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Active ingredient

Levetiracetam

304 finished FDA listings contain Levetiracetam as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
LEVETIRACETAM
Dosage 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
Manufacturers / labelers
90
Strengths listed
10 mg/ml · 100 mg/ml · 1000 mg/1 · 1000 mg/100ml · 1000 mg/10ml · 15 mg/ml · 1500 mg/1 · 1500 mg/100ml · 1500 mg/15ml · 250 mg/1 · 5 mg/ml · 500 mg/1 · 500 mg/100ml · 500 mg/5ml · 750 mg/1
Brand names in FDA listings
Elepsia Xr 1000 Mg, Elepsia Xr 1500 Mg, Keppra, Keppra Xr, Levetiracetam, Levetiracetam Er, Levetiracetam Extended-Release, Levetiracetam In Sodium Chloride, Levetiracetam Levetiracetam, Levetiracetam Solution, Roweepra, Spritam

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 114477

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 021035UCB INC1999-11-304
ANDA 076919MYLAN2008-11-046
ANDA 079042INGENUS PHARMS LLC2009-01-154
ANDA 078993AUROBINDO PHARMA2009-01-1526
ANDA 078154LUPIN2009-01-1511
ANDA 078858TORRENT PHARMS2009-01-1510
ANDA 090025LUPIN2009-01-152
ANDA 076920PHARMAZONE2009-01-153
ANDA 078234INVAGEN PHARMS2009-01-153
ANDA 079063AUROBINDO PHARMA2009-01-154
ANDA 078106PRINSTON INC2009-02-1013
ANDA 090263CHARTWELL MOLECULAR2009-04-032
ANDA 090767RISING2010-07-289
ANDA 090515HETERO LABS LTD III2010-10-0830
ANDA 091491ZHEJIANG JINGXIN2010-12-1423
ANDA 091399LUPIN LTD2011-09-124
ANDA 091261APOTEX INC2011-09-124
ANDA 090981HIKMA FARMACEUTICA2011-10-133
NDA 202543HQ SPCLT PHARMA2011-11-098
ANDA 090079QUAGEN2012-04-112
ANDA 203052HETERO LABS LTD III2013-02-284
ANDA 203468PRINSTON INC2015-05-216
ANDA 201157PHARM ASSOC2015-06-047
NDA 207958APRECIA PHARMS2015-07-316
ANDA 090876FRESENIUS KABI USA2015-08-132
ANDA 207160EUGIA PHARMA2017-01-043
ANDA 206880GLAND2017-10-2512
ANDA 209781HAINAN POLY PHARM2018-03-203
ANDA 213532NEXUS2020-07-063
ANDA 205130SCIEGEN PHARMS2020-11-278
ANDA 215069SCIEGEN PHARMS2021-06-117
ANDA 216375ALKEM LABS LTD2022-05-274
ANDA 214757MSN2022-07-153
ANDA 214815MSN2022-10-078
ANDA 208619FRESENIUS KABI USA2023-01-316
ANDA 217878GRANULES2023-06-134
ANDA 217059BAXTER HLTHCARE CORP2023-10-023
ANDA 211356HIKMA2024-02-123
ANDA 209705B BRAUN MEDICAL2024-02-273
ANDA 219562CAPLIN2025-01-166

Showing 40 of 63 applications.

Official labeling on DailyMed

Showing the 12 most recent of 167 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.