FDA.reportPublic FDA data

NDC 80425-0179-03 - Pantoprazole 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
80425-0179
Requested NDC
80425-0179-03
Package NDCs from labels
80425-0179-2, 80425-0179-3, 80425-0179-03
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Pantoprazole Sodium DR - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0179-2Pantoprazole SodiumDR60 in 1 BOTTLETABLET, DELAYED RELEASE605
80425-0179-3Pantoprazole SodiumDR90 in 1 BOTTLETABLET, DELAYED RELEASE905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0179PANTOPRAZOLE SODIUM DR (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]5Current NDC, Legacy NDC, 2 package rows20250101_d27e1fdd-e23f-0d60-e053-2a95a90a9087.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0179-2EA - Each80425-0179ec85c5fc-4329-4ce3-8b1f-b2f89920fac512023-04-07
80425-0179-3EA - Each80425-0179ea4e3343-e0e2-4eae-b3c9-2b33fcda718412023-04-07

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 7 · 137 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
pantoprazole sodiumPANTOPRAZOLE SODIUMCamber Pharmaceuticals, Inc.1bb94d3c-8bc3-4193-9dd8-e9a22066707c2026-08-31Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
PANTOPRAZOLE SODIUMPANTOPRAZOLEAvPAK59f50bcb-85e5-e3f6-e063-6294a90a11ae2026-08-26Warnings, Adverse reactionsExact identifier
rxcui: 314200
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMRedpharm Drug58d32be2-166e-1a64-e063-6394a90a26ea2026-08-12Warnings, Adverse reactionsExact identifier
rxcui: 314200
unii: 6871619Q5X
PantoprazolePANTOPRAZOLEPreferred Pharmaceuticals Inc.bb1e79ad-ff52-4696-8743-523f793b29d32026-08-11Warnings, Adverse reactionsExact identifier
rxcui: 251872
unii: 6871619Q5X
PANTOPRAZOLE SODIUMPANTOPRAZOLEPreferred Pharmaceuticals Inc.5c14e2f3-625d-4089-a404-440b0ecf72e72026-08-11Warnings, Adverse reactionsExact identifier
rxcui: 314200
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMAmerican Health Packaging5ff3cf6c-6f0a-4374-8b80-4e1eb1df62452026-08-07Warnings, Adverse reactionsExact identifier
rxcui: 251872
rxcui: 314200
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMCardinal Health 107, LLCe17e4a72-d6a4-4a83-a921-88af9ef028a62026-07-30Warnings, Adverse reactionsExact identifier
application number: ANDA090970
rxcui: 314200
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMEdenbridge Pharmaceuticals LLC.a0bb76bc-094a-4d61-9bb2-2226c9da4ae92026-07-22Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMREMEDYREPACK INC.76e1839b-7462-4344-b319-001a5f57d67a2026-07-14Warnings, Adverse reactionsExact identifier
rxcui: 251872
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMEugia US LLC9bed093a-9586-4c82-a2b7-c68f89d0faef2026-07-09Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMREMEDYREPACK INC.f38a6df2-1dd4-48bf-9ec4-1113ce492e782026-07-03Warnings, Adverse reactionsExact identifier
rxcui: 314200
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMUnit Dose Solutions, Inc.558dc7e1-dfd5-d3d7-e063-6394a90ab9c32026-07-01Warnings, Adverse reactionsExact identifier
rxcui: 314200
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMREMEDYREPACK INC.f313159c-115a-4cf6-b32e-9ddc833fd51c2026-07-01Warnings, Adverse reactionsExact identifier
rxcui: 314200
unii: 6871619Q5X
PANTOPRAZOLE SODIUMPANTOPRAZOLESportpharm LLCb58c376e-616b-4970-a375-52ff630e7f092026-06-29Warnings, Adverse reactionsExact identifier
rxcui: 251872
rxcui: 314200
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMUnit Dose Solutions, Inc.5566b4b1-b4f5-4020-e063-6394a90a52572026-06-29Warnings, Adverse reactionsExact identifier
rxcui: 251872
unii: 6871619Q5X
PANTOPRAZOLE SODIUMPANTOPRAZOLEHAWAII REPACK, INC.f85e6d64-1ddc-4f4a-86dc-0749081a6a5f2026-06-27Warnings, Adverse reactionsExact identifier
rxcui: 251872
rxcui: 314200
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMHAWAII REPACK, INC.f403c94d-68b7-43df-8c8e-c9fef3309cfc2026-06-26Warnings, Adverse reactionsExact identifier
rxcui: 251872
rxcui: 314200
unii: 6871619Q5X
PANTOPRAZOLE SODIUMPANTOPRAZOLESt. Mary's Medical Park Pharmacye1aa55ec-5e0e-3a58-e053-2a95a90abe4f2026-06-21Warnings, Adverse reactionsExact identifier
rxcui: 314200
unii: 6871619Q5X
PantoprazolePANTOPRAZOLECoupler LLC549da3e8-f223-2ee7-e063-6394a90a25d82026-06-19Warnings, Adverse reactionsExact identifier
rxcui: 251872
unii: 6871619Q5X
PantoprazolePANTOPRAZOLESt. Mary's Medical Park Pharmacyed264262-21bb-1bae-e053-2995a90a8a5e2026-06-17Warnings, Adverse reactionsExact identifier
rxcui: 251872
unii: 6871619Q5X

Reported adverse events (FAERS/openFDA)#

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