Details for New Drug Application (NDA): 218829

NDA 218829 describes OMEPRAZOLE MAGNESIUM, which is a drug marketed by Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, L Perrigo Co, Spil, Aurobindo Pharma, Hetero Labs Ltd Iii, Marksans Pharma, P And L, and Perrigo R And D, and is included in nine NDAs. It is available from fifty-two suppliers. Additional details are available on the OMEPRAZOLE MAGNESIUM profile page.

The generic ingredient in OMEPRAZOLE MAGNESIUM is omeprazole magnesium. There are one hundred and thirty-one drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the omeprazole magnesium profile page.

Summary for 218829

Tradename:	OMEPRAZOLE MAGNESIUM
Applicant:	Marksans Pharma
Ingredient:	omeprazole magnesium
Patents:	0

Pharmacology for NDA: 218829

Mechanism of Action

Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors

Suppliers and Packaging for NDA: 218829

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OMEPRAZOLE MAGNESIUM	omeprazole magnesium	TABLET, DELAYED RELEASE;ORAL	218829	ANDA	MARKSANS PHARMA LIMITED	25000-091	25000-091-76	1 BOTTLE in 1 CARTON (25000-091-76) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE
OMEPRAZOLE MAGNESIUM	omeprazole magnesium	TABLET, DELAYED RELEASE;ORAL	218829	ANDA	MARKSANS PHARMA LIMITED	25000-091	25000-091-77	2 BLISTER PACK in 1 CARTON (25000-091-77) / 7 TABLET, DELAYED RELEASE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	EQ 20MG BASE
Approval Date:	Aug 7, 2025	TE:		RLD:	No

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