Last Updated: September 25, 2026

Details for New Drug Application (NDA): 215880

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NDA 215880 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, Shuangcheng, 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-four NDAs. It is available from sixty-seven suppliers. Additional details are available on the PANTOPRAZOLE SODIUM profile page.

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

Summary for 215880

Tradename:	PANTOPRAZOLE SODIUM
Applicant:	Mankind Pharma
Ingredient:	pantoprazole sodium
Patents:	0

Pharmacology for NDA: 215880

Mechanism of Action	Proton Pump Inhibitors

Suppliers and Packaging for NDA: 215880

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PANTOPRAZOLE SODIUM	pantoprazole sodium	TABLET, DELAYED RELEASE;ORAL	215880	ANDA	Lifestar Pharma LLC	70756-018	70756-018-51	500 TABLET in 1 BOTTLE (70756-018-51)
PANTOPRAZOLE SODIUM	pantoprazole sodium	TABLET, DELAYED RELEASE;ORAL	215880	ANDA	Lifestar Pharma LLC	70756-018	70756-018-90	90 TABLET in 1 BOTTLE (70756-018-90)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	EQ 40MG BASE
Approval Date:	Jul 26, 2022	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	EQ 20MG BASE
Approval Date:	Apr 25, 2024	TE:		RLD:	No

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