Fluconazole

Product NDC
62559-991
11-digit product format
625590991
Labeler code
62559
Product ID
62559-991_eec2c521-a32a-482b-afb4-057860a109cf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA078423
Marketing category
ANDA
Marketing start
2021-04-22
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
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A078423-001FLUCONAZOLEFLUCONAZOLE50MGTABLET / ORALAB2011-03-07
A078423-002FLUCONAZOLEFLUCONAZOLE100MGTABLET / ORALAB2011-03-07
A078423-003FLUCONAZOLEFLUCONAZOLE150MGTABLET / ORALAB2011-03-07
A078423-004FLUCONAZOLEFLUCONAZOLE200MGTABLET / ORALAB2011-03-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078423-001AB
A078423-002AB
A078423-003AB
A078423-004AB

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 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078423-001FLUCONAZOLE50MGTABLET / ORALAB2011-03-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078423-002FLUCONAZOLE100MGTABLET / ORALAB2011-03-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078423-003FLUCONAZOLE150MGTABLET / ORALAB2011-03-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078423-004FLUCONAZOLE200MGTABLET / ORALAB2011-03-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078423-001FLUCONAZOLE50MGTABLET / ORALAB2011-03-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078423-002FLUCONAZOLE100MGTABLET / ORALAB2011-03-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078423-003FLUCONAZOLE150MGTABLET / ORALAB2011-03-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078423-004FLUCONAZOLE200MGTABLET / ORALAB2011-03-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A078423-001FLUCONAZOLE50MGTABLET / ORALAB2011-03-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078423-002FLUCONAZOLE100MGTABLET / ORALAB2011-03-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078423-003FLUCONAZOLE150MGTABLET / ORALAB2011-03-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078423-004FLUCONAZOLE200MGTABLET / ORALAB2011-03-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078423-001FLUCONAZOLE50MGTABLET / ORALAB2011-03-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078423-002FLUCONAZOLE100MGTABLET / ORALAB2011-03-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078423-003FLUCONAZOLE150MGTABLET / ORALAB2011-03-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078423-004FLUCONAZOLE200MGTABLET / ORALAB2011-03-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078423-001FLUCONAZOLE50MGTABLET / ORALAB2011-03-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078423-002FLUCONAZOLE100MGTABLET / ORALAB2011-03-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078423-003FLUCONAZOLE150MGTABLET / ORALAB2011-03-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078423-004FLUCONAZOLE200MGTABLET / ORALAB2011-03-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078423-001FLUCONAZOLE50MGTABLET / ORALAB2011-03-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078423-002FLUCONAZOLE100MGTABLET / ORALAB2011-03-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078423-003FLUCONAZOLE150MGTABLET / ORALAB2011-03-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078423-004FLUCONAZOLE200MGTABLET / ORALAB2011-03-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078423-001FLUCONAZOLE50MGTABLET / ORALAB2011-03-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078423-002FLUCONAZOLE100MGTABLET / ORALAB2011-03-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078423-003FLUCONAZOLE150MGTABLET / ORALAB2011-03-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078423-004FLUCONAZOLE200MGTABLET / ORALAB2011-03-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078423-001FLUCONAZOLE50MGTABLET / ORALAB2011-03-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078423-002FLUCONAZOLE100MGTABLET / ORALAB2011-03-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078423-003FLUCONAZOLE150MGTABLET / ORALAB2011-03-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078423-004FLUCONAZOLE200MGTABLET / ORALAB2011-03-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078423-001FLUCONAZOLE50MGTABLET / ORALAB2011-03-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078423-002FLUCONAZOLE100MGTABLET / ORALAB2011-03-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078423-003FLUCONAZOLE150MGTABLET / ORALAB2011-03-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078423-004FLUCONAZOLE200MGTABLET / ORALAB2011-03-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078423-001FLUCONAZOLE50MGTABLET / ORALAB2011-03-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A078423-002FLUCONAZOLE100MGTABLET / ORALAB2011-03-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A078423-003FLUCONAZOLE150MGTABLET / ORALAB2011-03-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A078423-004FLUCONAZOLE200MGTABLET / ORALAB2011-03-07d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A078423-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078423-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078423-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078423-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078423-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078423-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078423-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078423-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078423-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078423-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078423-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078423-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078423-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078423-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078423-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078423-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078423-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078423-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078423-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078423-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078423-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078423-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078423-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078423-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078423-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078423-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078423-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078423-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078423-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078423-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078423-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078423-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078423-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078423-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078423-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078423-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078423-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078423-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078423-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078423-004AB1d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
Fluconazole
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUCONAZOLE100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8VZV102JFYInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197698Internal RxNorm lookup
197699Internal RxNorm lookup
197700Internal RxNorm lookup
197701Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8f90f169-6a72-4c33-a2af-0bc943602bc2Available on FDA.report

