fluconazole

Product NDC
70934-935
Requested package NDC
70934-935-07
11-digit product format
709340935
Labeler code
70934
Product ID
70934-935_d3a8edf1-8a26-3355-e053-2995a90ae452
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA208963
Marketing category
ANDA
Marketing start
2021-12-16
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 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
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 packagepackage70934-93570934-935-07IInactivated by FDA2026-08-07

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 · 15 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…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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
A208963-001FLUCONAZOLEFLUCONAZOLE50MGTABLET / ORALAB2017-02-16
A208963-002FLUCONAZOLEFLUCONAZOLE100MGTABLET / ORALAB2017-02-16
A208963-003FLUCONAZOLEFLUCONAZOLE150MGTABLET / ORALAB2017-02-16
A208963-004FLUCONAZOLEFLUCONAZOLE200MGTABLET / ORALAB2017-02-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208963-001AB
A208963-002AB
A208963-003AB
A208963-004AB

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 UTC2026-02A208963-001FLUCONAZOLE50MGTABLET / ORALAB2017-02-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208963-002FLUCONAZOLE100MGTABLET / ORALAB2017-02-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208963-003FLUCONAZOLE150MGTABLET / ORALAB2017-02-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208963-004FLUCONAZOLE200MGTABLET / ORALAB2017-02-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208963-001FLUCONAZOLE50MGTABLET / ORALAB2017-02-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208963-002FLUCONAZOLE100MGTABLET / ORALAB2017-02-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208963-003FLUCONAZOLE150MGTABLET / ORALAB2017-02-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208963-004FLUCONAZOLE200MGTABLET / ORALAB2017-02-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A208963-001FLUCONAZOLE50MGTABLET / ORALAB2017-02-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208963-002FLUCONAZOLE100MGTABLET / ORALAB2017-02-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208963-003FLUCONAZOLE150MGTABLET / ORALAB2017-02-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208963-004FLUCONAZOLE200MGTABLET / ORALAB2017-02-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208963-001FLUCONAZOLE50MGTABLET / ORALAB2017-02-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208963-002FLUCONAZOLE100MGTABLET / ORALAB2017-02-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208963-003FLUCONAZOLE150MGTABLET / ORALAB2017-02-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208963-004FLUCONAZOLE200MGTABLET / ORALAB2017-02-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208963-001FLUCONAZOLE50MGTABLET / ORALAB2017-02-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208963-002FLUCONAZOLE100MGTABLET / ORALAB2017-02-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208963-003FLUCONAZOLE150MGTABLET / ORALAB2017-02-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208963-004FLUCONAZOLE200MGTABLET / ORALAB2017-02-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208963-001FLUCONAZOLE50MGTABLET / ORALAB2017-02-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208963-002FLUCONAZOLE100MGTABLET / ORALAB2017-02-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208963-003FLUCONAZOLE150MGTABLET / ORALAB2017-02-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208963-004FLUCONAZOLE200MGTABLET / ORALAB2017-02-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208963-001FLUCONAZOLE50MGTABLET / ORALAB2017-02-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208963-002FLUCONAZOLE100MGTABLET / ORALAB2017-02-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208963-003FLUCONAZOLE150MGTABLET / ORALAB2017-02-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208963-004FLUCONAZOLE200MGTABLET / ORALAB2017-02-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208963-001FLUCONAZOLE50MGTABLET / ORALAB2017-02-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208963-002FLUCONAZOLE100MGTABLET / ORALAB2017-02-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208963-003FLUCONAZOLE150MGTABLET / ORALAB2017-02-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208963-004FLUCONAZOLE200MGTABLET / ORALAB2017-02-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208963-001FLUCONAZOLE50MGTABLET / ORALAB2017-02-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208963-002FLUCONAZOLE100MGTABLET / ORALAB2017-02-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208963-003FLUCONAZOLE150MGTABLET / ORALAB2017-02-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208963-004FLUCONAZOLE200MGTABLET / ORALAB2017-02-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208963-001FLUCONAZOLE50MGTABLET / ORALAB2017-02-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A208963-002FLUCONAZOLE100MGTABLET / ORALAB2017-02-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A208963-003FLUCONAZOLE150MGTABLET / ORALAB2017-02-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A208963-004FLUCONAZOLE200MGTABLET / ORALAB2017-02-16d06236e962d9…

