FDA.reportPublic FDA data

Fluocinolone Acetonide

Product NDC
51672-1365
11-digit product format
516721365
Labeler code
51672
Product ID
51672-1365_390af125-04e3-1010-e063-6294a90a016d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluocinolone acetonide
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA089124
Marketing category
ANDA
Marketing start
2015-03-27
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
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
51672-1365-2Fluocinolone Acetonide1 in 1 CARTONSOLUTION13
51672-1365-2Fluocinolone Acetonide20 mL in 1 BOTTLESOLUTION203
51672-1365-4Fluocinolone Acetonide1 in 1 CARTONSOLUTION13
51672-1365-4Fluocinolone Acetonide60 mL in 1 BOTTLESOLUTION603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1365-4ML - Milliliter51672-1365bf5c5a2c-bf1b-450d-94e6-4e47bbabbbe912015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
fluocinolone acetonideACTIVE INGREDIENT0CD5FD6S2MFLUOCINOLONE ACETONIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]1
fluocinolone acetonideACTIVE MOIETY0CD5FD6S2MFLUOCINOLONE ACETONIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]1
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPFLUOCINOLONE ACETONIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3FLUOCINOLONE ACETONIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1365FLUOCINOLONE ACETONIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]2Current NDC, Legacy NDC, 4 package rows20170421_02352ed1-3568-441f-add8-45201351a11c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1191310fluocinolone acetonide 0.01 % Topical SolutionPSN02352ed1-3568-441f-add8-45201351a11c3
1191310fluocinolone acetonide 0.1 MG/ML Topical SolutionSCD02352ed1-3568-441f-add8-45201351a11c3
1191310fluocinolone acetonide 0.01 % Topical SolutionSY02352ed1-3568-441f-add8-45201351a11c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-1365-2516721365021 BOTTLE in 1 CARTON (51672-1365-2) / 20 mL in 1 BOTTLE1 bottle2015-03-270000-00-00NoNoCurrent
51672-1365-4516721365041 BOTTLE in 1 CARTON (51672-1365-4) / 60 mL in 1 BOTTLE1 bottle2015-03-270000-00-00NoNoCurrent