NDC Code(s) : 68462-310-65, 68462-310-66
Packager : Glenmark Pharmaceuticals Inc., USA

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CalcipotrieneCalcipotriene OINTMENT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-310
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCIPOTRIENE(UNII: 143NQ3779B)
(CALCIPOTRIENE - UNII:143NQ3779B) 		CALCIPOTRIENE50 ug in 1 g
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE(UNII: 94255I6E2T)
EDETATE DISODIUM(UNII: 7FLD91C86K)
MINERAL OIL(UNII: T5L8T28FGP)
PETROLATUM(UNII: 4T6H12BN9U)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL(UNII: H4N855PNZ1)
WATER(UNII: 059QF0KO0R)
STEARETH-2(UNII: V56DFE46J5)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68462-310-6560 g in 1 TUBE Type 0: Not a Combination Product24/03/2010
2NDC:68462-310-661 in 1 CARTON 24/03/2010
2120 g in 1 TUBE Type 0: Not a Combination Product24/03/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090633 03/24/2010

LABELER - Glenmark Pharmaceuticals Inc., USA(130597813)

Establishment
Name Address ID/FEI Business Operations
Glenmark Pharmaceuticals Limited 677318665 ANALYSIS(68462-310), MANUFACTURE(68462-310)

PRINCIPAL DISPLAY PANEL

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