Fluocinonide

Product NDC
71085-005
11-digit product format
710850005
Labeler code
71085
Product ID
71085-005_f4aac2fa-12c4-4711-8219-27db349a8ab2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluocinonide
Dosage form
CREAM
Route
TOPICAL
Labeler
IPG PHARMACEUTICALS, INC.
Application
ANDA071500
Marketing category
ANDA
Marketing start
2016-10-27
Marketing end
0000-00-00
Substance
FLUOCINONIDE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71085-005-602025-12-29C16284748780-13b156c62-2ef5-fb37-e063-e6dba90a4e07Fluocinonide Cream USP, 0.05%
71085-005-602025-07-29C16284748780-13b156c62-2ef5-fb37-e063-e6dba90a4e07Fluocinonide Cream USP, 0.05%

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71085-005-60GM - Gram71085-005cde3c418-ff92-4f27-81d8-801ffe67388312017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71085-005FLUOCINONIDE CREAM [IPG PHARMACEUTICALS, INC.]1Legacy NDC20170218_f96f4f15-9b99-446e-8e58-6a99ade5ba77.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71085-005-60710850005601 TUBE in 1 CARTON (71085-005-60) > 60 g in 1 TUBE1 tube2016-12-210000-00-00NoNoCurrent