Piperacillin and Tazobactam (Page 9 of 9)

PRINCIPAL DISPLAY PANEL — 2.25 gram Vial Label

NDC 68001-506-28

Rx Only

Piperacillin
and Tazobactam for Injection, USP

2.25 grams/vial*

For Intravenous Use Only

Single-dose Vial

2.25 gram Vial Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 2.25 Gram Vial Carton

NDC 68001-506-30

Rx Only

Piperacillin
and Tazobactam for Injection, USP

2.25 grams/vial*

For Intravenous Use Only

10 x 2.25 gram Single-dose Vials

2.25 gram Vial Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 3.375 gram Vial Label

NDC 68001-507-53

Rx Only

Piperacillin
and Tazobactam
for Injection, USP

3.375 grams/vial*

For Intravenous Use Only Single-dose Vial

3.375 gram Vial Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 3.375 Gram Vial Carton

NDC 68001-507-82

Rx Only

Piperacillin
and Tazobactam for Injection, USP

3.375 grams/vial*

For Intravenous Use Only

10 x 3.375 gram Single-dose Vials

3.375 gram Vial Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 4.5 gram Vial Label

NDC 68001-508-29

Rx Only

Piperacillin
and Tazobactam
for Injection, USP

4.5 grams/vial*

For Intravenous Use Only Single-dose Vial

4.5 gram Vial Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 4.5 Gram Vial Carton

NDC 68001-508-31

Rx Only

Piperacillin
and Tazobactam for Injection, USP

4.5 grams/vial*

For Intravenous Use Only

10 x 4.5 gram Single-dose Vials

4.5 gram Vial Carton
(click image for full-size original)
PIPERACILLIN AND TAZOBACTAM piperacillin and tazobactam injection, powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-506
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PIPERACILLIN SODIUM (PIPERACILLIN ANHYDROUS) PIPERACILLIN ANHYDROUS 2 g in 10 mL
TAZOBACTAM SODIUM (TAZOBACTAM) TAZOBACTAM 0.25 g in 10 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68001-506-30 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (68001-506-28)
1 NDC:68001-506-28 10 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (68001-506-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204959 08/11/2021
PIPERACILLIN AND TAZOBACTAM piperacillin and tazobactam injection, powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-507
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PIPERACILLIN SODIUM (PIPERACILLIN ANHYDROUS) PIPERACILLIN ANHYDROUS 3 g in 15 mL
TAZOBACTAM SODIUM (TAZOBACTAM) TAZOBACTAM 0.375 g in 15 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68001-507-82 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (68001-507-53)
1 NDC:68001-507-53 15 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (68001-507-82)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204959 08/11/2021
PIPERACILLIN AND TAZOBACTAM piperacillin and tazobactam injection, powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-508
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PIPERACILLIN SODIUM (PIPERACILLIN ANHYDROUS) PIPERACILLIN ANHYDROUS 4 g in 20 mL
TAZOBACTAM SODIUM (TAZOBACTAM) TAZOBACTAM 0.5 g in 20 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68001-508-31 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (68001-508-29)
1 NDC:68001-508-29 20 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (68001-508-31)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204959 08/11/2021
Labeler — BluePoint Laboratories (985523874)
Establishment
Name Address ID/FEI Operations
Shandong Anxin Pharmaceutical Co., Ltd. 554518058 manufacture (68001-506), manufacture (68001-507), manufacture (68001-508), analysis (68001-506), analysis (68001-507), analysis (68001-508), label (68001-506), label (68001-507), label (68001-508), pack (68001-506), pack (68001-507), pack (68001-508)

Revised: 06/2022 BluePoint Laboratories

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