FDA.reportPublic FDA data

Fluocinonide

Product NDC
52565-054
11-digit product format
525650054
Labeler code
52565
Product ID
52565-054_531184f7-770c-46a4-9bfa-3dbf2a575aa6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluocinonide
Dosage form
GEL
Route
TOPICAL
Labeler
Teligent Pharma, Inc.
Application
ANDA209030
Marketing category
ANDA
Marketing start
2018-06-20
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
52565-054-152023-01-30C16284748780-1f386c64a-0cbc-0266-e053-dadaa90a7c1aFluocinonide Gel USP, 0.05% For External Use Only. Not For Ophthalmic Use. Rx only
52565-054-302023-01-30C16284748780-1f386c64a-0cbc-0266-e053-dadaa90a7c1aFluocinonide Gel USP, 0.05% For External Use Only. Not For Ophthalmic Use. Rx only
52565-054-602023-01-30C16284748780-1f386c64a-0cbc-0266-e053-dadaa90a7c1aFluocinonide Gel USP, 0.05% For External Use Only. Not For Ophthalmic Use. Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52565-054-15Fluocinonide1 in 1 CARTONGEL13
52565-054-15Fluocinonide15 g in 1 TUBEGEL153
52565-054-30Fluocinonide1 in 1 CARTONGEL13
52565-054-30Fluocinonide30 g in 1 TUBEGEL303
52565-054-60Fluocinonide60 g in 1 TUBEGEL603
52565-054-60Fluocinonide1 in 1 CARTONGEL13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52565-054-15GM - Gram52565-054cb96e935-8c91-40a2-a957-1627d7d9d14a12019-02-13
52565-054-30GM - Gram52565-05483ea514f-c029-499d-bc81-6c137aac2a9612019-02-13
52565-054-60GM - Gram52565-054c45fb5e9-57bb-47ee-921e-66f85cf5702f12019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52565-054FLUOCINONIDE GEL [TELIGENT PHARMA, INC.]3Legacy NDC, 6 package rows20190911_2aa35781-40e0-7ce9-45fa-f97333f29085.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310362fluocinonide 0.05 % Topical GelPSN2aa35781-40e0-7ce9-45fa-f97333f290853
310362fluocinonide 0.0005 MG/MG Topical GelSCD2aa35781-40e0-7ce9-45fa-f97333f290853
310362fluocinonide 0.05 % Topical GelSY2aa35781-40e0-7ce9-45fa-f97333f290853

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52565-054-15525650054151 TUBE in 1 CARTON (52565-054-15) > 15 g in 1 TUBE1 tube2018-06-200000-00-00NoNoCurrent
52565-054-30525650054301 TUBE in 1 CARTON (52565-054-30) > 30 g in 1 TUBE1 tube2018-06-200000-00-00NoNoCurrent
52565-054-60525650054601 TUBE in 1 CARTON (52565-054-60) > 60 g in 1 TUBE1 tube2018-06-200000-00-00NoNoCurrent