Fluconazole

Product NDC
55111-145
11-digit product format
551110145
Labeler code
55111
Product ID
55111-145_69e67aa4-a859-7ab0-79df-d9bf8489998d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Dr. Reddy's Laboratories Limited
Application
ANDA076658
Marketing category
ANDA
Marketing start
2014-06-20
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

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
A076658-001FLUCONAZOLEFLUCONAZOLE50MGTABLET / ORALAB2004-07-29
A076658-002FLUCONAZOLEFLUCONAZOLE100MGTABLET / ORALAB2004-07-29
A076658-003FLUCONAZOLEFLUCONAZOLE150MGTABLET / ORALAB2004-07-29
A076658-004FLUCONAZOLEFLUCONAZOLE200MGTABLET / ORALAB2004-07-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076658-001AB
A076658-002AB
A076658-003AB
A076658-004AB

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 UTC2026-02A076658-001FLUCONAZOLE50MGTABLET / ORALAB2004-07-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076658-002FLUCONAZOLE100MGTABLET / ORALAB2004-07-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076658-003FLUCONAZOLE150MGTABLET / ORALAB2004-07-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076658-004FLUCONAZOLE200MGTABLET / ORALAB2004-07-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076658-001FLUCONAZOLE50MGTABLET / ORALAB2004-07-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076658-002FLUCONAZOLE100MGTABLET / ORALAB2004-07-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076658-003FLUCONAZOLE150MGTABLET / ORALAB2004-07-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076658-004FLUCONAZOLE200MGTABLET / ORALAB2004-07-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A076658-001FLUCONAZOLE50MGTABLET / ORALAB2004-07-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076658-002FLUCONAZOLE100MGTABLET / ORALAB2004-07-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076658-003FLUCONAZOLE150MGTABLET / ORALAB2004-07-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076658-004FLUCONAZOLE200MGTABLET / ORALAB2004-07-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076658-001FLUCONAZOLE50MGTABLET / ORALAB2004-07-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076658-002FLUCONAZOLE100MGTABLET / ORALAB2004-07-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076658-003FLUCONAZOLE150MGTABLET / ORALAB2004-07-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076658-004FLUCONAZOLE200MGTABLET / ORALAB2004-07-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076658-001FLUCONAZOLE50MGTABLET / ORALAB2004-07-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076658-002FLUCONAZOLE100MGTABLET / ORALAB2004-07-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076658-003FLUCONAZOLE150MGTABLET / ORALAB2004-07-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076658-004FLUCONAZOLE200MGTABLET / ORALAB2004-07-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076658-001FLUCONAZOLE50MGTABLET / ORALAB2004-07-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076658-002FLUCONAZOLE100MGTABLET / ORALAB2004-07-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076658-003FLUCONAZOLE150MGTABLET / ORALAB2004-07-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076658-004FLUCONAZOLE200MGTABLET / ORALAB2004-07-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076658-001FLUCONAZOLE50MGTABLET / ORALAB2004-07-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076658-002FLUCONAZOLE100MGTABLET / ORALAB2004-07-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076658-003FLUCONAZOLE150MGTABLET / ORALAB2004-07-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076658-004FLUCONAZOLE200MGTABLET / ORALAB2004-07-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076658-001FLUCONAZOLE50MGTABLET / ORALAB2004-07-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076658-002FLUCONAZOLE100MGTABLET / ORALAB2004-07-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076658-003FLUCONAZOLE150MGTABLET / ORALAB2004-07-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076658-004FLUCONAZOLE200MGTABLET / ORALAB2004-07-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076658-001FLUCONAZOLE50MGTABLET / ORALAB2004-07-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076658-002FLUCONAZOLE100MGTABLET / ORALAB2004-07-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076658-003FLUCONAZOLE150MGTABLET / ORALAB2004-07-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076658-004FLUCONAZOLE200MGTABLET / ORALAB2004-07-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076658-001FLUCONAZOLE50MGTABLET / ORALAB2004-07-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A076658-002FLUCONAZOLE100MGTABLET / ORALAB2004-07-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A076658-003FLUCONAZOLE150MGTABLET / ORALAB2004-07-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A076658-004FLUCONAZOLE200MGTABLET / ORALAB2004-07-29d06236e962d9…

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 UTC2026-02A076658-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076658-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076658-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076658-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076658-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076658-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076658-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076658-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076658-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076658-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076658-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076658-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076658-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076658-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076658-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076658-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076658-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076658-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076658-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076658-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076658-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076658-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076658-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076658-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076658-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076658-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076658-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076658-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076658-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076658-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076658-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076658-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076658-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076658-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076658-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076658-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076658-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076658-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076658-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076658-004AB1d06236e962d9…

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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197698Internal RxNorm lookup
197699Internal RxNorm lookup
197700Internal RxNorm lookup
197701Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d7fa1d79-4cd3-4a55-b74b-b31e82e616a3Available 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
55111-145-12Fluconazole12 in 1 CARTONTABLET1219
55111-145-71Fluconazole1 in 1 DOSE PACKTABLET119

