Fluocinonide

Product NDC
70700-146
11-digit product format
707000146
Labeler code
70700
Product ID
70700-146_2bfc0a7d-82bb-11d0-8ea7-c2d2a9c836ac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluocinonide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Xiromed LLC
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
70700-146-15Fluocinonide15 g in 1 TUBEOINTMENT158
70700-146-15Fluocinonide1 in 1 CARTONOINTMENT18
70700-146-16Fluocinonide1 in 1 CARTONOINTMENT18
70700-146-16Fluocinonide30 g in 1 TUBEOINTMENT308
70700-146-17Fluocinonide1 in 1 CARTONOINTMENT18
70700-146-17Fluocinonide60 g in 1 TUBEOINTMENT608

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70700-146-15GM - Gram70700-146ceccf47b-19f4-4064-bbe7-0f9b8be1ddb612020-09-14
70700-146-16GM - Gram70700-146dd8f51d9-4352-430b-85b5-2ca6be51bcf512020-09-14
70700-146-17GM - Gram70700-14699245cd3-9ea6-47a9-80ff-e6f4f3fc94d012020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70700-146FLUOCINONIDE (FLUOCINONIDE ) OINTMENT [XIROMED LLC]8Current NDC, Legacy NDC, 6 package rows20230707_d96cc4fd-abd3-1ce1-ac63-5d68a8332ecc.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70700-146-15707000146151 TUBE in 1 CARTON (70700-146-15) / 15 g in 1 TUBE1 tube2019-12-090000-00-00NoNoCurrent
70700-146-16707000146161 TUBE in 1 CARTON (70700-146-16) / 30 g in 1 TUBE1 tube2019-12-090000-00-00NoNoCurrent
70700-146-17707000146171 TUBE in 1 CARTON (70700-146-17) / 60 g in 1 TUBE1 tube2019-12-090000-00-00NoNoCurrent