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Active ingredient

Ondansetron

274 finished FDA listings contain Ondansetron as their only active ingredient.

FDA NDC Directory

Ingredient names as written by FDA
ONDANSETRON, ONDANSETRON HYDROCHLORIDE
Dosage forms
Injection, Injection, Solution, Solution, Tablet, Tablet, Film Coated, Tablet, Orally Disintegrating
Routes
Intramuscular, Intravenous, Oral
Manufacturers / labelers
78
Strengths listed
16 mg/1 · 2 mg/ml · 24 mg/1 · 4 mg/1 · 4 mg/2ml · 4 mg/5ml · 8 mg/1
Brand names in FDA listings
Ondansetron, Ondansetron Odt

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 26225

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
ANDA 077365HIKMA2006-12-262
ANDA 077473HOSPIRA2006-12-262
ANDA 076183DR REDDYS LABS LTD2006-12-2611
ANDA 076780HIKMA FARMACEUTICA2006-12-261
ANDA 077541HIKMA2006-12-267
ANDA 077548HOSPIRA2006-12-266
ANDA 077406CHARTWELL MOLECULES2006-12-265
ANDA 076781HIKMA FARMACEUTICA2006-12-262
ANDA 076974FRESENIUS KABI USA2006-12-262
ANDA 076960HIKMA2006-12-262
ANDA 076972FRESENIUS KABI USA2006-12-263
ANDA 077303CHARTWELL MOLECULES2007-06-252
ANDA 077851NATCO PHARMA LTD2007-06-2515
ANDA 077050SUN PHARM INDS (IN)2007-06-252
ANDA 077535GLENMARK PHARMS LTD2007-06-254
ANDA 078127PHARM ASSOC2007-06-252
ANDA 078152GLENMARK PHARMS LTD2007-06-2729
ANDA 078539AUROBINDO PHARMA2007-07-3175
ANDA 077557SUN PHARM INDS2007-08-028
ANDA 078776AUROBINDO PHARMA2007-11-284
ANDA 078257ONESOURCE SPECIALTY2008-04-231
ANDA 078244ONESOURCE SPECIALTY2008-04-231
ANDA 079224GLAND PHARMA LTD2009-09-255
ANDA 090469AUROBINDO PHARMA2010-04-1251
ANDA 091342CHARTWELL MOLECULAR2011-01-272
ANDA 091483AMNEAL PHARMS2011-01-314
ANDA 090648GLAND PHARMA LTD2012-06-155
ANDA 202600EUGIA PHARMA2012-12-211
ANDA 202599EUGIA PHARMA2012-12-211
ANDA 078287BAXTER HLTHCARE CORP2013-02-222
ANDA 202253FRESENIUS KABI USA2013-07-192
ANDA 203761IPCA LABS LTD2014-01-232
ANDA 203711QILU PHARM HAINAN2014-09-087
ANDA 206846ACCORD HLTHCARE2015-07-131
ANDA 209389IPCA LABS LTD2023-10-305

Official labeling on DailyMed

Showing the 12 most recent of 223 labels.

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