FDA.reportPublic FDA data

Fluocinolone Acetonide Topical Solution USP, 0.01%

Product NDC
63629-9584
11-digit product format
636299584
Labeler code
63629
Product ID
63629-9584_266c3c51-3913-4823-812b-7704a2caa570
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluocinolone Acetonide Topical Solution USP, 0.01%
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Application
ANDA209913
Marketing category
ANDA
Marketing start
2019-03-20
Substance
FLUOCINOLONE ACETONIDE
Active strength
.1 mg/mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fluocinolone Acetonide Topical Solution USP, 0.01%
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUOCINOLONE ACETONIDE.1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0CD5FD6S2M
Rxcui1191310

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
63629-9584-1Fluocinolone Acetonide Topical Solution USP, 0.01%60 mL in 1 BOTTLESOLUTION60104
63629-9584-1Fluocinolone Acetonide Topical Solution USP, 0.01%1 in 1 CARTONSOLUTION1104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-9584-1ML - Milliliter63629-95842b794636-6647-4316-8e52-a9484ed7ef6912023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9584FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01% SOLUTION [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 2 package rows20240821_ce89966d-d7ea-4986-936e-6d46aee497cd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1191310fluocinolone acetonide 0.01 % Topical SolutionPSNce89966d-d7ea-4986-936e-6d46aee497cd104
1191310fluocinolone acetonide 0.1 MG/ML Topical SolutionSCDce89966d-d7ea-4986-936e-6d46aee497cd104
1191310fluocinolone acetonide 0.01 % Topical SolutionSYce89966d-d7ea-4986-936e-6d46aee497cd104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-9584-1636299584011 BOTTLE in 1 CARTON (63629-9584-1) / 60 mL in 1 BOTTLE1 bottle2022-12-120000-00-00NoNoCurrent