Home NDC 70985-014 Fluconazole
Product NDC 70985-014
11-digit product format 709850014
Labeler code 70985
Product ID 70985-014_eb51cf40-8e0c-3478-e053-2995a90ac6e6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluconazole
Dosage form TABLET
Route ORAL
Labeler Drug Ocean LLC
Application ANDA076957
Marketing category ANDA
Marketing start 2021-06-26
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 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 · 3 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 product product 70985-014 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 70985-014 70985-014-03 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 70985-014 70985-014-01 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 A076957-001 FLUCONAZOLE FLUCONAZOLE 50MG TABLET / ORAL AB 2005-09-28 A076957-002 FLUCONAZOLE FLUCONAZOLE 100MG TABLET / ORAL AB 2005-09-28 A076957-003 FLUCONAZOLE FLUCONAZOLE 200MG TABLET / ORAL AB 2005-09-28 A076957-004 FLUCONAZOLE FLUCONAZOLE 150MG TABLET / ORAL AB 2017-02-27
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 · 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 A076957-001 FLUCONAZOLE 50MG TABLET / ORAL AB 2005-09-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076957-002 FLUCONAZOLE 100MG TABLET / ORAL AB 2005-09-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076957-003 FLUCONAZOLE 200MG TABLET / ORAL AB 2005-09-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076957-004 FLUCONAZOLE 150MG TABLET / ORAL AB 2017-02-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076957-001 FLUCONAZOLE 50MG TABLET / ORAL AB 2005-09-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076957-002 FLUCONAZOLE 100MG TABLET / ORAL AB 2005-09-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076957-003 FLUCONAZOLE 200MG TABLET / ORAL AB 2005-09-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076957-004 FLUCONAZOLE 150MG TABLET / ORAL AB 2017-02-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076957-001 FLUCONAZOLE 50MG TABLET / ORAL AB 2005-09-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076957-002 FLUCONAZOLE 100MG TABLET / ORAL AB 2005-09-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076957-003 FLUCONAZOLE 200MG TABLET / ORAL AB 2005-09-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076957-004 FLUCONAZOLE 150MG TABLET / ORAL AB 2017-02-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076957-001 FLUCONAZOLE 50MG TABLET / ORAL AB 2005-09-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076957-002 FLUCONAZOLE 100MG TABLET / ORAL AB 2005-09-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076957-003 FLUCONAZOLE 200MG TABLET / ORAL AB 2005-09-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076957-004 FLUCONAZOLE 150MG TABLET / ORAL AB 2017-02-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076957-001 FLUCONAZOLE 50MG TABLET / ORAL AB 2005-09-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076957-002 FLUCONAZOLE 100MG TABLET / ORAL AB 2005-09-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076957-003 FLUCONAZOLE 200MG TABLET / ORAL AB 2005-09-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076957-004 FLUCONAZOLE 150MG TABLET / ORAL AB 2017-02-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076957-001 FLUCONAZOLE 50MG TABLET / ORAL AB 2005-09-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076957-002 FLUCONAZOLE 100MG TABLET / ORAL AB 2005-09-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076957-003 FLUCONAZOLE 200MG TABLET / ORAL AB 2005-09-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076957-004 FLUCONAZOLE 150MG TABLET / ORAL AB 2017-02-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076957-001 FLUCONAZOLE 50MG TABLET / ORAL AB 2005-09-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076957-002 FLUCONAZOLE 100MG TABLET / ORAL AB 2005-09-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076957-003 FLUCONAZOLE 200MG TABLET / ORAL AB 2005-09-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076957-004 FLUCONAZOLE 150MG TABLET / ORAL AB 2017-02-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076957-001 FLUCONAZOLE 50MG TABLET / ORAL AB 2005-09-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076957-002 FLUCONAZOLE 100MG TABLET / ORAL AB 2005-09-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076957-003 FLUCONAZOLE 200MG TABLET / ORAL AB 2005-09-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076957-004 FLUCONAZOLE 150MG TABLET / ORAL AB 2017-02-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076957-001 FLUCONAZOLE 50MG TABLET / ORAL AB 2005-09-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076957-002 FLUCONAZOLE 100MG TABLET / ORAL AB 2005-09-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076957-003 FLUCONAZOLE 200MG TABLET / ORAL AB 2005-09-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076957-004 FLUCONAZOLE 150MG TABLET / ORAL AB 2017-02-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076957-001 FLUCONAZOLE 50MG TABLET / ORAL AB 2005-09-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076957-002 FLUCONAZOLE 100MG TABLET / ORAL AB 2005-09-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076957-003 FLUCONAZOLE 200MG TABLET / ORAL AB 2005-09-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076957-004 FLUCONAZOLE 150MG TABLET / ORAL AB 2017-02-27 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 observed states.
DailyMed Product Concepts# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70985-014 FLUCONAZOLE TABLET [DRUG OCEAN LLC] 14 Legacy NDC 20241118_c5bfc182-b35f-afc4-e053-2a95a90ae5c3.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70985-014-01 70985001401 100 TABLET in 1 BOTTLE (70985-014-01) 100 tablet 2021-06-26 0000-00-00 No No Current 70985-014-03 70985001403 30 TABLET in 1 BOTTLE (70985-014-03) 30 tablet 2021-06-26 0000-00-00 No No Current