NDC Code(s) : 68462-480-39, 68462-480-56
Packager : Glenmark Pharmaceuticals Inc., USA

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CLOBETASOL PROPIONATECLOBETASOL PROPIONATE SPRAY
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-480
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLOBETASOL PROPIONATE(UNII: 779619577M)
(CLOBETASOL - UNII:ADN79D536H) 		CLOBETASOL PROPIONATE0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL(UNII: 3K9958V90M)
ISOPROPYL MYRISTATE(UNII: 0RE8K4LNJS)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
UNDECYLENIC ACID(UNII: K3D86KJ24N)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68462-480-391 in 1 CARTON 26/03/2018
159 mL in 1 BOTTLE Type 0: Not a Combination Product
2NDC:68462-480-561 in 1 CARTON 26/03/2018
2125 mL in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209004 03/26/2018

LABELER - Glenmark Pharmaceuticals Inc., USA(130597813)

Establishment
Name Address ID/FEI Business Operations
Glenmark Pharmaceuticals Limited 676115028 ANALYSIS(68462-480), MANUFACTURE(68462-480)

PRINCIPAL DISPLAY PANEL

NDC 68462-480-39
Clobetasol Propionate Spray, 0.05%

For topical use only. Not for eye use.

CTN0-05jpg