NDC Code(s) : 65044-4441-1
Packager : Jubilant HollisterStier LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Kinevacsincalide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65044-4441
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SINCALIDE(UNII: M03GIQ7Z6P)
(SINCALIDE - UNII:M03GIQ7Z6P) 		SINCALIDE5 ug in 5 mL
Inactive Ingredients
Ingredient Name Strength
MANNITOL(UNII: 3OWL53L36A)170 mg in 5 mL
ARGININE HYDROCHLORIDE(UNII: F7LTH1E20Y)30 mg in 5 mL
LYSINE HYDROCHLORIDE(UNII: JNJ23Q2COM)15 mg in 5 mL
POTASSIUM PHOSPHATE, DIBASIC(UNII: CI71S98N1Z)9 mg in 5 mL
METHIONINE(UNII: AE28F7PNPL)4 mg in 5 mL
SODIUM METABISULFITE(UNII: 4VON5FNS3C)0.04 mg in 5 mL
POLYSORBATE 20(UNII: 7T1F30V5YH)0.005 ug in 5 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:65044-4441-110 in 1 PACKAGE 05/09/2007
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
APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT NDA017697 09/05/2007

PRINCIPAL DISPLAY PANEL

Kinevac Carton