fluconazole

Product NDC
70518-2415
11-digit product format
705182415
Labeler code
70518
Product ID
70518-2415_4f94ff0a-6184-d778-e063-6394a90a9de9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA208963
Marketing category
ANDA
Marketing start
2019-11-11
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
2027-12-31
Current FDA listing
Yes

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70518-241570518-2415-0DDiscontinued by firm2026-08-07
excluded packagepackage70518-241570518-2415-3DDiscontinued by firm2026-08-07

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 · 11 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…

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…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUCONAZOLE100 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
197698Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b5cfe0a1-f55c-41b1-8ad6-d1d0134a4d1dAvailable 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
70518-2415-0fluconazole30 in 1 BLISTER PACKTABLET3015
70518-2415-1fluconazole16 in 1 BOTTLE, PLASTICTABLET1615
70518-2415-2fluconazole8 in 1 BOTTLE, PLASTICTABLET815
70518-2415-3fluconazole30 in 1 BOXTABLET3015
70518-2415-4fluconazole1 in 1 POUCHTABLET115

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2415FLUCONAZOLE TABLET [REMEDYREPACK INC.]10Current NDC, Legacy NDC, 5 package rows20250315_b5cfe0a1-f55c-41b1-8ad6-d1d0134a4d1d.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
ndc (product): 70518-2415
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 TabletPSNb5cfe0a1-f55c-41b1-8ad6-d1d0134a4d1d15
197698fluconazole 100 MG Oral TabletSCDb5cfe0a1-f55c-41b1-8ad6-d1d0134a4d1d15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2415-07051824150030 TABLET in 1 BLISTER PACK (70518-2415-0) 30 tablet2019-11-110000-00-00NoNoCurrent
70518-2415-17051824150116 TABLET in 1 BOTTLE, PLASTIC (70518-2415-1) 16 tablet2024-08-23NoNoCurrent
70518-2415-2705182415028 TABLET in 1 BOTTLE, PLASTIC (70518-2415-2) 8 tablet2024-08-23NoNoCurrent
70518-2415-37051824150330 in 1 BOXHistorical
70518-2415-4705182415041 in 1 POUCHHistorical