FDA.reportPublic FDA data

Fluocinolone Acetonide

Product NDC
70752-158
11-digit product format
707520158
Labeler code
70752
Product ID
70752-158_bd02aa34-bd25-4a5b-8f8c-01a17d8410e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluocinolone acetonide
Dosage form
OIL
Route
TOPICAL
Labeler
Quagen Pharmaceuticals LLC
Application
ANDA212761
Marketing category
ANDA
Marketing start
2021-04-02
Substance
FLUOCINOLONE ACETONIDE
Active strength
.11 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.11 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0CD5FD6S2M
Rxcui1191307

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70752-158-062023-02-26C16284748780-1f386c649-c0f9-0266-e053-dadaa90a7c1aFluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil)
70752-158-062023-01-30C16284748780-1f386c649-c0f9-0266-e053-dadaa90a7c1aFluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70752-158-06Fluocinolone Acetonide1 in 1 CARTONOIL15
70752-158-06Fluocinolone Acetonide118.28 mL in 1 BOTTLEOIL118.285

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70752-158FLUOCINOLONE ACETONIDE OIL [QUAGEN PHARMACEUTICALS LLC]5Current NDC, Legacy NDC, 2 package rows20230227_fa5eba5b-57bf-4d46-b0e1-c7104542cb46.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1191307fluocinolone acetonide 0.01 % Topical OilPSN30b0013a-d289-4230-8f50-0a0ff05f4b5e101
1191307fluocinolone acetonide 0.1 MG/ML Topical OilSCD30b0013a-d289-4230-8f50-0a0ff05f4b5e101
1191307fluocinolone acetonide 0.01 % Topical OilSY30b0013a-d289-4230-8f50-0a0ff05f4b5e101
1191307fluocinolone acetonide 0.011 % Topical OilSY30b0013a-d289-4230-8f50-0a0ff05f4b5e101
1191307fluocinolone acetonide 0.01 % Topical OilPSN1539d6ac-b527-4ff0-afe4-083ceac655f3100
1191307fluocinolone acetonide 0.1 MG/ML Topical OilSCD1539d6ac-b527-4ff0-afe4-083ceac655f3100
1191307fluocinolone acetonide 0.01 % Topical OilSY1539d6ac-b527-4ff0-afe4-083ceac655f3100
1191307fluocinolone acetonide 0.011 % Topical OilSY1539d6ac-b527-4ff0-afe4-083ceac655f3100
1191307fluocinolone acetonide 0.01 % Topical OilPSNfa5eba5b-57bf-4d46-b0e1-c7104542cb465
1191307fluocinolone acetonide 0.1 MG/ML Topical OilSCDfa5eba5b-57bf-4d46-b0e1-c7104542cb465
1191307fluocinolone acetonide 0.01 % Topical OilSYfa5eba5b-57bf-4d46-b0e1-c7104542cb465
1191307fluocinolone acetonide 0.011 % Topical OilSYfa5eba5b-57bf-4d46-b0e1-c7104542cb465

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70752-158-06707520158061 BOTTLE in 1 CARTON (70752-158-06) / 118.28 mL in 1 BOTTLE1 bottle2021-04-020000-00-00NoNoCurrent