FDA.reportPublic FDA data

Fluocinolone Acetonide

Product NDC
62559-299
11-digit product format
625590299
Labeler code
62559
Product ID
62559-299_ef1837eb-defb-4edd-a11c-824a890d5a95
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluocinolone Acetonide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
ANI Pharmaceuticals, Inc.
Application
NDA013960
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2023-11-13
Substance
FLUOCINOLONE ACETONIDE
Active strength
.25 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fluocinolone Acetonide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUOCINOLONE ACETONIDE.25 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0CD5FD6S2M
Rxcui1191256

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62559-299-15Fluocinolone Acetonide1 in 1 CARTONOINTMENT12
62559-299-15Fluocinolone Acetonide15 g in 1 TUBEOINTMENT152
62559-299-60Fluocinolone Acetonide60 g in 1 TUBEOINTMENT602
62559-299-60Fluocinolone Acetonide1 in 1 CARTONOINTMENT12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-299-15GM - Gram62559-299baa4d5bf-5a09-45b4-a037-72115df32b7512023-12-05
62559-299-60GM - Gram62559-299367ed4c6-e55b-47e0-ab69-c619e68ebecb12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62559-299FLUOCINOLONE ACETONIDE OINTMENT [ANI PHARMACEUTICALS, INC.]1Current NDC, 4 package rows20231117_622c9804-0be0-4dec-a6ba-5cf4b5578a84.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1191256fluocinolone acetonide 0.025 % Topical OintmentPSN622c9804-0be0-4dec-a6ba-5cf4b5578a842
1191256fluocinolone acetonide 0.00025 MG/MG Topical OintmentSCD622c9804-0be0-4dec-a6ba-5cf4b5578a842
1191256fluocinolone acetonide 0.025 % Topical OintmentSY622c9804-0be0-4dec-a6ba-5cf4b5578a842

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62559-299-15625590299151 TUBE in 1 CARTON (62559-299-15) / 15 g in 1 TUBE1 tube2023-11-16NoNoHistorical
62559-299-60625590299601 TUBE in 1 CARTON (62559-299-60) / 60 g in 1 TUBE1 tube2023-11-16NoNoHistorical