NDC Code(s) : 0456-2700-01, 0456-2700-10
Packager : Allergan, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AVYCAZceftazidime, avibactam POWDER, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0456-2700
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFTAZIDIME(UNII: 9M416Z9QNR)
(CEFTAZIDIME ANHYDROUS - UNII:DZR1ENT301) 		CEFTAZIDIME ANHYDROUS2 g
AVIBACTAM SODIUM(UNII: 9V824P8TAI)
(AVIBACTAM - UNII:7352665165) 		AVIBACTAM0.5 g
Inactive Ingredients
Ingredient Name Strength
SODIUM CARBONATE(UNII: 45P3261C7T)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0456-2700-1010 in 1 CARTON 26/12/2014
1NDC:0456-2700-011 in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA206494 12/26/2014

LABELER - Allergan, Inc.(144796497)

PRINCIPAL DISPLAY PANEL

Principal Display Panel -Carton
NDC 0456-2700-10    Rx only       10 Single-dose vials
Avyca z ®   2.5 g per vial *
(ceftazidime and avibactam) for injection 
*Ceftazidime 2 gram (equivalent to 2.635 g ceftazidime pentahydrate/sodium carbonate)
and avibactam 0.5 g (equivalent to 0.551 g avibactam sodium).
MUST BE CONSTITU T ED THEN DILUTED. FOR INTRAVEN O US INFUSION.

Principal Display Panel - NDC 0456-2700-10 Rx only 10 Single-dose vials Avycaz® 2.5 g per vial* (ceftazidime and avibactam) for injection *Ceftazidime 2 gram (equivalent to 2.635 g ceftazidime pentahydrate/sodium carbonate) and avibactam 0.5 g (equivalent to 0.551 g avibactam sodium). MUST BE CONSTITUTED THEN DILUTED. FOR INTRAVENOUS INFUSION.