OLUX-E

Product NDC
0378-8147
11-digit product format
003788147
Labeler code
0378
Product ID
0378-8147_43842bec-36cf-42aa-96e9-eb78225b69e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clobetasol propionate
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
Mylan Pharmaceuticals Inc.
Application
NDA022013
Marketing category
NDA
Marketing start
2019-01-14
Marketing end
0000-00-00
Substance
CLOBETASOL PROPIONATE
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
0378-8147-01GM - Gram0378-8147957958b1-5424-422a-9828-efeb238c148512019-02-13
0378-8147-50GM - Gram0378-81475a0897fd-3726-44ec-92e2-c0a41f7e8a9b12019-09-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-8147-01003788147011 CAN in 1 CARTON (0378-8147-01) > 100 g in 1 CAN1 can2019-01-140000-00-00NoNoCurrent
0378-8147-06003788147061 CAN in 1 CARTON (0378-8147-06) > 10 g in 1 CAN1 can2019-03-110000-00-00YesNoCurrent
0378-8147-50003788147501 CAN in 1 CARTON (0378-8147-50) > 50 g in 1 CAN1 can2019-08-080000-00-00NoNoCurrent