FDA.reportPublic FDA data

Fluocinolone Acetonide Topical Solution USP, 0.01%

Product NDC
72162-1271
11-digit product format
721621271
Labeler code
72162
Product ID
72162-1271_10500bf6-853d-43bc-a231-07f349923a84
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fluocinolone Acetonide Topical Solution USP, 0.01%
Listing expiration
2027-12-31

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
65f6255d-41cc-425f-ba54-b1bea4947886Product name520210930
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
5ba208e4-886f-44da-e218-ab4f4cad2c49Product name520190612
e5a2793f-318b-72fd-b734-c44ecc6f6748Product name220190213
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
9e453f34-aacb-44d5-a119-c0e3dc1fca2aProduct name120160622
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
72162-1271-6Fluocinolone Acetonide Topical Solution USP, 0.01%60 mL in 1 BOTTLESOLUTION60102
72162-1271-6Fluocinolone Acetonide Topical Solution USP, 0.01%1 in 1 CARTONSOLUTION1102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1271-6ML - Milliliter72162-1271854b3ac5-72e5-474e-a3c1-5774c1ae83d912024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1271FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01% SOLUTION [BRYANT RANCH PREPACK]101Current NDC, 2 package rows20240412_3fa4d5db-b17f-44dc-aa6a-50934d42c68d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1191310fluocinolone acetonide 0.01 % Topical SolutionPSN3fa4d5db-b17f-44dc-aa6a-50934d42c68d102
1191310fluocinolone acetonide 0.1 MG/ML Topical SolutionSCD3fa4d5db-b17f-44dc-aa6a-50934d42c68d102
1191310fluocinolone acetonide 0.01 % Topical SolutionSY3fa4d5db-b17f-44dc-aa6a-50934d42c68d102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1271-6721621271061 BOTTLE in 1 CARTON (72162-1271-6) / 60 mL in 1 BOTTLE1 bottle2019-03-20NoNoHistorical