam 100 mg/mL solution | Brand: Keppra | $1.92 per mL |
| levetiracetam 1000 mg tablet | Generic | $0.1645 per tablet |
| levetiracetam 1000 mg tablet, film coated | Generic | $0.1645 per tablet |
| levetiracetam 1000 mg tablet, film coated | Brand: Keppra | $19.87 per tablet |
| levetiracetam 1000 mg tablet, for suspension | Brand: Spritam | $10.20 per tablet |
| levetiracetam 250 mg tablet | Generic | $0.0568 per tablet |
| levetiracetam 250 mg tablet, film coated | Generic | $0.0568 per tablet |
| levetiracetam 250 mg tablet, film coated | Brand: Keppra | $8.08 per tablet |
| levetiracetam 250 mg tablet, for suspension | Brand: Spritam | $10.27 per tablet |
| levetiracetam 500 mg tablet | Generic | $0.0722 per tablet |
| levetiracetam 500 mg tablet, extended release | Generic | $0.1773 per tablet |
| levetiracetam 500 mg tablet, film coated | Generic | $0.0722 per tablet |
| levetiracetam 500 mg tablet, film coated | Brand: Keppra | $9.92 per tablet |
| levetiracetam 500 mg tablet, film coated, extended release | Generic | $0.1773 per tablet |
| levetiracetam 500 mg tablet, film coated, extended release | Brand: Keppra XR | $9.02 per tablet |
| levetiracetam 500 mg tablet, for suspension | Brand: Spritam | $10.24 per tablet |
| levetiracetam 750 mg tablet | Generic | $0.1107 per tablet |
| levetiracetam 750 mg tablet, extended release | Generic | $0.2367 per tablet |
| levetiracetam 750 mg tablet, film coated | Generic | $0.1107 per tablet |
| levetiracetam 750 mg tablet, film coated | Brand: Keppra | $13.45 per tablet |
| levetiracetam 750 mg tablet, film coated, extended release | Generic | $0.2367 per tablet |
| levetiracetam 750 mg tablet, film coated, extended release | Brand: Keppra XR | $13.48 per tablet |
NADAC list of November 4, 2026; these prices took effect between December 17, 2025 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack14 products
- A-S Medication Solutions14 products
- Remedyrepack Inc.13 products
- Solco Healthcare US, LLC9 products
- UCB, Inc.8 products
- Coupler LLC7 products
- Novadoz Pharmaceuticals LLC6 products
- ScieGen Pharmaceuticals, Inc.6 products
- BluePoint Laboratories6 products
- Torrent Pharmaceuticals Limited6 products
- Dr. Reddy's Laboratories Inc.6 products
- Cardinal Health 107, LLC6 products
- Lupin Pharmaceuticals, Inc.6 products
- American Health Packaging5 products
- Major Pharmaceuticals5 products
- WG Critical Care, LLC5 products
- Amneal Pharmaceuticals LLC5 products
- Camber Pharmaceuticals, Inc.5 products
- Fresenius Kabi USA, LLC5 products
- Aurobindo Pharma Limited5 products
- Hikma Pharmaceuticals USA Inc.5 products
- Direct_Rx4 products
- XLCare Pharmaceuticals, Inc.4 products
- NCS HealthCare of KY, LLC dba Vangard Labs4 products
- Asclemed USA, Inc.4 products
- SOHM, Inc.4 products
- Dr. Reddy's Laboratories Limited4 products
- Baxter Healthcare Corporation4 products
- Rising Pharma Holdings, Inc.4 products
- Quallent Pharmaceuticals Health LLC4 products
- Cranbury Pharmaceuticals, LLC4 products
- PAI Holdings, LLC dba PAI Pharma4 products
- Mylan Institutional LLC4 products
- OWP Pharmaceuticals, Inc.4 products
- Granules Pharmaceuticals Inc.4 products
- Proficient Rx LP4 products
- NorthStar RxLLC4 products
- Eugia US LLC4 products
- Prinston Pharmaceutical Inc.4 products
- Aprecia Pharmaceuticals, LLC4 products
- Ascend Laboratories, LLC4 products
- Caplin Steriles Limited3 products
- Preferred Pharmaceuticals Inc.3 products
- B. Braun Medical Inc.3 products
- Hp Halden Pharma AS3 products
- Somerset Therapeutics, LLC3 products
- PD-Rx Pharmaceuticals, Inc.3 products
- Sagent Pharmaceuticals3 products
- Apotex Corp.3 products
- Gland Pharma Limited3 products
- Mylan Pharmaceuticals Inc.3 products
- Nexus Pharmaceuticals LLC3 products
- Exelan Pharmaceuticals Inc.3 products
- Tripoint Therapeutics, LLC2 products
