Fluocinolone acetonide

Product NDC
72162-1412
11-digit product format
721621412
Labeler code
72162
Product ID
72162-1412_18788998-75d3-4ca1-991e-af8d9c85e3bd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluocinolone acetonide
Dosage form
OIL
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Application
ANDA202848
Marketing category
ANDA
Marketing start
2017-06-14
Substance
FLUOCINOLONE ACETONIDE
Active strength
.01 mg/100mL
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
72162-1412-2721621412021 BOTTLE in 1 CARTON (72162-1412-2) / 118.28 mL in 1 BOTTLE1 bottle2024-03-13NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil)Bryant Ranch Prepack2025-10-29HUMAN PRESCRIPTION DRUG LABEL101
Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil)Bryant Ranch Prepack2024-03-13HUMAN PRESCRIPTION DRUG LABEL100