FDA.reportPublic FDA data

FLUOCINONIDE

Product NDC
70771-1393
11-digit product format
707711393
Labeler code
70771
Product ID
70771-1393_785b93c3-9489-4d35-9dc5-5f64d5c604ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FLUOCINONIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Zydus Lifesciences Limited
Application
ANDA208989
Marketing category
ANDA
Marketing start
2020-04-30
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
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
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
de14082b-1b4a-48ac-b75c-4ee3ff8a29beProduct name120180809
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1393-2FLUOCINONIDE30 g in 1 TUBECREAM304
70771-1393-3FLUOCINONIDE60 g in 1 TUBECREAM604
70771-1393-5FLUOCINONIDE120 g in 1 TUBECREAM1204

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1393FLUOCINONIDE CREAM [ZYDUS LIFESCIENCES LIMITED]4Current NDC, Legacy NDC, 3 package rows20240821_08d69d3f-c628-4b08-a7ae-0f7ec5599d3a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485647fluocinonide 0.1 % Topical CreamPSN08d69d3f-c628-4b08-a7ae-0f7ec5599d3a4
485647fluocinonide 1 MG/ML Topical CreamSCD08d69d3f-c628-4b08-a7ae-0f7ec5599d3a4
485647fluocinonide 0.1 % Topical CreamSY08d69d3f-c628-4b08-a7ae-0f7ec5599d3a4
485647fluocinonide 1 MG per 1 GM Topical CreamSY08d69d3f-c628-4b08-a7ae-0f7ec5599d3a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70771-1393-27077113930230 g in 1 TUBE (70771-1393-2) 30 g2020-04-300000-00-00NoNoCurrent
70771-1393-37077113930360 g in 1 TUBE (70771-1393-3) 60 g2020-04-300000-00-00NoNoCurrent
70771-1393-570771139305120 g in 1 TUBE (70771-1393-5) 120 g2020-04-300000-00-00NoNoCurrent