Fluconazole

Product NDC
66116-510
11-digit product format
661160510
Labeler code
66116
Product ID
66116-510_8267f4f7-a557-400e-a1d8-07825c39f9ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
MedVantx, Inc.
Application
ANDA076077
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
E
Listing certified through
2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct66116-510IInactivated by FDA2026-09-14
excluded packagepackage66116-51066116-510-02IInactivated by FDA2026-09-14

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 1 · 44 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 packagepackage66116-510-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66116-510-02f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66116-510-022ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66116-510-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66116-510-02cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66116-510-02cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66116-510-02302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66116-510-02ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66116-510-020efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage66116-510-02ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage66116-510-02367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66116-510-02557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage66116-510-028af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage66116-510-02834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage66116-510-021332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage66116-510-02fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage66116-510-0286f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage66116-510-02bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage66116-510-028dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage66116-510-02e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage66116-510-029bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage66116-510-02110d247fa046…a55b01930146…

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…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
74f0b828-cb79-42cb-bb6c-81c9f5bd2648Product name220250623
fe6bb120-ebc6-6290-9eab-e842fdb6c841Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66116-510-022019-11-27C16284748780-19855d018-dfb2-cd31-e053-dbdaa90ab51aFLUCONAZOLE TABLETS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66116-510-02Fluconazole2 in 1 BLISTER PACKTABLET21

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUCONAZOLEACTIVE INGREDIENT8VZV102JFYFLUCONAZOLE TABLET [MEDVANTX, INC.]1
FLUCONAZOLEACTIVE MOIETY8VZV102JFYFLUCONAZOLE TABLET [MEDVANTX, INC.]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933FLUCONAZOLE TABLET [MEDVANTX, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLUCONAZOLE TABLET [MEDVANTX, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FLUCONAZOLE TABLET [MEDVANTX, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAFLUCONAZOLE TABLET [MEDVANTX, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFLUCONAZOLE TABLET [MEDVANTX, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLUCONAZOLE TABLET [MEDVANTX, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FLUCONAZOLE TABLET [MEDVANTX, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFLUCONAZOLE TABLET [MEDVANTX, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UFLUCONAZOLE TABLET [MEDVANTX, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66116-510FLUCONAZOLE TABLET [MEDVANTX, INC.]1Legacy NDC, 1 package rows20130820_8267f4f7-a557-400e-a1d8-07825c39f9ef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197699fluconazole 150 MG Oral TabletPSN8267f4f7-a557-400e-a1d8-07825c39f9ef1
197699fluconazole 150 MG Oral TabletSCD8267f4f7-a557-400e-a1d8-07825c39f9ef1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
66116-510-02661160510022 in 1 BLISTER PACKHistorical