- Advanced Rx of Tennessee, LLC2 products
- Prasco Laboratories2 products
- Solco Healthcare U.S., LLC2 products
- Hospira, Inc.2 products
- Westminster Pharmaceuticals, LLC2 products
- Omnivium Pharmaceuticals LLC.2 products
- Golden State Medical Supply, Inc.2 products
- XGen Pharmaceuticals DJB, Inc.1 product
- Guardian Drug Company1 product
- TAGI Pharma, Inc.1 product
- Aryeh Pharma Corp1 product
- Atlantic Biologicals Corp.1 product
- Micro Labs Limited1 product
- Sun Pharmaceutical Industries, Inc.1 product
- Chartwell Governmental & Specialty RX, LLC.1 product
- Natco Pharma USA LLC1 product
- Mylan Institutional Inc.1 product
- Chartwell RX, LLC1 product
- Quagen Pharmaceuticals LLC1 product
- Injecta Medcial LLC1 product
- Precision Dose, Inc.1 product
- Bionpharma Inc.1 product
- NorthStar Rx LLC1 product
- Actavis Pharma, Inc.1 product
- Armas Pharmaceuticals Inc.1 product
- Civica, Inc.1 product
- Kesin Pharma Corporation1 product
- Unit Dose Solutions, Inc.1 product
- Safecor Health LLC1 product
- Method Pharmaceuticals, LLC1 product
- Patrin Pharma, Inc.1 product
- Northwind Health Company, LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021035 KEPPRA | Ucb Inc | November 30, 1999 | 54, latest March 12, 2024 2024: Labeling · 2023: Labeling · 2023: Labeling |
| NDA021505 KEPPRA | Ucb Inc | July 15, 2003 | 28, latest March 12, 2024 2024: Labeling · 2023: Labeling · 2023: Labeling |
| NDA021872 KEPPRA | Ucb Inc | July 31, 2006 | 18, latest March 12, 2024 2024: Labeling · 2023: Labeling · 2020: Labeling |
| NDA022285 KEPPRA XR | Ucb Inc | September 12, 2008 | 20, latest March 12, 2024 2024: Labeling · 2023: Labeling · 2020: Labeling |
| NDA202543 LEVETIRACETAM IN SODIUM CHLORIDE | Hq Spclt Pharma | November 9, 2011 | 12, latest March 12, 2024 2024: Labeling · 2021: Labeling · 2019: Labeling |
| NDA204417 ELEPSIA XR | Tripoint | December 20, 2018 | 2, latest March 12, 2024 2024: Labeling · 2020: Labeling |
| NDA207958 SPRITAM | Aprecia Pharms | July 31, 2015 | 9, latest June 27, 2025 2025: Efficacy · 2024: Labeling · 2024: Labeling |
Generic approvals (56)
- ANDA076919Mylan · November 4, 2008
- ANDA076920Pharmazone · January 15, 2009
- ANDA078154Lupin · January 15, 2009
- ANDA078234Invagen Pharms · January 15, 2009
- ANDA078582Strides Pharma · January 15, 2009
- ANDA078858Torrent Pharms · January 15, 2009
- ANDA078904Pharmazone · January 15, 2009
- ANDA078976Actavis Mid Atlantic · January 15, 2009
- ANDA078993Aurobindo Pharma · January 15, 2009
- ANDA079042Ingenus Pharms LLC · January 15, 2009
- ANDA079063Aurobindo Pharma · January 15, 2009
- ANDA090025Lupin · January 15, 2009
- ANDA079120Bionpharma · January 16, 2009
- ANDA078106Prinston Inc · February 10, 2009
- ANDA078774Taro · February 10, 2009
- ANDA090263Chartwell Molecular · April 3, 2009
- ANDA090992Amneal Pharms · October 27, 2009
- ANDA090261Mylan · December 8, 2009
- ANDA090767Rising · July 28, 2010
- ANDA090515Hetero Labs Ltd III · October 8, 2010
- ANDA091491Zhejiang Jingxin · December 14, 2010
- ANDA091485Xgen Pharms · August 5, 2011
- ANDA091261Apotex Inc · September 12, 2011
- ANDA091399Lupin Ltd · September 12, 2011
- ANDA090981Hikma Farmaceutica · October 13, 2011
- ANDA202869Hospira Inc · April 6, 2012
- ANDA090079Quagen · April 11, 2012
- ANDA091338Torrent Pharms Ltd · May 29, 2012
- ANDA203052Hetero Labs Ltd III · February 28, 2013
- ANDA202958Apotex · February 25, 2015
- ANDA203468Prinston Inc · May 21, 2015
- ANDA201157Pharm Assoc · June 4, 2015
- ANDA090876Fresenius Kabi USA · August 13, 2015
- ANDA204312Eugia Pharma · February 1, 2016
- ANDA203308Mylan Labs Ltd · September 16, 2016
- ANDA207160Eugia Pharma · January 4, 2017
- ANDA206880Gland · October 25, 2017
- ANDA209781Hainan Poly Pharm · March 20, 2018
- ANDA211954Micro Labs · August 9, 2019
- ANDA212688Yabao Pharm · June 11, 2020
Showing the 40 earliest of 56.
