FDA.reportPublic FDA data

NDC 63629-9134-01 - Fluconazole

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
63629-9134
Requested NDC
63629-9134-01
Package NDCs from labels
63629-9134-1, 63629-9134-01
Manufacturer
Bryant Ranch Prepack
Effective date
2024-10-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fluconazole - Bryant Ranch PrepackBryant Ranch Prepack2024-10-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-9134-1Fluconazole30 in 1 BOTTLETABLET30106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9134FLUCONAZOLE TABLET [BRYANT RANCH PREPACK]106Current NDC, Legacy NDC, 1 package rows20241024_c94b8ecf-249f-42d6-a030-4cfb83fddb08.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-9134-1EA - Each63629-9134e13ac9d2-3541-4e04-bc47-25fa4b86387012022-03-09

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 7 of 10 · 199 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gut Brain SpectrumABROTANUM (ARTEMISIA ABROTANUM), AETHUSA CYNAPIUM, BAPTISIA TINCTORIA, CICUTA VIROSA, CUPRUM METALLICUM, MEZEREUM, BUFO RANA, LAC MATERNA HUMANUM, SACCHARUM OFFICINALE, SEROTONIN (HYDROCHLORIDE), ALUMINA, CALCAREA PHOSPHORICA, CANDIDA ALBICANS, CARCINOSIN, LAC CANINUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, PROPIONIC ACID, SULPHUR, THUJA OCCIDENTALIS, FORMALINUM, MORBILLINUMEnergique, Inc.adfee6ce-05b0-4955-bf5f-9612b8db4c782024-12-26WarningsExact identifier
unii: LMI26O6933
Household DetoxALLIUM SATIVUM, ALUMINA, ANTIPYRINUM, BENZINUM, BISPHENOL A, CARBOLICUM ACIDUM, CARBONEUM SULPHURATUM, DIETHYLSTILBESTROL, DIOXIN, FOLLICULINUM, FORMALINUM, GLYPHOSATE, METHYLPARABEN, NAPHTHALINUM, PARAFFINUM, PETROLEUM, PHENACETINUM, PTELEA TRIFOLIATA, SODIUM CARBOXYMETHYL CELLULOSE, TEFLONDeseret Biologicals, Inc.7f79058a-c35a-429a-be3c-4cff1d6570872024-12-13WarningsExact identifier
unii: LMI26O6933
FluconazoleFLUCONAZOLEHospira, Inc22ebc3fb-ee81-44bd-a6e3-5e759ee724a82024-12-05Warnings, Adverse reactionsExact identifier
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEA-S Medication Solutions177322f4-9526-40cb-9e5d-bc24e8fb02db2024-11-18Warnings, Adverse reactionsExact identifier
rxcui: 197699
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEAurobindo Pharma Limited6ebf24fd-41cd-4b3c-8176-a1436253ba2d2024-11-14Warnings, Adverse reactionsExact identifier
rxcui: 197698
rxcui: 197699
rxcui: 197700
rxcui: 197701
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEProficient Rx LP4eaf5b04-c026-4a49-879f-2925b375f9032024-11-01Warnings, Adverse reactionsExact identifier
rxcui: 197699
unii: 8VZV102JFY
VaccistatBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, ALUMINA, ANTIMONIUM TARTARICUM, MEZEREUM, NATRUM MURIATICUM, MERCURIUS SOLUBILIS, SILICEA, THUJA OCCIDENTALIS, MALANDRINUM, VARIOLINUMEnergique, Inc.8c8d63b6-763a-44f8-87ef-e83a89ec37762024-10-31WarningsExact identifier
unii: LMI26O6933
VaccistatBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, ALUMINA, ANTIMONIUM TARTARICUM, MEZEREUM, NATRUM MURIATICUM, MERCURIUS SOLUBILIS, SILICEA, THUJA OCCIDENTALIS, MALANDRINUM, VARIOLINUMEnergique, Inc.5205cc3e-c9bc-48e9-9c9b-959a9be78b852024-10-31WarningsExact identifier
unii: LMI26O6933
FLUCONAZOLEFLUCONAZOLEChartwell RX, LLCf86ea347-78f5-43b8-9574-a52569a4237b2024-10-28Warnings, Adverse reactionsExact identifier
rxcui: 197698
rxcui: 197699
rxcui: 197700
