FDA.reportPublic FDA data

NDC 65219-385-01 - 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
65219-385
Requested NDC
65219-385-01
Package NDCs from labels
65219-385-01, 65219-385-10
Manufacturer
Fresenius Kabi USA, 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 - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65219-385-01Pantoprazole Sodium10 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,101
65219-385-10Pantoprazole Sodium10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65219-385PANTOPRAZOLE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]1Current NDC, 2 package rows20250131_340b57c2-bcf8-4f46-b522-886daaf80351.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65219-385-01EA - Each65219-3858fdbbe9f-4c55-452d-aa3d-fc51ee3f4ef712025-07-08
65219-385-10EA - Each65219-385d8dc8dac-f85e-4509-ba04-9eca32da047012025-06-13

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 4 of 7 · 136 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PantoprazolePANTOPRAZOLEPHOENIX RX LLC43fc6326-cfe6-7d1c-e063-6394a90abc242025-11-19Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMCardinal Health 107, LLC4ba4c797-3f97-4d85-971e-7b17bdf892212025-11-06Warnings, Adverse reactionsExact identifier
rxcui: 283669
unii: 6871619Q5X
PantoprazolePANTOPRAZOLEAdvanced Rx of Tennessee, LLC4136d983-75fa-9604-e063-6294a90aaac62025-10-15Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMCardinal Health 107, LLC362229c5-7b28-4563-aa62-d97d060054802025-10-13Warnings, Adverse reactionsExact identifier
rxcui: 283669
unii: 6871619Q5X
PANTOPRAZOLE SODIUM I.V.PANTOPRAZOLE SODIUMPiramal Critical Care0696b10c-972b-9dcf-e063-6294a90a10342025-10-07Warnings, Adverse reactionsExact identifier
rxcui: 283669
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMPD-Rx Pharmaceuticals, Inc.b422c5eb-9a6d-4f8c-863d-ca515ec780c22025-10-02Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLEBryant Ranch Prepackd212e8ec-f7ff-4727-a83e-0edc4ca7e6d12025-09-26Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole sodium delayed-releasePANTOPRAZOLE SODIUM DELAYED-RELEASELifestar Pharma LLC0502f935-af7a-4f1e-8c3e-29e20647c8852025-09-08Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
PANTOPRAZOLE SODIUM I.V.PANTOPRAZOLE SODIUMSandoz Inc22b71a1d-87f8-43ba-b53d-53ca3f70c63e2025-07-30Warnings, Adverse reactionsExact identifier
rxcui: 283669
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMDevatis Inc.13c337e7-1e7b-47bd-9f88-92b0d548ca9c2025-07-30Warnings, Adverse reactionsExact identifier
rxcui: 283669
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMMylan Institutional Inc.a9b0d279-118b-4372-bd51-d4bad9c1cfca2025-07-22Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMMeitheal Pharmaceuticals Inc.014f9762-6948-46b7-8659-5c89f35ad8bf2025-06-27Warnings, Adverse reactionsExact identifier
rxcui: 283669
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMAphena Pharma Solutions - Tennessee, LLCc9bc288b-e84c-4e31-a769-c87a592260862025-06-09Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Protonix I.V.PANTOPRAZOLE SODIUMCardinal Health 107, LLC3cde88e6-28f2-4cbe-8c3f-770b05cc0e1b2025-04-22Warnings, Adverse reactionsExact identifier
rxcui: 283669
unii: 6871619Q5X
PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUM INJECTIONAlembic Pharmaceuticals Limited02ee7ed6-217f-4128-bbbb-b9390475a65b2025-04-07Warnings, Adverse reactionsExact identifier
rxcui: 283669
unii: 6871619Q5X
PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUM INJECTIONAlembic Pharmaceuticals Inc.a9e5fac6-2db6-4311-a98b-eb3f0dde19d62025-04-07Warnings, Adverse reactionsExact identifier
rxcui: 283669
unii: 6871619Q5X
PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMRising Pharma Holdings, Inc.91a6b13f-457f-4136-9541-c4adb9c3c35c2025-04-02Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMAurobindo Pharma Limitedb3cec41e-e98b-470a-8ba2-c315370239892025-04-02Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
PANTOPRAZOLE SODIUM DELAYED-RELEASE delayed releasePANTOPRAZOLE SODIUM GRANULESCipla USA Inc.195e06db-b76c-4470-b6a5-a3979c25046d2025-04-01Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole sodiumPANTOPRAZOLE SODIUMSun Pharmaceutical Industries Limitedeb3f58d4-0c69-4377-be45-c36099c98d332025-04-01Warnings, Adverse reactionsExact identifier
rxcui: 283669
unii: 6871619Q5X

Reported adverse events (FAERS/openFDA)#

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