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
March 13, 2025 · Class I · Ongoing · D-0365-2025
LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL.
Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL), 1 x 100mL, Rx Only, Manufactured by: Gland Pharma Limited, Hyderabad, - 500 043 INDIA, Distributor: Dr. Reddy's Laboratories Inc., Princeton, N — Dr. Reddy's Laboratories, Inc.
-
March 18, 2020 · Class II · Terminated · D-1233-2020
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Levetiracetam Tablets USP 750 mg 120-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, NDC 65862-247-08 — Aurobindo Pharma USA Inc.
-
October 11, 2019 · Class III · Terminated · D-0519-2020
Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached.
Levetiracetam Injection, 500 mg/5mL, 10 single-use 5 mL vials, Rx only, Manufactured by: Agile Specialties Private Limited Pilot No. 14, Sipcot II, Hosur-635 109 Tamil Nadu, India, Manufactured for: X-Gen Pharmaceuticals — X-Gen Pharmaceuticals Inc.
-
July 18, 2019 · Class II · Terminated · D-1838-2019
Failed Dissolution Specifications.
Keppra (levetiracetam) 1000 mg tablets, 60 tablets per bottle, Rx only, Manufactured for UCB, Inc. Smyrna, GA 30080, NDC 50474-597-66. — Ucb, Inc
-
October 26, 2018 · Class I · Terminated · D-0485-2019
Labeling: Label Error on Declared Strength; the pre-printed text on the primary infusion bag and the NDC incorrectly identifies the product as Levetiracetam in 0.75% Sodium Chloride (1000 mg/100 mL) however, the external foil pouch correctly identifies the product as Levetiracetam in 0.54% Sodium Chloride Injection (1,
Levetiracetam in 0.54 % Sodium Chloride Injection 1,500/mg/100mL (15mg/mL), For intravenous Infusion Only, 1 x 100 mL Infusion bag, Manufactured by: Gland Pharma Limited Hyderabad - 500 043, India Distributor: Dr. Reddy' — Dr. Reddy's Laboratories, Inc.
-
March 27, 2018 · Class II · Terminated · D-0706-2018
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Levetiracetam in 0.75% Sodium Chloride Injection, 1000 mg per 100 mL (10 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-247-47. — AuroMedics Pharma LLC
-
March 27, 2018 · Class II · Terminated · D-0705-2018
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Levetiracetam in 0.82% Sodium Chloride Injection, 500 mg per 100 mL (5 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-246-47. — AuroMedics Pharma LLC
-
March 27, 2018 · Class II · Terminated · D-0707-2018
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Levetiracetam in 0.54% Sodium Chloride Injection, 1,500 mg per 100 mL (15 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-248-47. — AuroMedics Pharma LLC
-
October 12, 2017 · Class II · Terminated · D-0099-2018
Presence of foreign substance (screw)
Levetiracetam Oral Solution, USP, 100 mg/mL, packaged in a 16 fl oz (473 mL) bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: Hetero, Hetero Labs Limited, Jeedimetla,Hyderabad - — Hetero Labs, Ltd. - Unit III
-
July 27, 2012 · Class II · Terminated · D-1702-2012
Adulterated Presence of Foreign Tablets: Pharmaceutical manufacturer may have distributed foreign tablets in bottles of Levetiracetam Tablets, USP 500 mg.
Levetiracetam Tablets, USP 500 mg, 500 count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA, NDC 0378-5615-05 — Mylan Pharmaceuticals Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 261335, 261336, 284391, 311288, 311289, 311290, 387003, 403884, 404595, 630807 … (+10) |
|---|---|
| SPL set ID of the quoted label | 3ca9df05-a506-4ec8-a4fe-320f1219ab21 |
| FDA labels (SPL) | 159 |
| FDA applications | NDA021035, NDA021505, NDA021872, NDA022285, NDA202543, NDA204417, NDA207958, 56 ANDA |
| Active ingredients (FDA) | LEVETIRACETAM |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Keppra, UCB, Inc., effective January 28, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →