FDA.reportPublic FDA data

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 36 of 60 · 1,194 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ancient Secrets Breathe AgainSODIUM CHLORIDELOTUS BRANDS, INC.c6d2bab0-d363-4c09-a71b-ae15db915b372024-12-18WarningsExact identifier
unii: 451W47IQ8X
Walgreens Saline Mist Extra StrengthSODIUM CHLORIDEWalgreen's Corporation90cbe2dc-36b6-77fb-e053-2995a90a28972024-12-18WarningsExact identifier
unii: 451W47IQ8X
CVS Health Sterile Saline MistSODIUM CHLORIDECVS Pharmacy6f1fe980-ca09-401d-aed6-d3d3387cc49a2024-12-18WarningsExact identifier
unii: 451W47IQ8X
Mast Cell ProHYDRASTIS CANADENSIS, ASCORBICUM ACIDUM, CINCHONA OFFICINALIS, KIDNEY (SUIS), THIAMINUM HYDROCHLORICUM, URTICA DIOICA, APIS MELLIFICA, ARSENICUM ALBUM, BOVISTA, CARBOLICUM ACIDUM, COFFEA CRUDA, HISTAMINUM HYDROCHLORICUM, LACHESIS MUTUS, LEDUM PALUSTRE, NUX VOMICA, OXALICUM ACIDUM, PHOSPHORUS, RHUS TOX, SARCOLACTICUM ACIDUM, SECALE CORNUTUM, SEPIA, SEROTONIN (HYDROCHLORIDE), SULPHUR, THUJA OCCIDENTALIS, VENUS MERCENARIA, ACONITUM NAPELLUS, CALADIUM SEGUINUM, IGNATIA AMARA, NATRUM MURIATICUM,Energique, Inc.5cd31e1d-0312-48d1-9ecd-d01c6fe3b6722024-12-11WarningsExact identifier
unii: 451W47IQ8X
Fendall Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.afda6fc3-7615-b0be-e053-2995a90a62082024-12-10WarningsExact identifier
unii: 059QF0KO0R
FluconazoleFLUCONAZOLEHospira, Inc22ebc3fb-ee81-44bd-a6e3-5e759ee724a82024-12-05Warnings, Adverse reactionsExact identifier
rxcui: 1721314
rxcui: 1721315
unii: 8VZV102JFY
Junior MovesANACARDIUM, BRYONIA, MAG MUR, NAT MUR, PLUMB METSilver Star Brands822d5481-7854-3fe7-e053-2a91aa0abf552024-12-03WarningsExact identifier
unii: 451W47IQ8X
Migo-EaseACONITUM NAP, LYCOPODIUM, NAT MUR, NUX VOM, PULSATILLASilver Star Brands816837f5-4487-657d-e053-2991aa0a78f42024-12-03WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Company464c2d78-5c88-4668-a039-56dd3c1c9b202024-12-03Exact identifier
unii: 451W47IQ8X
XX Health ProLACHESIS, NAT MUR, PULSATILLA, SEPIA, SULPHURSilver Star Brands4d11a65e-696a-0727-e054-00144ff88e882024-12-02WarningsExact identifier
unii: 451W47IQ8X
Para-SiJUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHESIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR, NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBERNewton Laboratories, Inc.27d41602-9dcb-eaa8-e063-6394a90a7cfa2024-11-26WarningsExact identifier
unii: 451W47IQ8X
Para-SiJUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHEIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR, NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBERNewton Laboratories, Inc.27d4ddaf-9c07-a7fc-e063-6394a90adc0b2024-11-26WarningsExact identifier
unii: 451W47IQ8X
Para-SiJUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHESIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBERNewton Laboratories, Inc.27d5997b-1cae-41c2-e063-6394a90ac74a2024-11-26WarningsExact identifier
unii: 451W47IQ8X
PhysiciansCare Ophthalmic Solution Eyewash Purified Water, 98.3%PURIFIED WATER 98.3%Acme United Corporation9248ee71-2d47-620d-e053-2995a90af5c82024-11-26WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationcca454e0-b2bd-4215-bc06-426fcc3f7bd62024-11-26WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationd3812fa3-9334-464d-b50c-98548ff767272024-11-26WarningsExact identifier
unii: 059QF0KO0R
DANGTTEOLMINERAL WATERAQBC CO., LTD27db14a9-3812-433f-e063-6394a90a11e72024-11-26WarningsExact identifier
unii: 059QF0KO0R
ReHydrationADENOSINUM CYCLOPHOSPHORICUM, COFFEA CRUDA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS, KALI PHOS, NAT MUR, SARSAPARILLA, SILICEA, TARAXACUM, THYROIDINUMEnergetix Corporation37063a49-6b45-4167-875d-49c9dac3f79b2024-11-20WarningsExact identifier
unii: 451W47IQ8X
FluconazoleFLUCONAZOLEA-S Medication Solutions177322f4-9526-40cb-9e5d-bc24e8fb02db2024-11-18Warnings, Adverse reactionsExact identifier
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEAurobindo Pharma Limited6ebf24fd-41cd-4b3c-8176-a1436253ba2d2024-11-14Warnings, Adverse reactionsExact identifier
unii: 8VZV102JFY

Reported adverse events (FAERS/openFDA)#

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