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 UTC2026-02A208963-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208963-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208963-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208963-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208963-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208963-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208963-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208963-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208963-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208963-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208963-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208963-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208963-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208963-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208963-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208963-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208963-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208963-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208963-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208963-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208963-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208963-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208963-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208963-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208963-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208963-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208963-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208963-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208963-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208963-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208963-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208963-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208963-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208963-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208963-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208963-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208963-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208963-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208963-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208963-004AB1d06236e962d9…

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
70934-935-072023-01-30C16284748780-1f386c64a-10cf-0266-e053-dadaa90a7c1aFluconazole Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70934-935-07fluconazole7 in 1 BOTTLE, PLASTICTABLET71

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70934-935FLUCONAZOLE TABLET [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]1Legacy NDC, 1 package rows20211229_d3a8f0e4-cf55-2df6-e053-2a95a90a221c.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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
fluconazoleFLUCONAZOLEA-S Medication Solutions7961c029-746c-48c3-888b-8f83441028732026-07-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208963
application number: ANDA208963
fluconazoleFLUCONAZOLEREMEDYREPACK INC.b5cfe0a1-f55c-41b1-8ad6-d1d0134a4d1d2026-07-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208963
application number: ANDA208963
fluconazoleFLUCONAZOLEPreferred Pharmaceuticals Inc.16b6fba0-b96f-4252-a70d-31dc614002982026-07-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208963
application number: ANDA208963
fluconazoleFLUCONAZOLEBryant Ranch Prepack67af604c-928f-468b-ba27-ad45e95d3e7e2026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208963
application number: ANDA208963
fluconazoleFLUCONAZOLEBryant Ranch Prepack7259671f-a703-4a2a-81db-9a4839b340722026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208963
application number: ANDA208963
fluconazoleFLUCONAZOLEZydus Pharmaceuticals (USA) Inc.d1364455-1537-46d4-b093-38cca3be778f2026-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208963
application number: ANDA208963
fluconazoleFLUCONAZOLEA-S Medication Solutions1a8bd42a-2bce-4b41-8678-67033e7707dd2026-01-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208963
application number: ANDA208963
FLUCONAZOLEFLUCONAZOLEdirect rxb3db505a-9677-6f5a-e053-2a95a90a13d42025-01-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208963
application number: ANDA208963
fluconazoleFLUCONAZOLENuCare Pharmaceuticals,Inc.715c53f0-2aea-1f24-e053-2995a90ad4632024-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208963
application number: ANDA208963
fluconazoleFLUCONAZOLEZydus Lifesciences Limited0adb2f88-8a6f-4f33-9e2d-73f537e053132024-03-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208963
application number: ANDA208963
FluconazoleFLUCONAZOLEDirect Rx69f199fa-bb92-4837-8b12-427a1c71f6222024-01-09Adverse reactionsExact identifier
application applno (ANDA): 208963
application number: ANDA208963
fluconazoleFLUCONAZOLEA-S Medication Solutions08a54805-4fdf-48fd-bc3e-e9fa38f3c6912023-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208963
application number: ANDA208963
fluconazoleFLUCONAZOLEProficient Rx LPf232600e-70ce-4001-b9da-31442f0920b92020-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208963
application number: ANDA208963
fluconazoleFLUCONAZOLEProficient Rx LP7c8bb5ff-37e7-4f5e-8ea7-12269b2c7fd32019-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208963
application number: ANDA208963

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197698fluconazole 100 MG Oral TabletPSNd3a8f0e4-cf55-2df6-e053-2a95a90a221c1
197698fluconazole 100 MG Oral TabletSCDd3a8f0e4-cf55-2df6-e053-2a95a90a221c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70934-935-07709340935077 TABLET in 1 BOTTLE, PLASTIC (70934-935-07) 7 tablet2021-12-160000-00-00NoNoCurrent