NDC Code(s) : 0206-2404-01, 0206-2404-02, 0206-2405-01, 0206-2405-02, 0206-2408-01, 0206-2408-02, 0206-2416-01, 0206-2409-01, 0206-2409-02, 0206-2411-01, 0206-2411-02, 0206-2413-01, 0206-2413-02
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

Zosynpiperacillin sodium and tazobactam sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0206-2404
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:0206-2404-0210 in 1 CARTON 11/01/1993
1NDC:0206-2404-0110 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 11/01/1993 08/31/2017
Zosynpiperacillin sodium and tazobactam sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0206-2405
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:0206-2405-0210 in 1 CARTON 11/01/1993
1NDC:0206-2405-0115 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 11/01/1993 09/30/2017
Zosynpiperacillin sodium and tazobactam sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0206-2408
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:0206-2408-0210 in 1 CARTON 11/01/1993
1NDC:0206-2408-0120 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 11/01/1993 07/31/2017
Zosynpiperacillin sodium and tazobactam sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0206-2416
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:0206-2416-011 in 1 CARTON 11/01/1993
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 11/01/1993 11/30/2015
Zosyn PIPERACILLIN SODIUM and TAZOBACTAM SODIUM INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0206-2409
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TAZOBACTAM SODIUM(UNII: UXA545ABTT)
(TAZOBACTAM - UNII:SE10G96M8W) 		TAZOBACTAM250 mg in 50 mL
PIPERACILLIN SODIUM(UNII: M98T69Q7HP)
(PIPERACILLIN ANHYDROUS - UNII:9I628532GX) 		PIPERACILLIN ANHYDROUS2 g in 50 mL
Inactive Ingredients
Ingredient Name Strength
DEXTROSE MONOHYDRATE(UNII: LX22YL083G)1 g in 50 mL
SODIUM CITRATE, UNSPECIFIED FORM(UNII: 1Q73Q2JULR)100 mg in 50 mL
EDETATE DISODIUM(UNII: 7FLD91C86K)0.5 mg in 50 mL
SODIUM BICARBONATE(UNII: 8MDF5V39QO)
HYDROCHLORIC ACID(UNII: QTT17582CB)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0206-2409-0224 in 1 BOX 03/01/1998
1NDC:0206-2409-0150 mL in 1 BAG Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050750 03/01/1998
Zosyn PIPERACILLIN SODIUM and TAZOBACTAM SODIUM INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0206-2411
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TAZOBACTAM SODIUM(UNII: UXA545ABTT)
(TAZOBACTAM - UNII:SE10G96M8W) 		TAZOBACTAM375 mg in 50 mL
PIPERACILLIN SODIUM(UNII: M98T69Q7HP)
(PIPERACILLIN ANHYDROUS - UNII:9I628532GX) 		PIPERACILLIN ANHYDROUS3 g in 50 mL
Inactive Ingredients
Ingredient Name Strength
DEXTROSE MONOHYDRATE(UNII: LX22YL083G)350 mg in 50 mL
SODIUM CITRATE, UNSPECIFIED FORM(UNII: 1Q73Q2JULR)150 mg in 50 mL
EDETATE DISODIUM(UNII: 7FLD91C86K)0.75 mg in 50 mL
SODIUM BICARBONATE(UNII: 8MDF5V39QO)
HYDROCHLORIC ACID(UNII: QTT17582CB)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0206-2411-0224 in 1 BOX 03/01/1998
1NDC:0206-2411-0150 mL in 1 BAG Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050750 03/01/1998
Zosyn PIPERACILLIN SODIUM and TAZOBACTAM SODIUM INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0206-2413
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TAZOBACTAM SODIUM(UNII: UXA545ABTT)
(TAZOBACTAM - UNII:SE10G96M8W) 		TAZOBACTAM500 mg in 100 mL
PIPERACILLIN SODIUM(UNII: M98T69Q7HP)
(PIPERACILLIN ANHYDROUS - UNII:9I628532GX) 		PIPERACILLIN ANHYDROUS4 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
DEXTROSE MONOHYDRATE(UNII: LX22YL083G)2 g in 100 mL
SODIUM CITRATE, UNSPECIFIED FORM(UNII: 1Q73Q2JULR)200 mg in 100 mL
EDETATE DISODIUM(UNII: 7FLD91C86K)1 mg in 100 mL
SODIUM BICARBONATE(UNII: 8MDF5V39QO)
HYDROCHLORIC ACID(UNII: QTT17582CB)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0206-2413-0212 in 1 BOX 03/01/1998
1NDC:0206-2413-01100 mL in 1 BAG Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050750 03/01/1998

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 2.25 GRAM - LABEL

NDC 0206-2404-01

ZOSYN®

(Piperacillin and Tazobactam for Injection, USP)

2.25 GRAM

SINGLE USE VIAL

Each vial provides piperacillin and tazobactam cryodesiccated powders for injection equivalent to 2 grams piperacillin, 0.25 gram tazobactam and 5.58 mEq (128 mg) of sodium.

