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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 use Initial U.S. approval: 1993

Approved
Approval ID

0b90641f-bdcf-474a-a457-01884c5f8023

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 5, 2023

Manufacturers
FDA

Steriscience Specialties Private Limited

DUNS: 853179150

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 Code82449-500
Application NumberANDA065458
Product Classification
M
Marketing Category
C73584
G
Generic Name
piperacillin and tazobactam
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 5, 2023
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 Code82449-502
Application NumberANDA065458
Product Classification
M
Marketing Category
C73584
G
Generic Name
piperacillin and tazobactam
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 5, 2023
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 and tazobactam

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code82449-501
Application NumberANDA065458
Product Classification
M
Marketing Category
C73584
G
Generic Name
piperacillin and tazobactam
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 5, 2023
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

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piperacillin and tazobactam - FDA Drug Approval Details