NDC Code(s) : 0781-7117-35, 0781-7117-83
Packager : Sandoz Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CalcipotrieneCalcipotriene CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-7117
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCIPOTRIENE(UNII: 143NQ3779B)
(CALCIPOTRIENE - UNII:143NQ3779B) 		CALCIPOTRIENE0.05 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CETETH-20(UNII: I835H2IHHX)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
DIAZOLIDINYL UREA(UNII: H5RIZ3MPW4)
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE(UNII: 70WT22SF4B)
DICHLOROBENZYL ALCOHOL(UNII: 1NKX3648J9)
EDETATE DISODIUM(UNII: 7FLD91C86K)
GLYCERIN(UNII: PDC6A3C0OX)
MINERAL OIL(UNII: T5L8T28FGP)
PHOSPHORIC ACID(UNII: E4GA8884NN)
PETROLATUM(UNII: 4T6H12BN9U)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0781-7117-351 in 1 CARTON 27/07/2012
160 g in 1 TUBE Type 0: Not a Combination Product
2NDC:0781-7117-831 in 1 CARTON 27/07/2012
2120 g in 1 TUBE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200935 07/27/2012 09/30/2024

LABELER - Sandoz Inc.(005387188)

Establishment
Name Address ID/FEI Business Operations
TOLMAR, INC. 791156578 analysis(0781-7117), label(0781-7117), manufacture(0781-7117), pack(0781-7117)

Establishment
Name Address ID/FEI Business Operations
TOLMAR, INC. 079112310 analysis(0781-7117), label(0781-7117), manufacture(0781-7117), pack(0781-7117)

PRINCIPAL DISPLAY PANEL

120 g carton