Fluconazole

Product NDC
71335-0557
Requested package NDC
71335-0557-4
11-digit product format
713350557
Labeler code
71335
Product ID
71335-0557_a05264e3-4eac-473b-8b8b-e7e0688c81f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077253
Marketing category
ANDA
Marketing start
2006-01-25
Marketing end
0000-00-00
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
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage71335-055771335-0557-4DDiscontinued by firm2026-08-03

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0557-1EA - Each71335-0557711ea942-8791-4af0-8685-22b11bc33b6312018-03-08
71335-0557-2EA - Each71335-0557960539ce-7460-408e-8a6f-edb04f38ebe912018-03-08
71335-0557-3EA - Each71335-0557ebdbb9bf-0da5-4e6b-9307-89e25a83a7a012018-03-08
71335-0557-4EA - Each71335-0557189e75f4-bade-40d3-a98f-04ecdca9764c12018-03-08
71335-0557-5EA - Each71335-0557559d464c-b966-4416-bb14-4ab99eec9c8412018-03-08
71335-0557-6EA - Each71335-055721f4cadd-d8dd-4f1f-96e3-dd4e6301675912018-03-08
71335-0557-7EA - Each71335-0557471b704d-cd8b-4719-8310-4013635baaa212018-03-08

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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0557-4713350557046 TABLET in 1 BOTTLE (71335-0557-4) 6 tablet2021-12-270000-00-00NoNoCurrent