Home NDC 55289-148 Diflucan
Product NDC 55289-148
11-digit product format 552890148
Labeler code 55289
Product ID 55289-148_e5fd8a8a-5e65-49c1-e053-2995a90afbaa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fluconazole
Dosage form TABLET
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application NDA019949
Marketing category NDA
Marketing start 1990-01-29
Marketing end 0000-00-00
Substance FLUCONAZOLE
Active strength 200 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 · 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 55289-148-79 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 55289-148-79 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 55289-148-79 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 55289-148-79 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 55289-148-79 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 55289-148-79 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 55289-148-79 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 55289-148-79 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 55289-148-79 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 55289-148-79 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 55289-148-79 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 55289-148-79 557ba5c1ecfa…9c80585c8c6e…
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 Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded fluconazole ACTIVE INGREDIENT 8VZV102JFY DIFLUCAN (FLUCONAZOLE) TABLET [PD-RX PHARMACEUTICALS, INC.] 12 fluconazole ACTIVE MOIETY 8VZV102JFY DIFLUCAN (FLUCONAZOLE) TABLET [PD-RX PHARMACEUTICALS, INC.] 12 aluminum oxide INACTIVE INGREDIENT LMI26O6933 DIFLUCAN (FLUCONAZOLE) TABLET [PD-RX PHARMACEUTICALS, INC.] 12 anhydrous dibasic calcium phosphate INACTIVE INGREDIENT L11K75P92J DIFLUCAN (FLUCONAZOLE) TABLET [PD-RX PHARMACEUTICALS, INC.] 12 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U DIFLUCAN (FLUCONAZOLE) TABLET [PD-RX PHARMACEUTICALS, INC.] 12 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 DIFLUCAN (FLUCONAZOLE) TABLET [PD-RX PHARMACEUTICALS, INC.] 12 FD&C Red No. 40 INACTIVE INGREDIENT WZB9127XOA DIFLUCAN (FLUCONAZOLE) TABLET [PD-RX PHARMACEUTICALS, INC.] 12 magnesium stearate INACTIVE INGREDIENT 70097M6I30 DIFLUCAN (FLUCONAZOLE) TABLET [PD-RX PHARMACEUTICALS, INC.] 12 povidone INACTIVE INGREDIENT FZ989GH94E DIFLUCAN (FLUCONAZOLE) TABLET [PD-RX PHARMACEUTICALS, INC.] 12
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55289-148-79 55289014879 1 TABLET in 1 BOTTLE, PLASTIC (55289-148-79) 1 tablet 1990-01-29 0000-00-00 No No Current