Home NDC 66336-570 Fluconazole
Product NDC 66336-570
11-digit product format 663360570
Labeler code 66336
Product ID 66336-570_9edeab5c-754e-4739-89c1-a47f7a7f9873
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluconazole
Dosage form TABLET
Route ORAL
Labeler Dispensing Solutions, Inc.
Application ANDA076077
Marketing category ANDA
Marketing start 2010-12-01
Marketing end 0000-00-00
Substance FLUCONAZOLE
Active strength 100 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 E
Listing certified through 2017-12-31
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 2 · 66 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 · 176 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 2026-10-15 13:18:30 2026-09 A076077-001 FLUCONAZOLE 50MG TABLET / ORAL 2004-07-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 A076077-002 FLUCONAZOLE 100MG TABLET / ORAL 2004-07-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 A076077-003 FLUCONAZOLE 150MG TABLET / ORAL 2004-07-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 A076077-004 FLUCONAZOLE 200MG TABLET / ORAL 2004-07-29 c2088c7a36db…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…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 68 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 66336-570-11 Fluconazole 11 in 1 BOTTLE TABLET 11 2 66336-570-14 Fluconazole 14 in 1 BOTTLE TABLET 14 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FLUCONAZOLE ACTIVE INGREDIENT 8VZV102JFY FLUCONAZOLE TABLET [DISPENSING SOLUTIONS, INC.] 2 FLUCONAZOLE ACTIVE MOIETY 8VZV102JFY FLUCONAZOLE TABLET [DISPENSING SOLUTIONS, INC.] 2 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 FLUCONAZOLE TABLET [DISPENSING SOLUTIONS, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FLUCONAZOLE TABLET [DISPENSING SOLUTIONS, INC.] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 FLUCONAZOLE TABLET [DISPENSING SOLUTIONS, INC.] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA FLUCONAZOLE TABLET [DISPENSING SOLUTIONS, INC.] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X FLUCONAZOLE TABLET [DISPENSING SOLUTIONS, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FLUCONAZOLE TABLET [DISPENSING SOLUTIONS, INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 FLUCONAZOLE TABLET [DISPENSING SOLUTIONS, INC.] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ FLUCONAZOLE TABLET [DISPENSING SOLUTIONS, INC.] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U FLUCONAZOLE TABLET [DISPENSING SOLUTIONS, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66336-570 FLUCONAZOLE TABLET [DISPENSING SOLUTIONS, INC.] 2 Legacy NDC, 2 package rows 20130314_aebbf53e-43d2-4d44-8838-481723c4749e.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 66336-570-11 66336057011 11 in 1 BOTTLE Historical 66336-570-14 66336057014 14 in 1 BOTTLE Historical