Fluocinonide Cream

Product NDC
68071-2808
11-digit product format
680712808
Labeler code
68071
Product ID
68071-2808_e5bf0ef1-02a9-0b9d-e053-2995a90a763f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluocinonide
Dosage form
CREAM
Route
TOPICAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA210554
Marketing category
ANDA
Marketing start
2017-10-01
Marketing end
0000-00-00
Substance
FLUOCINONIDE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2808-52025-01-30C16284748780-12cef2736-6da9-d83d-e063-dadaa90ab31fFluocinonide Cream USP, 0.05% For External Use Only. Not For Ophthalmic Use. Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2808-5Fluocinonide Cream15 g in 1 TUBECREAM151
68071-2808-5Fluocinonide Cream1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2808FLUOCINONIDE CREAM (FLUOCINONIDE) CREAM [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 2 package rows20220810_e5bf009d-b80b-60f3-e053-2995a90a6d66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
103456fluocinonide 0.05 % Topical CreamPSNe5bf009d-b80b-60f3-e053-2995a90a6d661
103456fluocinonide 0.5 MG/ML Topical CreamSCDe5bf009d-b80b-60f3-e053-2995a90a6d661
103456fluocinonide 0.05 % Topical CreamSYe5bf009d-b80b-60f3-e053-2995a90a6d661

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2808-5680712808051 TUBE in 1 CARTON (68071-2808-5) > 15 g in 1 TUBE1 tube2022-08-080000-00-00NoNoCurrent