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 6 of 7 · 136 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pantoprazole SodiumPANTOPRAZOLE SODIUMNuCare Pharmaceuticals, Inc.4fbec80c-b38d-122c-e054-00144ff88e882024-07-15Warnings, Adverse reactionsExact identifier
rxcui: 314200
unii: 6871619Q5X
PANTOPRAZOLE SODIUMPANTOPRAZOLEProficient Rx LP50a278de-bd16-417c-a741-81bfe0d745f22024-07-01Warnings, Adverse reactionsExact identifier
application number: ANDA202882
rxcui: 314200
unii: 6871619Q5X
Pantoprazole Sodium DRPANTOPRAZOLE SODIUMAdvanced Rx of Tennessee, LLC1c46140c-2399-5ca3-e063-6394a90af33b2024-06-27Warnings, Adverse reactionsExact identifier
rxcui: 251872
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMNuCare Pharmaceuticals,Inc.924a80b9-de48-90c0-e053-2995a90a00e12024-06-19Warnings, Adverse reactionsExact identifier
rxcui: 251872
unii: 6871619Q5X
PANTOPRAZOLE SODIUMPANTOPRAZOLENuCare Pharmaceuticals,Inc.8748a588-a1e5-9dfc-e053-2a95a90a846c2024-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202882
rxcui: 314200
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMNuCare Pharmaceuticals,Inc.88f408cf-1b3e-4d7a-e053-2a95a90a369f2024-06-14Warnings, Adverse reactionsExact identifier
rxcui: 314200
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMNCS HealthCare of KY, LLC dba Vangard Labs1680b4ed-d5b0-4fd9-b1d1-04df6a2138be2024-06-12Warnings, Adverse reactionsExact identifier
rxcui: 251872
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMBryant Ranch Prepack7d51104d-b135-421f-8425-03b5772e71032024-05-20Warnings, Adverse reactionsExact identifier
rxcui: 314200
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMAsclemed USA, Inc.138b30cb-6b28-450e-9e7a-42576cc765452024-05-01Warnings, Adverse reactionsExact identifier
rxcui: 251872
rxcui: 314200
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMA-S Medication Solutions485212d4-caee-4a55-8299-87a28d6bd8f02024-04-29Warnings, Adverse reactionsExact identifier
rxcui: 314200
unii: 6871619Q5X
PANTOPRAZOLE SODIUMPANTOPRAZOLEA-S Medication Solutions39ba58cc-e4ef-4b82-a0f3-9583fa123a382024-04-25Warnings, Adverse reactionsExact identifier
application number: ANDA202882
rxcui: 251872
unii: 6871619Q5X
PANTOPRAZOLE SODIUMPANTOPRAZOLEA-S Medication Solutions3a8fa326-ad75-4b6d-8832-0a2357eeca2f2024-04-25Warnings, Adverse reactionsExact identifier
application number: ANDA202882
rxcui: 314200
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMBryant Ranch Prepack3e5421ef-0875-4a04-b17d-95cca0052c832024-04-04Warnings, Adverse reactionsExact identifier
rxcui: 314200
unii: 6871619Q5X
PANTOPRAZOLE SODIUMPANTOPRAZOLEBryant Ranch Prepack617bb464-5357-472f-8e9d-61aae5b2ebef2024-04-03Warnings, Adverse reactionsExact identifier
application number: ANDA202882
rxcui: 314200
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMGolden State Medical Supply, Inc.d6aae78e-308b-7072-e053-2a95a90aaa102024-03-29Warnings, Adverse reactionsExact identifier
rxcui: 251872
rxcui: 314200
unii: 6871619Q5X
PANTOPRAZOLE SODIUMPANTOPRAZOLEAsclemed USA, Inc.3540d01c-da0e-477e-9e90-994b96deb1d62024-03-13Warnings, Adverse reactionsExact identifier
application number: ANDA202882
rxcui: 251872
rxcui: 314200
unii: 6871619Q5X
PANTOPRAZOLE SODIUMPANTOPRAZOLEAsclemed USA, Inc.ff15c4f1-8869-4422-9631-dc488e09e5832024-02-14Warnings, Adverse reactionsExact identifier
application number: ANDA202882
rxcui: 251872
rxcui: 314200
unii: 6871619Q5X
PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDEBaxter Healthcare Companya476e063-9450-4793-9a22-16b0a0a61cd02024-02-14Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
PantoprazolePANTOPRAZOLENorthStar RxLLC82f0103a-2b97-d210-6d7d-c627d60ad6942023-12-19Warnings, Adverse reactionsExact identifier
rxcui: 251872
rxcui: 314200
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMA-S Medication Solutions517d6b02-0e68-4d6b-98b3-eac0be457e6b2023-12-16Warnings, Adverse reactionsExact identifier
rxcui: 251872
unii: 6871619Q5X

Reported adverse events (FAERS/openFDA)#

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