FDA.reportPublic FDA data

Fluocinolone Acetonide

Product NDC
52565-013
11-digit product format
525650013
Labeler code
52565
Product ID
52565-013_e619899e-3d8d-480b-a66d-49cbc9543f17
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluocinolone Acetonide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Teligent Pharma, Inc.
Application
NDA013960
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2012-12-27
Marketing end
0000-00-00
Substance
FLUOCINOLONE ACETONIDE
Active strength
0 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
0adb2af5-1ecf-4df5-912b-16ae89228294Product name620240829
65f6255d-41cc-425f-ba54-b1bea4947886Product name520210930
5ba208e4-886f-44da-e218-ab4f4cad2c49Product name520190612
e5a2793f-318b-72fd-b734-c44ecc6f6748Product name220190213
9e453f34-aacb-44d5-a119-c0e3dc1fca2aProduct name120160622
7df2570a-c555-4d82-9189-9247c722b62cProduct name120150402
85490a6b-2306-6bf2-c51b-eb63537dc2daProduct name120140508
a78a3633-fd06-b0af-63b3-c714de3b3bfaProduct name120140508
b2d0a9c2-fd0c-a9b4-ae41-f6a4eef4fbf6Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52565-013-152022-01-28C16284748780-1d6a99b39-4f11-a426-e053-dadaa90af4c2Fluocinolone Acetonide Ointment USP, 0.025%
52565-013-602022-01-28C16284748780-1d6a99b39-4f11-a426-e053-dadaa90af4c2Fluocinolone Acetonide Ointment USP, 0.025%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52565-013-15Fluocinolone Acetonide1 in 1 CARTONOINTMENT13
52565-013-15Fluocinolone Acetonide15 g in 1 TUBEOINTMENT153
52565-013-60Fluocinolone Acetonide1 in 1 CARTONOINTMENT13
52565-013-60Fluocinolone Acetonide60 g in 1 TUBEOINTMENT603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52565-013-15GM - Gram52565-013dd321336-875d-4f01-a24f-ab6f8a388fef12013-03-03
52565-013-60GM - Gram52565-013e1294812-ca15-422e-a5ef-1dcf60bb056a12013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Fluocinolone AcetonideACTIVE INGREDIENT0CD5FD6S2MFLUOCINOLONE ACETONIDE OINTMENT [IGI LABS, INC.]1
Fluocinolone AcetonideACTIVE MOIETY0CD5FD6S2MFLUOCINOLONE ACETONIDE OINTMENT [IGI LABS, INC.]1
PetrolatumINACTIVE INGREDIENT4T6H12BN9UFLUOCINOLONE ACETONIDE OINTMENT [IGI LABS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52565-013FLUOCINOLONE ACETONIDE OINTMENT [TELIGENT PHARMA, INC.]3Legacy NDC, 4 package rows20181017_dbf0ae16-5180-4397-9012-7e5181074511.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1191256fluocinolone acetonide 0.025 % Topical OintmentPSNdbf0ae16-5180-4397-9012-7e51810745113
1191256fluocinolone acetonide 0.00025 MG/MG Topical OintmentSCDdbf0ae16-5180-4397-9012-7e51810745113
1191256fluocinolone acetonide 0.025 % Topical OintmentSYdbf0ae16-5180-4397-9012-7e51810745113

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52565-013-15525650013151 TUBE in 1 CARTON (52565-013-15) > 15 g in 1 TUBE1 tube2012-12-270000-00-00NoNoCurrent
52565-013-60525650013601 TUBE in 1 CARTON (52565-013-60) > 60 g in 1 TUBE1 tube2012-12-270000-00-00NoNoCurrent