NDC Code(s) : 68180-551-11, 68180-551-22
Packager : Lupin Pharmaceuticals, Inc.

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:68180-551
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:68180-551-111 in 1 CARTON 28/03/2018
159 mL in 1 BOTTLE Type 0: Not a Combination Product
2NDC:68180-551-221 in 1 CARTON 28/03/2018
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 ANDA208125 03/28/2018

LABELER - Lupin Pharmaceuticals, Inc.(089153071)

REGISTRANT - LUPIN LIMITED(675923163)

Establishment
Name Address ID/FEI Business Operations
LUPIN LIMITED 650595213 MANUFACTURE(68180-551), PACK(68180-551)

PRINCIPAL DISPLAY PANEL

CLOBETASOL Propionate Spray, 0.05%

Rx Only

NDC 68180-551-22

For topical use only

4.25 FL OZ (125 mL) – Carton Label

Carton 125 ml

CLOBETASOL Propionate Spray, 0.05%

Rx Only

NDC 68180-551-22

For topical use only

4.25 FL OZ (125 mL) – Container Label

Carton 125 ml