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Data updated: Jun 28, 2026

PIPERACILLIN AND TAZOBACTAM (piperacillin sodium) · SHANDONG

Infectious Disease Approved 2009-09-15

Piperacillin and tazobactam is an intravenous combination of a penicillin-class antibacterial and a beta-lactamase inhibitor. It is indicated for the treatment of moderate-to-severe infections, including intra-abdominal infections (such as complicated appendicitis and peritonitis) and nosocomial pneumonia in both adults and pediatric patients (2 months of age and older). Additionally, it is indicated in adults for the treatment of community-acquired pneumonia, skin and skin structure infections (including cellulitis and abscesses), and female pelvic infections (such as postpartum endometritis or pelvic inflammatory disease).

How PIPERACILLIN AND TAZOBACTAM Works

Piperacillin is a beta-lactam antibiotic that exerts bactericidal activity by binding to specific penicillin-binding proteins (PBPs) located inside the bacterial cell wall. This binding inhibits the third and last stage of bacterial cell wall synthesis, leading to cell lysis. Tazobactam is a beta-lactamase inhibitor that irreversibly binds to and inactivates many plasmid-mediated and chromosomal beta-lactamase enzymes. By neutralizing these enzymes, tazobactam protects piperacillin from degradation, extending its spectrum of activity to include many beta-lactamase-producing bacteria that would otherwise be resistant to piperacillin alone.

NDA
Small Molecule
16
Indications
--
Phase 3 Trials
16
Years on Market

Details

Status
Prescription
First Approved
2009-09-15
Routes
INJECTION, POWDER,FOR SOLUTION
Dosage Forms
INJECTABLE, INJECTION

PIPERACILLIN AND TAZOBACTAM Approval History

2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
393 FDA actions from 2009 to 2024
Dec 2024 SUPPL
Label · Labeling
May 2024 SUPPL
Label · Labeling
Apr 2024 SUPPL
Label · Labeling

What PIPERACILLIN AND TAZOBACTAM Treats

12 indications

PIPERACILLIN AND TAZOBACTAM is approved for 12 conditions since its original approval in 2009. These indications span multiple therapeutic areas including oncology, immunology, and more.

Source: FDA Label

PIPERACILLIN AND TAZOBACTAM Boxed Warning

PHARMACY BULK PACKAGE-NOT FOR DIRECT INFUSION...

PIPERACILLIN AND TAZOBACTAM Competitive Set

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

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Active Pipeline

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Key Completed Trials

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Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

PIPERACILLIN AND TAZOBACTAM FDA Label Details

Indications & Usage

FDA Label (PDF)

Piperacillin and tazobactam for injection, for intravenous use is a combination of piperacillin, a penicillin-class antibacterial and tazobactam, a β-lactamase inhibitor indicated for the treatment of: • Intra-abdominal infections in adult and pediatric patients 2 months of age and older • Nosocomial pneumonia in adult and pediatric patients 2 months of age and older • Skin and skin structure infections in adults • Female pelvic infections in adults • Community-acquired pneumonia in adults To reduce the development of drug-resistant bacteria and maintain the effectiveness of Piperacillin and T...

⚠️ BOXED WARNING

PHARMACY BULK PACKAGE-NOT FOR DIRECT INFUSION...

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.