FDA.reportPublic FDA data

Fluocinonide

Product NDC
45802-151
11-digit product format
458020151
Labeler code
45802
Product ID
45802-151_72c72409-e1bc-4058-8957-4361d7f94d22
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluocinonide
Dosage form
CREAM
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA090256
Marketing category
ANDA
Marketing start
2014-01-14
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
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
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-151-94Fluopar1 in 1 CARTONCREAM1 mg in 1g5
45802-151-94Fluopar30 g in 1 TUBECREAM30 g1 mg in 1g5
45802-151-94Fluocinol Pak1 in 1 CARTONCREAM1 mg in 1g4
45802-151-94Fluocinol Pak30 g in 1 TUBECREAM30 g1 mg in 1g4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-151-53GM - Gram45802-1512f23ca90-e048-4a7a-bf90-aed5a0098c4512014-02-04
45802-151-94GM - Gram45802-1514854416e-88e8-4fbb-9c24-824a1377f2ab12014-02-04
45802-151-96GM - Gram45802-151bfe9b540-5012-446b-84d7-8c7cc8ac8fbf12014-02-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-151FLUOPAR (FLUOCINONIDE, DIMETHICONE) KIT [PURETEK CORPORATION]5Legacy NDC20241215_9ff7fa78-0fca-976f-e053-2995a90a4641.zip
45802-151FLUOCINOL PAK (FLUOCINONIDE) KIT [PURETEK CORPORATION]4Legacy NDC20230112_a9c88a41-3ff8-78f7-e053-2995a90adb8f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259090dimethicone 5 % Topical CreamPSN9ff7fa78-0fca-976f-e053-2995a90a46415
485647fluocinonide 0.1 % Topical CreamPSN9ff7fa78-0fca-976f-e053-2995a90a46415
259090dimethicone 50 MG/ML Topical CreamSCD9ff7fa78-0fca-976f-e053-2995a90a46415
485647fluocinonide 1 MG/ML Topical CreamSCD9ff7fa78-0fca-976f-e053-2995a90a46415
259090dimethicone 5 % Topical CreamSY9ff7fa78-0fca-976f-e053-2995a90a46415
485647fluocinonide 0.1 % Topical CreamSY9ff7fa78-0fca-976f-e053-2995a90a46415
485647fluocinonide 1 MG per 1 GM Topical CreamSY9ff7fa78-0fca-976f-e053-2995a90a46415
485647fluocinonide 0.1 % Topical CreamPSNa9c88a41-3ff8-78f7-e053-2995a90adb8f4
485647fluocinonide 1 MG/ML Topical CreamSCDa9c88a41-3ff8-78f7-e053-2995a90adb8f4
485647fluocinonide 0.1 % Topical CreamSYa9c88a41-3ff8-78f7-e053-2995a90adb8f4
485647fluocinonide 1 MG per 1 GM Topical CreamSYa9c88a41-3ff8-78f7-e053-2995a90adb8f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-151-53458020151531 TUBE in 1 CARTON (45802-151-53) > 120 g in 1 TUBE1 tube2014-01-140000-00-00NoNoCurrent
45802-151-94458020151941 TUBE in 1 CARTON (45802-151-94) > 30 g in 1 TUBE1 tube2014-01-140000-00-00NoNoCurrent
45802-151-96458020151961 TUBE in 1 CARTON (45802-151-96) > 60 g in 1 TUBE1 tube2014-01-140000-00-00NoNoCurrent