Last Updated: May 10, 2026

Details for New Drug Application (NDA): 216021

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NDA 216021 describes PANTOPRAZOLE SODIUM, which is a drug marketed by Ajanta Pharma Ltd, Annora Pharma, Aurobindo Pharma Ltd, Cipla, Dexcel, Sun Pharm, Alembic, Aspiro, Be Pharms, Deva Holding As, Epic Pharma Llc, Eugia Pharma, Gland, Hangzhou Zhongmei, Knack, Meitheal, Pharmobedient, Sandoz, Fresenius Kabi Usa, Hikma, Actavis Totowa, Amneal Pharms, Apotex, Dr Reddys Labs Ltd, Granules, Graviti Pharms, Hetero Labs Ltd V, Ingenus Pharms Llc, Jubilant Generics, L Perrigo Co, Lannett Co Inc, Macleods Pharms Ltd, Mankind Pharma, Mylan Pharms Inc, Orbion Pharms, Rubicon Research, Sun Pharm Inds Ltd, Teva, Torrent Pharms, and Baxter Hlthcare Corp, and is included in forty-three NDAs. It is available from sixty-three suppliers. Additional details are available on the PANTOPRAZOLE SODIUM profile page.

The generic ingredient in PANTOPRAZOLE SODIUM is pantoprazole sodium. There are forty-eight drug master file entries for this compound. Sixty-five suppliers are listed for this compound. Additional details are available on the pantoprazole sodium profile page.

Summary for 216021

Tradename:	PANTOPRAZOLE SODIUM
Applicant:	Fresenius Kabi Usa
Ingredient:	pantoprazole sodium
Patents:	0

Pharmacology for NDA: 216021

Mechanism of Action	Proton Pump Inhibitors

Suppliers and Packaging for NDA: 216021

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PANTOPRAZOLE SODIUM	pantoprazole sodium	POWDER;INTRAVENOUS	216021	ANDA	Fresenius Kabi USA, LLC	65219-385	65219-385-10	10 VIAL in 1 CARTON (65219-385-10) / 10 mL in 1 VIAL (65219-385-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	EQ 40MG BASE/VIAL
Approval Date:	Aug 1, 2024	TE:	AP	RLD:	No

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