Fluocinonide

Product NDC
0713-0803
11-digit product format
007130803
Labeler code
0713
Product ID
0713-0803_5fc8f96b-bc3d-4425-9abc-066cf5536927
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluocinonide
Dosage form
GEL
Route
TOPICAL
Labeler
Cosette Pharmaceuticals, Inc.
Application
ANDA072537
Marketing category
ANDA
Marketing start
2015-12-18
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0713-0803-15GM - Gram0713-080305f5a11a-bc1b-431e-8b5e-b4e1df4d560312017-10-13
0713-0803-31GM - Gram0713-0803987d8a8a-6e99-45de-a228-c276cb75f1e612017-10-13
0713-0803-60GM - Gram0713-08036f5d33ed-de20-4316-97e4-88520545d9d312016-01-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0713-0803-15007130803151 TUBE in 1 CARTON (0713-0803-15) > 15 g in 1 TUBE1 tube2017-08-170000-00-00NoNoCurrent
0713-0803-31007130803311 TUBE in 1 CARTON (0713-0803-31) > 30 g in 1 TUBE1 tube2017-08-170000-00-00NoNoCurrent
0713-0803-60007130803601 TUBE in 1 CARTON (0713-0803-60) > 60 g in 1 TUBE1 tube2015-12-180000-00-00NoNoCurrent