FLUOCINOLONE ACETONIDE

Product NDC
71335-2879
11-digit product format
713352879
Labeler code
71335
Product ID
71335-2879_0cd1128a-9159-4955-849b-054c9444ad0a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluocinolone acetonide
Dosage form
OIL
Route
AURICULAR (OTIC)
Labeler
Bryant Ranch Prepack
Application
ANDA212762
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
0CD5FD6S2MFLUOCINOLONE ACETONIDE67-73-2FLUOCINOLONE ACETONIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2879-1713352879011 BOTTLE in 1 CARTON (71335-2879-1) / 20 mL in 1 BOTTLE1 bottle2025-11-11NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Fluocinolone Acetonide Oil, 0.01% (Ear Drops)Bryant Ranch Prepack2025-11-11HUMAN PRESCRIPTION DRUG LABEL100