FDA.reportPublic FDA data

Fluocinonide

Product NDC
51672-1264
11-digit product format
516721264
Labeler code
51672
Product ID
51672-1264_46a43966-e83f-a3cc-e063-6394a90af22d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluocinonide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA075008
Marketing category
ANDA
Marketing start
1999-06-30
Substance
FLUOCINONIDE
Active strength
.5 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
FLUOCINONIDE.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2W4A77YPAN
Rxcui103456, 103457, 310362, 1801283

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
a338afdd-91bc-4c45-5113-8b445b8e6cf2Product name520200618
f3bf4e6e-291f-4372-8e90-b4047949153aProduct name320200514
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
934e8c63-e34a-6dfb-4224-efad2d76fafcProduct name520190405
ac5b31c4-5bd3-4df8-8f07-dbc9d194cdfeProduct name120181219
ef1d202f-16bf-4f17-a390-087db27f5314Product name120181203
de14082b-1b4a-48ac-b75c-4ee3ff8a29beProduct name120180809
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1264-1Fluocinonide1 in 1 CARTONOINTMENT18
51672-1264-1Fluocinonide15 g in 1 TUBEOINTMENT158
51672-1264-2Fluocinonide30 g in 1 TUBEOINTMENT308
51672-1264-2Fluocinonide1 in 1 CARTONOINTMENT18
51672-1264-3Fluocinonide60 g in 1 TUBEOINTMENT608
51672-1264-3Fluocinonide1 in 1 CARTONOINTMENT18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1264-1GM - Gram51672-1264958b2b2c-971f-4fde-8565-4476717f747512012-07-24
51672-1264-2GM - Gram51672-1264d8600fc2-2cc4-40a6-aec7-25b1f6d042da12012-07-24
51672-1264-3GM - Gram51672-12647790c8f0-c982-4e43-b534-ca531e38b35712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FluocinonideACTIVE INGREDIENT2W4A77YPANFLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
FluocinonideACTIVE MOIETY2W4A77YPANFLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
1,2,6-hexanetriolINACTIVE INGREDIENTW45XXM0XWEFLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLFLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
carbomer homopolymer type cINACTIVE INGREDIENT4Q93RCW27EFLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
cetyl alcoholINACTIVE INGREDIENT936JST6JCNFLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPFLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
edetate disodiumINACTIVE INGREDIENT7FLD91C86KFLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
glycerinINACTIVE INGREDIENTPDC6A3C0OXFLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4FLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
mineral oilINACTIVE INGREDIENTT5L8T28FGPFLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
petrolatumINACTIVE INGREDIENT4T6H12BN9UFLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
polyethylene glycol 3350INACTIVE INGREDIENTG2M7P15E5PFLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
polyethylene glycol 8000INACTIVE INGREDIENTQ662QK8M3BFLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MFLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
propyl gallateINACTIVE INGREDIENT8D4SNN7V92FLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
propylene carbonateINACTIVE INGREDIENT8D08K3S51EFLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3FLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
sodium hydroxideINACTIVE INGREDIENT55X04QC32IFLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XFLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YFLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
waterINACTIVE INGREDIENT059QF0KO0RFLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
white waxINACTIVE INGREDIENT7G1J5DA97FFLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1264FLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]5Current NDC, Legacy NDC, 6 package rows20240823_b0bc89a9-c9d5-4adb-9785-2d4487c4c656.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1801283fluocinonide 0.05 % Emollient Base Topical CreamPSNb0bc89a9-c9d5-4adb-9785-2d4487c4c6568
103456fluocinonide 0.05 % Topical CreamPSNb0bc89a9-c9d5-4adb-9785-2d4487c4c6568
310362fluocinonide 0.05 % Topical GelPSNb0bc89a9-c9d5-4adb-9785-2d4487c4c6568
103457fluocinonide 0.05 % Topical OintmentPSNb0bc89a9-c9d5-4adb-9785-2d4487c4c6568
1801283Emollient fluocinonide 0.5 MG/ML Topical CreamSCDb0bc89a9-c9d5-4adb-9785-2d4487c4c6568
310362fluocinonide 0.0005 MG/MG Topical GelSCDb0bc89a9-c9d5-4adb-9785-2d4487c4c6568
103457fluocinonide 0.0005 MG/MG Topical OintmentSCDb0bc89a9-c9d5-4adb-9785-2d4487c4c6568
103456fluocinonide 0.5 MG/ML Topical CreamSCDb0bc89a9-c9d5-4adb-9785-2d4487c4c6568
1801283fluocinonide 0.05 % Emollient Base Topical CreamSYb0bc89a9-c9d5-4adb-9785-2d4487c4c6568
103456fluocinonide 0.05 % Topical CreamSYb0bc89a9-c9d5-4adb-9785-2d4487c4c6568
310362fluocinonide 0.05 % Topical GelSYb0bc89a9-c9d5-4adb-9785-2d4487c4c6568
103457fluocinonide 0.05 % Topical OintmentSYb0bc89a9-c9d5-4adb-9785-2d4487c4c6568
103457fluocinonide 0.05 % Topical OintmentPSN80b72854-3fae-4cc7-bc41-2bdeb3e2cbe14
103457fluocinonide 0.0005 MG/MG Topical OintmentSCD80b72854-3fae-4cc7-bc41-2bdeb3e2cbe14
103457fluocinonide 0.05 % Topical OintmentSY80b72854-3fae-4cc7-bc41-2bdeb3e2cbe14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-1264-1516721264011 TUBE in 1 CARTON (51672-1264-1) / 15 g in 1 TUBE1 tube1999-06-300000-00-00NoNoCurrent
51672-1264-2516721264021 TUBE in 1 CARTON (51672-1264-2) / 30 g in 1 TUBE1 tube1999-06-300000-00-00NoNoCurrent
51672-1264-3516721264031 TUBE in 1 CARTON (51672-1264-3) / 60 g in 1 TUBE1 tube1999-06-300000-00-00NoNoCurrent