FLUTICASONE PROPIONATE

Product NDC
0168-0434
11-digit product format
001680434
Labeler code
0168
Product ID
0168-0434_5cc716a9-20fe-4aa0-be02-f72bb7c46017
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluticasone propionate
Dosage form
LOTION
Route
TOPICAL
Labeler
Fougera Pharmaceuticals Inc.
Application
NDA021152
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2012-12-03
Marketing end
0000-00-00
Substance
FLUTICASONE PROPIONATE
Active strength
1 mg/mL
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
0168-0434-04ML - Milliliter0168-04348ab59a0d-5f44-4ec6-9757-01e4769f68e012013-09-04
0168-0434-60ML - Milliliter0168-0434469893b4-d8e2-4593-92a0-4951b8fd293b12013-02-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0168-0434-04001680434041 BOTTLE in 1 CARTON (0168-0434-04) > 120 mL in 1 BOTTLE1 bottle2013-08-210000-00-00NoNoCurrent
0168-0434-60001680434601 BOTTLE in 1 CARTON (0168-0434-60) > 60 mL in 1 BOTTLE1 bottle2012-12-030000-00-00NoNoCurrent