FDA.reportPublic FDA data

Fluconazole

Product NDC
25021-184
11-digit product format
250210184
Labeler code
25021
Product ID
25021-184_bd560fcb-5efc-48d3-8d2c-e21f2d072215
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA079104
Marketing category
ANDA
Marketing start
2019-10-15
Substance
FLUCONAZOLE
Active strength
2 mg/mL
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
FLUCONAZOLE2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8VZV102JFY
Rxcui1721314, 1721315

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
74f0b828-cb79-42cb-bb6c-81c9f5bd2648Product name220250623
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508
fe6bb120-ebc6-6290-9eab-e842fdb6c841Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25021-184-82Fluconazole10 in 1 CARTONINJECTION, SOLUTION108
25021-184-82Fluconazole1 in 1 POUCHINJECTION, SOLUTION18
25021-184-87Fluconazole1 in 1 POUCHINJECTION, SOLUTION18
25021-184-87Fluconazole10 in 1 CARTONINJECTION, SOLUTION108
25021-184-66Fluconazole10 in 1 CARTONINJECTION, SOLUTION106
25021-184-66Fluconazole1 in 1 POUCHINJECTION, SOLUTION16
25021-184-67Fluconazole10 in 1 CARTONINJECTION, SOLUTION106
25021-184-67Fluconazole1 in 1 POUCHINJECTION, SOLUTION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-184-66ML - Milliliter25021-184358b08c2-862e-4789-bee9-be0ff7b6415f12020-05-08
25021-184-67ML - Milliliter25021-18419f8e9f9-250c-4ded-bf12-890fb9be1bfd12020-05-08
25021-184-82ML - Milliliter25021-18485b93b90-09ac-410d-a452-c17c355313a912018-05-09
25021-184-87ML - Milliliter25021-184ecc4e89b-2ce9-45f3-8d49-c50e27cc9ceb12018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-184FLUCONAZOLE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]8Current NDC, Legacy NDC, 4 package rows20241102_02f74fe7-0649-46c5-a06a-0700cd265773.zip
25021-184FLUCONAZOLE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]6Current NDC, Legacy NDC, 4 package rows20241102_c041227b-dab6-4c29-ab59-d31993d524b2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1721315fluconazole 200 MG in 100 ML InjectionPSN02f74fe7-0649-46c5-a06a-0700cd2657738
1721314fluconazole 400 MG in 200 ML InjectionPSN02f74fe7-0649-46c5-a06a-0700cd2657738
1721315100 ML fluconazole 2 MG/ML InjectionSCD02f74fe7-0649-46c5-a06a-0700cd2657738
1721314200 ML fluconazole 2 MG/ML InjectionSCD02f74fe7-0649-46c5-a06a-0700cd2657738
1721315fluconazole 200 MG per 100 ML InjectionSY02f74fe7-0649-46c5-a06a-0700cd2657738
1721314fluconazole 400 MG per 200 ML InjectionSY02f74fe7-0649-46c5-a06a-0700cd2657738
1721315fluconazole 200 MG in 100 ML InjectionPSNc041227b-dab6-4c29-ab59-d31993d524b26
1721314fluconazole 400 MG in 200 ML InjectionPSNc041227b-dab6-4c29-ab59-d31993d524b26
1721315100 ML fluconazole 2 MG/ML InjectionSCDc041227b-dab6-4c29-ab59-d31993d524b26
1721314200 ML fluconazole 2 MG/ML InjectionSCDc041227b-dab6-4c29-ab59-d31993d524b26
1721315fluconazole 200 MG per 100 ML InjectionSYc041227b-dab6-4c29-ab59-d31993d524b26
1721314fluconazole 400 MG per 200 ML InjectionSYc041227b-dab6-4c29-ab59-d31993d524b26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25021-184-662502101846610 POUCH in 1 CARTON (25021-184-66) / 1 BAG in 1 POUCH / 100 mL in 1 BAG10 pouch2019-10-150000-00-00NoNoCurrent
25021-184-672502101846710 POUCH in 1 CARTON (25021-184-67) / 1 BAG in 1 POUCH / 200 mL in 1 BAG10 pouch2019-10-150000-00-00NoNoCurrent
25021-184-822502101848210 POUCH in 1 CARTON (25021-184-82) / 1 BAG in 1 POUCH / 100 mL in 1 BAG10 pouch2018-01-150000-00-00NoNoCurrent
25021-184-872502101848710 POUCH in 1 CARTON (25021-184-87) / 1 BAG in 1 POUCH / 200 mL in 1 BAG10 pouch2018-01-150000-00-00NoNoCurrent