TheraRadar
Data updated: May 26, 2026

PIPERACILLIN (piperacillin sodium)

Infectious Disease Approved 2003-11-14

PIPERACILLIN is indicated for the treatment of Intra-abdominal Infections; Nosocomial Pneumonia; Skin and Skin Structure Infections; Female Pelvic Infections; Community-Acquired Pneumonia; Appendicitis; Peritonitis.

Source: FDA Label • ISTITUTO BIO ITA SPA
2
Indications
--
Phase 3 Trials
22
Years on Market

Details

Status
Prescription
First Approved
2003-11-14
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

Active Ingredient: PIPERACILLIN SODIUM

PIPERACILLIN Approval History

2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
24 FDA actions from 2003 to 2025
Nov 2025 SUPPL
Label · Labeling
May 2024 SUPPL
Label · Labeling
Aug 2020 SUPPL
Label · Labeling

What PIPERACILLIN Treats

7 indications

PIPERACILLIN is approved for 7 conditions since its original approval in 2003. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Intra-abdominal Infections
  • Nosocomial Pneumonia
  • Skin and Skin Structure Infections
  • Female Pelvic Infections
  • Community-Acquired Pneumonia
  • Appendicitis
  • Peritonitis
Source: FDA Label

PIPERACILLIN 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.

Drugs Similar to PIPERACILLIN

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINER
PIPERACILLIN SODIUM
7 shared
B BRAUN MEDICAL
Shared indications:
ZOSYN IN PLASTIC CONTAINER
PIPERACILLIN SODIUM
7 shared
Baxter
Shared indications:
ERTAPENEM SODIUM
ERTAPENEM SODIUM
3 shared
SAVIOR LIFETEC CORP
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Clinical Trial Registry

2 trials
Trial Sponsor ID Phase Status Title
NCT02493764 RESTORE-IMI 2 results posted 7655A-014 2015-000246-34, 163240 Ph 3 completed Imipenem/Relebactam/Cilastatin Versus Piperacillin/Tazobactam for Treatment of Participants With Bacterial Pneumonia (MK-7655A-014)
NCT00894439 3219K1-1002 Ph 1 completed Study Evaluating BLI-489 and Piperacillin in Healthy Subjects
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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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 FDA Label Details

Indications & Usage

PIPERACILLIN is indicated for the treatment of Intra-abdominal Infections; Nosocomial Pneumonia; Skin and Skin Structure Infections; Female Pelvic Infections; Community-Acquired Pneumonia; Appendicitis; Peritonitis.

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Data Sources

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