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 51 of 60 · 1,194 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PSORIASISARSENICUM ALBUM, ARSENICUM IODATUM, BORAX, CALCAREA CARBONICA, GRAPHITES, MEZEREUM, PROTEUS, NATRUM MURIATICUM, PHYTOLACCA DECANDRA, SEPIA, SILICEA, SULPHUR, THYROIDINUMZorex Internationalb5b8bb82-4d36-4faa-b023-e48066f4521c2023-01-09WarningsExact identifier
unii: 451W47IQ8X
VirimmuneALLIUM SATIVUM, ECHINACEA (ANGUSTIFOLIA), GINKGO BILOBA, VISCUM ALBUM, HAMAMELIS VIRGINIANA, ACONITUM NAPELLUS, ALLIUM CEPA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, CHELIDONIUM MAJUS, GELSEMIUM SEMPERVIRENS, MERCURIUS VIVUS, NATRUM MURIATICUM, NUX VOMICA, SELENIUM METALLICUM, INFLUENZINUM (2021-2022), MORBILLINUMDeseret Biologicals, Inc.56555cb5-89e5-4a30-8ebe-ce2c01bdd4262023-01-03WarningsExact identifier
unii: 451W47IQ8X
FluconazoleFLUCONAZOLEProficient Rx LP88d9904c-0c21-4188-95e2-6479bdf359df2023-01-01Warnings, Adverse reactionsExact identifier
unii: 8VZV102JFY
AILGENOAMANITA MUSCARIA FRUITING BODY, ARSENIC TRIOXIDE, MILK THISTLE, CEANOTHUS AMERICANUS LEAF, CINCHONA OFFICINALIS BARK, GLECHOMA HEDERACEA FLOWERING TOP, GRINDELIA HIRSUTULA WHOLE, AND SODIUM CHLORIDEPEKANA Naturheilmittel GmbH4e24f727-4c83-46b6-9549-8f66bd1356472022-12-21WarningsExact identifier
unii: 451W47IQ8X
Dextrose MonohydrateDEXTROSE MONOHYDRATEInternational Medication Systems, Limitedfcc7ac79-cd70-4f03-a4de-f051f9ca1f7d2022-12-20Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Weight Management HPARSENIC TRIOXIDE, GOLD, OYSTER SHELL CALCIUM CARBONATE, CRUDE, IODINE, LYCOPODIUM CLAVATUM SPORE, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORIC ACID, PHOSPHORUS, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, SEPIA OFFICINALIS JUICE, SULFURNatural Creations, Inc.93736f0b-a419-4b90-84b0-f27e4c71299b2022-12-20WarningsExact identifier
unii: 451W47IQ8X
SODIUM CHLORIDESODIUM CHLORIDELiebel-Flarsheim Company LLCe4540d03-06b4-4b4d-b859-75c13e5c20dd2022-12-20Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
NATRUM MURIATICUMSODIUM CHLORIDEHyland's Inc.21ee53eb-b41a-4d2e-8037-12973d2b73d92022-12-19WarningsExact identifier
unii: 451W47IQ8X
CataraccARSENICUM ALB., BRYONIA, CALC. FLUOR., CALENDULA, CAUSTICUM, CONIUM, EUPHRASIA, HYDROFLUORICUM AC., IODIUM, LEDUM, NAPHTHALINUM, NAT. MUR., NUX VOM., PHOS., PULSATILLA, SEPIA, SILICEA, TELLURIUM, THIOSINAMINUM, ZINC. MET.Newton Laboratories, Inc.eff981fd-5436-7c34-e053-2a95a90a3e8e2022-12-16WarningsExact identifier
unii: 451W47IQ8X
CVS Health Sterile Saline MistSODIUM CHLORIDECVS Pharmacy4df47f14-8268-4cd3-b29e-96446743e2f62022-12-16WarningsExact identifier
unii: 451W47IQ8X
Cold and CoughONION, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SULFUR, AND GOLDENSEALWal-Mart Stores, Inc.69349b4d-6c5b-7121-e053-2991aa0a35942022-12-15WarningsExact identifier
unii: 451W47IQ8X
Childrens Cold and Cough NighttimeONION, CALCIUM SULFIDE, SODIUM CHLORIDE, ANEMONE PULSATILLA, ARABICA COFFEE BEAN, MATRICARIA CHAMOMILLA, SULFUR, PHOSPHORUS AND GOLDENSEALWalgreen Company80c41b65-0411-4395-e053-2a91aa0a9df92022-12-15WarningsExact identifier
unii: 451W47IQ8X
Childrens Cold and CoughONION, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SULFUR, AND GOLDENSEALWalgreen Company80b5f707-a839-7729-e053-2991aa0a1c562022-12-15WarningsExact identifier
unii: 451W47IQ8X
FERRODONNAARSENIC TRIOXIDE, CEANOTHUS AMERICANUS LEAF, CINCHONA OFFICINALIS BARK, COBALTOUS NITRATE, CUPRIC SULFATE, IRON, MANGANESE ACETATE, AND SODIUM CHLORIDEPEKANA Naturheilmittel GmbH64c6f75a-382d-4aa0-b210-6be83a62fa3f2022-12-14WarningsExact identifier
unii: 451W47IQ8X
Nat MurSODIUM CHLORIDEHyland's Inc.d3ab4254-daaf-24ac-e053-2995a90afb8f2022-12-13WarningsExact identifier
unii: 451W47IQ8X
RestSILVER NITRATE,CAUSTICUM,MATRICARIA CHAMOMILLA,ANAMIRTA COCCULUS SEED,SODIUM CHLORIDE,PHOSPHORUS AND VALERIANHyland's Inc.5e9924be-4dad-324a-e053-2a91aa0a8ec12022-12-13WarningsExact identifier
unii: 451W47IQ8X
Defend Cold and MucusBRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PATENS, RUMEX CRISPUS ROOT, AND SILICON DIOXIDEHyland's Inc.bb851be1-0528-4199-91e7-e09f994b28622022-12-12WarningsExact identifier
unii: 451W47IQ8X
25% Dextrose Infant25% DEXTROSE INFANTHF Acquisition Co. LLC, DBA Health First73d04839-a2bb-65dd-e053-2991aa0a82ca2022-12-09Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
BACTERIOSTATIC SODIUM CHLORIDEBACTERIOSTATIC SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirst7611e508-6da2-3a2f-e053-2a91aa0a9f402022-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
BACTERIOSTATIC SODIUM CHLORIDEBACTERIOSTATIC SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirst763ff805-af1a-e8e9-e053-2a91aa0a82532022-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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