NDC 0143-9666-01 - 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
0143-9666
Requested NDC
0143-9666-01
Package NDCs from labels
0143-9666-01, 0143-9666-06
Manufacturer
Hikma Pharmaceuticals USA Inc. | HIKMA FARMACEUTICA (PORTUGAL), S.A
Effective date
2024-06-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
WATER - Hikma Pharmaceuticals USA Inc. | HIKMA FARMACEUTICA (PORTUGAL), S.AHikma Pharmaceuticals USA Inc. | HIKMA FARMACEUTICA (PORTUGAL), S.A2024-06-28HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-05-02Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9666-01Fluconazole200 mL in 1 CONTAINERINJECTION20019
0143-9666-06Fluconazole6 in 1 CARTONINJECTION619

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9666FLUCONAZOLE INJECTION [HIKMA PHARMACEUTICALS USA INC.]19Current NDC, Legacy NDC, 2 package rows20240629_d3ca59bd-ae00-48ab-89aa-87c7f56e9989.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9666-01ML - Milliliter0143-9666a590c705-1e13-491a-884a-c2652e8b990b12013-05-02
0143-9666-06ML - Milliliter0143-9666e3e5da98-5f04-4f73-9298-9d8548bb44cc12013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUCONAZOLEACTIVE INGREDIENT8VZV102JFYFLUCONAZOLE INJECTION [WEST-WARD PHARMACEUTICAL CORP]9
FLUCONAZOLEACTIVE MOIETY8VZV102JFYFLUCONAZOLE INJECTION [WEST-WARD PHARMACEUTICAL CORP]9
DEXTROSE MONOHYDRATEINACTIVE INGREDIENTLX22YL083GFLUCONAZOLE INJECTION [WEST-WARD PHARMACEUTICAL CORP]9
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XFLUCONAZOLE INJECTION [WEST-WARD PHARMACEUTICAL CORP]9
WATERINACTIVE INGREDIENT059QF0KO0RFLUCONAZOLE INJECTION [WEST-WARD PHARMACEUTICAL CORP]9

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 41 of 60 · 1,194 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Thompson Safety EyewashWATERThompson Safety1d0e96cf-245b-cfb7-e063-6294a90a4ced2024-07-12WarningsExact identifier
unii: 059QF0KO0R
FluconazoleFLUCONAZOLENorthStar Rx LLCd2acccda-8068-46c1-8562-950d7f70ee062024-07-04Warnings, Adverse reactionsExact identifier
unii: 8VZV102JFY
FluconazoleFLUCONAZOLERising Pharma Holdings, Inc.2ca7efcd-4a8d-4139-a3eb-930afd18b13f2024-07-04Warnings, Adverse reactionsExact identifier
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEHikma Pharmaceuticals USA Inc.d3ca59bd-ae00-48ab-89aa-87c7f56e99892024-06-28Warnings, Adverse reactionsExact identifier
application number: ANDA076736
application number: ANDA078764
application number: ANDA078698
ndc (package): 0143-9899-91
ndc (package): 0143-9669-01
ndc (package): 0143-9669-10
ndc (package): 0143-9668-01
ndc (package): 0143-9666-06
ndc (package): 0143-9666-01
ndc (package): 0143-9899-01
ndc (package): 0143-9667-01
ndc (package): 0143-9668-10
ndc (package): 0143-9667-06
ndc (product): 0143-9899
ndc (product): 0143-9668
ndc (product): 0143-9669
ndc (product): 0143-9667
ndc (product): 0143-9666
ndc11 (package): 00143966601
rxcui: 1721314
rxcui: 1721315
spl id: a90257a3-d842-4990-81a5-614293e23119
spl set id: d3ca59bd-ae00-48ab-89aa-87c7f56e9989
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEBaxter Healthcare Companycd24a261-9c15-42b4-8040-89d2dbda174e2024-06-24Warnings, Adverse reactionsExact identifier
rxcui: 1721314
rxcui: 1721315
unii: 8VZV102JFY
Isolyte P in DextroseDEXTROSE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, AND POTASSIUM PHOSPHATE, DIBASICB. Braun Medical Inc.4ea4397c-2fa4-4670-91e6-21ae498c88f72024-06-24Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Sodium ChlorideSODIUM CHLORIDECODAN US CORPORATIONaa06e286-75c6-4d7a-959f-6008d38aa6e52024-06-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.ad42a7e3-84ea-390d-e053-2a95a90a3a322024-06-14WarningsExact identifier
unii: 059QF0KO0R
Derma Pain PlusCROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOXICODENDRON, SARSAPARILLA (SMILAX REGELII)Peaceful Mountain, Inc.6fa79c31-e48e-4c83-baa2-96cef22cfee12024-06-13WarningsExact identifier
unii: 451W47IQ8X
Cold Sore RescueBORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEAPeaceful Mountain, Inc.a7fe6ec7-a758-43cf-b46f-c327e0632fb82024-06-13WarningsExact identifier
unii: 451W47IQ8X
fluconazoleFLUCONAZOLENuCare Pharmaceuticals,Inc.715c53f0-2aea-1f24-e053-2995a90ad4632024-06-10Warnings, Adverse reactionsExact identifier
unii: 8VZV102JFY
Eyes Alive Eye WashWATERRIVIERA PHARMA INC081079f4-1c06-4054-b771-00fedaa666f62024-06-05WarningsExact identifier
unii: 059QF0KO0R
NATRUM MURNATRUM MURRxhomeo Private Limited d.b.a. Rxhomeo, Inc1a22655a-68f3-4f13-e063-6294a90ae52c2024-06-05WarningsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERBecton Dickinson and Company6e43c5a3-dad2-49ed-b500-964cb4563cc92024-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
FluconazoleFLUCONAZOLEPharmasource Meds, LLCfe0cc56d-c0b6-f859-e053-6294a90ad9322024-05-28Warnings, Adverse reactionsExact identifier
unii: 8VZV102JFY
Mentox HPAURUM METALLICUM, BARYTA CARBONICA, CALCAREA CARBONICA, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUSEnergique, Inc.ebb23637-4931-4563-ab30-99bea02765802024-05-28WarningsExact identifier
unii: 451W47IQ8X
Potassium Chloride in Lactated Ringers and DextrosePOTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, AND DEXTROSE MONOHYDRATEFresenius Kabi USA, LLCdbed53b7-0109-4561-8342-0178ec8c64b02024-05-22Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
unii: LX22YL083G
Lactated Ringers and DextroseSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATEFresenius Kabi USA, LLC1b912c7e-f005-4af4-b683-0834409642492024-05-22Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
unii: LX22YL083G
Sodium chlorideSODIUM CHLORIDEFresenius Kabi USA, LLC239a5af1-7498-480f-862c-ab7c3d89d1832024-05-21Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium chlorideSODIUM CHLORIDEBecton Dickinson and Companyebc8b008-a8b3-4c41-89e4-b413f7aab89f2024-05-21Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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