Fluconazole

Product NDC
68788-9927
11-digit product format
687889927
Labeler code
68788
Product ID
68788-9927_7636b432-53df-44f3-aeb1-e3abc9812bd1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA076077
Marketing category
ANDA
Marketing start
2012-01-18
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 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 8 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68788-9927DDiscontinued by firm2026-09-14
excluded packagepackage68788-992768788-9927-0DDiscontinued by firm2026-09-14
excluded packagepackage68788-992768788-9927-1DDiscontinued by firm2026-09-14
excluded packagepackage68788-992768788-9927-2DDiscontinued by firm2026-09-14
excluded packagepackage68788-992768788-9927-3DDiscontinued by firm2026-09-14
excluded packagepackage68788-992768788-9927-5DDiscontinued by firm2026-09-14
excluded packagepackage68788-992768788-9927-6DDiscontinued by firm2026-09-14
excluded packagepackage68788-992768788-9927-9DDiscontinued by firm2026-09-14

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 · 96 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9927-0d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9927-9d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9927-5d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9927-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9927-6d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9927-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9927-3d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9927-0f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9927-9f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9927-5f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9927-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9927-6f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9927-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9927-3f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9927-02ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9927-92ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9927-52ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9927-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9927-62ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9927-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9927-32ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9927-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9927-9a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9927-5a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9927-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9927-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9927-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9927-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9927-0cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9927-9cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9927-5cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9927-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9927-6cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9927-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9927-3cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9927-0cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9927-9cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9927-5cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9927-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9927-6cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9927-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9927-3cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-9927-0302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-9927-9302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-9927-5302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-9927-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-9927-6302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-9927-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-9927-3302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-9927-0ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-9927-9ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-9927-5ed331223b511…672a5bd82f5f…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076077-001FLUCONAZOLEFLUCONAZOLE50MGTABLET / ORAL2004-07-29
A076077-002FLUCONAZOLEFLUCONAZOLE100MGTABLET / ORAL2004-07-29
A076077-003FLUCONAZOLEFLUCONAZOLE150MGTABLET / ORAL2004-07-29
A076077-004FLUCONAZOLEFLUCONAZOLE200MGTABLET / ORAL2004-07-29

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A076077-001FLUCONAZOLE50MGTABLET / ORAL2004-07-2984e616aacf4f…
2026-09-14 22:38:342026-08A076077-002FLUCONAZOLE100MGTABLET / ORAL2004-07-2984e616aacf4f…
2026-09-14 22:38:342026-08A076077-003FLUCONAZOLE150MGTABLET / ORAL2004-07-2984e616aacf4f…
2026-09-14 22:38:342026-08A076077-004FLUCONAZOLE200MGTABLET / ORAL2004-07-2984e616aacf4f…
2026-08-18 06:07:402026-07A076077-001FLUCONAZOLE50MGTABLET / ORAL2004-07-29caaa826d4ba7…
2026-08-18 06:07:402026-07A076077-002FLUCONAZOLE100MGTABLET / ORAL2004-07-29caaa826d4ba7…
2026-08-18 06:07:402026-07A076077-003FLUCONAZOLE150MGTABLET / ORAL2004-07-29caaa826d4ba7…
2026-08-18 06:07:402026-07A076077-004FLUCONAZOLE200MGTABLET / ORAL2004-07-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076077-001FLUCONAZOLE50MGTABLET / ORAL2004-07-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076077-002FLUCONAZOLE100MGTABLET / ORAL2004-07-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076077-003FLUCONAZOLE150MGTABLET / ORAL2004-07-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076077-004FLUCONAZOLE200MGTABLET / ORAL2004-07-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076077-001FLUCONAZOLE50MGTABLET / ORAL2004-07-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076077-002FLUCONAZOLE100MGTABLET / ORAL2004-07-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076077-003FLUCONAZOLE150MGTABLET / ORAL2004-07-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076077-004FLUCONAZOLE200MGTABLET / ORAL2004-07-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A076077-001FLUCONAZOLE50MGTABLET / ORAL2004-07-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076077-002FLUCONAZOLE100MGTABLET / ORAL2004-07-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076077-003FLUCONAZOLE150MGTABLET / ORAL2004-07-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076077-004FLUCONAZOLE200MGTABLET / ORAL2004-07-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076077-001FLUCONAZOLE50MGTABLET / ORAL2004-07-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076077-002FLUCONAZOLE100MGTABLET / ORAL2004-07-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076077-003FLUCONAZOLE150MGTABLET / ORAL2004-07-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076077-004FLUCONAZOLE200MGTABLET / ORAL2004-07-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076077-001FLUCONAZOLE50MGTABLET / ORAL2004-07-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076077-002FLUCONAZOLE100MGTABLET / ORAL2004-07-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076077-003FLUCONAZOLE150MGTABLET / ORAL2004-07-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076077-004FLUCONAZOLE200MGTABLET / ORAL2004-07-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076077-001FLUCONAZOLE50MGTABLET / ORAL2004-07-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076077-002FLUCONAZOLE100MGTABLET / ORAL2004-07-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076077-003FLUCONAZOLE150MGTABLET / ORAL2004-07-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076077-004FLUCONAZOLE200MGTABLET / ORAL2004-07-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076077-001FLUCONAZOLE50MGTABLET / ORAL2004-07-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076077-002FLUCONAZOLE100MGTABLET / ORAL2004-07-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076077-003FLUCONAZOLE150MGTABLET / ORAL2004-07-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076077-004FLUCONAZOLE200MGTABLET / ORAL2004-07-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076077-001FLUCONAZOLE50MGTABLET / ORAL2004-07-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076077-002FLUCONAZOLE100MGTABLET / ORAL2004-07-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076077-003FLUCONAZOLE150MGTABLET / ORAL2004-07-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076077-004FLUCONAZOLE200MGTABLET / ORAL2004-07-295bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076077-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076077-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076077-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076077-004AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076077-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076077-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076077-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076077-004AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076077-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076077-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076077-003AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076077-004AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076077-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076077-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076077-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076077-004AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076077-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A076077-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A076077-003AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A076077-004AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076077-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A076077-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A076077-003AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A076077-004AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076077-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076077-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076077-003AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076077-004AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A076077-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A076077-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A076077-003AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A076077-004AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076077-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A076077-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A076077-003AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A076077-004AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076077-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A076077-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A076077-003AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A076077-004AB1c0c555d07b60…