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PIPERACILLIN SODIUM and TAZOBACTAM SODIUM

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 use Initial U.S. Approval: 1993

Approved
Approval ID

184b5961-1ae7-474c-afaa-2a2b2ccfc9cd

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 26, 2022

Manufacturers
FDA

Xellia Pharmaceuticals USA LLC

DUNS: 116768762

Products 3

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

PIPERACILLIN SODIUM and TAZOBACTAM SODIUM

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70594-079
Application NumberANDA212287
Product Classification
M
Marketing Category
C73584
G
Generic Name
PIPERACILLIN SODIUM and TAZOBACTAM SODIUM
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 26, 2022
FDA Product Classification

INGREDIENTS (2)

PIPERACILLIN SODIUMActive
Quantity: 3 g in 100 mL
Code: M98T69Q7HP
Classification: ACTIM
TAZOBACTAM SODIUMActive
Quantity: 375 mg in 100 mL
Code: UXA545ABTT
Classification: ACTIM

PIPERACILLIN SODIUM and TAZOBACTAM SODIUM

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70594-080
Application NumberANDA212287
Product Classification
M
Marketing Category
C73584
G
Generic Name
PIPERACILLIN SODIUM and TAZOBACTAM SODIUM
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 26, 2022
FDA Product Classification

INGREDIENTS (2)

PIPERACILLIN SODIUMActive
Quantity: 4 g in 150 mL
Code: M98T69Q7HP
Classification: ACTIM
TAZOBACTAM SODIUMActive
Quantity: 500 mg in 150 mL
Code: UXA545ABTT
Classification: ACTIM

PIPERACILLIN SODIUM and TAZOBACTAM SODIUM

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70594-078
Application NumberANDA212287
Product Classification
M
Marketing Category
C73584
G
Generic Name
PIPERACILLIN SODIUM and TAZOBACTAM SODIUM
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 26, 2022
FDA Product Classification

INGREDIENTS (2)

PIPERACILLIN SODIUMActive
Quantity: 2 g in 50 mL
Code: M98T69Q7HP
Classification: ACTIM
TAZOBACTAM SODIUMActive
Quantity: 250 mg in 50 mL
Code: UXA545ABTT
Classification: ACTIM

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PIPERACILLIN SODIUM and TAZOBACTAM SODIUM - FDA Drug Approval Details