Fluconazole

Product NDC
68071-2557
11-digit product format
680712557
Labeler code
68071
Product ID
68071-2557_2dcc5468-9b13-b6d5-e063-6294a90a4139
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA077253
Marketing category
ANDA
Marketing start
2020-11-20
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
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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68071-2557-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68071-2557-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68071-2557-10efc9e666f02…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
A077253-001FLUCONAZOLEFLUCONAZOLE50MGTABLET / ORALAB2006-01-25
A077253-002FLUCONAZOLEFLUCONAZOLE100MGTABLET / ORALAB2006-01-25
A077253-003FLUCONAZOLEFLUCONAZOLE150MGTABLET / ORALAB2006-01-25
A077253-004FLUCONAZOLEFLUCONAZOLE200MGTABLET / ORALAB2006-01-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077253-001AB
A077253-002AB
A077253-003AB
A077253-004AB

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 UTC2026-02A077253-001FLUCONAZOLE50MGTABLET / ORALAB2006-01-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077253-002FLUCONAZOLE100MGTABLET / ORALAB2006-01-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077253-003FLUCONAZOLE150MGTABLET / ORALAB2006-01-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077253-004FLUCONAZOLE200MGTABLET / ORALAB2006-01-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077253-001FLUCONAZOLE50MGTABLET / ORALAB2006-01-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077253-002FLUCONAZOLE100MGTABLET / ORALAB2006-01-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077253-003FLUCONAZOLE150MGTABLET / ORALAB2006-01-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077253-004FLUCONAZOLE200MGTABLET / ORALAB2006-01-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A077253-001FLUCONAZOLE50MGTABLET / ORALAB2006-01-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077253-002FLUCONAZOLE100MGTABLET / ORALAB2006-01-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077253-003FLUCONAZOLE150MGTABLET / ORALAB2006-01-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077253-004FLUCONAZOLE200MGTABLET / ORALAB2006-01-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077253-001FLUCONAZOLE50MGTABLET / ORALAB2006-01-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077253-002FLUCONAZOLE100MGTABLET / ORALAB2006-01-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077253-003FLUCONAZOLE150MGTABLET / ORALAB2006-01-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077253-004FLUCONAZOLE200MGTABLET / ORALAB2006-01-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077253-001FLUCONAZOLE50MGTABLET / ORALAB2006-01-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077253-002FLUCONAZOLE100MGTABLET / ORALAB2006-01-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077253-003FLUCONAZOLE150MGTABLET / ORALAB2006-01-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077253-004FLUCONAZOLE200MGTABLET / ORALAB2006-01-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077253-001FLUCONAZOLE50MGTABLET / ORALAB2006-01-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077253-002FLUCONAZOLE100MGTABLET / ORALAB2006-01-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077253-003FLUCONAZOLE150MGTABLET / ORALAB2006-01-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077253-004FLUCONAZOLE200MGTABLET / ORALAB2006-01-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077253-001FLUCONAZOLE50MGTABLET / ORALAB2006-01-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077253-002FLUCONAZOLE100MGTABLET / ORALAB2006-01-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077253-003FLUCONAZOLE150MGTABLET / ORALAB2006-01-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077253-004FLUCONAZOLE200MGTABLET / ORALAB2006-01-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077253-001FLUCONAZOLE50MGTABLET / ORALAB2006-01-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077253-002FLUCONAZOLE100MGTABLET / ORALAB2006-01-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077253-003FLUCONAZOLE150MGTABLET / ORALAB2006-01-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077253-004FLUCONAZOLE200MGTABLET / ORALAB2006-01-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077253-001FLUCONAZOLE50MGTABLET / ORALAB2006-01-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077253-002FLUCONAZOLE100MGTABLET / ORALAB2006-01-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077253-003FLUCONAZOLE150MGTABLET / ORALAB2006-01-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077253-004FLUCONAZOLE200MGTABLET / ORALAB2006-01-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077253-001FLUCONAZOLE50MGTABLET / ORALAB2006-01-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A077253-002FLUCONAZOLE100MGTABLET / ORALAB2006-01-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A077253-003FLUCONAZOLE150MGTABLET / ORALAB2006-01-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A077253-004FLUCONAZOLE200MGTABLET / ORALAB2006-01-25d06236e962d9…

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 UTC2026-02A077253-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077253-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077253-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077253-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077253-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077253-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077253-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077253-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077253-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077253-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077253-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077253-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077253-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077253-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077253-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077253-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077253-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077253-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077253-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077253-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077253-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077253-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077253-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077253-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077253-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077253-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077253-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077253-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077253-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077253-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077253-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077253-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077253-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077253-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077253-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077253-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077253-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077253-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077253-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077253-004AB1d06236e962d9…

