FDA.reportPublic FDA data

Fluconazole

Product NDC
57237-005
11-digit product format
572370005
Labeler code
57237
Product ID
57237-005_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
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

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 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
57237-005-11Fluconazole12 in 1 CARTONTABLET1217
57237-005-11Fluconazole1 in 1 BLISTER PACKTABLET117

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-005FLUCONAZOLE 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
197699fluconazole 150 MG Oral TabletPSN6bb386b0-9dbe-40ee-b873-5215b190592023
197699fluconazole 150 MG Oral TabletSCD6bb386b0-9dbe-40ee-b873-5215b190592023
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
197699fluconazole 150 MG Oral TabletPSN177322f4-9526-40cb-9e5d-bc24e8fb02db12
197699fluconazole 150 MG Oral TabletSCD177322f4-9526-40cb-9e5d-bc24e8fb02db12
197699fluconazole 150 MG Oral TabletPSN5cbd78cd-2cd7-4882-9902-bdb7812fbc6b9
197699fluconazole 150 MG Oral TabletSCD5cbd78cd-2cd7-4882-9902-bdb7812fbc6b9
197699fluconazole 150 MG Oral TabletPSN90538767-c84b-4637-8ab6-8c147315eafa8
197699fluconazole 150 MG Oral TabletSCD90538767-c84b-4637-8ab6-8c147315eafa8
197699fluconazole 150 MG Oral TabletPSN4eaf5b04-c026-4a49-879f-2925b375f9037
197699fluconazole 150 MG Oral TabletSCD4eaf5b04-c026-4a49-879f-2925b375f9037
197699fluconazole 150 MG Oral TabletPSNc924c51c-ed7e-7e72-e053-2995a90adcd34
197699fluconazole 150 MG Oral TabletSCDc924c51c-ed7e-7e72-e053-2995a90adcd34
197699fluconazole 150 MG Oral TabletPSN01df20c4-7b94-044e-e063-6394a90a406a3
197699fluconazole 150 MG Oral TabletPSNfbcb4da9-e8ba-40d3-a596-dc60cde80fa63
197699fluconazole 150 MG Oral TabletPSN124c1ffa-08fd-eca5-e063-6294a90af0e23
197699fluconazole 150 MG Oral TabletPSN068623f9-0f87-50bc-e063-6294a90aea003
197699fluconazole 150 MG Oral TabletSCD068623f9-0f87-50bc-e063-6294a90aea003
197699fluconazole 150 MG Oral TabletSCD124c1ffa-08fd-eca5-e063-6294a90af0e23
197699fluconazole 150 MG Oral TabletSCDfbcb4da9-e8ba-40d3-a596-dc60cde80fa63
197699fluconazole 150 MG Oral TabletSCD01df20c4-7b94-044e-e063-6394a90a406a3
197698fluconazole 100 MG Oral TabletPSN2099c3a0-1911-4d4a-878a-36cf054bdd0b2
197699fluconazole 150 MG Oral TabletPSN2099c3a0-1911-4d4a-878a-36cf054bdd0b2
197699fluconazole 150 MG Oral TabletPSN5b95c88c-41c8-42a5-92f9-09611de09a762
197699fluconazole 150 MG Oral TabletPSN1c82929f-934b-4df4-b24f-1e5da090fd8a2
197699fluconazole 150 MG Oral TabletPSN126406ae-1fdc-df20-e063-6294a90a27182
197699fluconazole 150 MG Oral TabletPSNac9c72c5-5092-27db-e053-2995a90a7d122
197699fluconazole 150 MG Oral TabletPSNfe0cc56d-c0b6-f859-e053-6294a90ad9322
197700fluconazole 200 MG Oral TabletPSN2099c3a0-1911-4d4a-878a-36cf054bdd0b2
197701fluconazole 50 MG Oral TabletPSN2099c3a0-1911-4d4a-878a-36cf054bdd0b2
197698fluconazole 100 MG Oral TabletSCD2099c3a0-1911-4d4a-878a-36cf054bdd0b2
197699fluconazole 150 MG Oral TabletSCDfe0cc56d-c0b6-f859-e053-6294a90ad9322
197699fluconazole 150 MG Oral TabletSCDac9c72c5-5092-27db-e053-2995a90a7d122
197699fluconazole 150 MG Oral TabletSCD126406ae-1fdc-df20-e063-6294a90a27182
197699fluconazole 150 MG Oral TabletSCD1c82929f-934b-4df4-b24f-1e5da090fd8a2
197699fluconazole 150 MG Oral TabletSCD5b95c88c-41c8-42a5-92f9-09611de09a762
197699fluconazole 150 MG Oral TabletSCD2099c3a0-1911-4d4a-878a-36cf054bdd0b2
197700fluconazole 200 MG Oral TabletSCD2099c3a0-1911-4d4a-878a-36cf054bdd0b2
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
197699fluconazole 150 MG Oral TabletPSN277154a2-2783-3775-e054-00144ff88e881
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
197699fluconazole 150 MG Oral TabletSCD277154a2-2783-3775-e054-00144ff88e881
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
57237-005-115723700051112 BLISTER PACK in 1 CARTON (57237-005-11) / 1 TABLET in 1 BLISTER PACK12 blister pack2008-10-070000-00-00NoNoCurrent