Fluconazole

Product NDC
68788-7293
11-digit product format
687887293
Labeler code
68788
Product ID
68788-7293_ad4ab463-489e-442d-9f0e-e1d095f69cc6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA077731
Marketing category
ANDA
Marketing start
2019-01-04
Substance
FLUCONAZOLE
Active strength
150 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
2027-12-31
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
A077731-001FLUCONAZOLEFLUCONAZOLE50MGTABLET / ORALAB2008-10-07
A077731-002FLUCONAZOLEFLUCONAZOLE100MGTABLET / ORALAB2008-10-07
A077731-003FLUCONAZOLEFLUCONAZOLE150MGTABLET / ORALAB2008-10-07
A077731-004FLUCONAZOLEFLUCONAZOLE200MGTABLET / ORALAB2008-10-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077731-001AB
A077731-002AB
A077731-003AB
A077731-004AB

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 UTC2026-02A077731-001FLUCONAZOLE50MGTABLET / ORALAB2008-10-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077731-002FLUCONAZOLE100MGTABLET / ORALAB2008-10-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077731-003FLUCONAZOLE150MGTABLET / ORALAB2008-10-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077731-004FLUCONAZOLE200MGTABLET / ORALAB2008-10-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077731-001FLUCONAZOLE50MGTABLET / ORALAB2008-10-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077731-002FLUCONAZOLE100MGTABLET / ORALAB2008-10-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077731-003FLUCONAZOLE150MGTABLET / ORALAB2008-10-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077731-004FLUCONAZOLE200MGTABLET / ORALAB2008-10-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A077731-001FLUCONAZOLE50MGTABLET / ORALAB2008-10-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077731-002FLUCONAZOLE100MGTABLET / ORALAB2008-10-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077731-003FLUCONAZOLE150MGTABLET / ORALAB2008-10-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077731-004FLUCONAZOLE200MGTABLET / ORALAB2008-10-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077731-001FLUCONAZOLE50MGTABLET / ORALAB2008-10-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077731-002FLUCONAZOLE100MGTABLET / ORALAB2008-10-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077731-003FLUCONAZOLE150MGTABLET / ORALAB2008-10-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077731-004FLUCONAZOLE200MGTABLET / ORALAB2008-10-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077731-001FLUCONAZOLE50MGTABLET / ORALAB2008-10-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077731-002FLUCONAZOLE100MGTABLET / ORALAB2008-10-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077731-003FLUCONAZOLE150MGTABLET / ORALAB2008-10-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077731-004FLUCONAZOLE200MGTABLET / ORALAB2008-10-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077731-001FLUCONAZOLE50MGTABLET / ORALAB2008-10-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077731-002FLUCONAZOLE100MGTABLET / ORALAB2008-10-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077731-003FLUCONAZOLE150MGTABLET / ORALAB2008-10-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077731-004FLUCONAZOLE200MGTABLET / ORALAB2008-10-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077731-001FLUCONAZOLE50MGTABLET / ORALAB2008-10-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077731-002FLUCONAZOLE100MGTABLET / ORALAB2008-10-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077731-003FLUCONAZOLE150MGTABLET / ORALAB2008-10-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077731-004FLUCONAZOLE200MGTABLET / ORALAB2008-10-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077731-001FLUCONAZOLE50MGTABLET / ORALAB2008-10-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077731-002FLUCONAZOLE100MGTABLET / ORALAB2008-10-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077731-003FLUCONAZOLE150MGTABLET / ORALAB2008-10-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077731-004FLUCONAZOLE200MGTABLET / ORALAB2008-10-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077731-001FLUCONAZOLE50MGTABLET / ORALAB2008-10-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077731-002FLUCONAZOLE100MGTABLET / ORALAB2008-10-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077731-003FLUCONAZOLE150MGTABLET / ORALAB2008-10-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077731-004FLUCONAZOLE200MGTABLET / ORALAB2008-10-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077731-001FLUCONAZOLE50MGTABLET / ORALAB2008-10-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A077731-002FLUCONAZOLE100MGTABLET / ORALAB2008-10-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A077731-003FLUCONAZOLE150MGTABLET / ORALAB2008-10-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A077731-004FLUCONAZOLE200MGTABLET / ORALAB2008-10-07d06236e962d9…

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 UTC2026-02A077731-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077731-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077731-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077731-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077731-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077731-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077731-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077731-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077731-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077731-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077731-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077731-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077731-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077731-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077731-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077731-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077731-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077731-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077731-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077731-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077731-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077731-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077731-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077731-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077731-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077731-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077731-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077731-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077731-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077731-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077731-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077731-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077731-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077731-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077731-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077731-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077731-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077731-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077731-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077731-004AB1d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
Fluconazole
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUCONAZOLE150 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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5cbd78cd-2cd7-4882-9902-bdb7812fbc6bAvailable 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
68788-7293-1Fluconazole1 in 1 BLISTER PACKTABLET19
68788-7293-2Fluconazole2 in 1 BLISTER PACKTABLET29
68788-7293-8Fluconazole12 in 1 BLISTER PACKTABLET129

