Halobetasol Propionate

Product NDC
0168-0355
11-digit product format
001680355
Labeler code
0168
Product ID
0168-0355_13b31048-e881-404d-8321-ee882fc4456c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
halobetasol propionate
Dosage form
CREAM
Route
TOPICAL
Labeler
Fougera Pharmaceuticals Inc.
Application
ANDA077001
Marketing category
ANDA
Marketing start
2004-12-16
Marketing end
0000-00-00
Substance
HALOBETASOL PROPIONATE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0168-0355-15GM - Gram0168-03557c8b4f88-d962-4b98-8a35-84f3d05f4c0e12012-07-24
0168-0355-50GM - Gram0168-0355551435f9-7259-4098-a408-dd2a0ece1ed612012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0168-0355-150016803551515 g in 1 TUBE (0168-0355-15) 15 g2004-12-160000-00-00NoNoCurrent
0168-0355-500016803555050 g in 1 TUBE (0168-0355-50) 50 g2004-12-160000-00-00NoNoCurrent