FDA.reportPublic FDA data

NDC 80425-0133-01 - 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
80425-0133
Requested NDC
80425-0133-01
Package NDCs from labels
80425-0133-3, 80425-0133-2, 80425-0133-1, 80425-0133-01
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
80425-0133-1Pantoprazole SodiumDR30 in 1 BOTTLETABLET, DELAYED RELEASE309
80425-0133-2Pantoprazole SodiumDR60 in 1 BOTTLETABLET, DELAYED RELEASE609
80425-0133-3Pantoprazole SodiumDR90 in 1 BOTTLETABLET, DELAYED RELEASE909

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0133PANTOPRAZOLE SODIUM DR (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]9Current NDC, Legacy NDC, 3 package rows20250101_bd4759ac-46b5-6903-e053-2a95a90a6319.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0133-1EA - Each80425-01330f55e92b-0d43-402f-8fda-9d2c62a28aac12023-04-07
80425-0133-2EA - Each80425-0133a0ce25ef-3ad1-4dde-931a-0ef255b0b95e12023-04-07
80425-0133-3EA - Each80425-013313c7d2f8-3fce-4fb9-89a4-42818217f34612023-04-07

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 7 of 7 · 136 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pantoprazole SodiumPANTOPRAZOLE SODIUMCamber Pharmaceuticals, Inc.ee6278c0-d8c0-417c-a65c-b522ff76fe442023-11-02Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
PantoprazolePANTOPRAZOLEDr.Reddy's Laboratories Limited564709e8-358f-c185-4ecb-b3849c3fe59c2023-08-30Warnings, Adverse reactionsExact identifier
rxcui: 251872
rxcui: 314200
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMMylan Pharmaceuticals Inc.56ad5b97-8e5f-48a5-b2ba-a5484b43d0182023-08-15Warnings, Adverse reactionsExact identifier
rxcui: 251872
rxcui: 314200
unii: 6871619Q5X
PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMSun Pharmaceutical Industries, Inc.38353b9e-63bd-47e8-b7cb-b198d1e901f92023-08-03Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMA-S Medication Solutionsf1eb666a-120d-47fd-8c9f-73cef839294a2023-07-31Warnings, Adverse reactionsExact identifier
rxcui: 314200
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMLannett Company, Inc.e7705bf6-e473-4b9c-bb5d-57e26ffe7b972023-07-21Warnings, Adverse reactionsExact identifier
rxcui: 251872
rxcui: 314200
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMHikma Pharmaceuticals USA Inc.1e102c44-232b-4aaf-b457-2a740c47193a2023-07-19Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMHikma Pharmaceuticals USA Inc.b02f3f85-8f9b-4d06-8eae-73e592626f3e2023-07-10Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
PANTOPRAZOLE SODIUMPANTOPRAZOLEAphena Pharma Solutions - Tennessee, LLCc10e9c12-e39d-4b0b-bd4c-10d3e9a4cf342023-02-17Warnings, Adverse reactionsExact identifier
application number: ANDA202882
rxcui: 251872
unii: 6871619Q5X
PANTOPRAZOLE SODIUMPANTOPRAZOLEXLCare Pharmaceuticals Inc.17468dbf-84b6-4c53-9ad5-341350d2cfab2023-01-17Warnings, Adverse reactionsExact identifier
application number: ANDA202882
rxcui: 251872
rxcui: 314200
unii: 6871619Q5X
PANTOPRAZOLE SODIUMPANTOPRAZOLEAphena Pharma Solutions - Tennessee, LLCe3f711d8-b9d3-46a6-8bf9-6af1cc77003e2022-07-15Warnings, Adverse reactionsExact identifier
application number: ANDA202882
rxcui: 314200
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMProficient Rx LPa03aa46f-9eb5-4cf4-addf-745d94af82612022-06-01Warnings, Adverse reactionsExact identifier
rxcui: 314200
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLEProficient Rx LPa7dc4321-331d-49af-976c-cfd69d0055d92022-05-02Warnings, Adverse reactionsExact identifier
rxcui: 251872
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMNovadoz Pharmaceuticals LLC1172bc4e-1700-402f-8262-97f05bac0d092022-03-03Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
PANTOPRAZOLE SODIUMPANTOPRAZOLEProficient Rx LPdce2e97a-cd92-46b9-9444-91739bdcd5262019-11-01Warnings, Adverse reactionsExact identifier
application number: ANDA202882
rxcui: 251872
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLEProficient Rx LP6d03491f-20c6-4878-9741-2e21e221eff22019-11-01Warnings, Adverse reactionsExact identifier
rxcui: 314200
unii: 6871619Q5X

Reported adverse events (FAERS/openFDA)#

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