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7293-1EA - Each68788-7293310333f7-7b63-4bc1-bcad-b34d8fcd1f6e12019-04-11
68788-7293-2EA - Each68788-7293c4b46788-8bbf-4f32-befb-217448340f9212019-04-11
68788-7293-8EA - Each68788-729348b571ff-2278-4853-84e3-1b809c7c513a12019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7293FLUCONAZOLE TABLET [PREFERRED PHARMACEUTICALS INC.]8Current NDC, Legacy NDC, 3 package rows20250514_5cbd78cd-2cd7-4882-9902-bdb7812fbc6b.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 2 · 36 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FluconazoleFLUCONAZOLERedpharm Drug568d9f2f-3394-b972-e063-6394a90a86282026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077731
application number: ANDA077731
FluconazoleFLUCONAZOLEPD-Rx Pharmaceuticals, Inc.6bb386b0-9dbe-40ee-b873-5215b19059202026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077731
application number: ANDA077731
FluconazoleFLUCONAZOLESt. Mary's Medical Park Pharmacy126406ae-1fdc-df20-e063-6294a90a27182026-06-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077731
application number: ANDA077731
FluconazoleFLUCONAZOLEA-S Medication Solutionsa995790a-8470-4c51-801a-69347151a6fe2026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077731
application number: ANDA077731
FluconazoleFLUCONAZOLEREMEDYREPACK INC.726daf35-4c03-464f-a814-cc0a715d60312026-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077731
application number: ANDA077731
FluconazoleFLUCONAZOLEASCLEMED USA INC.2099c3a0-1911-4d4a-878a-36cf054bdd0b2026-05-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077731
application number: ANDA077731
FluconazoleFLUCONAZOLEPreferred Pharmaceuticals Inc.eeeb82e1-d668-418e-9716-f8bcf72f80c02026-04-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077731
application number: ANDA077731
FluconazoleFLUCONAZOLEPreferred Pharmaceuticals Inc.5cbd78cd-2cd7-4882-9902-bdb7812fbc6b2026-04-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077731
application number: ANDA077731
ndc (product): 68788-7293
FluconazoleFLUCONAZOLEA-S Medication Solutionsf25f31a6-4bad-40fa-bced-695552e27afd2026-02-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077731
application number: ANDA077731
FluconazoleFLUCONAZOLESportpharm LLC60f3e8af-d98f-48dd-83e6-a78315aaed222026-02-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077731
application number: ANDA077731
FluconazoleFLUCONAZOLESportpharm LLC98ac5455-d26c-4780-a5a3-bf8d859176262026-02-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077731
application number: ANDA077731
FluconazoleFLUCONAZOLEAvPAK551a5c8f-57eb-2643-12c6-7c700584b49f2026-01-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077731
application number: ANDA077731
FluconazoleFLUCONAZOLENorthwind Health Company, LLCc924c51c-ed7e-7e72-e053-2995a90adcd32026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077731
application number: ANDA077731
FluconazoleFLUCONAZOLENuCare Pharmaceuticals,Inc.124c1ffa-08fd-eca5-e063-6294a90af0e22025-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077731
application number: ANDA077731
FluconazoleFLUCONAZOLEA-S Medication Solutionsc6be26bb-af92-405b-9908-972d6e985cf02025-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077731
application number: ANDA077731
FluconazoleFLUCONAZOLENuCare Pharmaceuticals,Inc.01df20c4-7b94-044e-e063-6394a90a406a2025-11-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077731
application number: ANDA077731
FluconazoleFLUCONAZOLEPD-Rx Pharmaceuticals, Inc.28d53f27-a0cd-4d8d-e054-00144ff8d46c2025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077731
application number: ANDA077731
FluconazoleFLUCONAZOLEREMEDYREPACK INC.1c82929f-934b-4df4-b24f-1e5da090fd8a2025-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077731
application number: ANDA077731
FluconazoleFLUCONAZOLEREMEDYREPACK INC.2bd1c038-ab82-496c-8129-3182238ad1a12025-09-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077731
application number: ANDA077731
FluconazoleFLUCONAZOLEProficient Rx LPfef2222c-5d61-435e-8761-d8f3d435d6d82025-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077731
application number: ANDA077731

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197699fluconazole 150 MG Oral TabletPSN5cbd78cd-2cd7-4882-9902-bdb7812fbc6b9
197699fluconazole 150 MG Oral TabletSCD5cbd78cd-2cd7-4882-9902-bdb7812fbc6b9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7293-1687887293011 TABLET in 1 BLISTER PACK (68788-7293-1) 1 tablet2019-01-040000-00-00NoNoCurrent
68788-7293-2687887293022 TABLET in 1 BLISTER PACK (68788-7293-2) 2 tablet2019-01-040000-00-00NoNoCurrent
68788-7293-86878872930812 TABLET in 1 BLISTER PACK (68788-7293-8) 12 tablet2019-01-040000-00-00NoNoCurrent