JUBLIA

Product NDC
0187-5400
11-digit product format
001875400
Labeler code
0187
Product ID
0187-5400_aa387108-3f36-49af-bbcb-df681d4b9e51
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
efinaconazole
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Bausch Health US LLC
Application
NDA203567
Marketing category
NDA
Marketing start
2014-06-06
Substance
EFINACONAZOLE
Active strength
100 mg/mL
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EFINACONAZOLE100 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ82SB7FXWB
Rxcui1539757, 1539762

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e1c84cbe-2b36-41da-b08d-31bc95241cd1Product name320220118

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0187-5400-02JUBLIA2 mL in 1 BOTTLE, WITH APPLICATORSOLUTION221
0187-5400-02JUBLIA1 in 1 CARTONSOLUTION121
0187-5400-04JUBLIA1 in 1 CARTONSOLUTION121
0187-5400-04JUBLIA4 mL in 1 BOTTLE, WITH APPLICATORSOLUTION421
0187-5400-08JUBLIA8 mL in 1 BOTTLE, WITH APPLICATORSOLUTION821
0187-5400-08JUBLIA1 in 1 CARTONSOLUTION121
0187-5400-10JUBLIA4 mL in 1 BOTTLE, WITH APPLICATORSOLUTION421
0187-5400-10JUBLIA1 in 1 CARTONSOLUTION121

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0187-5400-04ML - Milliliter0187-540029516e7c-1d1f-4ef7-a561-bca4a4e4b35212014-07-02
0187-5400-08ML - Milliliter0187-5400a849e5d8-e2e6-41ea-b1b6-a38f4f52bfe812015-05-05

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0187-5400JUBLIA (EFINACONAZOLE) SOLUTION [BAUSCH HEALTH US LLC]20Current NDC, Legacy NDC, 8 package rows20220728_922d4d25-c530-11e1-9b21-0800200c9a66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1539757efinaconazole 10 % Topical SolutionPSN922d4d25-c530-11e1-9b21-0800200c9a6621
1539762JUBLIA 10 % Topical SolutionPSN922d4d25-c530-11e1-9b21-0800200c9a6621
1539762efinaconazole 100 MG/ML Topical Solution [Jublia]SBD922d4d25-c530-11e1-9b21-0800200c9a6621
1539757efinaconazole 100 MG/ML Topical SolutionSCD922d4d25-c530-11e1-9b21-0800200c9a6621
1539757efinaconazole 10 % Topical SolutionSY922d4d25-c530-11e1-9b21-0800200c9a6621
1539762Jublia 10 % Topical SolutionSY922d4d25-c530-11e1-9b21-0800200c9a6621

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0187-5400-02001875400021 BOTTLE, WITH APPLICATOR in 1 CARTON (0187-5400-02) / 2 mL in 1 BOTTLE, WITH APPLICATOR2015-12-170000-00-00NoNoCurrent
0187-5400-04001875400041 BOTTLE, WITH APPLICATOR in 1 CARTON (0187-5400-04) / 4 mL in 1 BOTTLE, WITH APPLICATOR2014-06-060000-00-00NoNoCurrent
0187-5400-08001875400081 BOTTLE, WITH APPLICATOR in 1 CARTON (0187-5400-08) / 8 mL in 1 BOTTLE, WITH APPLICATOR2014-06-060000-00-00NoNoCurrent
0187-5400-10001875400104 mL in 1 BOTTLE, WITH APPLICATOR4 mlHistorical