FDA.reportPublic FDA data

NDC 85534-0061-01 - 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
85534-0061
Requested NDC
85534-0061-01
Package NDCs from labels
85534-0061-0, 85534-0061-1, 85534-0061-2, 85534-0061-3, 85534-0061-4, 85534-0061-5, 85534-0061-01
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 5 of 54 · 1,064 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pantoprazole SodiumPANTOPRAZOLE SODIUMEugia US LLC9bed093a-9586-4c82-a2b7-c68f89d0faef2026-07-09Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Freskaro Ear Drops for SwimmersFRESKARO EAR DROPS FOR SWIMMERSPharma Nobis, LLC4f724d85-cd38-41da-e063-6394a90a9fd72026-07-08WarningsExact identifier
unii: ND2M416302
70%ISOPROPYL ALCOHOLSave-A-Lot Food Stores Ltda592326c-c062-4ebf-b8dd-83f7e6f2f22b2026-07-07Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Pantoprazole SodiumPANTOPRAZOLE SODIUMREMEDYREPACK INC.f38a6df2-1dd4-48bf-9ec4-1113ce492e782026-07-03Warnings, Adverse reactionsExact identifier
application number: ANDA202038
rxcui: 314200
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMUnit Dose Solutions, Inc.558dc7e1-dfd5-d3d7-e063-6394a90ab9c32026-07-01Warnings, Adverse reactionsExact identifier
application number: ANDA202038
rxcui: 314200
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMREMEDYREPACK INC.f313159c-115a-4cf6-b32e-9ddc833fd51c2026-07-01Warnings, Adverse reactionsExact identifier
application number: ANDA202038
rxcui: 314200
unii: 6871619Q5X
American Red Cross IPA 50% 6ozAMERICAN RED CROSS IPA 50% 6OZTSM BRANDS LLC29195bac-b096-ab8d-e063-6394a90a424a2026-07-01WarningsExact identifier
unii: ND2M416302
American Red Cross 6oz, 50% Isopropyl AlcoholAMERICAN RED CROSS 6 OZ, 50% ISOPROPYL ALCOHOL SPRAYMY IMPORTS USA LLC2929d580-cfff-e2b6-e063-6394a90a79aa2026-07-01WarningsExact identifier
unii: ND2M416302
McKesson Alcohol Prep PadISOPROPYL ALCOHOLMcKesson Medical-Surgicala8e759f3-91b1-44ae-960a-3a6cd4f746ce2026-06-30WarningsExact identifier
unii: ND2M416302
Tinted Isopropyl AlcoholISOPROPYL ALCOHOLMedical Chemical Corporationf3c1c8a3-6b34-46cf-845e-c89db8f096f12026-06-30WarningsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLMedical Chemical Corporationa04239d8-0fa9-4c00-aa81-d7a1242bc9312026-06-30WarningsExact identifier
unii: ND2M416302
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYTarget Corporation36602b7a-99c0-f6a4-e063-6294a90a87582026-06-29WarningsExact identifier
unii: 1K09F3G675
PANTOPRAZOLE SODIUMPANTOPRAZOLESportpharm LLCb58c376e-616b-4970-a375-52ff630e7f092026-06-29Warnings, Adverse reactionsExact identifier
rxcui: 251872
rxcui: 314200
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMUnit Dose Solutions, Inc.5566b4b1-b4f5-4020-e063-6394a90a52572026-06-29Warnings, Adverse reactionsExact identifier
application number: ANDA202038
rxcui: 251872
unii: 6871619Q5X
PANTOPRAZOLE SODIUMPANTOPRAZOLEHAWAII REPACK, INC.f85e6d64-1ddc-4f4a-86dc-0749081a6a5f2026-06-27Warnings, Adverse reactionsExact identifier
rxcui: 251872
rxcui: 314200
unii: 6871619Q5X
Macks Dry n ClearEAR DRYING AIDMcKeon Products Inc1ea1da54-2412-c25c-e063-6294a90aa2642026-06-26WarningsExact identifier
unii: ND2M416302
Lights Alcohol WipesISOPROPYL ALCOHOLLights Medical Manufacture Co., Ltd.f9601021-4c52-4b48-96c1-b25fe8fef8b12026-06-26WarningsExact identifier
unii: ND2M416302
Pantoprazole SodiumPANTOPRAZOLE SODIUMHAWAII REPACK, INC.f403c94d-68b7-43df-8c8e-c9fef3309cfc2026-06-26Warnings, Adverse reactionsExact identifier
application number: ANDA202038
ndc (package): 85534-0061-1
ndc (package): 85534-0061-2
ndc (package): 85534-0061-5
ndc (package): 85534-0061-0
ndc (package): 85534-0027-4
ndc (package): 85534-0061-3
ndc (package): 85534-0027-2
ndc (package): 85534-0027-0
ndc (package): 85534-0027-1
ndc (package): 85534-0061-4
ndc (package): 85534-0027-5
ndc (package): 85534-0027-3
ndc (product): 85534-0061
ndc (product): 85534-0027
ndc11 (package): 85534006101
rxcui: 251872
rxcui: 314200
spl id: 5522a929-a1b7-d0e4-e063-6394a90ae106
spl set id: f403c94d-68b7-43df-8c8e-c9fef3309cfc
unii: 6871619Q5X
Equate Swimmers Instant Ear DryEQUATE SWIMMERS INSTANT EAR DRYWalmart Stores, Inc76b58a7a-48cf-866c-e053-2a91aa0a7e632026-06-26WarningsExact identifier
unii: ND2M416302
Lights Medium AlcoholISOPROPYL ALCOHOLLights Medical Manufacture Co., Ltd.873e0c9d-e0aa-44bb-a1f4-4474584790232026-06-25WarningsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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