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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 208644

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NDA 208644 describes RABEPRAZOLE SODIUM, which is a drug marketed by Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma, Chartwell Rx, Dr Reddys, Lannett Co Inc, Pharmobedient, Rubicon Research, Teva Pharms Usa, and Torrent, and is included in ten NDAs. It is available from twenty-two suppliers. Additional details are available on the RABEPRAZOLE SODIUM profile page.

The generic ingredient in RABEPRAZOLE SODIUM is rabeprazole sodium. There are thirty drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the rabeprazole sodium profile page.

Summary for 208644

Tradename:	RABEPRAZOLE SODIUM
Applicant:	Alkem Labs Ltd
Ingredient:	rabeprazole sodium
Patents:	0

Pharmacology for NDA: 208644

Mechanism of Action	Proton Pump Inhibitors

Medical Subject Heading (MeSH) Categories for 208644

Anti-Ulcer Agents
Proton Pump Inhibitors

Suppliers and Packaging for NDA: 208644

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RABEPRAZOLE SODIUM	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	208644	ANDA	A-S Medication Solutions	50090-4751	50090-4751-0	30 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-4751-0)
RABEPRAZOLE SODIUM	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	208644	ANDA	A-S Medication Solutions	50090-4751	50090-4751-1	90 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-4751-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	20MG
Approval Date:	Apr 24, 2018	TE:	AB	RLD:	No

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