Fluocinonide

Product NDC
68071-4921
11-digit product format
680714921
Labeler code
68071
Product ID
68071-4921_1ae25b23-f463-5bc8-e063-6394a90a8e8b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluocinonide
Dosage form
CREAM
Route
TOPICAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA071500
Marketing category
ANDA
Marketing start
2016-10-27
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

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4921-5Fluocinonide30 g in 1 TUBECREAM303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4921FLUOCINONIDE CREAM [NUCARE PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 1 package rows20240616_8ac0ecd6-38b5-a5f9-e053-2a95a90af412.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
103456fluocinonide 0.05 % Topical CreamPSN8ac0ecd6-38b5-a5f9-e053-2a95a90af4123
103456fluocinonide 0.5 MG/ML Topical CreamSCD8ac0ecd6-38b5-a5f9-e053-2a95a90af4123
103456fluocinonide 0.05 % Topical CreamSY8ac0ecd6-38b5-a5f9-e053-2a95a90af4123

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4921-56807149210530 g in 1 TUBE (68071-4921-5) 30 g2019-06-070000-00-00NoNoCurrent