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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 219230

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NDA 219230 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, Norvium Bioscience, Sandoz, Fresenius Kabi Usa, Hikma, Actavis Totowa, Amneal Pharms, 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, Wockhardt Bio Ag, and Baxter Hlthcare Corp, and is included in forty-three 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 are forty-eight drug master file entries for this compound. Sixty-nine suppliers are listed for this compound. Additional details are available on the pantoprazole sodium profile page.

Summary for 219230

Tradename:	PANTOPRAZOLE SODIUM
Applicant:	Alembic
Ingredient:	pantoprazole sodium
Patents:	0

Pharmacology for NDA: 219230

Mechanism of Action	Proton Pump Inhibitors

Suppliers and Packaging for NDA: 219230

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PANTOPRAZOLE SODIUM	pantoprazole sodium	INJECTABLE;INTRAVENOUS	219230	ANDA	Alembic Pharmaceuticals Limited	46708-071	46708-071-01	1 VIAL in 1 CARTON (46708-071-01) / 10 mL in 1 VIAL
PANTOPRAZOLE SODIUM	pantoprazole sodium	INJECTABLE;INTRAVENOUS	219230	ANDA	Alembic Pharmaceuticals Limited	46708-071	46708-071-10	10 VIAL in 1 CARTON (46708-071-10) / 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	EQ 40MG BASE/VIAL
Approval Date:	Mar 31, 2025	TE:	AP	RLD:	No

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