FDA.reportPublic FDA data

Application 021456

Type
NDA
Sponsor
EISAI MEDCL RES

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACIPHEXRABEPRAZOLE SODIUMTablet, Delayed Release; Oral20MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 36 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rabeprazole SodiumRABEPRAZOLE SODIUMREMEDYREPACK INC.63e0b7ca-6b2d-42a9-b9d4-4523b8a204252026-07-27Warnings, Adverse reactionsName fallback
generic name: RABEPRAZOLE SODIUM
Rabeprazole sodiumRABEPRAZOLE SODIUMTorrent Pharmaceuticals Limited04e88b86-e1dd-4c56-8359-45fbcc161f7d2026-07-27Warnings, Adverse reactionsName fallback
generic name: RABEPRAZOLE SODIUM
Rabeprazole SodiumRABEPRAZOLE SODIUMSt. Mary's Medical Park Pharmacy9237eaa4-8eec-fb2a-e053-2995a90ab6c02026-06-26Warnings, Adverse reactionsName fallback
generic name: RABEPRAZOLE SODIUM
RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMSt. Mary's Medical Park Pharmacyc212c9d5-32d3-3c5f-e053-2a95a90af88b2026-06-02Warnings, Adverse reactionsName fallback
generic name: RABEPRAZOLE SODIUM
RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMBryant Ranch Prepack4e8b9858-23a1-4363-b26f-ee6b9ff7ebf92026-05-15Warnings, Adverse reactionsName fallback
generic name: RABEPRAZOLE SODIUM
Rabeprazole SodiumRABEPRAZOLE SODIUMProficient Rx LP68b7a793-f22b-4609-a640-94fdec703d932026-05-01Warnings, Adverse reactionsName fallback
generic name: RABEPRAZOLE SODIUM
RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMREMEDYREPACK INC.0e2e00fa-c4c5-4de7-adf9-cd9786b970162026-04-06Warnings, Adverse reactionsName fallback
generic name: RABEPRAZOLE SODIUM
Rabeprazole Sodium DRRABEPRAZOLE SODIUMAdvanced Rx Pharmacy of Tennessee, LLCbdad0b58-495e-2352-e053-2a95a90a31982026-03-26Warnings, Adverse reactionsName fallback
generic name: RABEPRAZOLE SODIUM
Rabeprazole Sodium DRRABEPRAZOLE SODIUMAdvanced Rx of Tennessee, LLCb354053c-cb83-79c6-e053-2a95a90afdbe2026-03-13Warnings, Adverse reactionsName fallback
generic name: RABEPRAZOLE SODIUM
RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMBryant Ranch Prepack350c20b0-1879-d4cb-e063-6294a90a37f22026-03-13Warnings, Adverse reactionsName fallback
generic name: RABEPRAZOLE SODIUM
Rabeprazole SodiumRABEPRAZOLE SODIUMAsclemed USA, Inc.3b6a25c2-fb61-4c86-9988-c6ffac7939c42026-02-14Warnings, Adverse reactionsName fallback
generic name: RABEPRAZOLE SODIUM
AciphexRABEPRAZOLE SODIUMWaylis Therapeutics LLC1eb38279-0237-4967-be7a-c53a826c11382026-01-27Warnings, Adverse reactionsName fallback
brand name: Aciphex
generic name: RABEPRAZOLE SODIUM
RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMAdvagen Pharma Limitedb1a12c83-74ab-febc-e053-2a95a90a14412026-01-13Warnings, Adverse reactionsName fallback
generic name: RABEPRAZOLE SODIUM
Rabeprazole SodiumRABEPRAZOLE SODIUMChartwell RX, LLCc5c43222-d167-4152-b5c7-84b55920a7ce2025-12-11Warnings, Adverse reactionsName fallback
generic name: RABEPRAZOLE SODIUM
Rabeprazole sodiumRABEPRAZOLE SODIUMPreferred Pharmaceuticals Inc.1855ccab-c377-4962-9225-3c5adc62e2bd2025-12-08Warnings, Adverse reactionsName fallback
generic name: RABEPRAZOLE SODIUM
Rabeprazole SodiumRABEPRAZOLE SODIUMPreferred Pharmaceuticals, Inc.ac9266ed-a9b2-4e77-8607-393b5dcdd2b62025-09-17Warnings, Adverse reactionsName fallback
generic name: RABEPRAZOLE SODIUM
RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMPreferred Pharmaceuticals Inc.4582d443-f1be-4f94-85da-49aa603f54e42025-09-17Warnings, Adverse reactionsName fallback
generic name: RABEPRAZOLE SODIUM
Rabeprazole SodiumRABEPRAZOLE SODIUMPHOENIX RX LLC3a674849-b2f6-5f43-e063-6294a90a9e202025-07-21Warnings, Adverse reactionsName fallback
generic name: RABEPRAZOLE SODIUM
RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMDIRECT RXb1b7def0-834f-37f5-e053-2a95a90ade1f2025-01-17Warnings, Adverse reactionsName fallback
generic name: RABEPRAZOLE SODIUM
RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMAdvanced Rx of Tennessee, LLC0863f340-4c7e-379a-e063-6394a90a758d2024-12-31Warnings, Adverse reactionsName fallback
generic name: RABEPRAZOLE SODIUM

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23663ORIG2011-12-20
36984ORIG2004-05-25
5442ORIG2004-05-25
21671ORIG2003-04-25