FDA.reportPublic FDA data

Fluconazole

Product NDC
57237-006
11-digit product format
572370006
Labeler code
57237
Product ID
57237-006_1018b9ad-7145-49b4-903a-b483797d7c86
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA077731
Marketing category
ANDA
Marketing start
2008-10-07
Substance
FLUCONAZOLE
Active strength
200 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

Additional Listing Data#

Finished product
Yes
Brand name base
Fluconazole
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUCONAZOLE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8VZV102JFY
Rxcui197698, 197699, 197700, 197701

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
57237-006-01Fluconazole100 in 1 BOTTLETABLET10017
57237-006-30Fluconazole30 in 1 BOTTLETABLET3017

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-006FLUCONAZOLE TABLET [RISING PHARMA HOLDINGS, INC.]17Current NDC, Legacy NDC, 2 package rows20240822_2ca7efcd-4a8d-4139-a3eb-930afd18b13f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197700fluconazole 200 MG Oral TabletPSN3f743514-615e-4e78-8321-24c545a7752f102
197700fluconazole 200 MG Oral TabletSCD3f743514-615e-4e78-8321-24c545a7752f102
197698fluconazole 100 MG Oral TabletPSN2ca7efcd-4a8d-4139-a3eb-930afd18b13f17
197699fluconazole 150 MG Oral TabletPSN2ca7efcd-4a8d-4139-a3eb-930afd18b13f17
197700fluconazole 200 MG Oral TabletPSN2ca7efcd-4a8d-4139-a3eb-930afd18b13f17
197701fluconazole 50 MG Oral TabletPSN2ca7efcd-4a8d-4139-a3eb-930afd18b13f17
197698fluconazole 100 MG Oral TabletSCD2ca7efcd-4a8d-4139-a3eb-930afd18b13f17
197699fluconazole 150 MG Oral TabletSCD2ca7efcd-4a8d-4139-a3eb-930afd18b13f17
197700fluconazole 200 MG Oral TabletSCD2ca7efcd-4a8d-4139-a3eb-930afd18b13f17
197701fluconazole 50 MG Oral TabletSCD2ca7efcd-4a8d-4139-a3eb-930afd18b13f17
197698fluconazole 100 MG Oral TabletPSNd7aacee3-9d9c-4b36-b735-39bcb9edf94112
197700fluconazole 200 MG Oral TabletPSNd7aacee3-9d9c-4b36-b735-39bcb9edf94112
197698fluconazole 100 MG Oral TabletSCDd7aacee3-9d9c-4b36-b735-39bcb9edf94112
197700fluconazole 200 MG Oral TabletSCDd7aacee3-9d9c-4b36-b735-39bcb9edf94112
197698fluconazole 100 MG Oral TabletPSN551a5c8f-57eb-2643-12c6-7c700584b49f10
197700fluconazole 200 MG Oral TabletPSN551a5c8f-57eb-2643-12c6-7c700584b49f10
197698fluconazole 100 MG Oral TabletSCD551a5c8f-57eb-2643-12c6-7c700584b49f10
197700fluconazole 200 MG Oral TabletSCD551a5c8f-57eb-2643-12c6-7c700584b49f10
197700fluconazole 200 MG Oral TabletPSN726daf35-4c03-464f-a814-cc0a715d60315
197700fluconazole 200 MG Oral TabletPSNc6be26bb-af92-405b-9908-972d6e985cf05
197700fluconazole 200 MG Oral TabletSCD726daf35-4c03-464f-a814-cc0a715d60315
197700fluconazole 200 MG Oral TabletSCDc6be26bb-af92-405b-9908-972d6e985cf05
197700fluconazole 200 MG Oral TabletPSNeeeb82e1-d668-418e-9716-f8bcf72f80c04
197700fluconazole 200 MG Oral TabletSCDeeeb82e1-d668-418e-9716-f8bcf72f80c04
197698fluconazole 100 MG Oral TabletPSN2099c3a0-1911-4d4a-878a-36cf054bdd0b2
197699fluconazole 150 MG Oral TabletPSN2099c3a0-1911-4d4a-878a-36cf054bdd0b2
197700fluconazole 200 MG Oral TabletPSN2099c3a0-1911-4d4a-878a-36cf054bdd0b2
197700fluconazole 200 MG Oral TabletPSNfd7ea788-29b7-1f0b-e053-6394a90a29802
197700fluconazole 200 MG Oral TabletPSNfef2222c-5d61-435e-8761-d8f3d435d6d82
197700fluconazole 200 MG Oral TabletPSN0aacafca-baf8-9a22-e063-6394a90a2ca92
197700fluconazole 200 MG Oral TabletPSN06f8f4b9-5289-2d59-e063-6294a90a72092
197701fluconazole 50 MG Oral TabletPSN2099c3a0-1911-4d4a-878a-36cf054bdd0b2
197698fluconazole 100 MG Oral TabletSCD2099c3a0-1911-4d4a-878a-36cf054bdd0b2
197699fluconazole 150 MG Oral TabletSCD2099c3a0-1911-4d4a-878a-36cf054bdd0b2
197700fluconazole 200 MG Oral TabletSCDfd7ea788-29b7-1f0b-e053-6394a90a29802
197700fluconazole 200 MG Oral TabletSCDfef2222c-5d61-435e-8761-d8f3d435d6d82
197700fluconazole 200 MG Oral TabletSCD2099c3a0-1911-4d4a-878a-36cf054bdd0b2
197700fluconazole 200 MG Oral TabletSCD0aacafca-baf8-9a22-e063-6394a90a2ca92
197700fluconazole 200 MG Oral TabletSCD06f8f4b9-5289-2d59-e063-6294a90a72092
197701fluconazole 50 MG Oral TabletSCD2099c3a0-1911-4d4a-878a-36cf054bdd0b2
197698fluconazole 100 MG Oral TabletPSN98ac5455-d26c-4780-a5a3-bf8d859176261
197699fluconazole 150 MG Oral TabletPSN98ac5455-d26c-4780-a5a3-bf8d859176261
197700fluconazole 200 MG Oral TabletPSN98ac5455-d26c-4780-a5a3-bf8d859176261
197701fluconazole 50 MG Oral TabletPSN98ac5455-d26c-4780-a5a3-bf8d859176261
197698fluconazole 100 MG Oral TabletSCD98ac5455-d26c-4780-a5a3-bf8d859176261
197699fluconazole 150 MG Oral TabletSCD98ac5455-d26c-4780-a5a3-bf8d859176261
197700fluconazole 200 MG Oral TabletSCD98ac5455-d26c-4780-a5a3-bf8d859176261
197701fluconazole 50 MG Oral TabletSCD98ac5455-d26c-4780-a5a3-bf8d859176261

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57237-006-0157237000601100 TABLET in 1 BOTTLE (57237-006-01) 100 tablet2008-10-070000-00-00NoNoCurrent
57237-006-305723700063030 TABLET in 1 BOTTLE (57237-006-30) 30 tablet2008-10-070000-00-00NoNoCurrent