FDA.reportPublic FDA data

NDC 65219-433-01 - Pantoprazole Sodium

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
65219-433
Requested NDC
65219-433-01
Package NDCs from labels
65219-433-01, 65219-433-15
Manufacturer
Fresenius Kabi USA, LLC
Effective date
2024-10-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Pantoprazole Sodium - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2024-10-17HUMAN PRESCRIPTION DRUG LABEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65219-433PANTOPRAZOLE SODIUM INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]6Legacy NDC20250228_c8271ff9-84e1-4e27-9646-130715be4bd4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65219-433-01EA - Each65219-4339bc30363-cd7e-4d34-b671-67107f15dd2b12021-09-07
65219-433-15EA - Each65219-43357da06cf-583e-4bcc-b615-49cd1730ed2212021-09-07

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 · 139 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
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
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMNuCare Pharmaceuticals,Inc.8aac1642-6cb0-6ad2-e053-2a95a90a4cbd2025-01-31Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
PantoprazolePANTOPRAZOLENuCare Pharmaceuticals, Inc.2bed1bae-519f-1bb9-e063-6294a90a795b2025-01-29Warnings, Adverse reactionsExact identifier
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
unii: 6871619Q5X
Pantoprazole Sodium DRPANTOPRAZOLE SODIUMAdvanced Rx of Tennessee, LLCb3277cb8-26d0-bce0-e053-2a95a90af6dd2024-12-31Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole Sodium DRPANTOPRAZOLE SODIUMAdvanced Rx Pharmacy of Tennessee, LLCc89a5396-1d94-c7fa-e053-2995a90a90632024-12-31Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole Sodium DRPANTOPRAZOLE SODIUMAdvanced Rx Pharmacy of Tennessee, LLCbd4759ac-46b5-6903-e053-2a95a90a63192024-12-31Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole Sodium DRPANTOPRAZOLE SODIUMAdvanced Rx Pharmacy of Tennessee, LLCd27e1fdd-e23f-0d60-e053-2a95a90a90872024-12-31Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole Sodium DRPANTOPRAZOLE SODIUMAdvanced Rx Pharmacy of Tennessee, LLCf5c9e3c6-d4b0-0ebe-e053-2995a90abe552024-12-31Warnings, Adverse reactionsExact identifier
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
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMCivica, Inc.c857dc41-7b47-4f26-a9f5-d76eb82b44ee2024-10-31Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
26d9d02b-69c3-448a-a6a7-9c205f948967c8271ff9-84e1-4e27-9646-130715be4bd42024-10-17Warnings, Adverse reactionsExact identifier
spl id: 26d9d02b-69c3-448a-a6a7-9c205f948967
spl set id: c8271ff9-84e1-4e27-9646-130715be4bd4
PANTOPRAZOLE SODIUMPANTOPRAZOLENuCare Pharmaceuticals,Inc.a9f32edf-e0b9-4e96-e053-2a95a90afbc82024-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
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

Reported adverse events (FAERS/openFDA)#

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