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
62559-991-30Fluconazole30 in 1 BOTTLETABLET3012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-991-30EA - Each62559-991a599f888-c66a-4e2d-b881-f8f39042dca912021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62559-991FLUCONAZOLE TABLET [ANI PHARMACEUTICALS, INC.]11Current NDC, Legacy NDC, 1 package rows20240920_8f90f169-6a72-4c33-a2af-0bc943602bc2.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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FluconazoleFLUCONAZOLEREMEDYREPACK INC.91adb548-9875-47e9-8054-578ed8c7572e2026-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078423
application number: ANDA078423
FluconazoleFLUCONAZOLEGolden State Medical Supply, Inc.c2c7242d-d172-4733-e053-2995a90acb2e2026-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078423
application number: ANDA078423
FluconazoleFLUCONAZOLEBryant Ranch Prepack2c9abaee-461f-437d-adda-e96d7ae3dd012026-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078423
application number: ANDA078423
FluconazoleFLUCONAZOLEA-S Medication Solutionsa0f1c111-e11e-4b7e-b990-8bc271cbc9402026-01-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078423
application number: ANDA078423
FluconazoleFLUCONAZOLEBryant Ranch Prepack701cd91f-4f79-48a7-8fe5-a9678d7a4ac82025-10-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078423
application number: ANDA078423
FluconazoleFLUCONAZOLEANI Pharmaceuticals, Inc.8f90f169-6a72-4c33-a2af-0bc943602bc22025-08-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078423
application number: ANDA078423
ndc (product): 62559-991
FluconazoleFLUCONAZOLEPD-Rx Pharmaceuticals, Inc.d9e772e9-d916-42ae-8020-89b2632361022025-04-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078423
application number: ANDA078423
FluconazoleFLUCONAZOLEBryant Ranch Prepackc94b8ecf-249f-42d6-a030-4cfb83fddb082024-10-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078423
application number: ANDA078423
FluconazoleFLUCONAZOLEBryant Ranch Prepack877aea10-b019-4eeb-8a1e-e6ac583df9662024-10-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078423
application number: ANDA078423
FluconazoleFLUCONAZOLEBryant Ranch Prepackb94ca865-ab2f-466c-9913-dde9376e45332024-10-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078423
application number: ANDA078423
FluconazoleFLUCONAZOLEBryant Ranch Prepack6b2bc10f-21a8-422a-9ea3-ed7788ffce6b2024-10-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078423
application number: ANDA078423
FluconazoleFLUCONAZOLEProficient Rx LPb0aa9b22-5aef-459f-bb11-b193343eeb862023-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078423
application number: ANDA078423

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197698fluconazole 100 MG Oral TabletPSN701cd91f-4f79-48a7-8fe5-a9678d7a4ac8107
197698fluconazole 100 MG Oral TabletSCD701cd91f-4f79-48a7-8fe5-a9678d7a4ac8107
197698fluconazole 100 MG Oral TabletPSNc94b8ecf-249f-42d6-a030-4cfb83fddb08106
197698fluconazole 100 MG Oral TabletSCDc94b8ecf-249f-42d6-a030-4cfb83fddb08106
197698fluconazole 100 MG Oral TabletPSN8f90f169-6a72-4c33-a2af-0bc943602bc212
197698fluconazole 100 MG Oral TabletPSNc2c7242d-d172-4733-e053-2995a90acb2e12
197699fluconazole 150 MG Oral TabletPSN8f90f169-6a72-4c33-a2af-0bc943602bc212
197699fluconazole 150 MG Oral TabletPSNc2c7242d-d172-4733-e053-2995a90acb2e12
197700fluconazole 200 MG Oral TabletPSNc2c7242d-d172-4733-e053-2995a90acb2e12
197700fluconazole 200 MG Oral TabletPSN8f90f169-6a72-4c33-a2af-0bc943602bc212
197701fluconazole 50 MG Oral TabletPSN8f90f169-6a72-4c33-a2af-0bc943602bc212
197701fluconazole 50 MG Oral TabletPSNc2c7242d-d172-4733-e053-2995a90acb2e12
197698fluconazole 100 MG Oral TabletSCD8f90f169-6a72-4c33-a2af-0bc943602bc212
197698fluconazole 100 MG Oral TabletSCDc2c7242d-d172-4733-e053-2995a90acb2e12
197699fluconazole 150 MG Oral TabletSCD8f90f169-6a72-4c33-a2af-0bc943602bc212
197699fluconazole 150 MG Oral TabletSCDc2c7242d-d172-4733-e053-2995a90acb2e12
197700fluconazole 200 MG Oral TabletSCD8f90f169-6a72-4c33-a2af-0bc943602bc212
197700fluconazole 200 MG Oral TabletSCDc2c7242d-d172-4733-e053-2995a90acb2e12
197701fluconazole 50 MG Oral TabletSCD8f90f169-6a72-4c33-a2af-0bc943602bc212
197701fluconazole 50 MG Oral TabletSCDc2c7242d-d172-4733-e053-2995a90acb2e12
197698fluconazole 100 MG Oral TabletPSN91adb548-9875-47e9-8054-578ed8c7572e6
197698fluconazole 100 MG Oral TabletSCD91adb548-9875-47e9-8054-578ed8c7572e6
197698fluconazole 100 MG Oral TabletPSNa0f1c111-e11e-4b7e-b990-8bc271cbc9403
197698fluconazole 100 MG Oral TabletSCDa0f1c111-e11e-4b7e-b990-8bc271cbc9403
197698fluconazole 100 MG Oral TabletPSNf3d2c5d6-8705-0dc1-e053-2995a90a2f042
197698fluconazole 100 MG Oral TabletPSNb0aa9b22-5aef-459f-bb11-b193343eeb862
197698fluconazole 100 MG Oral TabletSCDf3d2c5d6-8705-0dc1-e053-2995a90a2f042
197698fluconazole 100 MG Oral TabletSCDb0aa9b22-5aef-459f-bb11-b193343eeb862

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62559-991-306255909913030 TABLET in 1 BOTTLE (62559-991-30) 30 tablet2021-04-220000-00-00NoNoCurrent