FDA.reportPublic FDA data

Fluocinonide

Product NDC
0093-0263
11-digit product format
000930263
Labeler code
0093
Product ID
0093-0263_c70aebe7-b63b-468a-ada5-dc1e60391277
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluocinonide
Dosage form
CREAM
Route
TOPICAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA072490
Marketing category
ANDA
Marketing start
1990-09-30
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, 1801283

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
0093-0263-15Fluocinonide1 in 1 CARTONCREAM17
0093-0263-15Fluocinonide15 g in 1 TUBECREAM157
0093-0263-30Fluocinonide30 g in 1 TUBECREAM307
0093-0263-30Fluocinonide1 in 1 CARTONCREAM17
0093-0263-92Fluocinonide60 g in 1 TUBECREAM607
0093-0263-92Fluocinonide1 in 1 CARTONCREAM17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-0263-15GM - Gram0093-026370341eb0-76fd-4fba-a0c0-3e4239bf4c1112012-07-24
0093-0263-30GM - Gram0093-0263ff917159-b97b-4d78-8cdd-2f095661590612012-07-24
0093-0263-92GM - Gram0093-0263d3ba1aef-8061-42da-a3ce-dd77ece6fa1b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUOCINONIDEACTIVE INGREDIENT2W4A77YPANFLUOCINONIDE CREAM FLUOCINONIDE OINTMENT [TEVA PHARMACEUTICALS USA INC]1
FLUOCINONIDEACTIVE MOIETY2W4A77YPANFLUOCINONIDE CREAM FLUOCINONIDE OINTMENT [TEVA PHARMACEUTICALS USA INC]1
1,2,6-HEXANETRIOLINACTIVE INGREDIENTW45XXM0XWEFLUOCINONIDE CREAM FLUOCINONIDE OINTMENT [TEVA PHARMACEUTICALS USA INC]1
CASTOR OILINACTIVE INGREDIENTD5340Y2I9GFLUOCINONIDE CREAM FLUOCINONIDE OINTMENT [TEVA PHARMACEUTICALS USA INC]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNFLUOCINONIDE CREAM FLUOCINONIDE OINTMENT [TEVA PHARMACEUTICALS USA INC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPFLUOCINONIDE CREAM FLUOCINONIDE OINTMENT [TEVA PHARMACEUTICALS USA INC]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPFLUOCINONIDE CREAM FLUOCINONIDE OINTMENT [TEVA PHARMACEUTICALS USA INC]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UFLUOCINONIDE CREAM FLUOCINONIDE OINTMENT [TEVA PHARMACEUTICALS USA INC]1
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BFLUOCINONIDE CREAM FLUOCINONIDE OINTMENT [TEVA PHARMACEUTICALS USA INC]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MFLUOCINONIDE CREAM FLUOCINONIDE OINTMENT [TEVA PHARMACEUTICALS USA INC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3FLUOCINONIDE CREAM FLUOCINONIDE OINTMENT [TEVA PHARMACEUTICALS USA INC]1
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XFLUOCINONIDE CREAM FLUOCINONIDE OINTMENT [TEVA PHARMACEUTICALS USA INC]1
SORBITAN SESQUIOLEATEINACTIVE INGREDIENT0W8RRI5W5AFLUOCINONIDE CREAM FLUOCINONIDE OINTMENT [TEVA PHARMACEUTICALS USA INC]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YFLUOCINONIDE CREAM FLUOCINONIDE OINTMENT [TEVA PHARMACEUTICALS USA INC]1
WATERINACTIVE INGREDIENT059QF0KO0RFLUOCINONIDE CREAM FLUOCINONIDE OINTMENT [TEVA PHARMACEUTICALS USA INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-0263FLUOCINONIDE CREAM FLUOCINONIDE OINTMENT [TEVA PHARMACEUTICALS USA, INC.]7Current NDC, Legacy NDC, 6 package rows20241225_986c1ba3-2103-4773-a35c-2c0121a01783.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1801283fluocinonide 0.05 % Emollient Base Topical CreamPSN986c1ba3-2103-4773-a35c-2c0121a017837
103456fluocinonide 0.05 % Topical CreamPSN986c1ba3-2103-4773-a35c-2c0121a017837
103457fluocinonide 0.05 % Topical OintmentPSN986c1ba3-2103-4773-a35c-2c0121a017837
1801283Emollient fluocinonide 0.5 MG/ML Topical CreamSCD986c1ba3-2103-4773-a35c-2c0121a017837
103457fluocinonide 0.0005 MG/MG Topical OintmentSCD986c1ba3-2103-4773-a35c-2c0121a017837
103456fluocinonide 0.5 MG/ML Topical CreamSCD986c1ba3-2103-4773-a35c-2c0121a017837
1801283fluocinonide 0.05 % Emollient Base Topical CreamSY986c1ba3-2103-4773-a35c-2c0121a017837
103456fluocinonide 0.05 % Topical CreamSY986c1ba3-2103-4773-a35c-2c0121a017837
103457fluocinonide 0.05 % Topical OintmentSY986c1ba3-2103-4773-a35c-2c0121a017837

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-0263-15000930263151 TUBE in 1 CARTON (0093-0263-15) / 15 g in 1 TUBE1 tube1990-09-300000-00-00NoNoCurrent
0093-0263-30000930263301 TUBE in 1 CARTON (0093-0263-30) / 30 g in 1 TUBE1 tube1990-09-300000-00-00NoNoCurrent
0093-0263-92000930263921 TUBE in 1 CARTON (0093-0263-92) / 60 g in 1 TUBE1 tube1990-09-300000-00-00NoNoCurrent