Fluocinonide

Product NDC
68071-2541
11-digit product format
680712541
Labeler code
68071
Product ID
68071-2541_cc994be4-4792-8c01-e053-2995a90a8d24
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluocinonide
Dosage form
SOLUTION
Route
TOPICAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA209283
Marketing category
ANDA
Marketing start
2018-04-24
Marketing end
0000-00-00
Substance
FLUOCINONIDE
Active strength
1 mg/mL
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2541-6Fluocinonide60 mL in 1 BOTTLESOLUTION602
68071-2541-6Fluocinonide1 in 1 CARTONSOLUTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2541FLUOCINONIDE SOLUTION [NUCARE PHARMACEUTICALS,INC.]2Legacy NDC, 2 package rows20230715_cc994062-9f2e-8be3-e053-2995a90a3f8b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310364fluocinonide 0.05 % Topical SolutionPSNcc994062-9f2e-8be3-e053-2995a90a3f8b2
310364fluocinonide 0.5 MG/ML Topical SolutionSCDcc994062-9f2e-8be3-e053-2995a90a3f8b2
310364fluocinonide 0.05 % Topical SolutionSYcc994062-9f2e-8be3-e053-2995a90a3f8b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2541-6680712541061 BOTTLE in 1 CARTON (68071-2541-6) > 60 mL in 1 BOTTLE1 bottle2021-09-220000-00-00NoNoCurrent