FDA.reportPublic FDA data

fluocinolone acetonide

Product NDC
62559-288
11-digit product format
625590288
Labeler code
62559
Product ID
62559-288_9a3159b1-5a5c-4784-8f61-a132de5c4608
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluocinolone acetonide
Dosage form
CREAM
Route
TOPICAL
Labeler
ANI Pharmaceuticals, Inc.
Application
NDA012787
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2024-05-08
Substance
FLUOCINOLONE ACETONIDE
Active strength
.1 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.1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0CD5FD6S2M
Rxcui1191302, 1191315

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
62559-288-15fluocinolone acetonide15 g in 1 TUBECREAM153
62559-288-15fluocinolone acetonide1 in 1 CARTONCREAM13
62559-288-60fluocinolone acetonide60 g in 1 TUBECREAM603
62559-288-60fluocinolone acetonide1 in 1 CARTONCREAM13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-288-15GM - Gram62559-288b5f115f8-ce8d-4b9d-8de8-11f693126fde12024-06-10
62559-288-60GM - Gram62559-28819e27571-8293-415f-9b8d-24da84ba8f5912024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62559-288FLUOCINOLONE ACETONIDE CREAM [ANI PHARMACEUTICALS, INC.]2Current NDC, 4 package rows20240920_50e7006d-a51b-49aa-8e1c-330340e7bf82.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1191302fluocinolone acetonide 0.01 % Topical CreamPSN50e7006d-a51b-49aa-8e1c-330340e7bf823
1191315fluocinolone acetonide 0.025 % Topical CreamPSN50e7006d-a51b-49aa-8e1c-330340e7bf823
1191302fluocinolone acetonide 0.1 MG/ML Topical CreamSCD50e7006d-a51b-49aa-8e1c-330340e7bf823
1191315fluocinolone acetonide 0.25 MG/ML Topical CreamSCD50e7006d-a51b-49aa-8e1c-330340e7bf823
1191302fluocinolone acetonide 0.01 % Topical CreamSY50e7006d-a51b-49aa-8e1c-330340e7bf823
1191315fluocinolone acetonide 0.025 % Topical CreamSY50e7006d-a51b-49aa-8e1c-330340e7bf823

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62559-288-15625590288151 TUBE in 1 CARTON (62559-288-15) / 15 g in 1 TUBE1 tube2024-05-08NoNoHistorical
62559-288-60625590288601 TUBE in 1 CARTON (62559-288-60) / 60 g in 1 TUBE1 tube2024-05-08NoNoHistorical