Drug

Who makes levetiracetam?

81 companies list levetiracetam as a human prescription drug, including under the names ELEPSIA XR 1000 MG, ELEPSIA XR 1500 MG, Keppra, Keppra XR, Spritam, Roweepra. Forms: injection; injection, solution; injection, solution, concentrate; solution; tablet; tablet, extended release; tablet, film coated; tablet, film coated, extended release; tablet, for suspension. Routes: intravenous, oral.

Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology

Companies listing levetiracetam

CompanyFormsApplicationNDCsRegistered sites
Bryant Ranch PrepackUnited Statesinjection, solution, concentrate; solution; tablet; tablet, film coatedANDAANDA078106, ANDA078154, ANDA078582151
International Medication Systems, Ltd.United Statestablet; tablet, film coatedANDAANDA078993, ANDA090025, ANDA090515143
RemedyRepack, IncUnited Statessolution; tablet; tablet, film coated; tablet, film coated, extended releaseANDAANDA078154, ANDA079063, ANDA090515131
Solco healthcare U.S., LLCinjection; tablet, film coated; tablet, film coated, extended releaseANDAANDA078106, ANDA203468, ANDA209474110
UCB, Inc.Belgiuminjection, solution, concentrate; solution; tablet, film coated; tablet, film coated, extended releaseNDANDA021035, NDA021505, NDA02187282
Coupler LLCUnited Statestablet; tablet, film coatedANDAANDA078993, ANDA091491, ANDA21506971
Cardinal Health 418, Inc.United Statessolution; tablet, film coatedANDAANDA076919, ANDA078993, ANDA201157634
Lupin LimitedIndiatablet, extended release; tablet, film coatedANDAANDA078154, ANDA090025, ANDA091399614
Torrent Pharma, Inc.Indiatablet; tablet, extended releaseANDAANDA078858, ANDA09133865
ScieGen Pharmaceuticals India Private LimitedIndiatablet, film coated; tablet, film coated, extended releaseANDAANDA205130, ANDA21506963
BluePoint Laboratories Inc.tablet, extended release; tablet, film coatedANDAANDA078993, ANDA09139960
Novadoz Pharmaceuticals LLCinjection, solution, concentrate; solution; tablet, film coatedANDAANDA214757, ANDA214815, ANDA21598060
Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited Statessolution; tablet, film coatedANDAANDA078993, ANDA20305255
Amneal Ireland LimitedIrelandsolution; tablet, film coatedANDAANDA090767, ANDA09099251
MAJOR Pharmaceuticals Inc.solution; tablet, film coatedANDAANDA078993, ANDA201157, ANDA21475750
Mylan Institutional Inc.injection; injection, solution, concentrate; tablet, film coatedANDA, NDAANDA076919, ANDA203308, NDA20254350
Baxter Healthcare CorporationUnited Statesinjection; injection, solution, concentrateANDAANDA208458, ANDA217059416
Dr. Reddy's Laboratories LimitedIndiatabletANDAANDA076920, ANDA078904415
Granules Pharmaceuticals Inc.Indiatablet, film coatedANDAANDA21787848
Fresenius Kabi USA, LLCUnited Statesinjection; injection, solutionANDAANDA090876, ANDA20861946
SOHM, Inc.United StatestabletANDAANDA07904242
ASCLEMED USA INC. DBA ENOVACHEMUnited StatestabletANDAANDA09149141
Aprecia Pharmaceuticals, LLCUnited Statestablet, for suspensionNDANDA20795841
Camber Pharmaceuticals, Inc.United Statestablet, film coatedANDAANDA09051541
Cranbury Pharmaceuticals IncUnited StatestabletANDAANDA09149141
NCS HealthCare of KY, LLC dba Vangard LabsUnited Statestablet, film coatedANDAANDA21481541
PAI Holdings, LLCUnited StatessolutionANDAANDA20115741
Prinston Pharmaceutical Inc.United Statestablet, film coatedANDAANDA07810641
Proficient Rx LPUnited Statestablet, film coated; tablet, film coated, extended releaseANDAANDA078154, ANDA20513041
Rising Pharma Holdings, Inc.United Statestablet, film coatedANDAANDA09076741
XLCare Pharmaceuticals Inc.United Statestablet, film coatedANDAANDA09051541
ASCEND Therapeutics US, LLCtablet, film coatedANDAANDA21637540
NorthStar RxLLCtablet, film coatedANDAANDA09051540
OWP Pharmaceuticals, Inc.tabletANDAANDA07885840
Quallent Pharmaceuticals Health, LLCtablet, film coatedANDAANDA09051540
Apotex Inc.Canadatablet, film coated, extended releaseANDAANDA091261, ANDA20295836
