NDC Code(s) : 68462-300-17, 68462-300-47, 68462-300-65, 68462-299-17, 68462-299-47, 68462-299-65
Packager : Glenmark Pharmaceuticals Inc., USA

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Alclometasone DipropionateAlclometasone Dipropionate CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-300
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCLOMETASONE DIPROPIONATE(UNII: S56PQL4N1V)
(ALCLOMETASONE - UNII:136H45TB7B) 		ALCLOMETASONE DIPROPIONATE0.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
PETROLATUM(UNII: 4T6H12BN9U)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE(UNII: 593YOG76RN)
CHLOROCRESOL(UNII: 36W53O7109)
PHOSPHORIC ACID(UNII: E4GA8884NN)
WATER(UNII: 059QF0KO0R)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
PEG-100 STEARATE(UNII: YD01N1999R)
CETETH-20(UNII: I835H2IHHX)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68462-300-1715 g in 1 TUBE Type 0: Not a Combination Product23/06/2009
2NDC:68462-300-4745 g in 1 TUBE Type 0: Not a Combination Product23/06/2009
3NDC:68462-300-6560 g in 1 TUBE Type 0: Not a Combination Product23/06/2009
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079061 06/23/2009 11/01/2023
Alclometasone DipropionateAlclometasone Dipropionate OINTMENT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-299
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCLOMETASONE DIPROPIONATE(UNII: S56PQL4N1V)
(ALCLOMETASONE - UNII:136H45TB7B) 		ALCLOMETASONE DIPROPIONATE.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
HEXYLENE GLYCOL(UNII: KEH0A3F75J)
WHITE WAX(UNII: 7G1J5DA97F)
PROPYLENE GLYCOL MONOPALMITOSTEARATE(UNII: F76354LMGR)
PETROLATUM(UNII: 4T6H12BN9U)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68462-299-1715 g in 1 TUBE Type 0: Not a Combination Product30/07/2009
2NDC:68462-299-4745 g in 1 TUBE Type 0: Not a Combination Product30/07/2009
3NDC:68462-299-6560 g in 1 TUBE Type 0: Not a Combination Product30/07/2009
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079227 07/30/2009

LABELER - Glenmark Pharmaceuticals Inc., USA(130597813)

Establishment
Name Address ID/FEI Business Operations
Glenmark Pharmaceuticals Limited 676115028 ANALYSIS(68462-300, 68462-299), MANUFACTURE(68462-300, 68462-299)

PRINCIPAL DISPLAY PANEL

NDC 68462-300-47
Alclometasone Dipropionate Cream USP, 0.05%
For dermatologic use only – Not for ophthalmic use.

cream-carton

PRINCIPAL DISPLAY PANEL

NDC 68462-299-47
Alclometasone Dipropionate Ointment USP, 0.05%
For dermatologic use only – Not for ophthalmic use

ointment-carton