FDA.reportPublic FDA data

NDC 85534-0027-01 - 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
85534-0027
Requested NDC
85534-0027-01
Package NDCs from labels
85534-0027-0, 85534-0027-1, 85534-0027-2, 85534-0027-3, 85534-0027-4, 85534-0027-5, 85534-0027-01
Manufacturer
HAWAII REPACK, INC.
Effective date
2026-06-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Pantoprazole Sodium - HAWAII REPACK, INC.HAWAII REPACK, INC.2026-06-26HUMAN PRESCRIPTION DRUG LABEL

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 12 of 54 · 1,064 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pantoprazole SodiumPANTOPRAZOLEAmneal Pharmaceuticals LLCf3ded82a-cf0d-4844-944a-75f9f9215ff02026-03-03Warnings, Adverse reactionsExact identifier
rxcui: 251872
rxcui: 314200
unii: 6871619Q5X
CalamineFERRIC OXIDE REDOld East Main Co.c38c77fd-abbf-4c87-a9c0-a0e21ed3f97d2026-03-02Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
IsopropylISOPROPYL ALCOHOLOld East Main Co.ea6f3065-780e-4afc-a361-a2cb296ae4d52026-03-02Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLOld East Main Co.2a09f6c0-e9a6-4f48-bce1-6cf7345f2d872026-03-02Warnings, Adverse reactionsExact identifier
unii: ND2M416302
70%ISOPROPYL ALCOHOLOld East Main Co.3e7a7f3e-3e99-4999-95c2-1603aca08e892026-03-02Warnings, Adverse reactionsExact identifier
unii: ND2M416302
50% RubbingISOPROPYL ALCOHOLOld East Main Co.2b600254-2a70-4254-85fb-29b9adb56c9a2026-03-02Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl alcohol 91 percentISOPROPYL ALCOHOLTARGET Corporationc49f46c5-f9b2-4045-a31d-63cb222102332026-03-02WarningsExact identifier
unii: ND2M416302
Focus, Comprehension and LearningAGNUS CASTUS, AVENA SATIVA, BARYTA CARBONICA, CALCAREA CARBONICA, IGNATIA AMARA, LECITHIN, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, OLEANDER, PHOSPHORICUM ACIDUM, RNA AND ZINCUM METALLICUM.King Bio Inc.b2a4dd82-7dd4-4dff-8a03-770f524bce1f2026-03-02WarningsExact identifier
unii: 45P3261C7T
Isopropyl alcohol 91 percentISOPROPYL ALCOHOLSam's West, Inca9d6778a-e5ad-4e02-9142-4a932540eda72026-03-02WarningsExact identifier
unii: ND2M416302
CalamineFERRIC OXIDE REDChain Drug Marketing Association86ff4875-9007-4b7b-8f46-16cbd475d4bb2026-02-27Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineCALAMINE, PRAMOXINE HCLChain Drug Marketing Association6c848b98-f01c-40f2-a9aa-2af76cb370c82026-02-27Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Levico PrunusLEVICO PRUNUSUriel Pharmacy Inc.63db9374-8ee2-48cf-8799-454c958698082026-02-27WarningsExact identifier
unii: 1K09F3G675
Pantoprazole SodiumPANTOPRAZOLE SODIUMCardinal Health 107, LLC6b5ed424-2203-482f-bb85-2c97d9c356f22026-02-27Warnings, Adverse reactionsExact identifier
rxcui: 314200
unii: 6871619Q5X
Isopropyl AlcoholISOPROPYL ALCOHOLUnited Natural Foods, Inc. dba UNFI4eee73dd-039e-44a5-b380-21ff32efee222026-02-26Warnings, Adverse reactionsExact identifier
unii: ND2M416302
70%ISOPROPYL ALCOHOLUnited Natural Foods, Inc. dba UNFId39bc652-442d-4d91-9eba-a496636b95332026-02-26Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLUnited Natural Foods, Inc. dba UNFIf6be70d5-763c-42d8-9b4e-a55e84c747852026-02-26Warnings, Adverse reactionsExact identifier
unii: ND2M416302
PANTOPRAZOLE SODIUMPANTOPRAZOLEPD-Rx Pharmaceuticals, Inc.c1f37929-a981-4ace-95e6-ae6795a797b32026-02-25Warnings, Adverse reactionsExact identifier
rxcui: 314200
unii: 6871619Q5X
70% Isopropyl Rubbing AlcoholISOPROPYL RUBBING ALCOHOLBetter Living Brands, LLC4817df03-05a2-4e85-bec2-a06f9d57d0b82026-02-24Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLBetter Living Brands, LLC4031ea5d-cba4-44f5-9a81-0cab2367d97e2026-02-24Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLBetter Living Brands, LLC6391432a-a5b8-4528-88a6-862bc2062f682026-02-24Warnings, Adverse reactionsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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