Fluconazole

Product NDC
61919-380
11-digit product format
619190380
Labeler code
61919
Product ID
61919-380_da56d70d-707f-a820-e053-2995a90afc12
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Direct Rx
Application
ANDA076658
Marketing category
ANDA
Marketing start
2017-11-01
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 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
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 productproduct61919-380DDiscontinued by firm2026-08-17
excluded packagepackage61919-38061919-380-03DDiscontinued by firm2026-08-17

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 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 packagepackage61919-380-03d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61919-380-03f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61919-380-032ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61919-380-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-380-03cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-380-03cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-380-03302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-380-03ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-380-030efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61919-380-03ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61919-380-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61919-380-03557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A076658-001FLUCONAZOLEFLUCONAZOLE50MGTABLET / ORALAB2004-07-29
A076658-002FLUCONAZOLEFLUCONAZOLE100MGTABLET / ORALAB2004-07-29
A076658-003FLUCONAZOLEFLUCONAZOLE150MGTABLET / ORALAB2004-07-29
A076658-004FLUCONAZOLEFLUCONAZOLE200MGTABLET / ORALAB2004-07-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A076658-001AB
A076658-002AB
A076658-003AB
A076658-004AB

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 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A076658-001FLUCONAZOLE50MGTABLET / ORALAB2004-07-29caaa826d4ba7…
2026-08-18 06:07:402026-07A076658-002FLUCONAZOLE100MGTABLET / ORALAB2004-07-29caaa826d4ba7…
2026-08-18 06:07:402026-07A076658-003FLUCONAZOLE150MGTABLET / ORALAB2004-07-29caaa826d4ba7…
2026-08-18 06:07:402026-07A076658-004FLUCONAZOLE200MGTABLET / ORALAB2004-07-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076658-001FLUCONAZOLE50MGTABLET / ORALAB2004-07-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076658-002FLUCONAZOLE100MGTABLET / ORALAB2004-07-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076658-003FLUCONAZOLE150MGTABLET / ORALAB2004-07-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076658-004FLUCONAZOLE200MGTABLET / ORALAB2004-07-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076658-001FLUCONAZOLE50MGTABLET / ORALAB2004-07-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076658-002FLUCONAZOLE100MGTABLET / ORALAB2004-07-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076658-003FLUCONAZOLE150MGTABLET / ORALAB2004-07-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076658-004FLUCONAZOLE200MGTABLET / ORALAB2004-07-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A076658-001FLUCONAZOLE50MGTABLET / ORALAB2004-07-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076658-002FLUCONAZOLE100MGTABLET / ORALAB2004-07-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076658-003FLUCONAZOLE150MGTABLET / ORALAB2004-07-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076658-004FLUCONAZOLE200MGTABLET / ORALAB2004-07-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076658-001FLUCONAZOLE50MGTABLET / ORALAB2004-07-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076658-002FLUCONAZOLE100MGTABLET / ORALAB2004-07-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076658-003FLUCONAZOLE150MGTABLET / ORALAB2004-07-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076658-004FLUCONAZOLE200MGTABLET / ORALAB2004-07-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076658-001FLUCONAZOLE50MGTABLET / ORALAB2004-07-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076658-002FLUCONAZOLE100MGTABLET / ORALAB2004-07-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076658-003FLUCONAZOLE150MGTABLET / ORALAB2004-07-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076658-004FLUCONAZOLE200MGTABLET / ORALAB2004-07-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076658-001FLUCONAZOLE50MGTABLET / ORALAB2004-07-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076658-002FLUCONAZOLE100MGTABLET / ORALAB2004-07-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076658-003FLUCONAZOLE150MGTABLET / ORALAB2004-07-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076658-004FLUCONAZOLE200MGTABLET / ORALAB2004-07-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076658-001FLUCONAZOLE50MGTABLET / ORALAB2004-07-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076658-002FLUCONAZOLE100MGTABLET / ORALAB2004-07-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076658-003FLUCONAZOLE150MGTABLET / ORALAB2004-07-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076658-004FLUCONAZOLE200MGTABLET / ORALAB2004-07-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076658-001FLUCONAZOLE50MGTABLET / ORALAB2004-07-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076658-002FLUCONAZOLE100MGTABLET / ORALAB2004-07-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076658-003FLUCONAZOLE150MGTABLET / ORALAB2004-07-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076658-004FLUCONAZOLE200MGTABLET / ORALAB2004-07-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076658-001FLUCONAZOLE50MGTABLET / ORALAB2004-07-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076658-002FLUCONAZOLE100MGTABLET / ORALAB2004-07-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076658-003FLUCONAZOLE150MGTABLET / ORALAB2004-07-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076658-004FLUCONAZOLE200MGTABLET / ORALAB2004-07-29d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A076658-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076658-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076658-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076658-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076658-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076658-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076658-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076658-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076658-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076658-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076658-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076658-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076658-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076658-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076658-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076658-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076658-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076658-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076658-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076658-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076658-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076658-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076658-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076658-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076658-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076658-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076658-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076658-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076658-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076658-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076658-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076658-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076658-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076658-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076658-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076658-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076658-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076658-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076658-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076658-004AB1d8e5a09893c0…

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-380-03Fluconazole3 in 1 BOTTLETABLET36

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUCONAZOLEACTIVE INGREDIENT8VZV102JFYDIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX]1
FLUCONAZOLEACTIVE MOIETY8VZV102JFYDIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JDIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX]1
magnesium stearateINACTIVE INGREDIENT70097M6I30DIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX]1
povidoneINACTIVE INGREDIENTFZ989GH94EDIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-380FLUCONAZOLE TABLET [DIRECT RX]6Legacy NDC, 1 package rows20240110_69f199fa-bb92-4837-8b12-427a1c71f622.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FluconazoleFLUCONAZOLECardinal Health 107, LLCf1bfba3a-5b18-41c0-9084-b1f26bb93ef22026-04-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076658
application number: ANDA076658
FluconazoleFLUCONAZOLESportpharm LLC8a4d6d9e-02ae-42e4-83ec-f5c4e135273b2026-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076658
application number: ANDA076658
FluconazoleFLUCONAZOLEMajor Pharmaceuticals13184b13-e252-4b4d-a3e2-cfc4ad3d55b72026-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076658
application number: ANDA076658
FluconazoleFLUCONAZOLEDr. Reddy's Laboratories Limitedd7fa1d79-4cd3-4a55-b74b-b31e82e616a32025-09-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076658
application number: ANDA076658
FLUCONAZOLEFLUCONAZOLEdirect rxb3db505a-9677-6f5a-e053-2a95a90a13d42025-01-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076658
application number: ANDA076658
FluconazoleFLUCONAZOLEBryant Ranch Prepacka499c43e-0454-4a8c-a547-31e9816babdd2024-10-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076658
application number: ANDA076658
FluconazoleFLUCONAZOLEDirect Rx69f199fa-bb92-4837-8b12-427a1c71f6222024-01-09Adverse reactionsExact identifier
ndc (product): 61919-380

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197700fluconazole 200 MG Oral TabletPSN69f199fa-bb92-4837-8b12-427a1c71f6226
197700fluconazole 200 MG Oral TabletSCD69f199fa-bb92-4837-8b12-427a1c71f6226

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-380-03619190380033 TABLET in 1 BOTTLE (61919-380-03) 3 tablet2017-11-010000-00-00NoNoCurrent