Fluocinonide

Product NDC
52565-025
11-digit product format
525650025
Labeler code
52565
Product ID
52565-025_c95f0c00-d292-4b5b-a7f1-f7478bbfb94c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluocinonide
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Teligent Pharma, Inc.
Application
ANDA207554
Marketing category
ANDA
Marketing start
2019-03-18
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
2020-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52565-025-202023-01-30C16284748780-1f386c64a-0906-0266-e053-dadaa90a7c1aFluocinonide Topical Solution USP, 0.05%
52565-025-592023-01-30C16284748780-1f386c64a-0906-0266-e053-dadaa90a7c1aFluocinonide Topical Solution USP, 0.05%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52565-025-20Fluocinonide1 in 1 CARTONSOLUTION14
52565-025-20Fluocinonide20 mL in 1 BOTTLESOLUTION204
52565-025-59Fluocinonide60 mL in 1 BOTTLESOLUTION604
52565-025-59Fluocinonide1 in 1 CARTONSOLUTION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52565-025-20ML - Milliliter52565-025c118f0f2-1aa6-4968-afdd-2f50f3fc1e4112019-06-19
52565-025-59ML - Milliliter52565-025165ccd31-2f86-4d14-aed5-c78294ea392012019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52565-025FLUOCINONIDE SOLUTION [TELIGENT PHARMA, INC.]4Legacy NDC, 4 package rows20190911_edd2e419-44b0-4b7b-9037-d5cbd5d3b63c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310364fluocinonide 0.05 % Topical SolutionPSNedd2e419-44b0-4b7b-9037-d5cbd5d3b63c4
310364fluocinonide 0.5 MG/ML Topical SolutionSCDedd2e419-44b0-4b7b-9037-d5cbd5d3b63c4
310364fluocinonide 0.05 % Topical SolutionSYedd2e419-44b0-4b7b-9037-d5cbd5d3b63c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52565-025-20525650025201 BOTTLE in 1 CARTON (52565-025-20) > 20 mL in 1 BOTTLE1 bottle2019-03-180000-00-00NoNoCurrent
52565-025-59525650025591 BOTTLE in 1 CARTON (52565-025-59) > 60 mL in 1 BOTTLE1 bottle2019-03-180000-00-00NoNoCurrent