Home NDC 70710-1139-01 NDC 70710-1139-01 - 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 70710-1139
Requested NDC 70710-1139-01
Package NDCs from labels 70710-1139-3, 70710-1139-1, 70710-1139-5, 70710-1139-7, 70710-1139-8, 70710-1139-01
Manufacturer Zydus Pharmaceuticals (USA) Inc. | Zydus Lifesciences Limited
Effective date 2026-04-07
Current FDA listing Not matched in FDA.report NDC product tables DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70710-1139 FLUCONAZOLE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] 12 Current NDC, Legacy NDC, 7 package rows 20240306_d1364455-1537-46d4-b093-38cca3be778f.zip
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 13 of 13 · 252 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Fluconazole FLUCONAZOLE Proficient Rx LP b0aa9b22-5aef-459f-bb11-b193343eeb86 2023-02-01 Warnings, Adverse reactions Exact identifier rxcui: 197698 unii: 8VZV102JFY Fluconazole FLUCONAZOLE Proficient Rx LP 88d9904c-0c21-4188-95e2-6479bdf359df 2023-01-01 Warnings, Adverse reactions Exact identifier rxcui: 197699 unii: 8VZV102JFY Fluconazole FLUCONAZOLE Proficient Rx LP fbb1bda3-f733-4404-9c9d-46c418700c03 2022-08-01 Warnings, Adverse reactions Exact identifier rxcui: 197700 unii: 8VZV102JFY Fluconazole FLUCONAZOLE Asclemed USA, Inc. 56a9de97-bbb9-4210-9ace-f77317d5f33b 2022-03-04 Warnings, Adverse reactions Exact identifier rxcui: 197699 unii: 8VZV102JFY Melange combination CALCAREA SULPHURICA, CALCIUM PHOSPHORICUM, KALI MURIATICUM, KALIUM PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRIUM SULFURICUM, CALCAREA FLUORICA, FERRUM PHOSPHORICUM, SILICEA Seroyal USA 0a071fbf-0075-4479-e054-00144ff8d46c 2021-07-14 Warnings Exact identifier unii: L11K75P92J MEDULLOSSEINUM PLEX ARNICA MONTANA, CALCAREA PHOSPHORICA, CALENDULA OFFICINALIS, HYPERICUM PERFORATUM, MEDULLOSSEINUM, PULSATILLA, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALE Seroyal USA 22b7eafe-ef76-0677-e054-00144ff88e88 2020-10-09 Warnings Exact identifier unii: L11K75P92J d181832e-6355-4dbd-8e2b-b3f9de90f74e 2b59df21-160c-4f59-8129-526e865e24ad 2020-07-09 Warnings, Adverse reactions Exact identifier spl id: d181832e-6355-4dbd-8e2b-b3f9de90f74e spl set id: 2b59df21-160c-4f59-8129-526e865e24ad a8243a73-1d52-369c-e053-2a95a90ac5f6 6c6d6c93-f614-f87e-e053-2991aa0ac467 2020-06-15 Warnings, Adverse reactions Exact identifier spl set id: 6c6d6c93-f614-f87e-e053-2991aa0ac467 c082b848-f49d-4103-bd91-7aa283cbc7b2 05defa08-1cbd-43a0-bb12-d2d4e76fea19 2020-05-21 Warnings, Adverse reactions Exact identifier spl set id: 05defa08-1cbd-43a0-bb12-d2d4e76fea19 fluconazole FLUCONAZOLE Proficient Rx LP f232600e-70ce-4001-b9da-31442f0920b9 2020-03-01 Warnings, Adverse reactions Exact identifier application number: ANDA208963 rxcui: 197700 unii: 8VZV102JFY fluconazole FLUCONAZOLE Proficient Rx LP 7c8bb5ff-37e7-4f5e-8ea7-12269b2c7fd3 2019-10-01 Warnings, Adverse reactions Exact identifier application number: ANDA208963 ndc (package): 71205-081-01 ndc (package): 71205-081-04 ndc (package): 71205-081-02 ndc (product): 71205-081 rxcui: 197699 spl id: 40f55b8c-8674-413a-b58d-f1c8b767d680 spl set id: 7c8bb5ff-37e7-4f5e-8ea7-12269b2c7fd3 unii: 8VZV102JFY 23d5e14b-a501-46e7-89ac-59fe217c3376 7882901e-8e90-44f4-9963-5f87602cd5e9 2018-05-15 Warnings, Adverse reactions Exact identifier spl id: 23d5e14b-a501-46e7-89ac-59fe217c3376 spl set id: 7882901e-8e90-44f4-9963-5f87602cd5e9
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.