FDA.reportPublic FDA data

NDC 0143-9284-01 - 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
0143-9284
Requested NDC
0143-9284-01
Package NDCs from labels
0143-9284-01, 0143-9284-10
Manufacturer
Cardinal Health 107, LLC
Effective date
2025-10-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Pantoprazole Sodium - Cardinal Health 107, LLCCardinal Health 107, LLC2025-10-13HUMAN PRESCRIPTION DRUG LABEL
Pantoprazole Sodium - Hikma Pharmaceuticals USA Inc.Hikma Pharmaceuticals USA Inc.2023-07-10HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9284-01Pantoprazole Sodium1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,113
0143-9284-10Pantoprazole Sodium10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,1013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9284PANTOPRAZOLE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]13Current NDC, Legacy NDC, 2 package rows20231031_b02f3f85-8f9b-4d06-8eae-73e592626f3e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9284-01EA - Each0143-92849867232a-3b27-436a-826a-e60c5336b0f612017-11-06
0143-9284-10EA - Each0143-928465cbff8f-0d6b-4d90-92c1-4a26d19c0c5712017-11-06

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
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMMeitheal Pharmaceuticals Inc.c18aff31-f91e-4b6a-9713-52c9094c60822025-03-13Warnings, Adverse reactionsExact identifier
rxcui: 283669
unii: 6871619Q5X
Pantoprazole sodiumPANTOPRAZOLE SODIUMBE Pharmaceuticals Inc.52d5bc28-66df-43aa-bb1a-8ac4a2a7f6932025-03-07Warnings, Adverse reactionsExact identifier
rxcui: 283669
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
rxcui: 283669
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
rxcui: 283669
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
application number: NDA209463
rxcui: 283669
unii: 6871619Q5X
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
PANTOPRAZOLE SODIUMPANTOPRAZOLENuCare Pharmaceuticals,Inc.b2abc159-e450-99dc-e053-2a95a90abe6a2024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X

Reported adverse events (FAERS/openFDA)#

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