FDA.reportPublic FDA data

Fluocinolone Acetonide

Product NDC
70752-156
11-digit product format
707520156
Labeler code
70752
Product ID
70752-156_90812613-ed90-4fb2-8f78-e8f8775fd75f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluocinolone acetonide
Dosage form
OIL
Route
TOPICAL
Labeler
Quagen Pharmaceuticals LLC
Application
ANDA212760
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
70752-156-062023-02-26C16284748780-1f386c64a-2815-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use FLUOCINOLONE ACETONIDE TOPICAL OIL safely and effectively. See full prescribing information for FLUOCINOLONE ACETONIDE TOPICAL OIL. FLUOCINOLONE ACETONIDE topical oil (body oil), for topical use only Not for oral, ophthalmic, or intravaginal use Initial U.S. Approval: 1988
70752-156-062023-01-30C16284748780-1f386c64a-2815-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use FLUOCINOLONE ACETONIDE TOPICAL OIL safely and effectively. See full prescribing information for FLUOCINOLONE ACETONIDE TOPICAL OIL. FLUOCINOLONE ACETONIDE topical oil (body oil), for topical use only Not for oral, ophthalmic, or intravaginal use Initial U.S. Approval: 1988

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70752-156-06Fluocinolone Acetonide1 in 1 CARTONOIL16
70752-156-06Fluocinolone Acetonide118.28 mL in 1 BOTTLEOIL118.286

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70752-156FLUOCINOLONE ACETONIDE OIL [QUAGEN PHARMACEUTICALS LLC]6Current NDC, Legacy NDC, 2 package rows20230227_a625fe98-8630-4b27-b2fc-4b045847d8f1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1191307fluocinolone acetonide 0.01 % Topical OilPSN8ca4528d-7afa-451e-97ae-9c1c21c07a6e101
1191307fluocinolone acetonide 0.1 MG/ML Topical OilSCD8ca4528d-7afa-451e-97ae-9c1c21c07a6e101
1191307fluocinolone acetonide 0.01 % Topical OilSY8ca4528d-7afa-451e-97ae-9c1c21c07a6e101
1191307fluocinolone acetonide 0.011 % Topical OilSY8ca4528d-7afa-451e-97ae-9c1c21c07a6e101
1191307fluocinolone acetonide 0.01 % Topical OilPSN8b6cbb2e-9c9a-4bef-bf06-f62bdbed8c8b100
1191307fluocinolone acetonide 0.1 MG/ML Topical OilSCD8b6cbb2e-9c9a-4bef-bf06-f62bdbed8c8b100
1191307fluocinolone acetonide 0.01 % Topical OilSY8b6cbb2e-9c9a-4bef-bf06-f62bdbed8c8b100
1191307fluocinolone acetonide 0.011 % Topical OilSY8b6cbb2e-9c9a-4bef-bf06-f62bdbed8c8b100
1191307fluocinolone acetonide 0.01 % Topical OilPSNa625fe98-8630-4b27-b2fc-4b045847d8f16
1191307fluocinolone acetonide 0.1 MG/ML Topical OilSCDa625fe98-8630-4b27-b2fc-4b045847d8f16
1191307fluocinolone acetonide 0.01 % Topical OilSYa625fe98-8630-4b27-b2fc-4b045847d8f16
1191307fluocinolone acetonide 0.011 % Topical OilSYa625fe98-8630-4b27-b2fc-4b045847d8f16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70752-156-06707520156061 BOTTLE in 1 CARTON (70752-156-06) / 118.28 mL in 1 BOTTLE1 bottle2021-04-020000-00-00NoNoCurrent