For IV Use Only

Rx only

NOVAPLUS®

PRINCIPAL DISPLAY PANEL - 2.25 GRAM - LABEL

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 2.25 GRAM - CARTON

NDC 0206-2404-02

ZOSYN®

(Piperacillin and Tazobactam for Injection, USP)

2.25 GRAM

10 x 2.25 GRAM SINGLE USE VIALS

For IV Use Only

Rx only

NOVAPLUS®

PRINCIPAL DISPLAY PANEL - 2.25 GRAM - CARTON

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 3.375 GRAM - LABEL

NDC 0206-2405-01

ZOSYN®

(Piperacillin and Tazobactam for Injection, USP)

3.375 GRAM

SINGLE USE VIAL

Each vial provides piperacillin and tazobactam cryodesiccated powders for injection equivalent to 3 grams piperacillin, 0.375 gram tazobactam and 8.38 mEq (192 mg) of sodium.

For IV Use Only

Rx only

NOVAPLUS®

PRINCIPAL DISPLAY PANEL - 3.375 GRAM - LABEL

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 3.375 GRAM - CARTON

NDC 0206-2405-02

ZOSYN®

(Piperacillin and Tazobactam for Injection, USP)

3.375 GRAM

10 x 3.375 GRAM SINGLE USE VIALS

For IV Use Only

Rx only

NOVAPLUS®

PRINCIPAL DISPLAY PANEL - 3.375 GRAM - CARTON

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 4.5 GRAM Vial Label

NDC 0206-2408-01
Rx ONLY

ZOSYN® (Piperacillin and
Tazobactam for Injection, USP)

SINGLE USE VIAL

For IV Use Only

Each vial provides piperacillin and tazobactam
cryodesiccated powders for injection equivalent to
4 grams piperacillin, 0.5 gram tazobactam and
11.17 mEq (256 mg) of sodium.

NOVAPLUS®

4.5
GRAM

PRINCIPAL DISPLAY PANEL - 4.5 GRAM Vial Label

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 4.5 GRAM Vial Carton

NDC 0206-2408-02
Rx ONLY

ZOSYN®

(Piperacillin and Tazobactam for Injection, USP)

10 x 4.5 GRAM SINGLE USE VIALS

For IV Use Only

4.5
GRAM

NOVAPLUS®

PRINCIPAL DISPLAY PANEL - 4.5 GRAM Vial Carton

PRINCIPAL DISPLAY PANEL

NOVAPLUS®

PHARMACY BULK PACKAGE

NDC 0206-2416-01
Rx ONLY

ZOSYN®(Piperacillin and
Tazobactam for Injection, USP)

Not for Direct Infusion

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

40.5
GRAM
VIAL

PRINCIPAL DISPLAY PANEL - 40.5 GRAM Vial Label

PRINCIPAL DISPLAY PANEL

NDC 0206-2416-01
Rx ONLY

ZOSYN®(Piperacillin and
Tazobactam for Injection, USP)

Not for Direct Infusion

PHARMACY BULK PACKAGE

40.5
GRAM
VIAL

Contains piperacillin and tazobactam cryodesiccated powders for
injection equivalent to 36 grams of piperacillin, 4.5 grams of
tazobactam and 100.4 mEq (2,304 mg) of sodium.
Contains 9 mg of edetate disodium dihydrate.

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

NOVAPLUS®

PRINCIPAL DISPLAY PANEL - 40.5 GRAM Vial Carton

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 2.25 G SINGLE DOSE CONTAINER

NDC 0206-2409-01

ZOSYN®

(Piperacillin and Tazobactam Injection)

2.25 g

NOVAPLUS®

GALAXY

Single Dose

Container

Code 2G3585

50 mL Iso-osmotic

Sterile Nonpyrogenic

Rx ONLY

zosyn 2.25g single dose

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 2.25 G - LABEL UNIT

NDC 0206-2409-02

ZOSYN®

(Piperacillin and Tazobactam Injection)

2.25 g

NOVAPLUS®

Code 2G3585

12 - 50 mL Single Dose Containers

Iso-osmotic

Store at or below -20°C/-4°F.

Do not refreeze

Rx ONLY

zosyn 2.25 g label unit

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 3.375 G - SINGLE DOSE CONTAINER

NDC 0206-2411-01

ZOSYN®

(Piperacillin and Tazobactam Injection)

3.375 g

NOVAPLUS®

GALAXY

Single Dose

Container

50 mL Iso-osmotic

Code 2G3586

Sterile Nonpyrogenic

Rx ONLY

zosyn 3.375 g single dose

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 3.375 G - LABEL UNIT

NDC 0206-2411-02

ZOSYN®

(Piperacillin and Tazobactam Injection)

3.375 g

NOVAPLUS®

Code 2G3586

12 - 50 mL Single Dose Containers

Iso-osmotic

Store at or below -20°C/-4°F.

Do not refreeze

Rx ONLY

zosyn 3.375 g label unit

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 4.5 G - SINGLE DOSE CONTAINER

NDC 0206-2413-01

ZOSYN®

(Piperacillin and Tazobactam Injection)

4.5 g

NOVAPLUS®

GALAXY

Single Dose

Container

100 mL Iso-osmotic

Code 2G3587

Sterile Nonpyrogenic

Rx ONLY

zosyn 4.5 g single dose

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 4.5 G - LABEL UNIT

NDC 0206-2413-02

ZOSYN®

(Piperacillin and Tazobactam Injection)

4.5 g

NOVAPLUS®

Code 2G3587

6 - 100 mL Single Dose Containers

Iso-osmotic

Store at or below -20°C/-4°F.

Do not refreeze

Rx ONLY

zosyn 4.5 g label unit

NOVAPLUS is a registered trademark of Vizient, Inc.

LAB-0713-8.0