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Active ingredient

Pantoprazole

166 finished FDA listings contain Pantoprazole as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
PANTOPRAZOLE SODIUM
Dosage forms
For Suspension, Granule, Delayed Release, Injection, Powder, For Solution, Injection, Powder, Lyophilized, For Solution, Injection, Solution, Powder, For Solution, Suspension, Tablet, Tablet, Delayed Release
Routes
Intravenous, Oral
Manufacturers / labelers
70
Strengths listed
20 mg/1 · 40 mg/1 · 40 mg/100ml · 40 mg/10ml · 40 mg/50ml · 80 mg/100ml
Brand names in FDA listings
Pantoprazole Sodium, Pantoprazole Sodium Delayed-Release Delayed Release, Pantoprazole Sodium Dr, Pantoprazole Sodium I.v., Protonix Delayed-Release, Protonix I.v.

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 40790

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 020987WYETH PHARMS2000-02-022
NDA 020988WYETH PHARMS2001-03-224
NDA 022020WYETH PHARMS2007-11-141
ANDA 090074TORRENT PHARMS2011-01-196
ANDA 077619DR REDDYS LABS LTD2011-01-1912
ANDA 090970MYLAN PHARMS INC2011-01-1910
ANDA 078281LANNETT CO INC2011-01-2013
ANDA 202038AUROBINDO PHARMA LTD2012-09-2836
ANDA 202882HETERO LABS LTD V2014-09-1036
ANDA 205119AMNEAL PHARMS2016-01-267
ANDA 205675EUGIA PHARMA2016-03-302
NDA 209463HIKMA2017-06-304
ANDA 077674SUN PHARM2019-08-191
ANDA 213725SUN PHARM2020-06-302
ANDA 209524HANGZHOU ZHONGMEI2021-08-301
ANDA 216171BE PHARMS2022-05-182
ANDA 204400GLAND2022-05-183
ANDA 213778ASPIRO2022-05-181
ANDA 214680KNACK2022-05-191
ANDA 215880MANKIND PHARMA2022-07-262
ANDA 215860MEITHEAL2022-08-293
ANDA 217416AJANTA PHARMA LTD2023-02-092
ANDA 216247DEXCEL2023-06-161
ANDA 216139ANNORA PHARMA2023-10-271
ANDA 217282GRANULES2023-12-112
NDA 217512BAXTER HLTHCARE CORP2024-02-143
ANDA 216021FRESENIUS KABI USA2024-08-011
ANDA 219087GRAVITI PHARMS2025-01-162
ANDA 219230ALEMBIC2025-03-312
ANDA 217923AUROBINDO PHARMA LTD2025-03-311
ANDA 217458CIPLA2025-03-311
ANDA 215074DEVA HOLDING AS2025-05-161

Official labeling on DailyMed

Showing the 12 most recent of 135 labels.

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