FDA.reportPublic FDA data

NDC 70771-1065-01 - 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
70771-1065
Requested NDC
70771-1065-01
Package NDCs from labels
70771-1065-3, 70771-1065-1, 70771-1065-5, 70771-1065-7, 70771-1065-8, 70771-1065-01
Manufacturer
Zydus Lifesciences Limited
Effective date
2024-03-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
fluconazole - Zydus Lifesciences LimitedZydus Lifesciences Limited2024-03-04HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1065-1fluconazole100 in 1 BOTTLETABLET10010
70771-1065-3fluconazole30 in 1 BOTTLETABLET3010
70771-1065-5fluconazole500 in 1 BOTTLETABLET50010
70771-1065-7fluconazole1 in 1 CARTONTABLET110
70771-1065-7fluconazole1 in 1 BLISTER PACKTABLET110
70771-1065-8fluconazole1 in 1 BLISTER PACKTABLET110
70771-1065-8fluconazole12 in 1 CARTONTABLET1210

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1065FLUCONAZOLE TABLET [ZYDUS LIFESCIENCES LIMITED]10Current NDC, Legacy NDC, 7 package rows20240306_0adb2f88-8a6f-4f33-9e2d-73f537e05313.zip

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 6 of 6 · 118 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FluconazoleFLUCONAZOLEBaxter Healthcare Companycd24a261-9c15-42b4-8040-89d2dbda174e2024-06-24Warnings, Adverse reactionsExact identifier
unii: 8VZV102JFY
fluconazoleFLUCONAZOLENuCare Pharmaceuticals,Inc.715c53f0-2aea-1f24-e053-2995a90ad4632024-06-10Warnings, Adverse reactionsExact identifier
application number: ANDA208963
rxcui: 197698
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEPharmasource Meds, LLCfe0cc56d-c0b6-f859-e053-6294a90ad9322024-05-28Warnings, Adverse reactionsExact identifier
rxcui: 197699
unii: 8VZV102JFY
fluconazoleFLUCONAZOLEZydus Lifesciences Limited0adb2f88-8a6f-4f33-9e2d-73f537e053132024-03-04Warnings, Adverse reactionsExact identifier
application number: ANDA208963
ndc (package): 70771-1065-3
ndc (package): 70771-1066-1
ndc (package): 70771-1063-4
ndc (package): 70771-1064-5
ndc (package): 70771-1065-8
ndc (package): 70771-1063-1
ndc (package): 70771-1065-7
ndc (package): 70771-1064-1
ndc (package): 70771-1066-3
ndc (package): 70771-1066-4
ndc (package): 70771-1063-5
ndc (package): 70771-1066-5
ndc (package): 70771-1064-4
ndc (package): 70771-1063-3
ndc (package): 70771-1065-5
ndc (package): 70771-1064-3
ndc (package): 70771-1065-1
ndc (product): 70771-1063
ndc (product): 70771-1064
ndc (product): 70771-1066
ndc (product): 70771-1065
ndc11 (package): 70771106501
rxcui: 197698
rxcui: 197699
rxcui: 197700
rxcui: 197701
spl id: 4813fe26-a1f0-4782-a210-c669ae1ad899
spl set id: 0adb2f88-8a6f-4f33-9e2d-73f537e05313
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEDirect Rx69f199fa-bb92-4837-8b12-427a1c71f6222024-01-09Adverse reactionsExact identifier
application number: ANDA208963
rxcui: 197700
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEA-S Medication Solutions2fcac0e4-4f12-42d2-b129-106b4e1000752023-12-03Warnings, Adverse reactionsExact identifier
rxcui: 197699
unii: 8VZV102JFY
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
FluconazoleFLUCONAZOLEProficient Rx LPfa2fa2f8-f3a6-4bc0-943c-03dabd0f15812023-04-01Warnings, Adverse reactionsExact identifier
rxcui: 197699
unii: 8VZV102JFY
fluconazoleFLUCONAZOLEA-S Medication Solutions08a54805-4fdf-48fd-bc3e-e9fa38f3c6912023-02-06Warnings, Adverse reactionsExact identifier
application number: ANDA208963
rxcui: 197698
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEProficient Rx LPb0aa9b22-5aef-459f-bb11-b193343eeb862023-02-01Warnings, Adverse reactionsExact identifier
rxcui: 197698
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEProficient Rx LP88d9904c-0c21-4188-95e2-6479bdf359df2023-01-01Warnings, Adverse reactionsExact identifier
rxcui: 197699
unii: 8VZV102JFY
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
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
MEDULLOSSEINUM PLEXARNICA MONTANA, CALCAREA PHOSPHORICA, CALENDULA OFFICINALIS, HYPERICUM PERFORATUM, MEDULLOSSEINUM, PULSATILLA, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALESeroyal USA22b7eafe-ef76-0677-e054-00144ff88e882020-10-09WarningsExact identifier
unii: L11K75P92J
fluconazoleFLUCONAZOLEProficient Rx LPf232600e-70ce-4001-b9da-31442f0920b92020-03-01Warnings, Adverse reactionsExact identifier
application number: ANDA208963
rxcui: 197700
unii: 8VZV102JFY
fluconazoleFLUCONAZOLEProficient Rx LP7c8bb5ff-37e7-4f5e-8ea7-12269b2c7fd32019-10-01Warnings, Adverse reactionsExact identifier
application number: ANDA208963
rxcui: 197699
unii: 8VZV102JFY

Reported adverse events (FAERS/openFDA)#

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