NDC Code(s) : 57665-331-01
Packager : Sigma-Tau Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

DepoCytCytarabine INJECTION, LIPID COMPLEX
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57665-331
Route of Administration INTRATHECAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CYTARABINE(UNII: 04079A1RDZ)
(CYTARABINE - UNII:04079A1RDZ) 		CYTARABINE50 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
CHOLESTEROL(UNII: 97C5T2UQ7J)
WATER(UNII: 059QF0KO0R)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
GLYCERYL TRIOLEATE(UNII: O05EC62663)
1,2-DIOLEOYL-SN-GLYCERO-3-PHOSPHOCHOLINE(UNII: H026DM5V6U)
1,2-DIPALMITOYL-SN-GLYCERO-3-(PHOSPHO-RAC-(1-GLYCEROL))(UNII: 5045XZ24IY)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:57665-331-011 in 1 CARTON 22/10/2010
15 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021041 10/22/2010

PRINCIPAL DISPLAY PANEL

PDP

PRINCIPAL DISPLAY PANEL

PDP