Fluocinonide

Product NDC
76420-509
11-digit product format
764200509
Labeler code
76420
Product ID
76420-509_0cad6c91-0fe0-91c8-e063-6394a90a3fe8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluocinonide
Dosage form
CREAM
Route
TOPICAL
Labeler
Asclemed USA, Inc.
Application
ANDA200734
Marketing category
ANDA
Marketing start
2014-07-14
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUOCINONIDE1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2W4A77YPAN
Rxcui485647

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
76420-509-12Fluocinonide120 g in 1 TUBECREAM1201
76420-509-12Fluocinonide1 in 1 CARTONCREAM11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-509-12GM - Gram76420-509843dafd4-dac5-4353-b98e-fbbe4f404d3d12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-509FLUOCINONIDE CREAM [ASCLEMED USA, INC.]1Current NDC, 2 package rows20231219_cd5d8268-77ff-41c0-8699-b583e52da30c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485647fluocinonide 0.1 % Topical CreamPSNcd5d8268-77ff-41c0-8699-b583e52da30c1
485647fluocinonide 1 MG/ML Topical CreamSCDcd5d8268-77ff-41c0-8699-b583e52da30c1
485647fluocinonide 0.1 % Topical CreamSYcd5d8268-77ff-41c0-8699-b583e52da30c1
485647fluocinonide 1 MG per 1 GM Topical CreamSYcd5d8268-77ff-41c0-8699-b583e52da30c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-509-12764200509121 TUBE in 1 CARTON (76420-509-12) / 120 g in 1 TUBE1 tube2023-12-16NoNoCurrent