Aurobindo Pharma LimitedIndiasolution; tablet, film coatedANDAANDA078993, ANDA07906336
GLAND PHARMA LIMITEDIndiainjectionANDAANDA20688034
B. Braun US Pharmaceutical Manufacturing LLCUnited StatesinjectionANDAANDA20970533
Direct RxUnited Statestablet; tablet, film coatedANDAANDA090515, ANDA09149131
HP Halden Pharma ASNorwayinjectionANDAANDA20861931
Nexus Pharmaceuticals, LLCUnited StatesinjectionANDAANDA21353231
PD-Rx Pharmaceuticals Inc.United Statestablet; tablet, film coatedANDAANDA078154, ANDA078858, ANDA09051531
Preferred Pharmaceuticals Inc.United Statestablet; tablet, film coatedANDAANDA078154, ANDA090515, ANDA09149131
Exelan Pharmaceuticals, Inc.tabletANDAANDA07823430
Mylan Pharmaceuticals, Inc.tablet, film coatedANDAANDA076919, ANDA09026130
Sagent Pharmaceuticalsinjection, solutionANDAANDA20688030
WG Critical Care, LLC.injectionNDANDA20254330
Hospira, Inc.United Statesinjection, solutionANDAANDA20286927
Hikma Pharmaceuticals USA Inc.United StatesinjectionANDAANDA09098124
Golden State Medical Supply Inc.United Statestablet, film coated, extended releaseANDAANDA09126121
Advanced Rx of Tennessee, LLCtabletANDAANDA09149120
Omnivium Pharmaceuticals LLCtablet, extended releaseANDAANDA21268820
Prasco Laboratoriestablet, for suspensionNDA AUTHORIZED GENERICNDA20795820
TRIPOINT THERAPEUTICS, LLCtablet, extended releaseNDANDA20441720
Westminster Pharmaceuticals, LLCtablet, film coated, extended releaseANDAANDA20513020
Sun Pharmaceutical Industries LimitedIndiasolutionANDAANDA078774113
Micro Labs LimitedIndiainjectionANDAANDA21195415
NATCO PHARMA LIMITEDIndiasolutionANDAANDA20305215
Safecor Health, LLCUnited Statestablet, film coatedANDAANDA07691913
QUAGEN PHARMACEUTICALS LLCUnited StatessolutionANDAANDA09007912
Actavis LLCUnited StatessolutionANDAANDA07897611
Bionpharma Inc.IndiasolutionANDAANDA07912011
Civica, Inc. dba CivicaRxUnited StatesinjectionANDAANDA09098111
Guardian Drug Company, Inc.United StatessolutionANDAANDA21808011
Kesin Pharma CorporationUnited StatessolutionANDAANDA07912011
Northwind Health Company, LLCUnited Statestablet, film coatedANDAANDA09051511
Patrin Pharma, IncUnited StatessolutionANDAANDA07858211
Precision Dose Inc.United Statesinjection, solution, concentrateANDAANDA20978111
South Atlantic Corporation LLCUnited StatessolutionANDAANDA20305211
Unit Dose Solutions, Inc.United Statestablet, film coatedANDAANDA07899311
Armas Pharmaceuticals, Inc.injectionANDAANDA21195410
Aryeh Pharma Corpinjection, solution, concentrateANDAANDA09148510
Chartwell Governmental & Specialty RX, LLC.solutionANDAANDA09026310
Chartwell RX, LLC.solutionANDAANDA09026310
Eugia US LLCinjection, solutionANDAANDA20431210
Injecta Medcial LLCtablet, film coatedANDAANDA09051510
Method Pharmaceuticals, LLC.injectionANDAANDA20978110
Northstar Rx, LLC,solutionANDAANDA07906310
TAGI Pharma, Inc.injection, solution, concentrateANDAANDA20978110
XGen Pharmaceuticals DJB, Inc.injection, solution, concentrateANDAANDA09148510

Bulk ingredient listings

Orange Book patents

9 unexpired patents list levetiracetam as the active ingredient, expiring between Sept 2027 and Mar 2034. Application holders: APRECIA PHARMACEUTICALS LLC, TRIPOINT THERAPEUTICS, UCB INC.

Enquiry

Common questions

Who makes levetiracetam?
81 companies list levetiracetam as a human prescription drug in the openFDA NDC Directory, led by Bryant Ranch Prepack, International Medication Systems, Ltd., RemedyRepack, Inc, Solco healthcare U.S., LLC, UCB, Inc.. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
Is there a generic ELEPSIA XR 1000 MG?
76 companies list levetiracetam under an abbreviated new drug application (ANDA), the application type used for generics, and 5 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
Who supplies levetiracetam active ingredient?
29 companies list levetiracetam as a bulk ingredient, including Professional Compounding Centers of America dba PCCA, Zhejiang Huahai Pharmaceutical Technology Co Ltd, AX Pharmaceutical Corp, Aurobindo Pharma Limited.