Home NDC 0049-3450 Diflucan
Product NDC 0049-3450
11-digit product format 000493450
Labeler code 0049
Product ID 0049-3450_c835d7dd-af65-4b2c-a92c-42d1986f902d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fluconazole
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Roerig
Application NDA020090
Marketing category NDA
Marketing start 1993-12-23
Substance FLUCONAZOLE
Active strength 1400 mg/35mL
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 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 · 24 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 0049-3450-19 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 0049-3450-19 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0049-3450-19 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0049-3450-19 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0049-3450-19 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0049-3450-19 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0049-3450-19 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0049-3450-19 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0049-3450-19 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0049-3450-19 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0049-3450-19 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0049-3450-19 557ba5c1ecfa…9c80585c8c6e…
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 Diflucan
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUCONAZOLE 1400 mg/35mL
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 · 12 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 201900 Internal RxNorm lookup 201901 Internal RxNorm lookup 207106 Internal RxNorm lookup 207107 Internal RxNorm lookup 207108 Internal RxNorm lookup 207112 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 0049-3450-19 Diflucan 35 mL in 1 BOTTLE POWDER, FOR SUSPENSION 35 57 0049-3450-19 Diflucan 1 in 1 CARTON POWDER, FOR SUSPENSION 1 57
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FLUCONAZOLE ACTIVE INGREDIENT 8VZV102JFY DIFLUCAN (FLUCONAZOLE) TABLET DIFLUCAN (FLUCONAZOLE) POWDER, FOR SUSPENSION [ROERIG] 22 FLUCONAZOLE ACTIVE MOIETY 8VZV102JFY DIFLUCAN (FLUCONAZOLE) TABLET DIFLUCAN (FLUCONAZOLE) POWDER, FOR SUSPENSION [ROERIG] 22 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 DIFLUCAN (FLUCONAZOLE) TABLET DIFLUCAN (FLUCONAZOLE) POWDER, FOR SUSPENSION [ROERIG] 22 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL DIFLUCAN (FLUCONAZOLE) TABLET DIFLUCAN (FLUCONAZOLE) POWDER, FOR SUSPENSION [ROERIG] 22 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT L11K75P92J DIFLUCAN (FLUCONAZOLE) TABLET DIFLUCAN (FLUCONAZOLE) POWDER, FOR SUSPENSION [ROERIG] 22 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DIFLUCAN (FLUCONAZOLE) TABLET DIFLUCAN (FLUCONAZOLE) POWDER, FOR SUSPENSION [ROERIG] 22 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 DIFLUCAN (FLUCONAZOLE) TABLET DIFLUCAN (FLUCONAZOLE) POWDER, FOR SUSPENSION [ROERIG] 22 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA DIFLUCAN (FLUCONAZOLE) TABLET DIFLUCAN (FLUCONAZOLE) POWDER, FOR SUSPENSION [ROERIG] 22 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DIFLUCAN (FLUCONAZOLE) TABLET DIFLUCAN (FLUCONAZOLE) POWDER, FOR SUSPENSION [ROERIG] 22 POVIDONES INACTIVE INGREDIENT FZ989GH94E DIFLUCAN (FLUCONAZOLE) TABLET DIFLUCAN (FLUCONAZOLE) POWDER, FOR SUSPENSION [ROERIG] 22 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 DIFLUCAN (FLUCONAZOLE) TABLET DIFLUCAN (FLUCONAZOLE) POWDER, FOR SUSPENSION [ROERIG] 22 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU DIFLUCAN (FLUCONAZOLE) TABLET DIFLUCAN (FLUCONAZOLE) POWDER, FOR SUSPENSION [ROERIG] 22 SUCROSE INACTIVE INGREDIENT C151H8M554 DIFLUCAN (FLUCONAZOLE) TABLET DIFLUCAN (FLUCONAZOLE) POWDER, FOR SUSPENSION [ROERIG] 22 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DIFLUCAN (FLUCONAZOLE) TABLET DIFLUCAN (FLUCONAZOLE) POWDER, FOR SUSPENSION [ROERIG] 22 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K DIFLUCAN (FLUCONAZOLE) TABLET DIFLUCAN (FLUCONAZOLE) POWDER, FOR SUSPENSION [ROERIG] 22 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE DIFLUCAN (FLUCONAZOLE) TABLET DIFLUCAN (FLUCONAZOLE) POWDER, FOR SUSPENSION [ROERIG] 22
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0049-3450 DIFLUCAN (FLUCONAZOLE) TABLET DIFLUCAN (FLUCONAZOLE) POWDER, FOR SUSPENSION [ROERIG] 54 Current NDC, Legacy NDC, 2 package rows 20250328_f694c617-3383-416c-91b6-b94fda371204.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 0049-3450-19 00049345019 1 BOTTLE in 1 CARTON (0049-3450-19) / 35 mL in 1 BOTTLE 1 bottle 1993-12-23 0000-00-00 No No Current