FDA.reportPublic FDA data

FLUOCINONIDE

Product NDC
21922-064
11-digit product format
219220064
Labeler code
21922
Product ID
21922-064_d17e15ec-9150-4fe3-acd1-4573300d9bf3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluocinonide
Dosage form
CREAM
Route
TOPICAL
Labeler
Encube Ethicals, Inc.
Application
ANDA211410
Marketing category
ANDA
Marketing start
2025-02-25
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
Rxcui103456

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
a338afdd-91bc-4c45-5113-8b445b8e6cf2Product name520200618
f3bf4e6e-291f-4372-8e90-b4047949153aProduct name320200514
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
934e8c63-e34a-6dfb-4224-efad2d76fafcProduct name520190405
ac5b31c4-5bd3-4df8-8f07-dbc9d194cdfeProduct name120181219
ef1d202f-16bf-4f17-a390-087db27f5314Product name120181203
de14082b-1b4a-48ac-b75c-4ee3ff8a29beProduct name120180809
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21922-064-03FLUOCINONIDE1 in 1 CARTONCREAM12
21922-064-03FLUOCINONIDE120 g in 1 TUBECREAM1202
21922-064-04FLUOCINONIDE1 in 1 CARTONCREAM12
21922-064-04FLUOCINONIDE15 g in 1 TUBECREAM152
21922-064-05FLUOCINONIDE30 g in 1 TUBECREAM302
21922-064-05FLUOCINONIDE1 in 1 CARTONCREAM12
21922-064-07FLUOCINONIDE60 g in 1 TUBECREAM602
21922-064-07FLUOCINONIDE1 in 1 CARTONCREAM12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21922-064-03GM - Gram21922-0641dd2cdd4-1a9d-42f2-b52f-fd07be906a9612025-10-14
21922-064-04GM - Gram21922-06479d2112a-c115-485c-ae7b-a9753a5f033b12025-10-14
21922-064-05GM - Gram21922-06455fbbfe7-ce6a-47a4-8be6-ba302dd6eded12025-10-14
21922-064-07GM - Gram21922-064931b3985-f732-42d1-be24-d4cc37cc497f12025-10-14

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
103456fluocinonide 0.05 % Topical CreamPSNcb869315-8011-485b-8992-1d73fb27e19e2
103456fluocinonide 0.5 MG/ML Topical CreamSCDcb869315-8011-485b-8992-1d73fb27e19e2
103456fluocinonide 0.05 % Topical CreamSYcb869315-8011-485b-8992-1d73fb27e19e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
21922-064-03219220064031 TUBE in 1 CARTON (21922-064-03) / 120 g in 1 TUBE1 tube2025-09-17NoNoCurrent
21922-064-04219220064041 TUBE in 1 CARTON (21922-064-04) / 15 g in 1 TUBE1 tube2025-09-17NoNoCurrent
21922-064-05219220064051 TUBE in 1 CARTON (21922-064-05) / 30 g in 1 TUBE1 tube2025-02-25NoNoCurrent
21922-064-07219220064071 TUBE in 1 CARTON (21922-064-07) / 60 g in 1 TUBE1 tube2025-02-25NoNoCurrent