FDA.reportPublic FDA data

NDC 0172-5411-10 - 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
0172-5411
Requested NDC
0172-5411-10
Package NDCs from labels
0172-5411-46, 0172-5411-60, 0172-5411-10
Manufacturer
Teva Pharmaceuticals USA, Inc.
Effective date
2022-03-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fluconazole Tablets, USPTeva Pharmaceuticals USA, Inc.2022-03-30HUMAN PRESCRIPTION DRUG LABEL
Fluconazole - Proficient Rx LPProficient Rx LP2021-06-01HUMAN PRESCRIPTION DRUG LABEL
FLUCONAZOLE - DIRECT RXDIRECT RX2020-01-20HUMAN PRESCRIPTION DRUG LABEL
FLUCONAZOLE TABLETSDispensing Solutions, Inc. | PSS World Medical, Inc.2013-02-27HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0172-5411-00EA - Each0172-5411c677c13f-5013-4d7e-a44a-7727927f66ec12012-07-24
0172-5411-10EA - Each0172-54110e6d4538-7cae-40ec-a85e-54b3ec9228fb12012-07-24
0172-5411-46EA - Each0172-541163cbe012-5a8d-44d6-a9ab-66d847aaed1712012-07-24
0172-5411-60EA - Each0172-5411bf8ed5aa-3be8-413f-a15c-42c17cf3325612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUCONAZOLEACTIVE INGREDIENT8VZV102JFYFLUCONAZOLE TABLET [IVAX PHARMACEUTICALS, INC.]9
FLUCONAZOLEACTIVE MOIETY8VZV102JFYFLUCONAZOLE TABLET [IVAX PHARMACEUTICALS, INC.]9
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933FLUCONAZOLE TABLET [IVAX PHARMACEUTICALS, INC.]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLUCONAZOLE TABLET [IVAX PHARMACEUTICALS, INC.]9
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FLUCONAZOLE TABLET [IVAX PHARMACEUTICALS, INC.]9
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAFLUCONAZOLE TABLET [IVAX PHARMACEUTICALS, INC.]9
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFLUCONAZOLE TABLET [IVAX PHARMACEUTICALS, INC.]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLUCONAZOLE TABLET [IVAX PHARMACEUTICALS, INC.]9
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FLUCONAZOLE TABLET [IVAX PHARMACEUTICALS, INC.]9
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFLUCONAZOLE TABLET [IVAX PHARMACEUTICALS, INC.]9
TALCINACTIVE INGREDIENT7SEV7J4R1UFLUCONAZOLE TABLET [IVAX PHARMACEUTICALS, INC.]9
FLUCONAZOLEACTIVE INGREDIENT8VZV102JFYFLUCONAZOLE TABLET [DISPENSING SOLUTIONS, INC.]2
FLUCONAZOLEACTIVE MOIETY8VZV102JFYFLUCONAZOLE TABLET [DISPENSING SOLUTIONS, INC.]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933FLUCONAZOLE TABLET [DISPENSING SOLUTIONS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLUCONAZOLE TABLET [DISPENSING SOLUTIONS, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FLUCONAZOLE TABLET [DISPENSING SOLUTIONS, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAFLUCONAZOLE TABLET [DISPENSING SOLUTIONS, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFLUCONAZOLE TABLET [DISPENSING SOLUTIONS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLUCONAZOLE TABLET [DISPENSING SOLUTIONS, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FLUCONAZOLE TABLET [DISPENSING SOLUTIONS, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFLUCONAZOLE TABLET [DISPENSING SOLUTIONS, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UFLUCONAZOLE TABLET [DISPENSING SOLUTIONS, INC.]2
FLUCONAZOLEACTIVE INGREDIENT8VZV102JFYFLUCONAZOLE TABLET [DIRECT RX]1
FLUCONAZOLEACTIVE MOIETY8VZV102JFYFLUCONAZOLE TABLET [DIRECT RX]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933FLUCONAZOLE TABLET [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLUCONAZOLE TABLET [DIRECT RX]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FLUCONAZOLE TABLET [DIRECT RX]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAFLUCONAZOLE TABLET [DIRECT RX]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFLUCONAZOLE TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLUCONAZOLE TABLET [DIRECT RX]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FLUCONAZOLE TABLET [DIRECT RX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFLUCONAZOLE TABLET [DIRECT RX]1
TALCINACTIVE INGREDIENT7SEV7J4R1UFLUCONAZOLE TABLET [DIRECT RX]1

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 1 of 38 · 759 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
FluconazoleFLUCONAZOLEREMEDYREPACK INC.aaf9e5f8-048e-407c-bc11-ad4edff85c052026-09-10Warnings, Adverse reactionsExact identifier
