fluocinonide

Product NDC
0168-0457
11-digit product format
001680457
Labeler code
0168
Product ID
0168-0457_9b2a6817-78e5-4437-9fb0-efcdce64c617
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluocinonide
Dosage form
CREAM
Route
TOPICAL
Labeler
Fougera Pharmaceuticals Inc.
Application
ANDA200735
Marketing category
ANDA
Marketing start
2014-07-14
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0168-0457-04GM - Gram0168-0457e8becb8a-81ed-49ae-abe3-8c9133d6f89612015-12-02
0168-0457-30GM - Gram0168-0457f44c9a9a-876a-4f17-b330-4f9158cc7d6412015-12-02
0168-0457-60GM - Gram0168-04570e415fd0-5518-461a-96b6-b6b8dcdbc94b12015-12-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0168-0457-04001680457041 TUBE in 1 CARTON (0168-0457-04) > 120 g in 1 TUBE1 tube2014-07-140000-00-00NoNoCurrent
0168-0457-30001680457301 TUBE in 1 CARTON (0168-0457-30) > 30 g in 1 TUBE1 tube2014-07-140000-00-00NoNoCurrent
0168-0457-60001680457601 TUBE in 1 CARTON (0168-0457-60) > 60 g in 1 TUBE1 tube2014-07-140000-00-00NoNoCurrent