NDC Code(s) : 71665-430-01, 71665-430-02, 71665-430-03, 71665-440-01, 71665-440-02, 71665-440-03, 71665-330-01, 71665-330-02, 71665-330-03, 71665-340-01, 71665-340-02, 71665-340-03
Packager : Emergent Product Development Gaithersburg Inc.

Category : VACCINE LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ACAM2000smallpox and mpox (vaccinia) vaccine, live INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Product Information
Product Type VACCINE Item Code (Source) NDC:71665-430
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(UNII: 4SV59689SK)
(VACCINIA VIRUS STRAIN NEW YORK CITY BOARD OF HEALTH LIVE ANTIGEN - UNII:4SV59689SK) 		VACCINIA VIRUS STRAIN NEW YORK CITY BOARD OF HEALTH LIVE ANTIGEN100000000 [PFU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALBUMIN HUMAN(UNII: ZIF514RVZR)20 mg in 1 mL
SODIUM CHLORIDE(UNII: 451W47IQ8X)6 mg in 1 mL
MANNITOL(UNII: 3OWL53L36A)50 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:71665-430-038 in 1 CASE
1NDC:71665-430-0250 in 1 CARTON
1NDC:71665-430-010.3 mL in 1 VIAL, MULTI-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125158 08/31/2007
Diluent for ACAM2000diluent for smallpox and mpox (vaccinia) vaccine, live SOLUTION
Product Information
Product Type VACCINE Item Code (Source) NDC:71665-440
Route of Administration PERCUTANEOUS DEA Schedule
Inactive Ingredients
Ingredient Name Strength
GLYCERIN(UNII: PDC6A3C0OX)
PHENOL(UNII: 339NCG44TV)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:71665-440-038 in 1 CASE
1NDC:71665-440-0250 in 1 CARTON
1NDC:71665-440-010.6 mL in 1 VIAL, GLASS Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125158 08/31/2007
ACAM2000smallpox and mpox (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(UNII: 4SV59689SK)
(VACCINIA VIRUS STRAIN NEW YORK CITY BOARD OF HEALTH LIVE ANTIGEN - UNII:4SV59689SK) 		VACCINIA VIRUS STRAIN NEW YORK CITY BOARD OF HEALTH LIVE ANTIGEN100000000 [PFU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALBUMIN HUMAN(UNII: ZIF514RVZR)20 mg in 1 mL
SODIUM CHLORIDE(UNII: 451W47IQ8X)6 mg in 1 mL
MANNITOL(UNII: 3OWL53L36A)50 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:71665-330-038 in 1 CASE
1NDC:71665-330-0250 in 1 CARTON
1NDC:71665-330-010.3 mL in 1 VIAL, MULTI-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125158 08/31/2007
Diluent for ACAM2000diluent for smallpox and mpox (vaccinia) vaccine, live SOLUTION
Product Information
Product Type VACCINE Item Code (Source) NDC:71665-340
Route of Administration PERCUTANEOUS DEA Schedule
Inactive Ingredients
Ingredient Name Strength
GLYCERIN(UNII: PDC6A3C0OX)
PHENOL(UNII: 339NCG44TV)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:71665-340-038 in 1 CASE
1NDC:71665-340-0250 in 1 CARTON
1NDC:71665-340-010.6 mL in 1 VIAL, GLASS Type 0: Not a Combination Product
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)

PRINCIPAL DISPLAY PANEL

Lyophylized Antigen Component, Live

NOT TO BE USED ALONE

Reconstitute with Diluent
Component to form ACAM2000®.
After reconstitution vial contains
100 nominal doses of approx..
0.0025 mL each.
For percutaneous use.
Lot No.
Frozen Exp. Date: DDMMMYYYY
Refrig. Exp. Date:

Vial 1 of 2

Store at -25°C to -15°C (-13°F to
5°F). Store at 2°C to 8°C (36°F to
46°F) for up to 18 months. After
reconstitution store at 2°C to 8°C
(36°F to 46°F) for up to 30 days.

