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Active ingredient

Oxcarbazepine

126 finished FDA listings contain Oxcarbazepine as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
OXCARBAZEPINE
Dosage forms
For Suspension, Suspension, Tablet, Tablet, Extended Release, Tablet, Film Coated
Routes
Oral
Manufacturers / labelers
45
Strengths listed
150 mg/1 · 300 mg/1 · 300 mg/5ml · 60 mg/ml · 600 mg/1
Brand names in FDA listings
Oxtellar Xr, Trileptal

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 32624

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 021014NOVARTIS2000-01-143
NDA 021285NOVARTIS2001-05-251
ANDA 077794SUN PHARM INDS2007-10-094
ANDA 077802GLENMARK PHARMS LTD2007-10-099
ANDA 078005ANI PHARMS2007-12-117
ANDA 078069BRECKENRIDGE PHARM2008-01-1132
ANDA 077747RUBICON RESEARCH2008-04-093
ANDA 202961AMNEAL PHARMS2012-09-173
NDA 202810SUPERNUS PHARMS2012-10-193
ANDA 212428CHARTWELL RX2021-06-212
ANDA 215939ANNORA PHARMA2022-01-1123
ANDA 215726RUBICON RESEARCH2022-08-301
ANDA 209652BIONPHARMA2022-11-041
ANDA 215332AUCTA2022-11-301
ANDA 211747ZYDUS2023-07-036
ANDA 213369APOTEX2023-07-133
ANDA 216749HETERO LABS LTD III2023-10-202
ANDA 217782KANCHAN HLTHCARE2024-02-143
ANDA 217659AJANTA PHARMA LTD2024-02-223
ANDA 218278BIOCON PHARMA2024-03-011
ANDA 207717RUBICON RESEARCH2024-03-053
ANDA 213183ALKEM LABS LTD2024-03-181
ANDA 215796RICONPHARMA LLC2024-11-223
ANDA 207300MACLEODS PHARMS2025-07-111
ANDA 218341UMEDICA LABS PVT2026-04-296
ANDA 209020MSN2026-05-291

Official labeling on DailyMed

Showing the 12 most recent of 72 labels.

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