NDC 57665-331-01
API & Excipient Details

Cytarabine marketed by Sigma-Tau Pharmaceuticals, Inc. under NDC Code 57665-331-01

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CYTARABINE(UNII: 04079A1RDZ) (CYTARABINE - UNII:04079A1RDZ)	CYTARABINE	50 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:57665-331-01	1 in 1 CARTON	22/10/2010
1		5 mL in 1 VIAL Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA021041	10/22/2010

PRINCIPAL DISPLAY PANEL

PDP

PRINCIPAL DISPLAY PANEL

PDP