Additional Listing Data#

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

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
cf6c7cca-d074-2178-e053-2a95a90a3af7Available 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
68071-2557-12025-02-10C16284748780-12cef2736-abcc-d83d-e063-dadaa90ab31fFluconazole Tablets
68071-2557-12025-01-30C16284748780-12cef2736-abcc-d83d-e063-dadaa90ab31fFluconazole Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2557-1Fluconazole12 in 1 CARTONTABLET124
68071-2557-1Fluconazole1 in 1 BLISTER PACKTABLET14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2557FLUCONAZOLE TABLET [NUCARE PHARMACEUTICALS,INC.]4Current NDC, Legacy NDC, 2 package rows20250212_cf6c7cca-d074-2178-e053-2a95a90a3af7.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 · 19 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FluconazoleFLUCONAZOLESt. Mary's Medical Park Pharmacyc89c3bbd-1170-4170-e053-2a95a90a8e412026-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077253
application number: ANDA077253
FluconazoleFLUCONAZOLENorthwind Health Company, LLC0de7211d-b8ce-214d-e063-6294a90aec412026-06-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077253
application number: ANDA077253
FluconazoleFLUCONAZOLEPD-Rx Pharmaceuticals, Inc.dd975843-c3e4-44f4-bb0d-33b294c1f6fb2026-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077253
application number: ANDA077253
FluconazoleFLUCONAZOLEBryant Ranch Prepacke222031d-58f6-46d6-99f8-320b9aacf2b22026-05-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077253
application number: ANDA077253
FluconazoleFLUCONAZOLECoupler LLC519e44f4-9318-572e-e063-6394a90afe932026-05-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077253
application number: ANDA077253
FluconazoleFLUCONAZOLEREMEDYREPACK INC.2cbf3c6c-318c-4dd9-ad44-a8eb9eccb0f52026-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077253
application number: ANDA077253
FluconazoleFLUCONAZOLEGlenmark Pharmaceuticals Inc., USA3da5f41d-5200-45ac-b89d-00881237ec852026-01-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077253
application number: ANDA077253
FluconazoleFLUCONAZOLENorthwind Health Company, LLCf76bf2f7-1752-7656-e053-6394a90a8d222026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077253
application number: ANDA077253
FluconazoleFLUCONAZOLEBluePoint Laboratories83bcb8fc-53f1-4d7b-b083-0905b52c6c7e2025-12-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077253
application number: ANDA077253
FluconazoleFLUCONAZOLERadha Pharmaceuticals Inc4616c7ad-be61-7ac0-e063-6394a90ab9ed2025-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077253
application number: ANDA077253
FluconazoleFLUCONAZOLEREMEDYREPACK INC.aaf9e5f8-048e-407c-bc11-ad4edff85c052025-08-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077253
application number: ANDA077253
FluconazoleFLUCONAZOLECoupler LLC325d5d69-5132-79ea-e063-6294a90afdd02025-04-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077253
application number: ANDA077253
FluconazoleFLUCONAZOLEProficient Rx LPc0193e27-f1a4-4698-a6bb-3df772c162562025-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077253
application number: ANDA077253
FluconazoleFLUCONAZOLENuCare Pharmaceuticals,Inc.cf6c7cca-d074-2178-e053-2a95a90a3af72025-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077253
application number: ANDA077253
ndc (product): 68071-2557
FLUCONAZOLEFLUCONAZOLEDirect Rxdb886cfe-ea23-50c9-e053-2995a90a4d102025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077253
application number: ANDA077253
FluconazoleFLUCONAZOLEA-S Medication Solutions2fcac0e4-4f12-42d2-b129-106b4e1000752023-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077253
application number: ANDA077253
FluconazoleFLUCONAZOLEProficient Rx LPfa2fa2f8-f3a6-4bc0-943c-03dabd0f15812023-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077253
application number: ANDA077253
FluconazoleFLUCONAZOLEProficient Rx LPfbb1bda3-f733-4404-9c9d-46c418700c032022-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077253
application number: ANDA077253
FluconazoleFLUCONAZOLEAsclemed USA, Inc.56a9de97-bbb9-4210-9ace-f77317d5f33b2022-03-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077253
application number: ANDA077253

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197699fluconazole 150 MG Oral TabletPSNcf6c7cca-d074-2178-e053-2a95a90a3af74
197699fluconazole 150 MG Oral TabletSCDcf6c7cca-d074-2178-e053-2a95a90a3af74

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2557-16807125570112 BLISTER PACK in 1 CARTON (68071-2557-1) / 1 TABLET in 1 BLISTER PACK12 blister pack2021-10-280000-00-00NoNoCurrent