FDA.reportPublic FDA data

NDC 80425-0134-03 - Rabeprazole Sodium DR

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
80425-0134
Requested NDC
80425-0134-03
Package NDCs from labels
80425-0134-2, 80425-0134-1, 80425-0134-3, 80425-0134-4, 80425-0134-03
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2026-03-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Rabeprazole Sodium DR - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2026-03-26HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0134-1Rabeprazole SodiumDR30 in 1 BOTTLETABLET, DELAYED RELEASE309
80425-0134-2Rabeprazole SodiumDR60 in 1 BOTTLETABLET, DELAYED RELEASE609
80425-0134-3Rabeprazole SodiumDR90 in 1 BOTTLETABLET, DELAYED RELEASE909
80425-0134-4Rabeprazole SodiumDR6 in 1 BOTTLETABLET, DELAYED RELEASE69

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0134RABEPRAZOLE SODIUM DR (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]8Current NDC, Legacy NDC, 4 package rows20250101_bdad0b58-495e-2352-e053-2a95a90a3198.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0134-1EA - Each80425-013446a95f21-cdc8-4907-b4ba-c646a92204d712023-03-13
80425-0134-2EA - Each80425-0134e46ac006-dd6d-4ebe-b3e2-eb28e82a058412023-03-13
80425-0134-3EA - Each80425-013473fa05d4-1265-40c0-85db-99022dc6088512023-06-06

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 · 37 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rabeprazole SodiumRABEPRAZOLE SODIUMAscend Laboratories, LLC45092108-7c4a-48f9-8222-ca8612e821892026-08-28Warnings, Adverse reactionsExact identifier
application number: ANDA208644
ndc (product): 67877-443
rxcui: 854868
spl id: a12d4fab-6c30-456f-9c53-2b18c488cf4f
spl set id: 45092108-7c4a-48f9-8222-ca8612e82189
unii: 3L36P16U4R
RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMPreferred Pharmaceuticals Inc.4582d443-f1be-4f94-85da-49aa603f54e42026-08-25Warnings, Adverse reactionsExact identifier
rxcui: 854868
unii: 3L36P16U4R
Rabeprazole SodiumRABEPRAZOLE SODIUMPreferred Pharmaceuticals, Inc.ac9266ed-a9b2-4e77-8607-393b5dcdd2b62026-08-25Warnings, Adverse reactionsExact identifier
application number: ANDA208644
rxcui: 854868
unii: 3L36P16U4R
RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMREMEDYREPACK INC.0e2e00fa-c4c5-4de7-adf9-cd9786b970162026-08-04Warnings, Adverse reactionsExact identifier
rxcui: 854868
unii: 3L36P16U4R
Rabeprazole SodiumRABEPRAZOLE SODIUMREMEDYREPACK INC.63e0b7ca-6b2d-42a9-b9d4-4523b8a204252026-07-27Warnings, Adverse reactionsExact identifier
application number: ANDA208644
rxcui: 854868
unii: 3L36P16U4R
Rabeprazole sodiumRABEPRAZOLE SODIUMTorrent Pharmaceuticals Limited04e88b86-e1dd-4c56-8359-45fbcc161f7d2026-07-27Warnings, Adverse reactionsExact identifier
rxcui: 854868
unii: 3L36P16U4R
Rabeprazole SodiumRABEPRAZOLE SODIUMSt. Mary's Medical Park Pharmacy9237eaa4-8eec-fb2a-e053-2995a90ab6c02026-06-26Warnings, Adverse reactionsExact identifier
application number: ANDA208644
rxcui: 854868
unii: 3L36P16U4R
RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMSt. Mary's Medical Park Pharmacyc212c9d5-32d3-3c5f-e053-2a95a90af88b2026-06-02Warnings, Adverse reactionsExact identifier
rxcui: 854868
unii: 3L36P16U4R
RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMBryant Ranch Prepack4e8b9858-23a1-4363-b26f-ee6b9ff7ebf92026-05-15Warnings, Adverse reactionsExact identifier
rxcui: 854868
unii: 3L36P16U4R
Rabeprazole SodiumRABEPRAZOLE SODIUMProficient Rx LP68b7a793-f22b-4609-a640-94fdec703d932026-05-01Warnings, Adverse reactionsExact identifier
application number: ANDA208644
rxcui: 854868
unii: 3L36P16U4R
Rabeprazole Sodium DRRABEPRAZOLE SODIUMAdvanced Rx Pharmacy of Tennessee, LLCbdad0b58-495e-2352-e053-2a95a90a31982026-03-26Warnings, Adverse reactionsExact identifier
application number: ANDA208644
ndc (package): 80425-0134-2
ndc (package): 80425-0134-1
ndc (package): 80425-0134-4
ndc (package): 80425-0134-3
ndc (product): 80425-0134
ndc11 (package): 80425013403
rxcui: 854868
spl id: 4df0b57a-090c-2350-e063-6394a90addbe
spl set id: bdad0b58-495e-2352-e053-2a95a90a3198
unii: 3L36P16U4R
Rabeprazole Sodium DRRABEPRAZOLE SODIUMAdvanced Rx of Tennessee, LLCb354053c-cb83-79c6-e053-2a95a90afdbe2026-03-13Warnings, Adverse reactionsExact identifier
application number: ANDA208644
rxcui: 854868
unii: 3L36P16U4R
RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMBryant Ranch Prepack350c20b0-1879-d4cb-e063-6294a90a37f22026-03-13Warnings, Adverse reactionsExact identifier
rxcui: 854868
unii: 3L36P16U4R
Rabeprazole SodiumRABEPRAZOLE SODIUMAsclemed USA, Inc.3b6a25c2-fb61-4c86-9988-c6ffac7939c42026-02-14Warnings, Adverse reactionsExact identifier
application number: ANDA208644
rxcui: 854868
unii: 3L36P16U4R
AciphexRABEPRAZOLE SODIUMWaylis Therapeutics LLC1eb38279-0237-4967-be7a-c53a826c11382026-01-27Warnings, Adverse reactionsExact identifier
rxcui: 854868
unii: 3L36P16U4R
RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMAdvagen Pharma Limitedb1a12c83-74ab-febc-e053-2a95a90a14412026-01-13Warnings, Adverse reactionsExact identifier
rxcui: 854868
unii: 3L36P16U4R
Rabeprazole SodiumRABEPRAZOLE SODIUMChartwell RX, LLCc5c43222-d167-4152-b5c7-84b55920a7ce2025-12-11Warnings, Adverse reactionsExact identifier
rxcui: 854868
unii: 3L36P16U4R
Rabeprazole sodiumRABEPRAZOLE SODIUMPreferred Pharmaceuticals Inc.1855ccab-c377-4962-9225-3c5adc62e2bd2025-12-08Warnings, Adverse reactionsExact identifier
rxcui: 854868
unii: 3L36P16U4R
Rabeprazole SodiumRABEPRAZOLE SODIUMPHOENIX RX LLC3a674849-b2f6-5f43-e063-6294a90a9e202025-07-21Warnings, Adverse reactionsExact identifier
application number: ANDA208644
rxcui: 854868
unii: 3L36P16U4R
RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMDIRECT RXb1b7def0-834f-37f5-e053-2a95a90ade1f2025-01-17Warnings, Adverse reactionsExact identifier
application number: ANDA208644
rxcui: 854868
unii: 3L36P16U4R

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.