Home NDC 0172-5412 Fluconazole
Product NDC 0172-5412
11-digit product format 001725412
Labeler code 0172
Product ID 0172-5412_27a18adf-4a27-479c-bd3c-a58938662ee1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluconazole
Dosage form TABLET
Route ORAL
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA076077
Marketing category ANDA
Marketing start 2004-07-29
Marketing end 2022-06-30
Substance FLUCONAZOLE
Active strength 150 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 0000-00-00
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 0172-5412-11 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 0172-5412-11 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 0172-5412-11 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 0172-5412-11 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 0172-5412-11 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 0172-5412-11 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 0172-5412-11 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 0172-5412-11 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 0172-5412-11 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 0172-5412-11 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 0172-5412-11 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 0172-5412-11 557ba5c1ecfa…9c80585c8c6e…
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 A076077-001 FLUCONAZOLE FLUCONAZOLE 50MG TABLET / ORAL 2004-07-29 A076077-002 FLUCONAZOLE FLUCONAZOLE 100MG TABLET / ORAL 2004-07-29 A076077-003 FLUCONAZOLE FLUCONAZOLE 150MG TABLET / ORAL 2004-07-29 A076077-004 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 A076077-001 FLUCONAZOLE 50MG TABLET / ORAL 2004-07-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076077-002 FLUCONAZOLE 100MG TABLET / ORAL 2004-07-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076077-003 FLUCONAZOLE 150MG TABLET / ORAL 2004-07-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076077-004 FLUCONAZOLE 200MG TABLET / ORAL 2004-07-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076077-001 FLUCONAZOLE 50MG TABLET / ORAL 2004-07-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076077-002 FLUCONAZOLE 100MG TABLET / ORAL 2004-07-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076077-003 FLUCONAZOLE 150MG TABLET / ORAL 2004-07-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076077-004 FLUCONAZOLE 200MG TABLET / ORAL 2004-07-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076077-001 FLUCONAZOLE 50MG TABLET / ORAL 2004-07-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076077-002 FLUCONAZOLE 100MG TABLET / ORAL 2004-07-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076077-003 FLUCONAZOLE 150MG TABLET / ORAL 2004-07-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076077-004 FLUCONAZOLE 200MG TABLET / ORAL 2004-07-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076077-001 FLUCONAZOLE 50MG TABLET / ORAL 2004-07-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076077-002 FLUCONAZOLE 100MG TABLET / ORAL 2004-07-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076077-003 FLUCONAZOLE 150MG TABLET / ORAL 2004-07-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076077-004 FLUCONAZOLE 200MG TABLET / ORAL 2004-07-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076077-001 FLUCONAZOLE 50MG TABLET / ORAL 2004-07-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076077-002 FLUCONAZOLE 100MG TABLET / ORAL 2004-07-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076077-003 FLUCONAZOLE 150MG TABLET / ORAL 2004-07-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076077-004 FLUCONAZOLE 200MG TABLET / ORAL 2004-07-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076077-001 FLUCONAZOLE 50MG TABLET / ORAL 2004-07-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076077-002 FLUCONAZOLE 100MG TABLET / ORAL 2004-07-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076077-003 FLUCONAZOLE 150MG TABLET / ORAL 2004-07-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076077-004 FLUCONAZOLE 200MG TABLET / ORAL 2004-07-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076077-001 FLUCONAZOLE 50MG TABLET / ORAL 2004-07-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076077-002 FLUCONAZOLE 100MG TABLET / ORAL 2004-07-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076077-003 FLUCONAZOLE 150MG TABLET / ORAL 2004-07-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076077-004 FLUCONAZOLE 200MG TABLET / ORAL 2004-07-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076077-001 FLUCONAZOLE 50MG TABLET / ORAL 2004-07-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076077-002 FLUCONAZOLE 100MG TABLET / ORAL 2004-07-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076077-003 FLUCONAZOLE 150MG TABLET / ORAL 2004-07-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076077-004 FLUCONAZOLE 200MG TABLET / ORAL 2004-07-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076077-001 FLUCONAZOLE 50MG TABLET / ORAL 2004-07-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076077-002 FLUCONAZOLE 100MG TABLET / ORAL 2004-07-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076077-003 FLUCONAZOLE 150MG TABLET / ORAL 2004-07-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076077-004 FLUCONAZOLE 200MG TABLET / ORAL 2004-07-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076077-001 FLUCONAZOLE 50MG TABLET / ORAL 2004-07-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076077-002 FLUCONAZOLE 100MG TABLET / ORAL 2004-07-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076077-003 FLUCONAZOLE 150MG TABLET / ORAL 2004-07-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076077-004 FLUCONAZOLE 200MG TABLET / ORAL 2004-07-29 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 68 observed states.