NDC Code(s) : 57970-100-01
Packager : Allergan, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

DALVANCEDalbavancin INJECTION, POWDER, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57970-100
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DALBAVANCIN HYDROCHLORIDE(UNII: 33WDQ7T81E)
(DALBAVANCIN - UNII:808UI9MS5K) 		DALBAVANCIN500 mg in 25 mL
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)129 mg in 25 mL
MANNITOL(UNII: 3OWL53L36A)129 mg in 25 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:57970-100-011 in 1 PACKAGE 23/05/2014
125 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
NDA NDA021883 05/23/2014

LABELER - Allergan, Inc.(144796497)

PRINCIPAL DISPLAY PANEL

NDC 57970-100-01
Rx Only
DALVANCE
(dalbavancin) for Injection
500 mg per vial
For Intravenous Infusion Only
Sterile Single-Use Vial
Discard Unused Portion
One Vial

PRINCIPAL DISPLAY PANEL NDC 57970-100-01 Rx Only DALVANCE (dalbavancin) for Injection 500 mg per vial For Intravenous Infusion Only Sterile Single-Use Vial Discard Unused Portion One Vial