Fluocinolone Acetonide Topical

Product NDC
0591-2990
11-digit product format
005912990
Labeler code
0591
Product ID
0591-2990_8c1b96a1-47e6-4fac-9bda-0b299ac25800
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluocinolone Acetonide Topical
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Actavis Pharma, Inc.
Application
ANDA208386
Marketing category
ANDA
Marketing start
2016-12-07
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

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0591-2990-60005912990601 BOTTLE, WITH APPLICATOR in 1 CARTON (0591-2990-60) / 60 mL in 1 BOTTLE, WITH APPLICATOR2016-12-07NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
FLUOCINOLONE ACETONIDE TOPICAL SOLUTION, USP 0.01% Rx OnlyActavis Pharma, Inc.2016-08-01HUMAN PRESCRIPTION DRUG LABEL12