Fluconazole

Product NDC
68462-101
11-digit product format
684620101
Labeler code
68462
Product ID
68462-101_639b832d-b798-4efb-8db0-e64b8ba81574
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA077253
Marketing category
ANDA
Marketing start
2006-01-25
Substance
FLUCONAZOLE
Active strength
50 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

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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUCONAZOLE50 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
3da5f41d-5200-45ac-b89d-00881237ec85Available 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
68462-101-10Fluconazole1000 in 1 BOTTLETABLET100023
68462-101-30Fluconazole30 in 1 BOTTLETABLET3023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-101-30EA - Each68462-10149d606a2-4d25-439d-83cd-dd16285dc0a212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUCONAZOLEACTIVE INGREDIENT8VZV102JFYFLUCONAZOLE TABLET [GLENMARK PHARMACEUTICALS INC., USA]10
FLUCONAZOLEACTIVE MOIETY8VZV102JFYFLUCONAZOLE TABLET [GLENMARK PHARMACEUTICALS INC., USA]10
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JFLUCONAZOLE TABLET [GLENMARK PHARMACEUTICALS INC., USA]10
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FLUCONAZOLE TABLET [GLENMARK PHARMACEUTICALS INC., USA]10
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAFLUCONAZOLE TABLET [GLENMARK PHARMACEUTICALS INC., USA]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLUCONAZOLE TABLET [GLENMARK PHARMACEUTICALS INC., USA]10
POVIDONESINACTIVE INGREDIENTFZ989GH94EFLUCONAZOLE TABLET [GLENMARK PHARMACEUTICALS INC., USA]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-101FLUCONAZOLE TABLET [GLENMARK PHARMACEUTICALS INC., USA]22Current NDC, Legacy NDC, 2 package rows20240405_3da5f41d-5200-45ac-b89d-00881237ec85.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
ndc (product): 68462-101
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197698fluconazole 100 MG Oral TabletPSN3da5f41d-5200-45ac-b89d-00881237ec8523
197699fluconazole 150 MG Oral TabletPSN3da5f41d-5200-45ac-b89d-00881237ec8523
197700fluconazole 200 MG Oral TabletPSN3da5f41d-5200-45ac-b89d-00881237ec8523
197701fluconazole 50 MG Oral TabletPSN3da5f41d-5200-45ac-b89d-00881237ec8523
197698fluconazole 100 MG Oral TabletSCD3da5f41d-5200-45ac-b89d-00881237ec8523
197699fluconazole 150 MG Oral TabletSCD3da5f41d-5200-45ac-b89d-00881237ec8523
197700fluconazole 200 MG Oral TabletSCD3da5f41d-5200-45ac-b89d-00881237ec8523
197701fluconazole 50 MG Oral TabletSCD3da5f41d-5200-45ac-b89d-00881237ec8523

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-101-10684620101101000 TABLET in 1 BOTTLE (68462-101-10) 1000 tablet2006-01-250000-00-00NoNoCurrent
68462-101-306846201013030 TABLET in 1 BOTTLE (68462-101-30) 30 tablet2006-01-250000-00-00NoNoCurrent