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Active ingredient

Zonisamide

51 finished FDA listings contain Zonisamide as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
ZONISAMIDE
Dosage forms
Capsule, Suspension
Routes
Oral
Manufacturers / labelers
22
Strengths listed
100 mg/1 · 100 mg/5ml · 25 mg/1 · 50 mg/1
Brand names in FDA listings
Zonegran, Zonisade

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 39998

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 020789ADVANZ PHARMA2000-03-272
ANDA 077645AUROBINDO PHARMA LTD2005-12-225
ANDA 077651GLENMARK PHARMS2006-01-309
ANDA 077634SUN PHARM INDS (IN)2006-03-178
ANDA 077869INVAGEN PHARMS2006-05-318
ANDA 077625ZYDUS LIFESCIENCES2006-10-1612
ANDA 214492UNICHEM2021-01-266
NDA 214273AZURITY2022-07-151

Official labeling on DailyMed

Showing the 12 most recent of 33 labels.

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