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 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
application number: NDA209463
ndc (package): 55154-7477-5
ndc (product): 55154-7477
rxcui: 283669
spl id: 2e1a3814-c91d-49e3-a4f9-2c9db758fed1
spl set id: 362229c5-7b28-4563-aa62-d97d06005480
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.