rxcui: 197701
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEBryant Ranch Prepackc94b8ecf-249f-42d6-a030-4cfb83fddb082024-10-08Warnings, Adverse reactionsExact identifier
application number: ANDA078423
ndc (package): 63629-9134-1
ndc (product): 63629-9134
ndc11 (package): 63629913401
rxcui: 197698
spl id: 6884e445-29ae-4168-9512-299bea7c57c1
spl set id: c94b8ecf-249f-42d6-a030-4cfb83fddb08
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEBryant Ranch Prepack877aea10-b019-4eeb-8a1e-e6ac583df9662024-10-08Warnings, Adverse reactionsExact identifier
application number: ANDA078423
rxcui: 197700
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEBryant Ranch Prepackb94ca865-ab2f-466c-9913-dde9376e45332024-10-08Warnings, Adverse reactionsExact identifier
application number: ANDA078423
rxcui: 197701
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEBryant Ranch Prepack6b2bc10f-21a8-422a-9ea3-ed7788ffce6b2024-10-07Warnings, Adverse reactionsExact identifier
application number: ANDA078423
rxcui: 197700
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEBryant Ranch Prepacka499c43e-0454-4a8c-a547-31e9816babdd2024-10-07Warnings, Adverse reactionsExact identifier
rxcui: 197699
unii: 8VZV102JFY
Energy CatalystVISCUM ALBUM, COBALT GLUCONATE, CUPRUM SULPHURICUM, FERROUS FUMARATE, MAGNESIUM ASPARTATE, MANGANESE GLUCONATE, PHOSPHORUS, POTASSIUM ASPARTATE, SODIUM MOLYBDATE, ADENOSINUM, CYCLOPHOSPHORICUM, CERIUM OXALICUM, NICKEL ACETATE, ALUMINIUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, ARSENICUM ALBUM, AURUM METALLICUM, BARYTA CARBONICA, BERYLLIUM METALLICUM, BISMUTHUM METALLICUM, BROMIUM, CADMIUM METALLICUM, CERIUM METALLICUM, CESIUM CHLORIDE, DYSPROSIUM METALLICUM, ERBIUM METALLICUM, ALUMINA,Deseret Biologicals, Inc.99529dd4-f8ab-4348-8b65-dc8c89e1ad542024-10-04WarningsExact identifier
unii: LMI26O6933
Household DetoxPTELEA TRIFOLIATA, ALLIUM SATIVUM, PETROLEUM, CARBONEUM SULPHURATUM, ALUMINA, BENZINUM, BISPHENOL A, CARBOLICUM ACIDUM, FORMALINUM, GLYPHOSATE, METHYLPARABEN, NAPHTHALINUM, PARAFFINUM, PHENACETINUM, SODIUM CARBOXYMETHYL CELLULOSE, FOLLICULINUM, ANTIPYRINUM, DIOXIN, DIETHYLSTILBESTROL, TEFLONDeseret Biologicals, Inc.7e32c1f4-c88e-43d0-9f6c-de736d358d462024-09-27WarningsExact identifier
unii: LMI26O6933
Gut Brain SpectrumABROTANUM (ARTEMISIA ABROTANUM), AETHUSA CYNAPIUM, BAPTISIA TINCTORIA, CICUTA VIROSA, CUPRUM METALLICUM, MEZEREUM, BUFO RANA, LAC MATERNA HUMANUM, SACCHARUM OFFICINALE, SEROTONIN (HYDROCHLORIDE), ALUMINA, CALCAREA PHOSPHORICA, CANDIDA ALBICANS, CARCINOSIN, HELIUM, LAC CANINUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, SULPHUR, THUJA OCCIDENTALIS, FORMALINUM, MORBILLINUMEnergique, Inc.cb1566a4-92d4-4f1a-9211-f0c538a83c272024-09-27WarningsExact identifier
unii: LMI26O6933
FluconazoleFLUCONAZOLEBryant Ranch Prepack3f743514-615e-4e78-8321-24c545a7752f2024-09-06Warnings, Adverse reactionsExact identifier
rxcui: 197700
unii: 8VZV102JFY
FluconazoleFLUCONAZOLERising Pharma Holdings, Inc.ccbe0991-27a1-4ddb-bfc7-1b3422e533902024-08-22Warnings, Adverse reactionsExact identifier
unii: 8VZV102JFY
FluconazoleFLUCONAZOLENorthStar Rx LLCafde17e7-b95b-4cd5-97eb-e361724014bd2024-08-22Warnings, Adverse reactionsExact identifier
unii: 8VZV102JFY

Reported adverse events (FAERS/openFDA)#

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