FDA.reportPublic FDA data

Fluocinonide

Product NDC
76420-530
11-digit product format
764200530
Labeler code
76420
Product ID
76420-530_efb3276f-d261-59b5-e053-2a95a90ab9fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluocinonide
Dosage form
CREAM
Route
TOPICAL
Labeler
Asclemed USA, Inc.
Application
ANDA211111
Marketing category
ANDA
Marketing start
2018-07-31
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
76420-530-06Fluocinonide60 g in 1 TUBECREAM601
76420-530-06Fluocinonide1 in 1 CARTONCREAM11
76420-530-12Fluocinonide120 g in 1 TUBECREAM1201
76420-530-12Fluocinonide1 in 1 CARTONCREAM11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-530-06GM - Gram76420-530253970af-732e-4ed7-a943-77438f666c8d12023-02-06
76420-530-12GM - Gram76420-53005a29dc1-1717-4908-9f44-5a675366444d12023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-530FLUOCINONIDE CREAM [ASCLEMED USA, INC.]1Current NDC, Legacy NDC, 4 package rows20221217_b387f926-1109-41b2-9fe0-f77db6b10280.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485647fluocinonide 0.1 % Topical CreamPSNb387f926-1109-41b2-9fe0-f77db6b102801
485647fluocinonide 1 MG/ML Topical CreamSCDb387f926-1109-41b2-9fe0-f77db6b102801
485647fluocinonide 0.1 % Topical CreamSYb387f926-1109-41b2-9fe0-f77db6b102801
485647fluocinonide 1 MG per 1 GM Topical CreamSYb387f926-1109-41b2-9fe0-f77db6b102801

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76420-530-06764200530061 TUBE in 1 CARTON (76420-530-06) / 60 g in 1 TUBE1 tube2022-12-130000-00-00NoNoCurrent
76420-530-12764200530121 TUBE in 1 CARTON (76420-530-12) / 120 g in 1 TUBE1 tube2022-12-130000-00-00NoNoCurrent