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Active ingredient

Eslicarbazepine

40 finished FDA listings contain Eslicarbazepine as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
ESLICARBAZEPINE ACETATE
Dosage forms
Tablet
Routes
Oral
Manufacturers / labelers
10
Strengths listed
200 mg/1 · 400 mg/1 · 600 mg/1 · 800 mg/1
Brand names in FDA listings
Aptiom

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 1482502

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 022416SUMITOMO PHARMA AM2013-11-084
ANDA 211238DR REDDYS2021-06-294
ANDA 211186HETERO LABS LTD V2023-08-034
ANDA 211199ALKEM LABS LTD2023-10-064
ANDA 211236APOTEX2023-12-078
ANDA 211227TORRENT2024-02-274
ANDA 211246LUPIN2024-03-274
ANDA 211219JUBILANT GENERICS2025-08-044
ANDA 216481AUROBINDO PHARMA2026-08-054

Official labeling on DailyMed

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