FDA.reportPublic FDA data

NDC 63629-8970-01 - 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
63629-8970
Requested NDC
63629-8970-01
Package NDCs from labels
63629-8970-1, 63629-8970-01
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
63629-8970-1Fluconazole30 in 1 BOTTLETABLET30104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8970FLUCONAZOLE TABLET [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 1 package rows20241024_b94ca865-ab2f-466c-9913-dde9376e4533.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8970-1EA - Each63629-89704ef0cdb5-2cf6-441f-9ce7-48c2f44cb28412022-03-09

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 9 of 10 · 195 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AluminaALUMINUM OXIDEBoiron84b528ab-23f7-e42c-e053-2991aa0acc4d2023-10-18Exact identifier
unii: LMI26O6933
FluconazoleFLUCONAZOLEProficient Rx LPfc4fccd8-19d2-4704-afa9-9ce0ab1d2b5f2023-10-01Warnings, Adverse reactionsExact identifier
rxcui: 197700
unii: 8VZV102JFY
FLUCONAZOLEFLUCONAZOLEAsclemed USA, Inc.3208dc64-6117-4b2d-9008-76a819cef7d72023-09-01Warnings, Adverse reactionsExact identifier
rxcui: 197699
unii: 8VZV102JFY
AluminaALUMINUM OXIDEBoiron84b4fd05-f2cc-3b45-e053-2991aa0ad5d92023-07-11Exact identifier
unii: LMI26O6933
AluminaALUMINAHahnemann Laboratories, INC.ffdbdb70-8666-f0c6-e053-6394a90a65962023-07-06Exact identifier
unii: LMI26O6933
AluminaALUMINUM OXIDEBoirona9603cb0-7c3b-11e6-8197-424c583030312023-06-26Exact identifier
unii: LMI26O6933
AluminaALUMINUM OXIDEBoiron8426bd35-372c-4417-e053-2a91aa0a79032023-04-11Exact identifier
unii: LMI26O6933
FluconazoleFLUCONAZOLEProficient Rx LPfa2fa2f8-f3a6-4bc0-943c-03dabd0f15812023-04-01Warnings, Adverse reactionsExact identifier
rxcui: 197699
unii: 8VZV102JFY
AluminaALUMINUM OXIDEBoiron84274737-2fed-d542-e053-2a91aa0a1ead2023-03-28Exact identifier
unii: LMI26O6933
AluminaALUMINUM OXIDEBoiron84270ebe-2cd9-7fb5-e053-2a91aa0ab7d52023-03-27Exact identifier
unii: LMI26O6933
fluconazoleFLUCONAZOLEA-S Medication Solutions08a54805-4fdf-48fd-bc3e-e9fa38f3c6912023-02-06Warnings, Adverse reactionsExact identifier
rxcui: 197698
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEProficient Rx LPb0aa9b22-5aef-459f-bb11-b193343eeb862023-02-01Warnings, Adverse reactionsExact identifier
application number: ANDA078423
rxcui: 197698
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEProficient Rx LP88d9904c-0c21-4188-95e2-6479bdf359df2023-01-01Warnings, Adverse reactionsExact identifier
rxcui: 197699
unii: 8VZV102JFY
COLIC CPAETHUSA CYNAPIUM, ALUMINUM OXIDE, BRYONIA ALBA ROOT, OYSTER SHELL CALCIUM CARBONATE CRUDE, MATRICARIA RECUTITA, LYCOPODIUM CLAVATUM SPORE, PHOSPHORUS, ANEMONE PULSATILLA, SILICON DIOXIDE, SULFUR.Natural Creations, Inc.7c2a2f6e-a332-4c68-a7a8-fdc390f1827e2022-12-19WarningsExact identifier
unii: LMI26O6933
Metals DetoxALUMINA, ARSENICUM METALLICUM, MERCURIUS CORROSIVUS, NICCOLUM METALLICUM, PLUMBUM METALLICUM, RADIUM BROMATUM, STANNUM METALLICUMProBLEN41b750f2-7330-4769-aa48-4ec3537116c12022-11-30WarningsExact identifier
unii: LMI26O6933
FluconazoleFLUCONAZOLEProficient Rx LPfbb1bda3-f733-4404-9c9d-46c418700c032022-08-01Warnings, Adverse reactionsExact identifier
rxcui: 197700
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEAsclemed USA, Inc.56a9de97-bbb9-4210-9ace-f77317d5f33b2022-03-04Warnings, Adverse reactionsExact identifier
rxcui: 197699
unii: 8VZV102JFY
CONSTIPATION CPALUMINUM OXIDE, BRYONIA ALBA ROOT, MATRICARIA RECUTITA, GRAPHITE, LYCOPODIUM CLAVATUM SPORE, STRYCHNOS NUX-VOMICA SEED, SILICON DIOXIDE, SULFUR, SODIUM CHLORIDE, MAGNESIUM CHLORIDE, LEAD, SEPIA OFFICINALIS JUICE.Natural Creations, Inc.961b3ddf-41fe-46ed-b5e4-0fd8d9652edf2021-11-15WarningsExact identifier
unii: LMI26O6933
ALUMINAALUMINARxhomeo Private Limited d.b.a. Rxhomeo, Incf23b1f6d-d962-482b-9479-dcddf793aad32021-09-26WarningsExact identifier
unii: LMI26O6933
Melange combinationCALCAREA SULPHURICA, CALCIUM PHOSPHORICUM, KALI MURIATICUM, KALIUM PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRIUM SULFURICUM, CALCAREA FLUORICA, FERRUM PHOSPHORICUM, SILICEASeroyal USA0a071fbf-0075-4479-e054-00144ff8d46c2021-07-14WarningsExact identifier
unii: L11K75P92J

Reported adverse events (FAERS/openFDA)#

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