NDC Code(s) : 51672-1316-5, 51672-1316-1, 51672-1316-6, 51672-1316-3
Packager : Sun Pharmaceutical Industries, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Alclometasone DipropionateAlclometasone dipropionate OINTMENT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51672-1316
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
HEXYLENE GLYCOL(UNII: KEH0A3F75J)
PROPYLENE GLYCOL MONOPALMITOSTEARATE(UNII: F76354LMGR)
PETROLATUM(UNII: 4T6H12BN9U)
WHITE WAX(UNII: 7G1J5DA97F)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51672-1316-55 g in 1 TUBE Type 0: Not a Combination Product29/07/2004
2NDC:51672-1316-11 in 1 CARTON 29/07/2004
215 g in 1 TUBE Type 0: Not a Combination Product29/07/2004
3NDC:51672-1316-61 in 1 CARTON 29/07/2004
345 g in 1 TUBE Type 0: Not a Combination Product29/07/2004
4NDC:51672-1316-31 in 1 CARTON 29/07/2004
460 g in 1 TUBE Type 0: Not a Combination Product29/07/2004
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076730 07/29/2004

LABELER - Sun Pharmaceutical Industries, Inc.(146974886)

Establishment
Name Address ID/FEI Business Operations
Sun Pharma Canada Inc. 243339023 manufacture(51672-1316)

PRINCIPAL DISPLAY PANEL

NDC 51672-1316-1

15 g

Alclometasone Dipropionate
Ointment USP, 0.05%

carton-taro

carton-taro