FDA.reportPublic FDA data

Fluocinonide

Product NDC
68462-505
11-digit product format
684620505
Labeler code
68462
Product ID
68462-505_9c6c8ea8-4836-4bb8-882b-2375184485d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluocinonide
Dosage form
CREAM
Route
TOPICAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA091282
Marketing category
ANDA
Marketing start
2014-07-14
Substance
FLUOCINONIDE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUOCINONIDE1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2W4A77YPAN
Rxcui485647

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a338afdd-91bc-4c45-5113-8b445b8e6cf2Product name520200618
f3bf4e6e-291f-4372-8e90-b4047949153aProduct name320200514
934e8c63-e34a-6dfb-4224-efad2d76fafcProduct name520190405
ac5b31c4-5bd3-4df8-8f07-dbc9d194cdfeProduct name120181219
ef1d202f-16bf-4f17-a390-087db27f5314Product name120181203
de14082b-1b4a-48ac-b75c-4ee3ff8a29beProduct name120180809

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-505-35Fluocinonide30 g in 1 TUBECREAM306
68462-505-65Fluocinonide60 g in 1 TUBECREAM606
68462-505-66Fluocinonide120 g in 1 TUBECREAM1206

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-505-35GM - Gram68462-505739b842c-7563-48c8-927f-d13088e84b7f12014-08-01
68462-505-65GM - Gram68462-505097a0bd1-7f30-4bef-9f87-435d8d37b41c12014-08-01
68462-505-66GM - Gram68462-50526b6312b-e25c-45d3-a2a1-4e9df6806dc312014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUOCINONIDEACTIVE INGREDIENT2W4A77YPANFLUOCINONIDE CREAM [GLENMARK PHARMACEUTICALS INC., USA]2
FLUOCINONIDEACTIVE MOIETY2W4A77YPANFLUOCINONIDE CREAM [GLENMARK PHARMACEUTICALS INC., USA]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLFLUOCINONIDE CREAM [GLENMARK PHARMACEUTICALS INC., USA]2
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT4Q93RCW27EFLUOCINONIDE CREAM [GLENMARK PHARMACEUTICALS INC., USA]2
CETEARETH-100INACTIVE INGREDIENTDK070R75PWFLUOCINONIDE CREAM [GLENMARK PHARMACEUTICALS INC., USA]2
DIETHYLENE GLYCOL MONOETHYL ETHERINACTIVE INGREDIENTA1A1I8X02BFLUOCINONIDE CREAM [GLENMARK PHARMACEUTICALS INC., USA]2
DIISOPROPANOLAMINEINACTIVE INGREDIENT0W44HYL8T5FLUOCINONIDE CREAM [GLENMARK PHARMACEUTICALS INC., USA]2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4FLUOCINONIDE CREAM [GLENMARK PHARMACEUTICALS INC., USA]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3FLUOCINONIDE CREAM [GLENMARK PHARMACEUTICALS INC., USA]2
WATERINACTIVE INGREDIENT059QF0KO0RFLUOCINONIDE CREAM [GLENMARK PHARMACEUTICALS INC., USA]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-505FLUOCINONIDE CREAM [GLENMARK PHARMACEUTICALS INC., USA]6Current NDC, Legacy NDC, 3 package rows20240104_50f1c216-78c6-4b93-b732-b3beeb78bd62.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485647fluocinonide 0.1 % Topical CreamPSN50f1c216-78c6-4b93-b732-b3beeb78bd626
485647fluocinonide 1 MG/ML Topical CreamSCD50f1c216-78c6-4b93-b732-b3beeb78bd626
485647fluocinonide 0.1 % Topical CreamSY50f1c216-78c6-4b93-b732-b3beeb78bd626
485647fluocinonide 1 MG per 1 GM Topical CreamSY50f1c216-78c6-4b93-b732-b3beeb78bd626

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-505-356846205053530 g in 1 TUBE (68462-505-35) 30 g2014-07-140000-00-00NoNoCurrent
68462-505-656846205056560 g in 1 TUBE (68462-505-65) 60 g2014-07-140000-00-00NoNoCurrent
68462-505-6668462050566120 g in 1 TUBE (68462-505-66) 120 g2014-07-140000-00-00NoNoCurrent