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Active ingredient

Esomeprazole

254 finished FDA listings contain Esomeprazole as their only active ingredient; 21 combination products also contain it.

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FDA NDC Directory

Ingredient names as written by FDA
ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM DIHYDRATE, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, ESOMEPRAZOLE SODIUM, ESOMEPRAZOLE STRONTIUM
Dosage forms
Capsule, Capsule, Coated Pellets, Capsule, Delayed Release, Capsule, Delayed Release Pellets, For Suspension, Granule, Delayed Release, Granule, For Suspension, Extended Release, Injection, Injection, Powder, Lyophilized, For Solution, Tablet, Tablet, Delayed Release
Routes
Intravenous, Oral
Manufacturers / labelers
123
Strengths listed
10 mg/1 · 2.5 mg/1 · 20 mg/1 · 20 mg/5ml · 40 mg/1 · 40 mg/5ml · 5 mg/1
Brand names in FDA listings
24 Hour Esomeprazole Magnesium, Acid Reducer, Basic Care Esomeprazole Magnesium, Berkley And Jensen Heartburn Treatment, Careone Esomeprazole Magnesium, Dg Health Esomeprazole Magnesium, Equate Esomeprazole Magnesium, Esomeprazole, Esomeprazole Magnesium, Esomeprazole Magnesium Delayed Release, Esomeprazole Magnesium Dr, Esomeprazole Magnesium For Delayed-Release Oral Suspension, Esomeprazole Magnesium Minis, Exchange Select Esomeprazole Magnesium, Foster And Thrive Acid Reducer, Good Neighbor Pharmacy Esomeprazole Magnesium, Good Sense Esomeprazole Magnesium, Goodmeds Acid Reducer 24hr Esomeprazole Magnesium Delayed-Release 20mg, Kirkland Signature Esomeprazole Magnesium, Leader Esomeprazole Magnesium, Members Mark Esomeprazole Magnesium, Nexium, Nexium 24hr, Nexium 24hr Clearminis, Riopan, Signature Care Esomeprazole Magnesium, Topcare Esomeprazole Magnesium, Up And Up Esomeprazole Magnesium

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 283742

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 021153ASTRAZENECA2001-02-202
NDA 021957ASTRAZENECA2006-10-204
NDA 202342BELCHER2013-08-062
NDA 204655ASTRAZENECA LP2014-03-283
ANDA 078936MYLAN2015-08-032
ANDA 078279DR REDDYS2015-09-2515
ANDA 205606AUROBINDO PHARMA LTD2016-04-2110
ANDA 207193PERRIGO R AND D2017-08-1844
ANDA 205563LANNETT CO INC2017-09-013
ANDA 209339AUROBINDO PHARMA2017-10-1620
ANDA 208333ALKEM LABS LTD2017-10-202
ANDA 209735SUN PHARM2018-04-304
ANDA 207673DR REDDYS2018-05-157
ANDA 209495GLENMARK SPECLT2019-05-104
ANDA 206296ZYDUS PHARMS2019-05-226
ANDA 211752CIPLA2020-03-231
ANDA 211751CIPLA2020-03-232
ANDA 203349GLAND2020-04-012
ANDA 212866SUN PHARM2020-05-0410
ANDA 211571DR REDDYS2020-05-144
ANDA 211977HETERO LABS LTD III2020-06-0217
ANDA 212507HETERO LABS LTD III2020-06-024
ANDA 212088MYLAN2020-06-252
ANDA 212949CSPC OUYI2020-10-023
ANDA 213859GUANGZHOU NOVAKEN2020-11-187
ANDA 210559INDCHEMIE HEALTH2021-02-266
ANDA 213486GRAVITI PHARMS2021-03-1910
ANDA 216349GRAVITI PHARMS2022-06-245
ANDA 216149GUARDIAN DRUG2023-03-151
ANDA 214920PRINSTON INC2023-03-282
ANDA 206055ZYDUS PHARMS2023-06-074
ANDA 214473AUROBINDO PHARMA LTD2023-07-124
ANDA 217264PHARMAZONE2023-09-2911
ANDA 217427GRANULES2023-10-184
ANDA 217022ZHEJIANG YONGTAI2023-12-272
ANDA 207198DR REDDYS2024-04-308
ANDA 208511MACLEODS PHARMS2024-10-232
ANDA 217714CIPLA2025-01-072
ANDA 212651TORRENT2025-03-054
ANDA 218948AUROBINDO PHARMA LTD2025-04-153

Showing 40 of 46 applications.

Official labeling on DailyMed

Showing the 12 most recent of 206 labels.

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