Fluocinonide

Product NDC
63629-2337
11-digit product format
636292337
Labeler code
63629
Product ID
63629-2337_813a433f-8108-434b-a275-f59fe7164752
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluocinonide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Application
ANDA212976
Marketing category
ANDA
Marketing start
2019-12-09
Substance
FLUOCINONIDE
Active strength
.05 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

Additional Listing Data#

Finished product
Yes
Brand name base
Fluocinonide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUOCINONIDE.05 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2W4A77YPAN

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a338afdd-91bc-4c45-5113-8b445b8e6cf2Product name520200618
f3bf4e6e-291f-4372-8e90-b4047949153aProduct name320200514
934e8c63-e34a-6dfb-4224-efad2d76fafcProduct name520190405
ac5b31c4-5bd3-4df8-8f07-dbc9d194cdfeProduct name120181219
ef1d202f-16bf-4f17-a390-087db27f5314Product name120181203
de14082b-1b4a-48ac-b75c-4ee3ff8a29beProduct name120180809

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-2337-1Fluocinonide60 g in 1 TUBEOINTMENT60102
63629-2337-1Fluocinonide1 in 1 CARTONOINTMENT1102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2337-1GM - Gram63629-233748876c26-87e0-4fa5-96b2-9b9d0e9f8cba12022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2337FLUOCINONIDE (FLUOCINONIDE ) OINTMENT [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 2 package rows20240112_9ee44ed9-e274-4673-8829-0032a36e5b79.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2337-1636292337011 TUBE in 1 CARTON (63629-2337-1) / 60 g in 1 TUBE1 tube2021-04-190000-00-00NoNoCurrent