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-145-12EA - Each55111-145877bd8c0-59bb-425a-ba37-96e79521532a12014-12-01
55111-145-71EA - Each55111-1454099acd9-0b2d-4694-af73-32a5f3b2b86412015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FluconazoleACTIVE INGREDIENT8VZV102JFYFLUCONAZOLE TABLET [DR. REDDY'S LABORATORIES LIMITED]4
FluconazoleACTIVE MOIETY8VZV102JFYFLUCONAZOLE TABLET [DR. REDDY'S LABORATORIES LIMITED]4
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JFLUCONAZOLE TABLET [DR. REDDY'S LABORATORIES LIMITED]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLUCONAZOLE TABLET [DR. REDDY'S LABORATORIES LIMITED]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675FLUCONAZOLE TABLET [DR. REDDY'S LABORATORIES LIMITED]4
magnesium stearateINACTIVE INGREDIENT70097M6I30FLUCONAZOLE TABLET [DR. REDDY'S LABORATORIES LIMITED]4
povidoneINACTIVE INGREDIENTFZ989GH94EFLUCONAZOLE TABLET [DR. REDDY'S LABORATORIES LIMITED]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2FLUCONAZOLE TABLET [DR. REDDY'S LABORATORIES LIMITED]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFLUCONAZOLE TABLET [DR. REDDY'S LABORATORIES LIMITED]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-145FLUCONAZOLE TABLET [DR. REDDY'S LABORATORIES LIMITED]18Current NDC, Legacy NDC, 2 package rows20240927_d7fa1d79-4cd3-4a55-b74b-b31e82e616a3.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FluconazoleFLUCONAZOLECardinal Health 107, LLCf1bfba3a-5b18-41c0-9084-b1f26bb93ef22026-04-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076658
application number: ANDA076658
FluconazoleFLUCONAZOLESportpharm LLC8a4d6d9e-02ae-42e4-83ec-f5c4e135273b2026-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076658
application number: ANDA076658
FluconazoleFLUCONAZOLEMajor Pharmaceuticals13184b13-e252-4b4d-a3e2-cfc4ad3d55b72026-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076658
application number: ANDA076658
FluconazoleFLUCONAZOLEDr. Reddy's Laboratories Limitedd7fa1d79-4cd3-4a55-b74b-b31e82e616a32025-09-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076658
application number: ANDA076658
ndc (product): 55111-145
FLUCONAZOLEFLUCONAZOLEdirect rxb3db505a-9677-6f5a-e053-2a95a90a13d42025-01-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076658
application number: ANDA076658
FluconazoleFLUCONAZOLEBryant Ranch Prepacka499c43e-0454-4a8c-a547-31e9816babdd2024-10-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076658
application number: ANDA076658

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197698fluconazole 100 MG Oral TabletPSNd7fa1d79-4cd3-4a55-b74b-b31e82e616a319
197699fluconazole 150 MG Oral TabletPSNd7fa1d79-4cd3-4a55-b74b-b31e82e616a319
197700fluconazole 200 MG Oral TabletPSNd7fa1d79-4cd3-4a55-b74b-b31e82e616a319
197701fluconazole 50 MG Oral TabletPSNd7fa1d79-4cd3-4a55-b74b-b31e82e616a319
197698fluconazole 100 MG Oral TabletSCDd7fa1d79-4cd3-4a55-b74b-b31e82e616a319
197699fluconazole 150 MG Oral TabletSCDd7fa1d79-4cd3-4a55-b74b-b31e82e616a319
197700fluconazole 200 MG Oral TabletSCDd7fa1d79-4cd3-4a55-b74b-b31e82e616a319
197701fluconazole 50 MG Oral TabletSCDd7fa1d79-4cd3-4a55-b74b-b31e82e616a319
197698fluconazole 100 MG Oral TabletPSNb3db505a-9677-6f5a-e053-2a95a90a13d45
197699fluconazole 150 MG Oral TabletPSNa499c43e-0454-4a8c-a547-31e9816babdd5
197699fluconazole 150 MG Oral TabletPSNb3db505a-9677-6f5a-e053-2a95a90a13d45
197698fluconazole 100 MG Oral TabletSCDb3db505a-9677-6f5a-e053-2a95a90a13d45
197699fluconazole 150 MG Oral TabletSCDa499c43e-0454-4a8c-a547-31e9816babdd5
197699fluconazole 150 MG Oral TabletSCDb3db505a-9677-6f5a-e053-2a95a90a13d45
197698fluconazole 100 MG Oral TabletPSN8a4d6d9e-02ae-42e4-83ec-f5c4e135273b2
197699fluconazole 150 MG Oral TabletPSN8a4d6d9e-02ae-42e4-83ec-f5c4e135273b2
197700fluconazole 200 MG Oral TabletPSN8a4d6d9e-02ae-42e4-83ec-f5c4e135273b2
197701fluconazole 50 MG Oral TabletPSN8a4d6d9e-02ae-42e4-83ec-f5c4e135273b2
197698fluconazole 100 MG Oral TabletSCD8a4d6d9e-02ae-42e4-83ec-f5c4e135273b2
197699fluconazole 150 MG Oral TabletSCD8a4d6d9e-02ae-42e4-83ec-f5c4e135273b2
197700fluconazole 200 MG Oral TabletSCD8a4d6d9e-02ae-42e4-83ec-f5c4e135273b2
197701fluconazole 50 MG Oral TabletSCD8a4d6d9e-02ae-42e4-83ec-f5c4e135273b2
197699fluconazole 150 MG Oral TabletPSN1f3f1922-648e-1233-e063-6294a90a76f61
197699fluconazole 150 MG Oral TabletSCD1f3f1922-648e-1233-e063-6294a90a76f61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-145-125511101451212 DOSE PACK in 1 CARTON (55111-145-12) / 1 TABLET in 1 DOSE PACK (55111-145-71) 12 dose pack2014-06-200000-00-00NoNoCurrent
55111-145-71551110145711 in 1 DOSE PACKHistorical