Fluocinonide

Product NDC
70710-1284
11-digit product format
707101284
Labeler code
70710
Product ID
70710-1284_bd0eaa0d-0a5b-48a2-bc7e-78b8bde33962
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluocinonide
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA208948
Marketing category
ANDA
Marketing start
2018-11-01
Substance
FLUOCINONIDE
Active strength
.5 mg/mL
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/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2W4A77YPAN
Rxcui310364

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
70710-1284-3Fluocinonide60 mL in 1 BOTTLESOLUTION605
70710-1284-8Fluocinonide20 mL in 1 BOTTLESOLUTION205

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1284FLUOCINONIDE SOLUTION [ZYDUS PHARMACEUTICALS USA INC.]5Current NDC, Legacy NDC, 2 package rows20221011_73315c87-4e55-41ea-883b-23d504c1b10d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310364fluocinonide 0.05 % Topical SolutionPSN73315c87-4e55-41ea-883b-23d504c1b10d5
310364fluocinonide 0.5 MG/ML Topical SolutionSCD73315c87-4e55-41ea-883b-23d504c1b10d5
310364fluocinonide 0.05 % Topical SolutionSY73315c87-4e55-41ea-883b-23d504c1b10d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70710-1284-37071012840360 mL in 1 BOTTLE (70710-1284-3) 60 ml2018-11-010000-00-00NoNoCurrent
70710-1284-87071012840820 mL in 1 BOTTLE (70710-1284-8) 20 ml2018-11-010000-00-00NoNoCurrent