FDA.reportPublic FDA data

Fluocinonide

Product NDC
52565-079
11-digit product format
525650079
Labeler code
52565
Product ID
52565-079_285c6180-cee8-4878-9e76-e8bb321c1af8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluocinonide
Dosage form
CREAM
Route
TOPICAL
Labeler
Teligent Pharma, Inc.
Application
ANDA211758
Marketing category
ANDA
Marketing start
2018-03-15
Marketing end
0000-00-00
Substance
FLUOCINONIDE
Active strength
1 mg/g
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
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
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
de14082b-1b4a-48ac-b75c-4ee3ff8a29beProduct name120180809
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52565-079-112023-01-30C16284748780-1f386c64a-133c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use FLUOCINONIDE CREAM safely and effectively. See full prescribing information for FLUOCINONIDE CREAM. Fluocinonide cream, for topical use Initial U.S. Approval: 1971
52565-079-302023-01-30C16284748780-1f386c64a-133c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use FLUOCINONIDE CREAM safely and effectively. See full prescribing information for FLUOCINONIDE CREAM. Fluocinonide cream, for topical use Initial U.S. Approval: 1971
52565-079-602023-01-30C16284748780-1f386c64a-133c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use FLUOCINONIDE CREAM safely and effectively. See full prescribing information for FLUOCINONIDE CREAM. Fluocinonide cream, for topical use Initial U.S. Approval: 1971

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52565-079-11Fluocinonide120 g in 1 TUBECREAM1201
52565-079-11Fluocinonide1 in 1 CARTONCREAM11
52565-079-30Fluocinonide30 g in 1 TUBECREAM301
52565-079-30Fluocinonide1 in 1 CARTONCREAM11
52565-079-60Fluocinonide1 in 1 CARTONCREAM11
52565-079-60Fluocinonide60 g in 1 TUBECREAM601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52565-079-11GM - Gram52565-079fe191fb9-8ebd-4b3c-bf1a-7d74e50fa7b512019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52565-079FLUOCINONIDE CREAM [TELIGENT PHARMA, INC.]1Legacy NDC, 6 package rows20190416_43770897-5784-4817-9fb1-7057b5447d5c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485647fluocinonide 0.1 % Topical CreamPSN43770897-5784-4817-9fb1-7057b5447d5c1
485647fluocinonide 1 MG/ML Topical CreamSCD43770897-5784-4817-9fb1-7057b5447d5c1
485647fluocinonide 0.1 % Topical CreamSY43770897-5784-4817-9fb1-7057b5447d5c1
485647fluocinonide 1 MG per 1 GM Topical CreamSY43770897-5784-4817-9fb1-7057b5447d5c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52565-079-11525650079111 TUBE in 1 CARTON (52565-079-11) > 120 g in 1 TUBE1 tube2019-04-030000-00-00NoNoCurrent
52565-079-30525650079301 TUBE in 1 CARTON (52565-079-30) > 30 g in 1 TUBE1 tube2019-04-030000-00-00NoNoCurrent
52565-079-60525650079601 TUBE in 1 CARTON (52565-079-60) > 60 g in 1 TUBE1 tube2019-04-030000-00-00NoNoCurrent