Vaccine Information: ACAM2000 (Page 6 of 6)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

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Package/Label Display Panel

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ACAM2000
smallpox (vaccinia) vaccine, live injection, powder, lyophilized, for solution
Product Information
Product Type VACCINE Item Code (Source) NDC:71665-330
Route of Administration PERCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VACCINIA VIRUS STRAIN NEW YORK CITY BOARD OF HEALTH LIVE ANTIGEN (VACCINIA VIRUS STRAIN NEW YORK CITY BOARD OF HEALTH LIVE ANTIGEN) VACCINIA VIRUS STRAIN NEW YORK CITY BOARD OF HEALTH LIVE ANTIGEN 100000000 [PFU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALBUMIN HUMAN 20 mg in 1 mL
SODIUM CHLORIDE 6 mg in 1 mL
MANNITOL 50 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71665-330-02 50 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE (71665-330-01)
1 NDC:71665-330-01 0.3 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (71665-330-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125158 08/31/2007
Labeler — Emergent Product Development Gaithersburg Inc. (189488554)

Revised: 03/2018 Emergent Product Development Gaithersburg Inc.

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