FDA.reportPublic FDA data

Fluocinonide

Product NDC
52565-040
11-digit product format
525650040
Labeler code
52565
Product ID
52565-040_73762cba-77e3-42b5-a7cf-6c5b0bccac6f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluocinonide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Teligent Pharma, Inc.
Application
ANDA207680
Marketing category
ANDA
Marketing start
2016-08-09
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
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
52565-040-152023-01-30C16284748780-1f386c649-c85d-0266-e053-dadaa90a7c1aFluocinonide Ointment USP, 0.05% For External Use Only. Not For Ophthalmic Use. Rx only
52565-040-302023-01-30C16284748780-1f386c649-c85d-0266-e053-dadaa90a7c1aFluocinonide Ointment USP, 0.05% For External Use Only. Not For Ophthalmic Use. Rx only
52565-040-602023-01-30C16284748780-1f386c649-c85d-0266-e053-dadaa90a7c1aFluocinonide Ointment USP, 0.05% For External Use Only. Not For Ophthalmic Use. Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52565-040-15Fluocinonide15 g in 1 TUBEOINTMENT151
52565-040-15Fluocinonide1 in 1 CARTONOINTMENT11
52565-040-30Fluocinonide1 in 1 CARTONOINTMENT11
52565-040-30Fluocinonide30 g in 1 TUBEOINTMENT301
52565-040-60Fluocinonide1 in 1 CARTONOINTMENT11
52565-040-60Fluocinonide60 g in 1 TUBEOINTMENT601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52565-040-15GM - Gram52565-04023a2d61e-d292-42b6-b98d-37deda3fc87512019-01-24
52565-040-30GM - Gram52565-040e7b52bd2-0edb-4eee-b945-e3acc0c0ab1812019-01-24
52565-040-60GM - Gram52565-0408de6593c-f388-415a-86ab-585433508d6c12019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52565-040FLUOCINONIDE (FLUOCINONIDE) OINTMENT [TELIGENT PHARMA, INC.]1Legacy NDC, 6 package rows20181010_222eaeb1-778b-4bd6-801a-13d51eadf111.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
103457fluocinonide 0.05 % Topical OintmentPSN222eaeb1-778b-4bd6-801a-13d51eadf1111
103457fluocinonide 0.0005 MG/MG Topical OintmentSCD222eaeb1-778b-4bd6-801a-13d51eadf1111
103457fluocinonide 0.05 % Topical OintmentSY222eaeb1-778b-4bd6-801a-13d51eadf1111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52565-040-15525650040151 TUBE in 1 CARTON (52565-040-15) > 15 g in 1 TUBE1 tube2016-08-090000-00-00NoNoCurrent
52565-040-30525650040301 TUBE in 1 CARTON (52565-040-30) > 30 g in 1 TUBE1 tube2016-08-090000-00-00NoNoCurrent
52565-040-60525650040601 TUBE in 1 CARTON (52565-040-60) > 60 g in 1 TUBE1 tube2016-08-090000-00-00NoNoCurrent