rxcui: 197698
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEREMEDYREPACK INC.1c82929f-934b-4df4-b24f-1e5da090fd8a2026-09-04Warnings, Adverse reactionsExact identifier
unii: 8VZV102JFY
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
FluconazoleFLUCONAZOLEREMEDYREPACK INC.2bd1c038-ab82-496c-8129-3182238ad1a12026-09-01Warnings, Adverse reactionsExact identifier
rxcui: 197698
unii: 8VZV102JFY
BMNP SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro5a58454f-aed6-24ba-e063-6294a90a47fb2026-08-31WarningsExact identifier
unii: ETJ7Z6XBU4
BMNP ALUMINUM OXIDEALUMINUM OXIDETotal Operations Management LLC DBA:Bestmade Natural Products Micro5a5ad83a-0ecb-21fa-e063-6294a90a14222026-08-31WarningsExact identifier
unii: LMI26O6933
Argentum QuartzARGENTUM QUARTZUriel Pharmacy Inc.765c8c8f-0727-45da-a77e-c3907a3d07932026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Endometrium ArgentumENDOMETRIUM ARGENTUMUriel Pharmacy Incd2d1428a-c8b5-9529-e053-2995a90a23432026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
S12 AIRBORNEALFALFA, ALLIUM SATIVUM, ARSENICUM IODATUM, BARLEY, BETULA PUBESCENS, BROWN RICE, CORN GRAIN, EUPHRASIA OFFICINALIS, FEATHER MIX, HAIR MIX, HISTAMINUM, HOUSE DUST MITE, LOLIUM PERENNE, OAT, PERFOLIATE HONEYSUCKLE, PHLEUM PRATENSE, POLLEN MIX, RYE, SABADILLA, SILICEA, SKIN MIX, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TEREBINTHINA, WHEATApex Energetics Inc.bb0036c3-1e4d-5750-e053-2995a90ae8952026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Aging Eye FormulaCINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, GERMANIUM METALLICUM, NATRUM MURIATICUMNutritional Specialties, Inc.d5b44f79-5299-4b31-ba45-0e511cdbe17c2026-08-24WarningsExact identifier
unii: ETJ7Z6XBU4
Bio Combination 28SCHUESSLER SALTSLDD Bioscience Private Limited597caf33-5107-9dec-e063-6294a90a5fcd2026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
fluconazoleFLUCONAZOLEPreferred Pharmaceuticals Inc.16b6fba0-b96f-4252-a70d-31dc614002982026-08-20Warnings, Adverse reactionsExact identifier
unii: 8VZV102JFY
Psorinum ComplexPHOSPHORUS, SILICEA, SULPHUR, ALOEBioActive Nutritional, Inc.d4746927-e6d4-463d-a084-56ffc48d1e672026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Boneforce HPCALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, RHUS TOX, SILICEA, SYMPHYTUM OFFICINALEBioActive Nutritional, Inc.d96ca52b-781d-431c-ad2a-a54fd57eb1062026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Cerebellum Thalamus A AurmCEREBELLUM THALAMUS A AURUMUriel Pharmacy Inc.e1c395b8-9221-401f-8980-c91ff88434582026-08-17WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM134 DROPSARSENIC ALBUM, HYDRASTIS, MYRISTICA, NITRIC ACID, PAEONIA, RHUS TOX, SILICEABM Private Limited59023500-89be-cc76-e063-6294a90a6e022026-08-14WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM173 DROPSECHINACEA, EUPHRASIA, NATRUM MUR, RHUS TOX, SILICEA, SULPHUR, URTICA URENBM Private Limited59036ca4-e7bb-bbe7-e063-6394a90a410a2026-08-14WarningsExact identifier
unii: ETJ7Z6XBU4
AdaptopathADENOSINUM CYCLOPHOSPHORICUM, ALPHA-LIPOICUM ACIDUM, ARGENTUM METALLICUM, AVENA SATIVA, CAPSICUM ANNUUM, CITRICUM ACIDUM, COENZYME A, CUPRUM METALLICUM, GINKGO BILOBA, GLANDULA SUPRARENALIS SUIS, GLYCYRRHIZA GLABRA, HYPOTHALAMUS (BOVINE), IODIUM, LEDUM PALUSTRE, MANGANUM ACETICUM, NADIDUM, NATRUM CARBONICUM, OLEUM MORRHUAE, PHOSPHORICUM ACIDUM, PICRICUM ACIDUM, RIBOFLAVINUM, SELENIUM METALLICUM SEPIA, SILICEA, THIAMINUM HYDROCHLORICUM, THYROIDINUM (BOVINE), VANADIUM METALLICUMEnergetix Corporation41234598-0cb5-41c2-bfbe-1c15ee9bf5022026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Agri-ChordARSENICUM ALB, BELLADONNA, CALC CARB, CEANOTHUS, CHELIDONIUM MAJ, CUPRUM SULPH, FUMARICUM AC, GALIUM, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, KALI IOD, LYCOPODIUM, PANCREAS SUIS, PETROLEUM, PHOSPHORICUM AC, PHOSPHORUS, PHYTOLACCA, SARSAPARILLA, SILICEA, SULPHUR, THYROIDINUM, TRIFOLIUM PRAT, XANTHOXYLUM, ZINC PHOSEnergetix Corporation9eb50e9a-3528-4809-bd76-47d99ef03f0e2026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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