Fluocinolone Acetonide

Product NDC
0713-0325
11-digit product format
007130325
Labeler code
0713
Product ID
0713-0325_4c9ed5ab-e309-4cc3-bcdf-57b93968437f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluocinolone Acetonide
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Cosette Pharmaceuticals, Inc.
Application
ANDA207441
Marketing category
ANDA
Marketing start
2016-09-28
Marketing end
0000-00-00
Substance
FLUOCINOLONE ACETONIDE
Active strength
0 mg/mL
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
0713-0325-53ML - Milliliter0713-0325deb1a58d-1667-415a-8f3c-b9b88153201d12016-11-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0713-0325-53007130325531 BOTTLE in 1 CARTON (0713-0325-53) > 60 mL in 1 BOTTLE1 bottle2016-09-280000-00-00NoNoCurrent