FDA.reportPublic FDA data

Fluocinonide

Product NDC
51672-1353
11-digit product format
516721353
Labeler code
51672
Product ID
51672-1353_390c3bf3-dd9d-f100-e063-6294a90a81f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluocinonide
Dosage form
CREAM
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA200734
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
51672-1353-2Fluocinonide30 g in 1 TUBECREAM306
51672-1353-2Fluocinonide1 in 1 CARTONCREAM16
51672-1353-3Fluocinonide1 in 1 CARTONCREAM16
51672-1353-3Fluocinonide60 g in 1 TUBECREAM606
51672-1353-4Fluocinonide120 g in 1 TUBECREAM1206
51672-1353-4Fluocinonide1 in 1 CARTONCREAM16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1353-2GM - Gram51672-13535b23c884-1697-4a4e-95bb-f2038ad8541012014-08-01
51672-1353-3GM - Gram51672-13532f7e90bc-8374-481e-b8fa-d6769ca070a612014-08-01
51672-1353-4GM - Gram51672-1353cd8e6294-5b40-4ce0-9ee8-e15d2a8a1e1f12014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FluocinonideACTIVE INGREDIENT2W4A77YPANFLUOCINONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
FluocinonideACTIVE MOIETY2W4A77YPANFLUOCINONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
carbomer homopolymer type c (allyl pentaerythritol crosslinked)INACTIVE INGREDIENT4Q93RCW27EFLUOCINONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPFLUOCINONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
diethylene glycol monoethyl etherINACTIVE INGREDIENTA1A1I8X02BFLUOCINONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1AFLUOCINONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
polyoxyl 20 cetostearyl etherINACTIVE INGREDIENTYRC528SWUYFLUOCINONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
propylene glycolINACTIVE INGREDIENT6DC9Q167V3FLUOCINONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XFLUOCINONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
trolamineINACTIVE INGREDIENT9O3K93S3TKFLUOCINONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1353FLUOCINONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]5Current NDC, Legacy NDC, 6 package rows20241222_16c7d142-e695-4e33-986f-78cb37f7b387.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485647fluocinonide 0.1 % Topical CreamPSN16c7d142-e695-4e33-986f-78cb37f7b3876
485647fluocinonide 1 MG/ML Topical CreamSCD16c7d142-e695-4e33-986f-78cb37f7b3876
485647fluocinonide 0.1 % Topical CreamSY16c7d142-e695-4e33-986f-78cb37f7b3876
485647fluocinonide 1 MG per 1 GM Topical CreamSY16c7d142-e695-4e33-986f-78cb37f7b3876
485647fluocinonide 0.1 % Topical CreamPSNcd5d8268-77ff-41c0-8699-b583e52da30c1
485647fluocinonide 1 MG/ML Topical CreamSCDcd5d8268-77ff-41c0-8699-b583e52da30c1
485647fluocinonide 0.1 % Topical CreamSYcd5d8268-77ff-41c0-8699-b583e52da30c1
485647fluocinonide 1 MG per 1 GM Topical CreamSYcd5d8268-77ff-41c0-8699-b583e52da30c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-1353-2516721353021 TUBE in 1 CARTON (51672-1353-2) / 30 g in 1 TUBE1 tube2014-07-140000-00-00NoNoCurrent
51672-1353-3516721353031 TUBE in 1 CARTON (51672-1353-3) / 60 g in 1 TUBE1 tube2014-07-140000-00-00NoNoCurrent
51672-1353-4516721353041 TUBE in 1 CARTON (51672-1353-4) / 120 g in 1 TUBE1 tube2014-07-140000-00-00NoNoCurrent