LoKara

Product NDC
0462-0392
11-digit product format
004620392
Labeler code
0462
Product ID
0462-0392_8e63984c-c59a-4c5c-b52f-465fb6e17a67
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
desonide
Dosage form
LOTION
Route
TOPICAL
Labeler
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Application
ANDA075860
Marketing category
ANDA
Marketing start
2002-03-19
Marketing end
0000-00-00
Substance
DESONIDE
Active strength
1 mg/mL
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5dd568b3-c283-39c3-9c72-0b51d8c13e5dProduct name220201006
0d789796-3334-08b7-795a-b9c3762179bcProduct name220200506
6da396dc-a1b2-d109-14be-877a0fdbfa18Product name520200408
4fa39b20-3e53-46d7-85e4-edc2360cfdffProduct name120171115
a4783074-7e0b-e965-10c3-0421e26d5edeProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0462-0392-022020-01-31C16284748780-19d75b9d0-e164-f424-e053-dadaa90a57ceLoKara™ Lotion (desonide lotion 0.05%)
0462-0392-042020-01-31C16284748780-19d75b9d0-e164-f424-e053-dadaa90a57ceLoKara™ Lotion (desonide lotion 0.05%)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0462-0392-02LoKara1 in 1 CARTONLOTION13
0462-0392-02LoKara59 mL in 1 BOTTLELOTION593
0462-0392-04LoKara118 mL in 1 BOTTLELOTION1183
0462-0392-04LoKara1 in 1 CARTONLOTION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0462-0392-02ML - Milliliter0462-03923772ffe0-0511-4de5-bba2-4f9fbbc144d212012-07-24
0462-0392-04ML - Milliliter0462-0392bfa2576f-f87c-468f-a23f-289ad527e1db12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
desonideACTIVE INGREDIENTJ280872D1OLOKARA (DESONIDE) LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]3
desonideACTIVE MOIETYJ280872D1OLOKARA (DESONIDE) LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]3
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLLOKARA (DESONIDE) LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]3
cetyl alcoholINACTIVE INGREDIENT936JST6JCNLOKARA (DESONIDE) LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]3
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPLOKARA (DESONIDE) LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]3
edetate sodiumINACTIVE INGREDIENTMP1J8420LULOKARA (DESONIDE) LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]3
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4LOKARA (DESONIDE) LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]3
light mineral oilINACTIVE INGREDIENTN6K5787QVPLOKARA (DESONIDE) LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]3
methylparabenINACTIVE INGREDIENTA2I8C7HI9TLOKARA (DESONIDE) LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]3
propylene glycolINACTIVE INGREDIENT6DC9Q167V3LOKARA (DESONIDE) LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]3
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHLOKARA (DESONIDE) LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]3
sodium hydroxideINACTIVE INGREDIENT55X04QC32ILOKARA (DESONIDE) LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]3
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JLOKARA (DESONIDE) LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]3
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XLOKARA (DESONIDE) LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]3
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YLOKARA (DESONIDE) LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]3
waterINACTIVE INGREDIENT059QF0KO0RLOKARA (DESONIDE) LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0462-0392LOKARA (DESONIDE) LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]3Legacy NDC, 4 package rows20131123_bb3f4085-03d2-4499-b5df-f290513efde9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197572desonide 0.05 % Topical LotionPSNbb3f4085-03d2-4499-b5df-f290513efde93
584513Lokara 0.05 % Topical LotionPSNbb3f4085-03d2-4499-b5df-f290513efde93
584513desonide 0.5 MG/ML Topical Lotion [Lokara]SBDbb3f4085-03d2-4499-b5df-f290513efde93
197572desonide 0.5 MG/ML Topical LotionSCDbb3f4085-03d2-4499-b5df-f290513efde93
197572desonide 0.05 % Topical LotionSYbb3f4085-03d2-4499-b5df-f290513efde93
584513Lokara 0.05 % Topical LotionSYbb3f4085-03d2-4499-b5df-f290513efde93
584513Lokara 0.5 MG/ML Topical LotionSYbb3f4085-03d2-4499-b5df-f290513efde93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
0462-0392-02004620392021 in 1 CARTONHistorical
0462-0392-0400462039204118 mL in 1 BOTTLE118 mlHistorical