FDA.reportPublic FDA data

Fluocinonide

Product NDC
51672-1386
11-digit product format
516721386
Labeler code
51672
Product ID
51672-1386_3972605f-b081-0289-e063-6294a90ab0e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluocinonide
Dosage form
CREAM
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA071500
Marketing category
ANDA
Marketing start
2016-10-27
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
51672-1386-1Fluocinonide15 g in 1 TUBECREAM153
51672-1386-1Fluocinonide1 in 1 CARTONCREAM13
51672-1386-2Fluocinonide30 g in 1 TUBECREAM303
51672-1386-2Fluocinonide1 in 1 CARTONCREAM13
51672-1386-3Fluocinonide60 g in 1 TUBECREAM603
51672-1386-3Fluocinonide1 in 1 CARTONCREAM13
51672-1386-4Fluocinonide120 g in 1 TUBECREAM1203
51672-1386-4Fluocinonide1 in 1 CARTONCREAM13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1386-1GM - Gram51672-138694eaa54a-220f-4e16-a8cb-eb3c6fd2a84e12017-04-05
51672-1386-2GM - Gram51672-1386e709049c-b525-42c0-9c77-65fd58599d8f12017-04-05
51672-1386-3GM - Gram51672-138656fc2100-c2f3-4fc5-9602-8739f611c56812017-04-05
51672-1386-4GM - Gram51672-138673d0a0da-2a64-4d2b-be5a-dfdfa3e5a4a212017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1386FLUOCINONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1Current NDC, Legacy NDC, 8 package rows20161118_5782d791-48fd-4cee-853d-235eb4d04a40.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
103456fluocinonide 0.05 % Topical CreamPSNa2e8aa7a-8996-4dc8-a36b-e8c29fb8540e13
103456fluocinonide 0.5 MG/ML Topical CreamSCDa2e8aa7a-8996-4dc8-a36b-e8c29fb8540e13
103456fluocinonide 0.05 % Topical CreamSYa2e8aa7a-8996-4dc8-a36b-e8c29fb8540e13
103456fluocinonide 0.05 % Topical CreamPSN624c81a7-282a-95be-e053-2991aa0a6b444
103456fluocinonide 0.5 MG/ML Topical CreamSCD624c81a7-282a-95be-e053-2991aa0a6b444
103456fluocinonide 0.05 % Topical CreamSY624c81a7-282a-95be-e053-2991aa0a6b444
103456fluocinonide 0.05 % Topical CreamPSN5782d791-48fd-4cee-853d-235eb4d04a403
103456fluocinonide 0.05 % Topical CreamPSN8ac0ecd6-38b5-a5f9-e053-2a95a90af4123
103456fluocinonide 0.5 MG/ML Topical CreamSCD5782d791-48fd-4cee-853d-235eb4d04a403
103456fluocinonide 0.5 MG/ML Topical CreamSCD8ac0ecd6-38b5-a5f9-e053-2a95a90af4123
103456fluocinonide 0.05 % Topical CreamSY5782d791-48fd-4cee-853d-235eb4d04a403
103456fluocinonide 0.05 % Topical CreamSY8ac0ecd6-38b5-a5f9-e053-2a95a90af4123
103456fluocinonide 0.05 % Topical CreamPSNd823803c-a125-4695-a04b-6c14b6a66ab61
103456fluocinonide 0.05 % Topical CreamPSN1f1b7129-3eda-8dae-e063-6394a90aa7751
103456fluocinonide 0.5 MG/ML Topical CreamSCDd823803c-a125-4695-a04b-6c14b6a66ab61
103456fluocinonide 0.5 MG/ML Topical CreamSCD1f1b7129-3eda-8dae-e063-6394a90aa7751
103456fluocinonide 0.05 % Topical CreamSY1f1b7129-3eda-8dae-e063-6394a90aa7751
103456fluocinonide 0.05 % Topical CreamSYd823803c-a125-4695-a04b-6c14b6a66ab61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-1386-1516721386011 TUBE in 1 CARTON (51672-1386-1) / 15 g in 1 TUBE1 tube2016-10-270000-00-00NoNoCurrent
51672-1386-2516721386021 TUBE in 1 CARTON (51672-1386-2) / 30 g in 1 TUBE1 tube2016-10-270000-00-00NoNoCurrent
51672-1386-3516721386031 TUBE in 1 CARTON (51672-1386-3) / 60 g in 1 TUBE1 tube2016-10-270000-00-00NoNoCurrent
51672-1386-4516721386041 TUBE in 1 CARTON (51672-1386-4) / 120 g in 1 TUBE1 tube2016-10-270000-00-00NoNoCurrent