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 6 of 7 · 139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PANTOPRAZOLE SODIUMPANTOPRAZOLENuCare Pharmaceuticals,Inc.b2abc159-e450-99dc-e053-2a95a90abe6a2024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMNuCare Pharmaceuticals, Inc.4fbec80c-b38d-122c-e054-00144ff88e882024-07-15Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
PANTOPRAZOLE SODIUMPANTOPRAZOLEProficient Rx LP50a278de-bd16-417c-a741-81bfe0d745f22024-07-01Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole Sodium DRPANTOPRAZOLE SODIUMAdvanced Rx of Tennessee, LLC1c46140c-2399-5ca3-e063-6394a90af33b2024-06-27Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMNuCare Pharmaceuticals,Inc.924a80b9-de48-90c0-e053-2995a90a00e12024-06-19Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
PANTOPRAZOLE SODIUMPANTOPRAZOLENuCare Pharmaceuticals,Inc.8748a588-a1e5-9dfc-e053-2a95a90a846c2024-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMNuCare Pharmaceuticals,Inc.88f408cf-1b3e-4d7a-e053-2a95a90a369f2024-06-14Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMNCS HealthCare of KY, LLC dba Vangard Labs1680b4ed-d5b0-4fd9-b1d1-04df6a2138be2024-06-12Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMBryant Ranch Prepack7d51104d-b135-421f-8425-03b5772e71032024-05-20Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMAsclemed USA, Inc.138b30cb-6b28-450e-9e7a-42576cc765452024-05-01Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMA-S Medication Solutions485212d4-caee-4a55-8299-87a28d6bd8f02024-04-29Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
PANTOPRAZOLE SODIUMPANTOPRAZOLEA-S Medication Solutions39ba58cc-e4ef-4b82-a0f3-9583fa123a382024-04-25Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
PANTOPRAZOLE SODIUMPANTOPRAZOLEA-S Medication Solutions3a8fa326-ad75-4b6d-8832-0a2357eeca2f2024-04-25Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMBryant Ranch Prepack3e5421ef-0875-4a04-b17d-95cca0052c832024-04-04Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
PANTOPRAZOLE SODIUMPANTOPRAZOLEBryant Ranch Prepack617bb464-5357-472f-8e9d-61aae5b2ebef2024-04-03Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMGolden State Medical Supply, Inc.d6aae78e-308b-7072-e053-2a95a90aaa102024-03-29Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
PANTOPRAZOLE SODIUMPANTOPRAZOLEAsclemed USA, Inc.3540d01c-da0e-477e-9e90-994b96deb1d62024-03-13Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
PANTOPRAZOLE SODIUMPANTOPRAZOLEAsclemed USA, Inc.ff15c4f1-8869-4422-9631-dc488e09e5832024-02-14Warnings, Adverse reactionsExact identifier
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
unii: 6871619Q5X

Reported adverse events (FAERS/openFDA)#

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