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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, for intravenous useInitial U.S. approval: 1993

Approved
Approval ID

1eb40c84-0cb3-4648-a39f-f4ebc4dbcb16

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 2, 2021

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 and Tazobactam

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code63323-983
Application NumberANDA203719
Product Classification
M
Marketing Category
C73584
G
Generic Name
Piperacillin and Tazobactam
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 23, 2020
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 and Tazobactam

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code63323-981
Application NumberANDA203719
Product Classification
M
Marketing Category
C73584
G
Generic Name
Piperacillin and Tazobactam
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 23, 2020
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

Piperacillin and Tazobactam

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code63323-982
Application NumberANDA203719
Product Classification
M
Marketing Category
C73584
G
Generic Name
Piperacillin and Tazobactam
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 23, 2020
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

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Piperacillin and Tazobactam - FDA Drug Approval Details