Fluconazole

Product NDC
68071-3547
Requested package NDC
68071-3547-3
11-digit product format
680713547
Labeler code
68071
Product ID
68071-3547_2d3fb96f-feec-5b60-e063-6394a90a46e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA077731
Marketing category
ANDA
Marketing start
2008-10-07
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
2026-12-31
Current FDA listing
Yes

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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68071-354768071-3547-3UExcluded because listing certification expiredexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68071-354768071-3547-3UExcluded because listing certification expiredexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68071-354768071-3547-3UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUCONAZOLE200 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
197700Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0aacafca-baf8-9a22-e063-6394a90a2ca9Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-3547-32025-02-03C16284748780-12cef2736-95fa-d83d-e063-dadaa90ab31fFluconazole Tablets USP Rx only
68071-3547-32025-01-30C16284748780-12cef2736-95fa-d83d-e063-dadaa90ab31fFluconazole Tablets USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3547-3Fluconazole30 in 1 BOTTLETABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3547FLUCONAZOLE TABLET [NUCARE PHARMACEUTICALS,INC.]2Current NDC, 1 package rows20250205_0aacafca-baf8-9a22-e063-6394a90a2ca9.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
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
197700fluconazole 200 MG Oral TabletPSN0aacafca-baf8-9a22-e063-6394a90a2ca92
197700fluconazole 200 MG Oral TabletSCD0aacafca-baf8-9a22-e063-6394a90a2ca92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3547-36807135470330 TABLET in 1 BOTTLE (68071-3547-3) 30 tablet2023-11-21NoNoCurrent