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 5 of 7 · 136 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pantoprazole SodiumPANTOPRAZOLE SODIUMA-S Medication Solutions81696241-17d5-4d35-9e59-8c28469ffd2c2025-03-14Warnings, Adverse reactionsExact identifier
rxcui: 314200
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMMeitheal Pharmaceuticals Inc.c18aff31-f91e-4b6a-9713-52c9094c60822025-03-13Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole sodiumPANTOPRAZOLE SODIUMBE Pharmaceuticals Inc.52d5bc28-66df-43aa-bb1a-8ac4a2a7f6932025-03-07Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
PantoprazolePANTOPRAZOLENuCare Pharmaceuticals,Inc.07ff83f9-7039-ac26-e063-6394a90a37ce2025-02-03Warnings, Adverse reactionsExact identifier
rxcui: 314200
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMNuCare Pharmaceuticals,Inc.8aac1642-6cb0-6ad2-e053-2a95a90a4cbd2025-01-31Warnings, Adverse reactionsExact identifier
rxcui: 314200
unii: 6871619Q5X
PantoprazolePANTOPRAZOLENuCare Pharmaceuticals, Inc.2bed1bae-519f-1bb9-e063-6294a90a795b2025-01-29Warnings, Adverse reactionsExact identifier
rxcui: 251872
unii: 6871619Q5X
PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMSun Pharmaceutical Industries, Inc.d9fcf6a2-3788-4955-84d9-3c319b13267c2025-01-22Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
PANTOPRAZOLE SODIUMPANTOPRAZOLEDIRECT RXa7e7c1ab-3e75-1ff8-e053-2995a90a75392025-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202882
rxcui: 251872
unii: 6871619Q5X
Pantoprazole Sodium DRPANTOPRAZOLE SODIUMAdvanced Rx of Tennessee, LLCb3277cb8-26d0-bce0-e053-2a95a90af6dd2024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 251872
unii: 6871619Q5X
Pantoprazole Sodium DRPANTOPRAZOLE SODIUMAdvanced Rx Pharmacy of Tennessee, LLCc89a5396-1d94-c7fa-e053-2995a90a90632024-12-31Warnings, Adverse reactionsExact identifier
application number: ANDA202882
rxcui: 314200
unii: 6871619Q5X
Pantoprazole Sodium DRPANTOPRAZOLE SODIUMAdvanced Rx Pharmacy of Tennessee, LLCbd4759ac-46b5-6903-e053-2a95a90a63192024-12-31Warnings, Adverse reactionsExact identifier
application number: ANDA202882
ndc (package): 80425-0133-1
ndc (package): 80425-0133-2
ndc (package): 80425-0133-3
ndc (product): 80425-0133
ndc11 (package): 80425013301
rxcui: 314200
spl id: 2a99a7c1-c4bc-2b01-e063-6294a90aa3b8
spl set id: bd4759ac-46b5-6903-e053-2a95a90a6319
unii: 6871619Q5X
Pantoprazole Sodium DRPANTOPRAZOLE SODIUMAdvanced Rx Pharmacy of Tennessee, LLCd27e1fdd-e23f-0d60-e053-2a95a90a90872024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 251872
unii: 6871619Q5X
Pantoprazole Sodium DRPANTOPRAZOLE SODIUMAdvanced Rx Pharmacy of Tennessee, LLCf5c9e3c6-d4b0-0ebe-e053-2995a90abe552024-12-31Warnings, Adverse reactionsExact identifier
application number: ANDA202882
rxcui: 251872
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMFresenius Kabi USA, LLC340b57c2-bcf8-4f46-b522-886daaf803512024-12-31Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMQuality Care Products, LLCa9fbf3b5-ddf4-4d3a-8b69-a0c38b3fa5e22024-12-19Warnings, Adverse reactionsExact identifier
rxcui: 251872
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMCivica, Inc.c857dc41-7b47-4f26-a9f5-d76eb82b44ee2024-10-31Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
PANTOPRAZOLE SODIUMPANTOPRAZOLENuCare Pharmaceuticals,Inc.a9f32edf-e0b9-4e96-e053-2a95a90afbc82024-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202882
rxcui: 314200
unii: 6871619Q5X
Pantoprazole sodiumPANTOPRAZOLE SODIUMAmerican Health Packaging423dac8b-bb1e-4456-9b6e-913c028b11bc2024-10-01Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMNorthStar RxLLC4494f9d0-a1c8-477f-9b4a-f65d7637d9ec2024-08-14Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
PANTOPRAZOLE SODIUMPANTOPRAZOLENuCare Pharmaceuticals,Inc.b2abc159-e450-99dc-e053-2a95a90abe6a2024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202882
rxcui: 251872
unii: 6871619Q5X

Reported adverse events (FAERS/openFDA)#

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