LULICONAZOLE

Product NDC
68682-850
11-digit product format
686820850
Labeler code
68682
Product ID
68682-850_9c57ca2a-cc38-40fc-ac2e-40b21cc18c43
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LULICONAZOLE
Dosage form
CREAM
Route
TOPICAL
Labeler
Oceanside Pharmaceuticals
Application
NDA204153
Marketing category
NDA
Marketing start
2018-06-15
Substance
LULICONAZOLE
Active strength
10 mg/g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 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
LULICONAZOLE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LULICONAZOLE10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRE91AN4S8G
Rxcui1482684

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5984a8e6-24e4-43b7-9512-346486417e1eProduct name120180515

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68682-850-60LULICONAZOLE60 g in 1 TUBECREAM609
68682-850-60LULICONAZOLE1 in 1 CARTONCREAM19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68682-850-60GM - Gram68682-850a05fe7f8-11fa-432f-b468-30bc42459e8412018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68682-850LULICONAZOLE CREAM [OCEANSIDE PHARMACEUTICALS]8Current NDC, Legacy NDC, 2 package rows20200605_7ccda3ba-9c98-468d-83c6-7f0cc7c88c33.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1482684luliconazole 1 % Topical CreamPSN7ccda3ba-9c98-468d-83c6-7f0cc7c88c339
1482684luliconazole 10 MG/ML Topical CreamSCD7ccda3ba-9c98-468d-83c6-7f0cc7c88c339
1482684luliconazole 1 % Topical CreamSY7ccda3ba-9c98-468d-83c6-7f0cc7c88c339

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68682-850-60686820850601 TUBE in 1 CARTON (68682-850-60) / 60 g in 1 TUBE1 tube2018-06-150000-00-00NoNoCurrent