Fluocinonide

Product NDC
0168-0135
11-digit product format
001680135
Labeler code
0168
Product ID
0168-0135_ab8112d1-2b6e-4d6e-a5a7-470205dfa6ac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluocinonide
Dosage form
GEL
Route
TOPICAL
Labeler
Fougera Pharmaceuticals Inc.
Application
ANDA072933
Marketing category
ANDA
Marketing start
1994-12-30
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
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0168-0135-15GM - Gram0168-013562de58fb-f280-4a4f-8497-354aaf0fa1a712012-07-24
0168-0135-60GM - Gram0168-01355594bbe9-e81d-45a6-a89f-3cbd119bcc8d12012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0168-0135-150016801351515 g in 1 TUBE (0168-0135-15) 15 g1994-12-300000-00-00NoNoCurrent
0168-0135-600016801356060 g in 1 TUBE (0168-0135-60) 60 g1994-12-300000-00-00NoNoCurrent