KINEVAC- sincalide injection, powder, lyophilized, for solution 
Jubilant HollisterStier LLC

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Kinevac

PRINCIPAL DISPLAY PANEL

Kinevac Carton
KINEVAC 
sincalide injection, powder, lyophilized, for solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65044-4441
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SINCALIDE (UNII: M03GIQ7Z6P) (SINCALIDE - UNII:M03GIQ7Z6P) SINCALIDE5 ug  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65044-4441-110 in 1 PACKAGE09/05/2007
15 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACTNDA01769709/05/2007
Labeler - Jubilant HollisterStier LLC (069263643)

Revised: 11/2017
Document Id: 2e27f649-6380-43a3-982b-560321d6cd82
Set id: 2ddaa192-2698-470b-b8e3-0e02093c4ecd
Version: 1
Effective Time: 20171103
 
Jubilant HollisterStier LLC