FLUOCINONIDE

Product NDC
63629-2508
11-digit product format
636292508
Labeler code
63629
Product ID
63629-2508_044103f1-8aa3-4d79-b0ee-acf105a841e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FLUOCINONIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Application
ANDA208989
Marketing category
ANDA
Marketing start
2020-04-30
Substance
FLUOCINONIDE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA Listing Details

Product ID
63629-2508_044103f1-8aa3-4d79-b0ee-acf105a841e9
Product type
HUMAN PRESCRIPTION DRUG
Finished product
Yes
Brand name base
FLUOCINONIDE
Generic name
FLUOCINONIDE
Dosage form
CREAM
Route
TOPICAL
Marketing start
2020-04-30
Marketing category
ANDA
Application number
ANDA208989
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA]; Corticosteroid [EPC]
Listing expiration
2026-12-31

Related Records

openFDA Active Ingredients

IngredientStrength
FLUOCINONIDE1 mg/g

openFDA Harmonized Identifiers

FieldValues
Unii2W4A77YPAN
Rxcui485647
Spl Set Id7055d0d3-b148-4ab3-b423-9fc417204b0a
Manufacturer NameBryant Ranch Prepack

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
2W4A77YPANFLUOCINONIDE356-12-7FLUOCINONIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2508-163629250801120 g in 1 TUBE (63629-2508-1) 120 g2021-05-180000-00-00NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
FLUOCINONIDEBryant Ranch Prepack2023-03-03HUMAN PRESCRIPTION DRUG LABEL102