NDC Code(s) : 0206-3501-01, 0206-3501-10, 0206-2501-01, 0206-2501-10, 0206-4501-01, 0206-4501-10, 0206-5501-01
Packager : Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Zosyntazobactam sodium and piperacillin sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0206-3501
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TAZOBACTAM SODIUM(UNII: UXA545ABTT)
(TAZOBACTAM - UNII:SE10G96M8W) 		TAZOBACTAM0.375 g in 15 mL
PIPERACILLIN SODIUM(UNII: M98T69Q7HP)
(PIPERACILLIN ANHYDROUS - UNII:9I628532GX) 		PIPERACILLIN ANHYDROUS3 g in 15 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CITRATE, UNSPECIFIED FORM(UNII: 1Q73Q2JULR)
EDETATE DISODIUM(UNII: 7FLD91C86K)0.75 mg in 15 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0206-3501-1010 in 1 CARTON
1NDC:0206-3501-0115 mL in 1 VIAL, SINGLE-USE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050684 06/01/2013
Zosyntazobactam sodium and piperacillin sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0206-2501
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TAZOBACTAM SODIUM(UNII: UXA545ABTT)
(TAZOBACTAM - UNII:SE10G96M8W) 		TAZOBACTAM0.25 g in 10 mL
PIPERACILLIN SODIUM(UNII: M98T69Q7HP)
(PIPERACILLIN ANHYDROUS - UNII:9I628532GX) 		PIPERACILLIN ANHYDROUS2 g in 10 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CITRATE, UNSPECIFIED FORM(UNII: 1Q73Q2JULR)
EDETATE DISODIUM(UNII: 7FLD91C86K)0.5 mg in 10 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0206-2501-1010 in 1 CARTON
1NDC:0206-2501-0110 mL in 1 VIAL, SINGLE-USE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050684 06/01/2013
Zosyntazobactam sodium and piperacillin sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0206-4501
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TAZOBACTAM SODIUM(UNII: UXA545ABTT)
(TAZOBACTAM - UNII:SE10G96M8W) 		TAZOBACTAM0.5 g in 20 mL
PIPERACILLIN SODIUM(UNII: M98T69Q7HP)
(PIPERACILLIN ANHYDROUS - UNII:9I628532GX) 		PIPERACILLIN ANHYDROUS4 g in 20 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CITRATE, UNSPECIFIED FORM(UNII: 1Q73Q2JULR)
EDETATE DISODIUM(UNII: 7FLD91C86K)1 mg in 20 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0206-4501-1010 in 1 CARTON
1NDC:0206-4501-0120 mL in 1 VIAL, SINGLE-USE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050684 06/01/2013
Zosyn tazobactam sodium and piperacillin sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0206-5501
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TAZOBACTAM SODIUM(UNII: UXA545ABTT)
(TAZOBACTAM - UNII:SE10G96M8W) 		TAZOBACTAM4.5 g in 180 mL
PIPERACILLIN SODIUM(UNII: M98T69Q7HP)
(PIPERACILLIN ANHYDROUS - UNII:9I628532GX) 		PIPERACILLIN ANHYDROUS36 g in 180 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CITRATE, UNSPECIFIED FORM(UNII: 1Q73Q2JULR)
EDETATE DISODIUM(UNII: 7FLD91C86K)9 mg in 180 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0206-5501-011 in 1 CARTON
1180 mL in 1 VIAL, PHARMACY BULK PACKAGE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050684 06/01/2013

PRINCIPAL DISPLAY PANEL

NDC 0206-3501-01

3.375 gram Single Use Vial

Zosyn ®

(piperacillin and
tazobactam for
injection, USP)

3.375 gram

For IV Use Only
Rx only

PREMIERPro™ Rx

PRINCIPAL DISPLAY PANEL - 3.375 gram Vial Label

PRINCIPAL DISPLAY PANEL

NDC 0206-3501-10
Contains 10 vials of
NDC 0206-3501-01
Rx only

10 x 3.375 gram Single Use Vials

Zosyn®

(piperacillin and tazobactam for injection, USP)

3.375 gram

For IV Use Only

PREMIERPro™ Rx

PRINCIPAL DISPLAY PANEL - 10 x 3.375 gram Vial Carton

PRINCIPAL DISPLAY PANEL

NDC 0206-2501-01

2.25 gram Single Use Vial

Zosyn®

(piperacillin and
tazobactam for
injection, USP)

2.25 gram

For IV Use Only
Rx only

PREMIERPro™ Rx

PRINCIPAL DISPLAY PANEL - 2.25 gram Vial Label

PRINCIPAL DISPLAY PANEL

NDC 0206-2501-10
Contains 10 vials of
NDC 0206-2501-01
Rx only

10 x 2.25 gram Single Use Vials

Zosyn®

(piperacillin and tazobactam for injection, USP)

2.25 gram

For IV Use Only

PREMIERPro™ Rx

PRINCIPAL DISPLAY PANEL - 10 x 2.25 gram Vial Carton

PRINCIPAL DISPLAY PANEL

NDC 0206-4501-01

4.5 gram Single Use Vial

Zosyn ®

(piperacillin and
tazobactam for
injection, USP)

4.5 gram

For IV Use Only
Rx only

PREMIERPro™ Rx

PRINCIPAL DISPLAY PANEL - 4.5 gram Vial Label

PRINCIPAL DISPLAY PANEL

NDC 0206-4501-10
Contains 10 of
NDC 0206-4501-01
Rx only

10 x 4.5 gram Single Use Vials

Zosyn®

(piperacillin and tazobactam for Injection, USP)

4.5 gram

For IV Use Only

PREMIERPro™ Rx

PRINCIPAL DISPLAY PANEL - 10 x 4.5 gram Vial Carton

PRINCIPAL DISPLAY PANEL

PREMIERPro™ Rx

NDC 0206-5501-01

Zosyn ®
(Piperacillin and Tazobactam
for Injection, USP)

Rx only

40.5 gram vial

PHARMACY BULK PACKAGE
Not for Direct Infusion

Distributed by Wyeth Pharmaceuticals Inc
A subsidiary of Pfizer Inc, Philadelphia, PA 19101

PRINCIPAL DISPLAY PANEL - 40.5 gram Vial Label

PRINCIPAL DISPLAY PANEL

NDC 0206-5501-01
Rx only

Zosyn ®
(Piperacillin and Tazobactam
for Injection, USP)

40.5 gram vial

PHARMACY BULK PACKAGE
Not for Direct Infusion

RECONSTITUTED STOCK SOLUTION MUST BE
TRANSFERRED AND FURTHER DILUTED
FOR I.V. INFUSION

PREMIERPro™ Rx

PRINCIPAL DISPLAY PANEL - 40.5 gram Vial Carton