Home NDC 51672-4066-7 Fluconazole
Product NDC 51672-4066
Requested package NDC 51672-4066-7
11-digit product format 516724066
Labeler code 51672
Product ID 51672-4066_8d540365-1548-467f-9701-a84829a7d086
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluconazole
Dosage form TABLET
Route ORAL
Labeler Taro Pharmaceuticals U.S.A., Inc.
Application ANDA076507
Marketing category ANDA
Marketing start 2004-07-29
Marketing end 0000-00-00
Substance FLUCONAZOLE
Active strength 150 mg/1
Pharmacologic classes Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2021-12-31
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 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 51672-4066 51672-4066-7 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A076507-001 FLUCONAZOLE FLUCONAZOLE 50MG TABLET / ORAL 2004-07-29 A076507-002 FLUCONAZOLE FLUCONAZOLE 100MG TABLET / ORAL 2004-07-29 A076507-003 FLUCONAZOLE FLUCONAZOLE 150MG TABLET / ORAL 2004-07-29 A076507-004 FLUCONAZOLE FLUCONAZOLE 200MG TABLET / ORAL 2004-07-29
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 · 172 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 2026-09-14 22:38:34 2026-08 A076507-001 FLUCONAZOLE 50MG TABLET / ORAL 2004-07-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076507-002 FLUCONAZOLE 100MG TABLET / ORAL 2004-07-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076507-003 FLUCONAZOLE 150MG TABLET / ORAL 2004-07-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076507-004 FLUCONAZOLE 200MG TABLET / ORAL 2004-07-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076507-001 FLUCONAZOLE 50MG TABLET / ORAL 2004-07-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076507-002 FLUCONAZOLE 100MG TABLET / ORAL 2004-07-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076507-003 FLUCONAZOLE 150MG TABLET / ORAL 2004-07-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076507-004 FLUCONAZOLE 200MG TABLET / ORAL 2004-07-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076507-001 FLUCONAZOLE 50MG TABLET / ORAL 2004-07-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076507-002 FLUCONAZOLE 100MG TABLET / ORAL 2004-07-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076507-003 FLUCONAZOLE 150MG TABLET / ORAL 2004-07-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076507-004 FLUCONAZOLE 200MG TABLET / ORAL 2004-07-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076507-001 FLUCONAZOLE 50MG TABLET / ORAL 2004-07-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076507-002 FLUCONAZOLE 100MG TABLET / ORAL 2004-07-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076507-003 FLUCONAZOLE 150MG TABLET / ORAL 2004-07-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076507-004 FLUCONAZOLE 200MG TABLET / ORAL 2004-07-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076507-001 FLUCONAZOLE 50MG TABLET / ORAL AB 2004-07-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076507-002 FLUCONAZOLE 100MG TABLET / ORAL AB 2004-07-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076507-003 FLUCONAZOLE 150MG TABLET / ORAL AB 2004-07-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076507-004 FLUCONAZOLE 200MG TABLET / ORAL AB 2004-07-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076507-001 FLUCONAZOLE 50MG TABLET / ORAL AB 2004-07-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076507-002 FLUCONAZOLE 100MG TABLET / ORAL AB 2004-07-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076507-003 FLUCONAZOLE 150MG TABLET / ORAL AB 2004-07-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076507-004 FLUCONAZOLE 200MG TABLET / ORAL AB 2004-07-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076507-001 FLUCONAZOLE 50MG TABLET / ORAL AB 2004-07-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076507-002 FLUCONAZOLE 100MG TABLET / ORAL AB 2004-07-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076507-003 FLUCONAZOLE 150MG TABLET / ORAL AB 2004-07-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076507-004 FLUCONAZOLE 200MG TABLET / ORAL AB 2004-07-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076507-001 FLUCONAZOLE 50MG TABLET / ORAL AB 2004-07-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076507-002 FLUCONAZOLE 100MG TABLET / ORAL AB 2004-07-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076507-003 FLUCONAZOLE 150MG TABLET / ORAL AB 2004-07-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076507-004 FLUCONAZOLE 200MG TABLET / ORAL AB 2004-07-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076507-001 FLUCONAZOLE 50MG TABLET / ORAL AB 2004-07-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076507-002 FLUCONAZOLE 100MG TABLET / ORAL AB 2004-07-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076507-003 FLUCONAZOLE 150MG TABLET / ORAL AB 2004-07-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076507-004 FLUCONAZOLE 200MG TABLET / ORAL AB 2004-07-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076507-001 FLUCONAZOLE 50MG TABLET / ORAL AB 2004-07-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076507-002 FLUCONAZOLE 100MG TABLET / ORAL AB 2004-07-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076507-003 FLUCONAZOLE 150MG TABLET / ORAL AB 2004-07-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076507-004 FLUCONAZOLE 200MG TABLET / ORAL AB 2004-07-29 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 152 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Fluconazole ACTIVE INGREDIENT 8VZV102JFY FLUCONAZOLE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 6 Fluconazole ACTIVE MOIETY 8VZV102JFY FLUCONAZOLE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 6 aluminum oxide INACTIVE INGREDIENT LMI26O6933 FLUCONAZOLE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 6 calcium phosphate, dibasic, anhydrous INACTIVE INGREDIENT L11K75P92J FLUCONAZOLE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 6 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U FLUCONAZOLE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 6 d&c red no. 6 INACTIVE INGREDIENT 481744AI4O FLUCONAZOLE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 6 fd&c red no. 40 INACTIVE INGREDIENT WZB9127XOA FLUCONAZOLE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 6 magnesium stearate INACTIVE INGREDIENT 70097M6I30 FLUCONAZOLE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 6 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 FLUCONAZOLE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 6 sodium lauryl sulfate INACTIVE INGREDIENT 368GB5141J FLUCONAZOLE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 6 sodium starch glycolate type a potato INACTIVE INGREDIENT 5856J3G2A2 FLUCONAZOLE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-4066 FLUCONAZOLE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 8 Legacy NDC 20241211_4d7cf836-d115-456c-a636-6f05eae043cd.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51672-4066-7 51672406607 12 BLISTER PACK in 1 CARTON (51672-4066-7) > 1 TABLET in 1 BLISTER PACK 12 blister pack 2004-07-29 0000-00-00 No No Current