Home NDC 59762-5015 Fluconazole
Product NDC 59762-5015
11-digit product format 597625015
Labeler code 59762
Product ID 59762-5015_297f4b86-6b87-405c-a2b3-28d61717970f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fluconazole
Dosage form TABLET
Route ORAL
Labeler Greenstone LLC
Application NDA019949
Marketing category NDA AUTHORIZED GENERIC
Marketing start 1990-01-29
Marketing end 0000-00-00
Substance FLUCONAZOLE
Active strength 50 mg/1
Pharmacologic classes Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 59762-5015-1 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 59762-5015-1 f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019949-001 DIFLUCAN FLUCONAZOLE 50MG TABLET / ORAL AB RLD 1990-01-29 N019949-002 DIFLUCAN FLUCONAZOLE 100MG TABLET / ORAL AB RLD 1990-01-29 N019949-003 DIFLUCAN FLUCONAZOLE 200MG TABLET / ORAL AB RLD, RS 1990-01-29 N019949-004 DIFLUCAN FLUCONAZOLE 150MG TABLET / ORAL AB RLD 1994-06-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 5 · 168 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N019949-001 DIFLUCAN 50MG TABLET / ORAL AB RLD 1990-01-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019949-002 DIFLUCAN 100MG TABLET / ORAL AB RLD 1990-01-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019949-003 DIFLUCAN 200MG TABLET / ORAL AB RLD, RS 1990-01-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019949-004 DIFLUCAN 150MG TABLET / ORAL AB RLD 1994-06-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019949-001 DIFLUCAN 50MG TABLET / ORAL AB RLD 1990-01-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019949-002 DIFLUCAN 100MG TABLET / ORAL AB RLD 1990-01-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019949-003 DIFLUCAN 200MG TABLET / ORAL AB RLD, RS 1990-01-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019949-004 DIFLUCAN 150MG TABLET / ORAL AB RLD 1994-06-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019949-001 DIFLUCAN 50MG TABLET / ORAL AB RLD 1990-01-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019949-002 DIFLUCAN 100MG TABLET / ORAL AB RLD 1990-01-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019949-003 DIFLUCAN 200MG TABLET / ORAL AB RLD, RS 1990-01-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019949-004 DIFLUCAN 150MG TABLET / ORAL AB RLD 1994-06-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019949-001 DIFLUCAN 50MG TABLET / ORAL AB RLD 1990-01-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019949-002 DIFLUCAN 100MG TABLET / ORAL AB RLD 1990-01-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019949-003 DIFLUCAN 200MG TABLET / ORAL AB RLD, RS 1990-01-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019949-004 DIFLUCAN 150MG TABLET / ORAL AB RLD 1994-06-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019949-001 DIFLUCAN 50MG TABLET / ORAL AB RLD 1990-01-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019949-002 DIFLUCAN 100MG TABLET / ORAL AB RLD 1990-01-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019949-003 DIFLUCAN 200MG TABLET / ORAL AB RLD, RS 1990-01-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019949-004 DIFLUCAN 150MG TABLET / ORAL AB RLD 1994-06-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019949-001 DIFLUCAN 50MG TABLET / ORAL AB RLD 1990-01-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019949-002 DIFLUCAN 100MG TABLET / ORAL AB RLD 1990-01-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019949-003 DIFLUCAN 200MG TABLET / ORAL AB RLD, RS 1990-01-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019949-004 DIFLUCAN 150MG TABLET / ORAL AB RLD 1994-06-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019949-001 DIFLUCAN 50MG TABLET / ORAL AB RLD 1990-01-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019949-002 DIFLUCAN 100MG TABLET / ORAL AB RLD 1990-01-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019949-003 DIFLUCAN 200MG TABLET / ORAL AB RLD, RS 1990-01-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019949-004 DIFLUCAN 150MG TABLET / ORAL AB RLD 1994-06-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019949-001 DIFLUCAN 50MG TABLET / ORAL AB RLD 1990-01-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019949-002 DIFLUCAN 100MG TABLET / ORAL AB RLD 1990-01-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019949-003 DIFLUCAN 200MG TABLET / ORAL AB RLD, RS 1990-01-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019949-004 DIFLUCAN 150MG TABLET / ORAL AB RLD 1994-06-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019949-001 DIFLUCAN 50MG TABLET / ORAL AB RLD 1990-01-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019949-002 DIFLUCAN 100MG TABLET / ORAL AB RLD 1990-01-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019949-003 DIFLUCAN 200MG TABLET / ORAL AB RLD, RS 1990-01-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019949-004 DIFLUCAN 150MG TABLET / ORAL AB RLD 1994-06-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019949-001 DIFLUCAN 50MG TABLET / ORAL AB RLD 1990-01-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019949-002 DIFLUCAN 100MG TABLET / ORAL AB RLD 1990-01-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019949-003 DIFLUCAN 200MG TABLET / ORAL AB RLD, RS 1990-01-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019949-004 DIFLUCAN 150MG TABLET / ORAL AB RLD 1994-06-30 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 168 observed states.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59762-5015-1 Fluconazole 30 in 1 BOTTLE TABLET 30 43
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FLUCONAZOLE ACTIVE INGREDIENT 8VZV102JFY FLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC] 17 FLUCONAZOLE ACTIVE MOIETY 8VZV102JFY FLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC] 17 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 FLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC] 17 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL FLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC] 17 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT L11K75P92J FLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC] 17 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC] 17 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 FLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC] 17 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA FLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC] 17 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC] 17 POVIDONES INACTIVE INGREDIENT FZ989GH94E FLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC] 17 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 FLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC] 17 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU FLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC] 17 SUCROSE INACTIVE INGREDIENT C151H8M554 FLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC] 17 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP FLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC] 17 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K FLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC] 17 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE FLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC] 17
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59762-5015 FLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [MYLAN PHARMACEUTICALS INC.] 40 Legacy NDC, 1 package rows 20250523_737e0fac-a2d2-4053-a0d7-edbfb6248f69.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 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 59762-5015-1 59762501501 30 TABLET in 1 BOTTLE (59762-5015-1) 30 tablet 1990-01-29 0000-00-00 No No Current