FLUOCINONIDE

Product NDC
45802-761
11-digit product format
458020761
Labeler code
45802
Product ID
45802-761_9f42e872-a537-4ef0-85f0-7c5e0445a92a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluocinonide
Dosage form
GEL
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA209030
Marketing category
ANDA
Marketing start
2025-04-10
Substance
FLUOCINONIDE
Active strength
.5 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.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2W4A77YPAN
Rxcui310362

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
45802-761-15FLUOCINONIDE1 in 1 CARTONGEL12
45802-761-15FLUOCINONIDE15 g in 1 TUBEGEL152
45802-761-30FLUOCINONIDE30 g in 1 TUBEGEL302
45802-761-30FLUOCINONIDE1 in 1 CARTONGEL12
45802-761-60FLUOCINONIDE1 in 1 CARTONGEL12
45802-761-60FLUOCINONIDE60 g in 1 TUBEGEL602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-761-15GM - Gram45802-761c2ddc30d-6b66-4cf6-ae9b-8009eac6f19812025-05-14
45802-761-30GM - Gram45802-7614ee9e94b-9c65-4c1e-9747-04850104060012025-05-14
45802-761-60GM - Gram45802-761fc62acd0-6332-4ca0-843a-28c3af92ff7512025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-761FLUOCINONIDE GEL [PADAGIS ISRAEL PHARMACEUTICALS LTD]2Current NDC, 6 package rows20250522_8e22600e-a1a2-432c-a47c-b7b99a0b1e46.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310362fluocinonide 0.05 % Topical GelPSN8e22600e-a1a2-432c-a47c-b7b99a0b1e462
310362fluocinonide 0.0005 MG/MG Topical GelSCD8e22600e-a1a2-432c-a47c-b7b99a0b1e462
310362fluocinonide 0.05 % Topical GelSY8e22600e-a1a2-432c-a47c-b7b99a0b1e462

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
45802-761-15458020761151 TUBE in 1 CARTON (45802-761-15) / 15 g in 1 TUBE1 tube2025-04-10NoNoHistorical
45802-761-30458020761301 TUBE in 1 CARTON (45802-761-30) / 30 g in 1 TUBE1 tube2025-04-10NoNoHistorical
45802-761-60458020761601 TUBE in 1 CARTON (45802-761-60) / 60 g in 1 TUBE1 tube2025-04-10NoNoHistorical