Clobetasol Propionate

Product NDC
0378-8055
11-digit product format
003788055
Labeler code
0378
Product ID
0378-8055_d04aa36f-abc2-46a0-b843-044bfa9e9863
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobetasol Propionate
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
Mylan Pharmaceuticals Inc.
Application
NDA022013
Marketing category
NDA AUTHORIZED GENERIC
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
0378-8055-01GM - Gram0378-8055df62a345-77fb-4342-8ae2-2f84d197478412019-02-13
0378-8055-50GM - Gram0378-8055572e467d-4ac0-4543-87c3-511e63d08aa212019-12-10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-8055-01003788055011 CAN in 1 CARTON (0378-8055-01) > 100 g in 1 CAN1 can2019-01-140000-00-00NoNoCurrent
0378-8055-50003788055501 CAN in 1 CARTON (0378-8055-50) > 50 g in 1 CAN1 can2019-11-140000-00-00NoNoCurrent