Reconst. Date:

Manufactured by:
Emergent Product
Development Gaithersburg Inc.
Gaithersburg, MD 20879 USA, Lic. 2089

LBL040437-01

‘Rx only’

Lyophilized Antigen Component, Live - Vial Label



STRATEGIC NATIONAL STOCKPILE USE ONLY

Smallpox (Vaccinia) Vaccine,
Live ACAM2000®

'Rx Only'. For percutaneous
inoculation with Bifurcated Needle
only. Do not administer by injection.
Contains trace amounts of antibiotics.

Lot No.

Mfg. Date:

Recon Date:

Store at 2-8°C (36-46°F). Use within
30 days of reconstitution.

Fill volume: 0.3 mL/100 doses.

Approximate Dose: 2.5µ L

Potency: 1-5x108 PFU/mL

Manufactured by:
Emergent Product
Development Gaithersburg Inc.
Gaithersburg, MD 20879 USA, Lic. 2089

COMPONENT # LBL040020-01

Lyophilized Antigen Component, Live - Vial Label

PRINCIPAL DISPLAY PANEL

Lyophylized Antigen Component, Live

Vial 1 of 2

NOT TO BE USED ALONE

Reconstitute with Diluent Component to form Smallpox and Mpox (Vaccinia) Vaccine,
Live (ACAM2000®)

For percutaneous use. A single dose is approximately 0.0025 mL.

Contains trace amounts of antibiotics (Neomycin and Polmyxin B).

For additional information see ACAM2000 Prescribing Information. A Medication Guide for
ACAM2000 is available in electronic format and is to be provided to each potential vaccinee.

Store at -25°C to -15°C (-13°F to 5°F).
May be stored at 2°C to 8°C (36°F to 46°F) for up to 18 months.
After reconstitution, store at 2°C to 8°C (36°F to 46°F) and use within 30 days.

Frozen Expiration Date: DDMMMYYYY                   Lot No. XXXXXXX
Refrig. Exp. Date:

Contents: 50 vials; After reconstitution with Diluent Component each vial contains 100
nominal doses.

Manufactured by:
Emergent Product Development Gaithersburg Inc.
Gaithersburg, MD 20879 USA, Lic. 2089

LBL040022-02

‘Rx only’

EMERGENT®

Lyophilized Antigen Component, Live - 50 Vials Carton Label



STRATEGIC NATIONAL STOCKPILE USE ONLY

Smallpox (Vaccinia) Vaccine, Live
ACAM2000®

'Rx Only'. For percutaneous inoculation with Bifurcated Needle only. Do not administer
by injection. Live Vaccinia virus derived from cloning Dryvax® (Wyeth Laboratories,
NYCBH Strain) and grown in Vero cells. For full prescribing and product information, see
ACAM2000® Package Insert.
Contains trace amounts of antibiotics (Neomycin and Polymyxin B).
A Medication Guide for ACAM2000® is available in electronic format, and is to be
provided to each potential vaccinee.

Approximate dose: 2.5 µL
Lot No. XXXXXXX

Potency: 1-5x108 PFU/mL
Expiration Date: DDMMMYYYY

Store at -25 to -15°C (-13 to 5°F) until distributed for use. Upon distribution, product
may be stored at 2-8°C (36-46°F) for up to 18 months. Do not use after expiration date.
Store reconstituted vaccine at 2-8°C (36-46°F). Use within 30 days of reconstitution date.

Manufactured by:
Emergent Product Development Gaithersburg Inc.
Gaithersburg, MD 20879 USA, Lic. 2089

Contents: 50 Vials; 0.3 mL/100 doses/vial

Component # LBL040022-01

emergent
biosolutions®

Lyophilized Antigen Component, Live - 50 Vials Carton Label



Lyophylized Antigen Component, Live

Vial 1 of 2

NOT TO BE USED ALONE

Reconstitute with Diluent Component to form Smallpox and Mpox (Vaccinia) Vaccine,
Live (ACAM2000®)

For percutaneous use. A single dose is approximately 0.0025 mL.

Contains trace amounts of antibiotics (Neomycin and Polmyxin B).

For additional information see ACAM2000 Prescribing Information. A Medication Guide for
ACAM2000 is available in electronic format and is to be provided to each potential vaccinee.

Store at -25°C to -15°C (-13°F to 5°F).
May be stored at 2°C to 8°C (36°F to 46°F) for up to 18 months.
After reconstitution, store at 2°C to 8°C (36°F to 46°F) and use within 30 days.

