Fluocinonide

Product NDC
40032-095
11-digit product format
400320095
Labeler code
40032
Product ID
40032-095_9eb4edbd-dc0b-48cc-b088-6d1871d61157
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluocinonide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Novel Laboratories, Inc.
Application
ANDA207538
Marketing category
ANDA
Marketing start
2017-07-31
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
40032-095-602024-01-30C16284748780-11030e365-298e-111a-e063-dadaa90a10e2Fluocinonide Ointment USP, 0.05% Rx only
40032-095-612024-01-30C16284748780-11030e365-298e-111a-e063-dadaa90a10e2Fluocinonide Ointment USP, 0.05% Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
40032-095-60Fluocinonide1 in 1 CARTONOINTMENT12
40032-095-60Fluocinonide15 g in 1 TUBEOINTMENT152
40032-095-61Fluocinonide1 in 1 CARTONOINTMENT12
40032-095-61Fluocinonide60 g in 1 TUBEOINTMENT602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
40032-095FLUOCINONIDE OINTMENT [NOVEL LABORATORIES, INC.]2Legacy NDC, 4 package rows20171130_ee0ffda0-c09c-4f64-a7c6-efb1bb24eee2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
103457fluocinonide 0.05 % Topical OintmentPSNee0ffda0-c09c-4f64-a7c6-efb1bb24eee22
103457fluocinonide 0.0005 MG/MG Topical OintmentSCDee0ffda0-c09c-4f64-a7c6-efb1bb24eee22
103457fluocinonide 0.05 % Topical OintmentSYee0ffda0-c09c-4f64-a7c6-efb1bb24eee22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
40032-095-60400320095601 TUBE in 1 CARTON (40032-095-60) > 15 g in 1 TUBE1 tube2017-07-310000-00-00NoNoCurrent
40032-095-61400320095611 TUBE in 1 CARTON (40032-095-61) > 60 g in 1 TUBE1 tube2017-07-310000-00-00NoNoCurrent