NDC Code(s) : 52584-556-15
Packager : General Injectables & Vaccines, Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Kinevac Sincalide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52584-556(NDC:0270-0556)
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)
Arginine hydrochloride(UNII: F7LTH1E20Y)
Lysine hydrochloride(UNII: JNJ23Q2COM)
Potassium phosphate, dibasic(UNII: CI71S98N1Z)
Methionine(UNII: AE28F7PNPL)
Pentetic acid(UNII: 7A314HQM0I)
Sodium metabisulfite(UNII: 4VON5FNS3C)
Polysorbate 20(UNII: 7T1F30V5YH)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52584-556-151 in 1 BAG
15 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017697 11/05/2010

PRINCIPAL DISPLAY PANEL

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