MedPath

Piperacillin and Tazobactam

These highlights do not include all the information needed to use Piperacillin and Tazobactam for Injection safely and effectively. See full prescribing information for Piperacillin and Tazobactam for Injection. PIPERACILLIN AND TAZOBACTAM FOR INJECTION: single-dose vials Initial U.S. Approval: 1993 To reduce the development of drug-resistant bacteria and maintain the effectiveness of Piperacillin and Tazobactam for Injection and other antibacterial drugs, Piperacillin and Tazobactam for Injection should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.

Approved
Approval ID

ba87ade3-4d41-40c0-9f6a-27e121a4136d

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 31, 2019

Manufacturers
FDA

Fresenius Kabi USA, LLC

DUNS: 608775388

Products 3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

PIPERACILLIN SODIUM,TAZOBACTAM SODIUM

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code63323-300
Application NumberANDA065523
Product Classification
M
Marketing Category
C73584
G
Generic Name
PIPERACILLIN SODIUM,TAZOBACTAM SODIUM
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 31, 2019
FDA Product Classification

INGREDIENTS (2)

PIPERACILLIN SODIUMActive
Quantity: 3 g in 15 mL
Code: M98T69Q7HP
Classification: ACTIM
TAZOBACTAM SODIUMActive
Quantity: 0.375 g in 15 mL
Code: UXA545ABTT
Classification: ACTIM

PIPERACILLIN SODIUM,TAZOBACTAM SODIUM

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code63323-320
Application NumberANDA065523
Product Classification
M
Marketing Category
C73584
G
Generic Name
PIPERACILLIN SODIUM,TAZOBACTAM SODIUM
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 31, 2019
FDA Product Classification

INGREDIENTS (2)

PIPERACILLIN SODIUMActive
Quantity: 4 g in 20 mL
Code: M98T69Q7HP
Classification: ACTIM
TAZOBACTAM SODIUMActive
Quantity: 0.5 g in 20 mL
Code: UXA545ABTT
Classification: ACTIM

PIPERACILLIN SODIUM,TAZOBACTAM SODIUM

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code63323-309
Application NumberANDA065523
Product Classification
M
Marketing Category
C73584
G
Generic Name
PIPERACILLIN SODIUM,TAZOBACTAM SODIUM
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 31, 2019
FDA Product Classification

INGREDIENTS (2)

PIPERACILLIN SODIUMActive
Quantity: 2 g in 10 mL
Code: M98T69Q7HP
Classification: ACTIM
TAZOBACTAM SODIUMActive
Quantity: 0.25 g in 10 mL
Code: UXA545ABTT
Classification: ACTIM

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Piperacillin and Tazobactam - FDA Drug Approval Details