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 43 of 53 · 1,053 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PANTOPRAZOLE SODIUMPANTOPRAZOLEProficient Rx LP50a278de-bd16-417c-a741-81bfe0d745f22024-07-01Warnings, Adverse reactionsExact identifier
rxcui: 314200
unii: 6871619Q5X
EMFARGENTUM NITRICUM, ARNICA MONTANA, BAPTISIA TINCTORIA, CINCHONA OFFICINALIS, GALIUM APARINE, HEPAR SUIS, NATRUM CARBONICUM, PANAX GINSENG, PHOSPHORICUM ACIDUM, PHOSPHORUS, RHODODENDRON CHRYSANTHUM, STRONTIUM CARBONICUM, SULPHUR IODATUM, THUJA OCCIDENTALIS, X-RAYLiddell Laboratories, Inc.3fa1b8d3-7c09-431b-b843-03b2ef8a92b12024-07-01WarningsExact identifier
unii: 45P3261C7T
Pantoprazole Sodium DRPANTOPRAZOLE SODIUMAdvanced Rx of Tennessee, LLC1c46140c-2399-5ca3-e063-6394a90af33b2024-06-27Warnings, Adverse reactionsExact identifier
application number: ANDA202038
rxcui: 251872
unii: 6871619Q5X
Genuine First Aid Alcohol Cleansing PadISOPROPYL ALCOHOLGFA Production(Xiamen) Co.,Ltdd8842561-f61e-4cac-80d6-001e5369f0d12024-06-25WarningsExact identifier
unii: ND2M416302
Pantoprazole SodiumPANTOPRAZOLE SODIUMNuCare Pharmaceuticals,Inc.924a80b9-de48-90c0-e053-2995a90a00e12024-06-19Warnings, Adverse reactionsExact identifier
application number: ANDA202038
rxcui: 251872
unii: 6871619Q5X
PANTOPRAZOLE SODIUMPANTOPRAZOLENuCare Pharmaceuticals,Inc.8748a588-a1e5-9dfc-e053-2a95a90a846c2024-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 314200
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMNuCare Pharmaceuticals,Inc.88f408cf-1b3e-4d7a-e053-2a95a90a369f2024-06-14Warnings, Adverse reactionsExact identifier
application number: ANDA202038
rxcui: 314200
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMNCS HealthCare of KY, LLC dba Vangard Labs1680b4ed-d5b0-4fd9-b1d1-04df6a2138be2024-06-12Warnings, Adverse reactionsExact identifier
application number: ANDA202038
rxcui: 251872
unii: 6871619Q5X
SwabsISOPROPYL ALCOHOLMcKesson4650c945-8e38-5ad9-e054-00144ff8d46c2024-06-07WarningsExact identifier
unii: ND2M416302
CalamineFERRIC OXIDE REDNuCare Pharmaceuticals,Inc.66e98554-e158-a519-e053-2a91aa0a67832024-06-06Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Pantoprazole SodiumPANTOPRAZOLE SODIUMBryant Ranch Prepack7d51104d-b135-421f-8425-03b5772e71032024-05-20Warnings, Adverse reactionsExact identifier
rxcui: 314200
unii: 6871619Q5X
IntimateNATRUM CARBONICUM, SACCHARUM OFFICINALE, LITHIUM CARBONICUM, PLACENTA TOTALIS SUIS, LAC CANINUM, ANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, GERMANIUM METALLICUM, HELLEBORUS NIGER, MAGNESIA OXYDATA, RHUS GLABRA, STRAMONIUM, THUJA OCCIDENTALIS, DNA (HUMAN), OXYTOCIN, HYDROGEN, NEON, LAC MATERNA HUMANUMDeseret Biologicals, Inc.ca0447c1-606e-443a-b789-7d65143fec282024-05-13WarningsExact identifier
unii: 45P3261C7T
Debrox KidsISOPROPYL ALCOHOLMedtech Products Inc.f42eee70-c4ee-44ad-85d5-a06d98ecb8b02024-05-09WarningsExact identifier
unii: ND2M416302
EnviroclenzBERBERIS VULGARIS, CARDUUS MARIANUS, CHELIDONIUM MAJUS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, STILLINGIA SYLVATICA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, GERMANIUM SESQUIOXIDE, PHYTOLACCA DECANDRA, ACETONE, AMMONIUM MURIATICUM, BENZINUM, PROPYLENE GLYCOL, SODIUM LAURYL SULFATE, SODIUM TRIPOLYPHOSPHATE, TEREBINTHINA, METHANOL, CHLORINUM, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUMDeseret Biologicals, Inc.92816bbe-96d6-45fc-9929-d3e6df394a332024-05-02WarningsExact identifier
unii: 6DC9Q167V3
Pantoprazole SodiumPANTOPRAZOLE SODIUMAsclemed USA, Inc.138b30cb-6b28-450e-9e7a-42576cc765452024-05-01Warnings, Adverse reactionsExact identifier
application number: ANDA202038
rxcui: 251872
rxcui: 314200
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMA-S Medication Solutions485212d4-caee-4a55-8299-87a28d6bd8f02024-04-29Warnings, Adverse reactionsExact identifier
application number: ANDA202038
rxcui: 314200
unii: 6871619Q5X
Isopropyl AlcoholISOPROPYL ALCOHOLJHK Incabae6a80-e859-47b5-8e34-d391eb8545832024-04-26WarningsExact identifier
unii: ND2M416302
PANTOPRAZOLE SODIUMPANTOPRAZOLEA-S Medication Solutions39ba58cc-e4ef-4b82-a0f3-9583fa123a382024-04-25Warnings, Adverse reactionsExact identifier
rxcui: 251872
unii: 6871619Q5X
PANTOPRAZOLE SODIUMPANTOPRAZOLEA-S Medication Solutions3a8fa326-ad75-4b6d-8832-0a2357eeca2f2024-04-25Warnings, Adverse reactionsExact identifier
rxcui: 314200
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMBryant Ranch Prepack3e5421ef-0875-4a04-b17d-95cca0052c832024-04-04Warnings, Adverse reactionsExact identifier
rxcui: 314200
unii: 6871619Q5X

Reported adverse events (FAERS/openFDA)#

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