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FLUCONAZOLE ACTIVE INGREDIENT 8VZV102JFY FLUCONAZOLE TABLET [IVAX PHARMACEUTICALS, INC.] 9 FLUCONAZOLE ACTIVE MOIETY 8VZV102JFY FLUCONAZOLE TABLET [IVAX PHARMACEUTICALS, INC.] 9 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 FLUCONAZOLE TABLET [IVAX PHARMACEUTICALS, INC.] 9 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FLUCONAZOLE TABLET [IVAX PHARMACEUTICALS, INC.] 9 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 FLUCONAZOLE TABLET [IVAX PHARMACEUTICALS, INC.] 9 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA FLUCONAZOLE TABLET [IVAX PHARMACEUTICALS, INC.] 9 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X FLUCONAZOLE TABLET [IVAX PHARMACEUTICALS, INC.] 9 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FLUCONAZOLE TABLET [IVAX PHARMACEUTICALS, INC.] 9 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 FLUCONAZOLE TABLET [IVAX PHARMACEUTICALS, INC.] 9 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ FLUCONAZOLE TABLET [IVAX PHARMACEUTICALS, INC.] 9 TALC INACTIVE INGREDIENT 7SEV7J4R1U FLUCONAZOLE TABLET [IVAX PHARMACEUTICALS, INC.] 9 FLUCONAZOLE ACTIVE INGREDIENT 8VZV102JFY FLUCONAZOLE TABLET [DIRECT RX] 2 FLUCONAZOLE ACTIVE MOIETY 8VZV102JFY FLUCONAZOLE TABLET [DIRECT RX] 2 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 FLUCONAZOLE TABLET [DIRECT RX] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FLUCONAZOLE TABLET [DIRECT RX] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 FLUCONAZOLE TABLET [DIRECT RX] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA FLUCONAZOLE TABLET [DIRECT RX] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X FLUCONAZOLE TABLET [DIRECT RX] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FLUCONAZOLE TABLET [DIRECT RX] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 FLUCONAZOLE TABLET [DIRECT RX] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ FLUCONAZOLE TABLET [DIRECT RX] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U FLUCONAZOLE TABLET [DIRECT RX] 2 Fluconazole ACTIVE INGREDIENT 8VZV102JFY FLUCONAZOLE TABLET [APOTHECARY SHOP WHOLESALE INC.] 1 FLUCONAZOLE ACTIVE INGREDIENT 8VZV102JFY FLUCONAZOLE TABLET [MEDVANTX, INC.] 1 FLUCONAZOLE ACTIVE INGREDIENT 8VZV102JFY FLUCONAZOLE TABLET [MEDVANTX, INC.] 1 FLUCONAZOLE ACTIVE MOIETY 8VZV102JFY FLUCONAZOLE TABLET [MEDVANTX, INC.] 1 FLUCONAZOLE ACTIVE MOIETY 8VZV102JFY FLUCONAZOLE TABLET [MEDVANTX, INC.] 1 Fluconazole ACTIVE MOIETY 8VZV102JFY FLUCONAZOLE TABLET [APOTHECARY SHOP WHOLESALE INC.] 1 Aluminum Oxide INACTIVE INGREDIENT LMI26O6933 FLUCONAZOLE TABLET [APOTHECARY SHOP WHOLESALE INC.] 1 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 FLUCONAZOLE TABLET [MEDVANTX, INC.] 1 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 FLUCONAZOLE TABLET [MEDVANTX, INC.] 1 Cellulose, Microcrystalline INACTIVE INGREDIENT OP1R32D61U FLUCONAZOLE TABLET [APOTHECARY SHOP WHOLESALE INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FLUCONAZOLE TABLET [MEDVANTX, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FLUCONAZOLE TABLET [MEDVANTX, INC.] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 FLUCONAZOLE TABLET [MEDVANTX, INC.] 1 Croscarmellose Sodium INACTIVE INGREDIENT M28OL1HH48 FLUCONAZOLE TABLET [APOTHECARY SHOP WHOLESALE INC.] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 FLUCONAZOLE TABLET [MEDVANTX, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA FLUCONAZOLE TABLET [MEDVANTX, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA FLUCONAZOLE TABLET [MEDVANTX, INC.] 1 FD&C Red NO. 40 INACTIVE INGREDIENT WZB9127XOA FLUCONAZOLE TABLET [APOTHECARY SHOP WHOLESALE INC.] 1 Lactose Monohydrate INACTIVE INGREDIENT EWQ57Q8I5X FLUCONAZOLE TABLET [APOTHECARY SHOP WHOLESALE INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X FLUCONAZOLE TABLET [MEDVANTX, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X FLUCONAZOLE TABLET [MEDVANTX, INC.] 1 Magnesium Stearate INACTIVE INGREDIENT 70097M6I30 FLUCONAZOLE TABLET [APOTHECARY SHOP WHOLESALE INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FLUCONAZOLE TABLET [MEDVANTX, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FLUCONAZOLE TABLET [MEDVANTX, INC.] 1 Silicon Dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 FLUCONAZOLE TABLET [APOTHECARY SHOP WHOLESALE INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 FLUCONAZOLE TABLET [MEDVANTX, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 FLUCONAZOLE TABLET [MEDVANTX, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ FLUCONAZOLE TABLET [MEDVANTX, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ FLUCONAZOLE TABLET [MEDVANTX, INC.] 1 Starch, Corn INACTIVE INGREDIENT O8232NY3SJ FLUCONAZOLE TABLET [APOTHECARY SHOP WHOLESALE INC.] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U FLUCONAZOLE TABLET [MEDVANTX, INC.] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U FLUCONAZOLE TABLET [MEDVANTX, INC.] 1 Talc INACTIVE INGREDIENT 7SEV7J4R1U FLUCONAZOLE TABLET [APOTHECARY SHOP WHOLESALE INC.] 1
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 0172-5412-11 00172541211 12 BLISTER PACK in 1 BOX (0172-5412-11) > 1 TABLET in 1 BLISTER PACK (0172-5412-79) 12 blister pack 2004-07-29 2022-06-30 No No Current