Frozen Expiration Date: DDMMMYYYY                   Lot No. XXXXXXX
Refrig. Exp. Date:

Contents: 50 vials; After reconstitution with Diluent Component each vial contains 100
nominal doses.

Manufactured by:
Emergent Product Development Gaithersburg Inc.
Gaithersburg, MD 20879 USA, Lic. 2089

LBL040023-02

‘Rx only’

EMERGENT®

Lyophilized Antigen Component, Live - 50 Vials Carton Label



STRATEGIC NATIONAL STOCKPILE USE ONLY

Smallpox (Vaccinia) Vaccine, Live
ACAM2000®

'Rx Only'. For percutaneous inoculation with Bifurcated Needle only. Do not administer
by injection. Live Vaccinia virus derived from cloning Dryvax® (Wyeth Laboratories,
NYCBH Strain) and grown in Vero cells. For full prescribing and product information, see
ACAM2000® Package Insert.
Contains trace amounts of antibiotics (Neomycin and Polymyxin B).
A Medication Guide for ACAM2000® is available in electronic format, and is to be
provided to each potential vaccinee.

Approximate dose: 2.5 µL
Lot No. XXXXXXX

Potency: 1-5x108 PFU/mL
Expiration Date: DDMMMYYYY

Store at -25 to -15°C (-13 to 5°F) until distributed for use. Upon distribution, product
may be stored at 2-8°C (36-46°F) for up to 18 months. Do not use after expiration date.
Store reconstituted vaccine at 2-8°C (36-46°F). Use within 30 days of reconstitution date.

Manufactured by:
Emergent Product Development Gaithersburg Inc.
Gaithersburg, MD 20879 USA, Lic. 2089

Contents: 50 Vials; 0.3 mL/100 doses/vial

Component # LBL040023-01

emergent
biosolutions®

Lyophilized Antigen Component, Live - 50 Vials Carton Label

PRINCIPAL DISPLAY PANEL

Lyophylized Antigen Component, Live

Vial 1 of 2

NOT TO BE USED ALONE

Reconstitute with Diluent Component to form Smallpox and Mpox (Vaccinia) Vaccine,
Live (ACAM2000®)

For percutaneous use. A single dose is approximately 0.0025 mL.

Contains trace amounts of antibiotics (Neomycin and Polmyxin B).

For additional information see ACAM2000 Prescribing Information. A Medication Guide for
ACAM2000 is available in electronic format and is to be provided to each potential vaccinee.

Store at -25°C to -15°C (-13°F to 5°F).
May be stored at 2°C to 8°C (36°F to 46°F) for up to 18 months.
After reconstitution, store at 2°C to 8°C (36°F to 46°F) and use within 30 days.

Frozen Expiration Date: DDMMMYYYY                   Lot No. XXXXXXX
Refrig. Exp. Date:

Contents: 8 Cartons of 50 vials; After reconstitution with Diluent Component each vial contains
100 nominal doses.

Manufactured by:
Emergent Product Development Gaithersburg Inc.
Gaithersburg, MD 20879 USA, Lic. 2089

LBL040021-02

‘Rx only’

EMERGENT®

Lyophilized Antigen Component, Live - 8 Cartons of 50 Vials Case Label



STRATEGIC NATIONAL STOCKPILE USE ONLY

Smallpox (Vaccinia) Vaccine, Live
ACAM2000®

'Rx Only'. For percutaneous inoculation with Bifurcated Needle only. Do not administer by injection.
Live Vaccinia virus derived from cloning Dryvax® (Wyeth Laboratories, NYCBH Strain) and grown in
Vero cells. For full prescribing and product information, see ACAM2000® Package Insert.
Contains trace amounts of antibiotics (Neomycin and Polymyxin B).
A Medication Guide for ACAM2000® is available in electronic format, and is to be
provided to each potential vaccinee.

Approximate dose: 2.5 µL
Lot No. XXXXXXX

Potency: 1-5x108 PFU/mL
Expiration Date: DDMMMYYYY

Store at -25 to -15°C (-13 to 5°F) until distributed for use. Upon distribution, product may
be stored at 2-8°C (36-46°F) for up to 18 months. Do not use after expiration date. Store
reconstituted vaccine at 2-8°C (36-46°F). Use within 30 days of reconstitution date.

