Home NDC 59762-5030 Fluconazole
Product NDC 59762-5030
11-digit product format 597625030
Labeler code 59762
Product ID 59762-5030_5a926244-1653-4a4e-9a60-9713a91d2485
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fluconazole
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application NDA020090
Marketing category NDA AUTHORIZED GENERIC
Marketing start 1993-12-23
Substance FLUCONAZOLE
Active strength 40 mg/mL
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020090-001 DIFLUCAN FLUCONAZOLE 50MG/5ML FOR SUSPENSION / ORAL AB RLD 1993-12-23 N020090-002 DIFLUCAN FLUCONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 1993-12-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 3 · 82 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 2026-02-19 14:30 UTC 2026-02 N020090-001 DIFLUCAN 50MG/5ML FOR SUSPENSION / ORAL AB RLD 1993-12-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020090-002 DIFLUCAN 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 1993-12-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020090-001 DIFLUCAN 50MG/5ML FOR SUSPENSION / ORAL AB RLD 1993-12-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020090-002 DIFLUCAN 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 1993-12-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020090-001 DIFLUCAN 50MG/5ML FOR SUSPENSION / ORAL AB RLD 1993-12-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020090-002 DIFLUCAN 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 1993-12-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020090-001 DIFLUCAN 50MG/5ML FOR SUSPENSION / ORAL AB RLD 1993-12-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020090-002 DIFLUCAN 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 1993-12-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020090-001 DIFLUCAN 50MG/5ML FOR SUSPENSION / ORAL AB RLD 1993-12-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020090-002 DIFLUCAN 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 1993-12-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020090-001 DIFLUCAN 50MG/5ML FOR SUSPENSION / ORAL AB RLD 1993-12-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020090-002 DIFLUCAN 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 1993-12-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020090-001 DIFLUCAN 50MG/5ML FOR SUSPENSION / ORAL AB RLD 1993-12-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020090-002 DIFLUCAN 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 1993-12-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020090-001 DIFLUCAN 50MG/5ML FOR SUSPENSION / ORAL AB RLD 1993-12-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020090-002 DIFLUCAN 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 1993-12-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020090-001 DIFLUCAN 50MG/5ML FOR SUSPENSION / ORAL AB RLD 1993-12-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020090-002 DIFLUCAN 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 1993-12-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020090-001 DIFLUCAN 50MG/5ML FOR SUSPENSION / ORAL AB RLD 1993-12-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020090-002 DIFLUCAN 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 1993-12-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020090-001 DIFLUCAN 50MG/5ML FOR SUSPENSION / ORAL AB RLD 1993-12-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020090-002 DIFLUCAN 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 1993-12-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020090-001 DIFLUCAN 50MG/5ML FOR SUSPENSION / ORAL AB RLD 1993-12-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020090-002 DIFLUCAN 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 1993-12-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020090-001 DIFLUCAN 50MG/5ML FOR SUSPENSION / ORAL AB RLD 1993-12-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020090-002 DIFLUCAN 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 1993-12-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020090-001 DIFLUCAN 50MG/5ML FOR SUSPENSION / ORAL AB RLD 1993-12-23 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020090-002 DIFLUCAN 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 1993-12-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020090-001 DIFLUCAN 50MG/5ML FOR SUSPENSION / ORAL AB RLD 1993-12-23 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020090-002 DIFLUCAN 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 1993-12-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020090-001 DIFLUCAN 50MG/5ML FOR SUSPENSION / ORAL AB RLD 1993-12-23 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020090-002 DIFLUCAN 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 1993-12-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020090-001 DIFLUCAN 50MG/5ML FOR SUSPENSION / ORAL AB RLD 1993-12-23 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020090-002 DIFLUCAN 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 1993-12-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020090-001 DIFLUCAN 50MG/5ML FOR SUSPENSION / ORAL AB RLD 1993-12-23 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020090-002 DIFLUCAN 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 1993-12-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020090-001 DIFLUCAN 50MG/5ML FOR SUSPENSION / ORAL AB RLD 1993-12-23 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020090-002 DIFLUCAN 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 1993-12-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020090-001 DIFLUCAN 50MG/5ML FOR SUSPENSION / ORAL AB RLD 1993-12-23 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N020090-002 DIFLUCAN 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 1993-12-23 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Fluconazole
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUCONAZOLE 40 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8VZV102JFY Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197698 Internal RxNorm lookup 197699 Internal RxNorm lookup 197700 Internal RxNorm lookup 197701 Internal RxNorm lookup 310352 Internal RxNorm lookup 310353 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59762-5030-1 Fluconazole 1 in 1 CARTON POWDER, FOR SUSPENSION 1 43 59762-5030-1 Fluconazole 35 mL in 1 BOTTLE POWDER, FOR SUSPENSION 35 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 FLUCONAZOLE ACTIVE INGREDIENT 8VZV102JFY FLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 13 FLUCONAZOLE ACTIVE MOIETY 8VZV102JFY FLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 13 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 FLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 13 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL FLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 13 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT L11K75P92J FLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 13 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 13 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 FLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 13 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA FLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 13 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 13 POVIDONES INACTIVE INGREDIENT FZ989GH94E FLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 13 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 FLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 13 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU FLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 13 SUCROSE INACTIVE INGREDIENT C151H8M554 FLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 13 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP FLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 13 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K FLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 13 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE FLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59762-5030 FLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [MYLAN PHARMACEUTICALS INC.] 40 Current NDC, Legacy NDC, 2 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 · 2 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 59762-5030-1 59762503001 1 BOTTLE in 1 CARTON (59762-5030-1) / 35 mL in 1 BOTTLE 1 bottle 1993-12-23 0000-00-00 No No Current