NDC 85534-0049-00 - 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
85534-0049
Requested NDC
85534-0049-00
Package NDCs from labels
85534-0049-0, 85534-0049-00
Manufacturer
HAWAII REPACK, INC. | ASCLEMED USA INC. DBA ENOVACHEM
Effective date
2026-07-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
FLUCONAZOLE - HAWAII REPACK, INC. | ASCLEMED USA INC. DBA ENOVACHEMHAWAII REPACK, INC. | ASCLEMED USA INC. DBA ENOVACHEM2026-07-03HUMAN PRESCRIPTION DRUG LABEL

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 3 of 35 · 694 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FluconazoleFLUCONAZOLERedpharm Drug568d9f2f-3394-b972-e063-6394a90a86282026-07-14Warnings, Adverse reactionsExact identifier
rxcui: 197699
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEPD-Rx Pharmaceuticals, Inc.6bb386b0-9dbe-40ee-b873-5215b19059202026-07-14Warnings, Adverse reactionsExact identifier
rxcui: 197699
unii: 8VZV102JFY
Jacksons Cell Salts SILICA 12X 12SILICEAZettl Health Inc.5647dafc-1fff-6a25-e063-6294a90a8b4f2026-07-10Exact identifier
unii: ETJ7Z6XBU4
FLUCONAZOLEFLUCONAZOLEHAWAII REPACK, INC.8aa296e2-ad8d-42f6-8b41-468e2b9cdfb82026-07-03Warnings, Adverse reactionsExact identifier
application number: ANDA076665
ndc (package): 85534-0049-0
ndc (product): 85534-0049
ndc11 (package): 85534004900
rxcui: 197699
spl id: 55adedaa-a28a-27e3-e063-6394a90a63ad
spl set id: 8aa296e2-ad8d-42f6-8b41-468e2b9cdfb8
unii: 8VZV102JFY
The Cell Salt Co. Daily Blend 12 in 1CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEAThe Cell Salt Company LLC55826f59-acf4-7370-e063-6394a90afed72026-07-01WarningsExact identifier
unii: ETJ7Z6XBU4
Bambusa StannumBAMBUSA STANNUMUriel Pharmacy Inc.a0d4d0ac-e2d2-4381-8f93-e417195218592026-06-30WarningsExact identifier
unii: ETJ7Z6XBU4
FluconazoleFLUCONAZOLESt. Mary's Medical Park Pharmacy126406ae-1fdc-df20-e063-6294a90a27182026-06-29Warnings, Adverse reactionsExact identifier
rxcui: 197699
unii: 8VZV102JFY
fluconazoleFLUCONAZOLEBryant Ranch Prepack67af604c-928f-468b-ba27-ad45e95d3e7e2026-06-24Warnings, Adverse reactionsExact identifier
rxcui: 197698
unii: 8VZV102JFY
fluconazoleFLUCONAZOLEBryant Ranch Prepack7259671f-a703-4a2a-81db-9a4839b340722026-06-24Warnings, Adverse reactionsExact identifier
rxcui: 197700
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEA-S Medication Solutionsa995790a-8470-4c51-801a-69347151a6fe2026-06-24Warnings, Adverse reactionsExact identifier
rxcui: 197698
unii: 8VZV102JFY
FluconazoleFLUCONAZOLENorthwind Health Company, LLC0de7211d-b8ce-214d-e063-6294a90aec412026-06-22Warnings, Adverse reactionsExact identifier
rxcui: 197699
unii: 8VZV102JFY
H-Scars FormulaCALENDULA OFFICINALLIS, SILICEAHealing Natural Oils LLC8433ff00-d815-45e0-b0ec-1448668dd8f82026-06-16WarningsExact identifier
unii: ETJ7Z6XBU4
E-Z-GAS IIANTACID/ANTIFLATULENTE-Z-EM, INC.4e12e1cb-b033-076d-e054-00144ff8d46c2026-06-15WarningsExact identifier
unii: ETJ7Z6XBU4
BM BIO28 ALCOHOLCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro544b66c4-49df-556f-e063-6394a90af3ed2026-06-15WarningsExact identifier
unii: ETJ7Z6XBU4
BM Tooth RemineralizationCALC PHOS, CALC FLUOR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro543bc298-ec32-38e9-e063-6394a90aac152026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4
Nail Fungus Control Extra StrengthCALENDULA OFFICINALIS FLOWERING TOP, SILICON DIOXIDE, AND HYPERICUM PERFORATUMForces of Natured02b88a6-1999-4dcd-91b5-fad88a664fcb2026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4
Nerve PainARABICA COFFEE BEAN, SILICON DIOXIDE, AND HYPERICUM PERFORATUMForces of Naturea9c3ba2e-9254-4ccd-9fe9-7a360fdf2bb72026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4
Scar ControlCALENDULA OFFICINALIS FLOWERING TOP, ALLYLTHIOUREA, AND SILICON DIOXIDEForces of Nature595c3423-6b52-48fc-8a95-00b53c1ecc7b2026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM186 DROPSARNICA, FERR PHOS, HYPERICUM, IGNATIA, SILICATotal Operations Management LLC DBA:Bestmade Natural Products Micro54243745-bd67-19c1-e063-6394a90a4b722026-06-13WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM186 DROPSARNICA, FERR PHOS, HYPERICUM, IGNATIA, SILICABM Private Limited540d8fbe-3bdb-1b54-e063-6394a90a114d2026-06-12WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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