Manufactured by:
Emergent Product Development Gaithersburg Inc.
Gaithersburg, MD 20879 USA, Lic. 2089

Contents: 8 Boxes of 50 Vials; 0.3 mL/100 doses/vial

Component #  LBL040021-01

emergent
biosolutions®

Lyophilized Antigen Component, Live - 8 Cartons of 50 Vials Case Label

PRINCIPAL DISPLAY PANEL

Diluent Component

NOT TO BE USED ALONE

Add 0.3 mL to one of
Lyophilized Antigen
Component, Live to form
ACAM2000®

Lot No. / Exp. Date:

Vial 2 of 2

Store at 15°C to 30°C
(59°F to 86°F)

50% (v/v) Glycerin USP
0.25% (v/v) Phenol USP

Manufactured by:
Emergent Product Development
Gaithersburg Inc.
Gaithersburg MD 20879 USA

LBL040438-01

Diluent Component - Vial Label



Diluent for Smallpox
(Vaccinia) Vaccine, Live,
ACAM2000 ®

50% (v/v) Glycerin USP
0.25% (v/v) Phenol USP
in Water for Injection USP

Lot No. / Exp. Date:

Store at 15-30°C (59-86°F)

For vaccine reconstitution –
do not administer by injection

Fill Volume: 0.6mL – Transfer
0.3mL to vaccine vial

Manufactured by:
Emergent Product Development
Gaithersburg Inc.
Gaithersburg MD 20879 USA

50000001 151-H02

Diluent Component - Vial Label

PRINCIPAL DISPLAY PANEL

Diluent Component

NOT TO BE USED ALONE

Vial 2 of 2

Use to reconstitute Lyophilized Antigen Component, Live to form Smallpox
and Mpox (Vaccinia) Vaccine, Live (ACAM2000®)

50% (v/v) Glycerin USP, 0.25% (v/v) Phenol USP, in Water for Injection USP

Lot No.
Expiration Date:

Store at 15°C to 30°C (59°F to 86°F)
Contents: 50 Vials of Diluent Component

Manufactured by:
Emergent Product Development Gaithersburg Inc.
Gaithersburg, MD 20879 USA

LBL040025-02

EMERGENT®

Diluent Component - 50 Vials Carton Label



Diluent for Smallpox (Vaccinia) Vaccine, Live,
ACAM2000 ®

50% (v/v) Glycerin USP, 0.25% (v/v) Phenol USP, in Water for Injection USP
For vaccine reconstitution. Do not administer by injection.

Lot No.
Expiration Date:

Store at 15-30°C (59-86°F)

Manufactured by:
Emergent Product Development Gaithersburg Inc.
Gaithersburg, MD 20879 USA

Contents: 50 Vials

876389-H02

emergent
biosolutions®

Diluent Component - 50 Vials Carton Label

PRINCIPAL DISPLAY PANEL

Diluent Component

NOT TO BE USED ALONE

Vial 2 of 2

Use to reconstitute Lyophilized Antigen Component, Live to form Smallpox and
Mpox (Vaccinia) Vaccine, Live (ACAM2000®)

50% (v/v) Glycerin USP, 0.25% (v/v) Phenol USP, in Water for Injection USP

Lot No.
Expiration Date:

Store at 15°C to 30°C (59°F to 86°F)
Contents: 8 Cartons of 50 Vials of Diluent Component

Manufactured by:
Emergent Product Development Gaithersburg Inc.
Gaithersburg, MD 20879 USA

LBL040026-02

EMERGENT

Diluent Component - 8 Cartons of 50 Vials Case Label

Diluent for Smallpox (Vaccinia) Vaccine, Live,
ACAM2000 ®

50% (v/v) Glycerin USP, 0.25% (v/v) Phenol USP, in Water for Injection USP
For vaccine reconstitution. Do not administer by injection.

Lot No.
Expiration Date:

Store at 15-30°C (59-86°F)
Manufactured by:
Emergent Product Development Gaithersburg Inc.
Gaithersburg, MD 20879 USA

Contents: 8 Boxes of 50 Vials

876390-H02

emergent
biosolutions®

Diluent Component - 8 Cartons of 50 Vials Case Label