Regulatory PathRegulatory requirements compared

Active substances

Piperacillin + Tazobactam

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
PIPERACILLIN - TAZOPACTAM SANDOZ 2.25GM VIAL2,0.25 g,gPowder for solution for infusion · Intravenous use1 VialSAR 23.25Generic · PrescriptionSANDOZValid
PIPERACILLIN - TAZOPACTAM SANDOZ 4.5GM VIAL4,0.5 g,gPowder for solution for infusion · Intravenous use10 VialSAR 550.55Generic · PrescriptionSANDOZValid
PRIZMA 2GM/0.25GM POWDER FOR I.V. INFUSION2,0.25 g,gPowder for solution for infusion · Intravenous use1 VialSAR 35.60Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
PRIZMA 4GM-0.5GM POWDER FOR I.V INFUSION4,0.5 g,gPowder for solution for infusion · Intravenous use1 VialSAR 71.25Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
Pipractam4.5 gLyophilisate for solution for infusion · Intravenous use10 VialSAR 562.65Generic · PrescriptionSAUDI DOX FOR PHARMACEUTICAL INDUSTRIESValid
Pipractam2.25 gLyophilisate for solution for infusion · Intravenous use10 VialSAR 299.45Generic · PrescriptionSAUDI DOX FOR PHARMACEUTICAL INDUSTRIESValid
TAZOCIN 4.5GM VIAL + EDTA4,0.5 g,gPowder for solution for infusion · Intravenous use1 VialSAR 92.85Generic · PrescriptionWYETHValid
TAZORAX 2.25 GM Powder for injection2,0.25 g,gpowder for solution for injection · Intravenous use1 VialSAR 32.05Generic · PrescriptionTabuk Pharmaceutical Manufacturing CompanyValid
TAZORAX 4.5 GM Powder for injection4,0.5 g,gpowder for solution for injection · Intravenous use1 VialSAR 64.10Generic · PrescriptionTabuk Pharmaceutical Manufacturing CompanyValid
PIPERACILLIN - TAZOPACTAM SANDOZ 4.5GM VIAL4,0.5 g,gPowder for solution for infusion · Intravenous use1 VialSAR 46.55Generic · PrescriptionSANDOZWithdrawn by MAH · Not Marketed
TAZOCIN 2.25G VIAL2000, 250 mgSolution · Intravenous use1 VialSAR 29.05NCE · PrescriptionLEDERLEWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

ACUTE BACTERIAL PROSTATITIS; ACUTE EXACERBATION OF BRONCHIECTASIS (NON-CYSTIC FIBROSIS); ACUTE EXACERBATION OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD); ACUTE PANCREATITIS; ACUTE PYELONEPHRITIS; ANTIBIOTIC SURGICAL PROPHYLAXIS; BACTERIAL SKIN INFECTIONS - ERYSIPELAS AND CELLULITIS; BACTERIAL SKIN INFECTIONS - GAS GANGRENE; BACTERIAL SKIN INFECTIONS - NECROTIZING FASCIITIS; BACTERIAL SKIN INFECTIONS - SURGICAL SITE INFECTIONS; COMMUNITY ACQUIRED PNEUMONEA; DENTAL ABSCESS; HOSPITAL AND VENTILATER ACQUIRED PNEUMONIA; INTRA-ABDOMINAL INFECTIONS; OSTEOMYELITIS; PERITONITIS; Pyogenic Arthritis; RECURRENT URINARY TRACT INFECTIONS (UTI); Septic Shock

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
ZOSYN IN PLASTIC CONTAINEREQ 40MG BASE/ML;EQ 5MG BASE/ML; EQ 60MG BASE/ML;EQ 7.5MG BASE/ML; EQ 4GM BASE/100ML;EQ 500MG BASE/100MLinjectable · injectionBAXTER HLTHCARE CORPPrescription24 Feb 1998
PIPERACILLIN AND TAZOBACTAMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL; EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL; EQ 4GM BASE/VIAL;EQ 500MG BASE/VIALinjectable · injectionSANDOZPrescription21 Oct 2010
PIPERACILLIN AND TAZOBACTAMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL; EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL; EQ 4GM BASE/VIAL;EQ 500MG BASE/VIALinjectable · injectionEUGIA PHARMA SPECLTSPrescription23 May 2011
PIPERACILLIN AND TAZOBACTAMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL; EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL; EQ 4GM BASE/VIAL;EQ 500MG BASE/VIALinjectable · injectionACS DOBFAR SPAPrescription31 May 2011
PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALinjectable · injectionACS DOBFAR SPAPrescription31 May 2011
PIPERACILLIN AND TAZOBACTAMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL; EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL; EQ 4GM BASE/VIAL;EQ 500MG BASE/VIALinjectable · injectionONESOURCE SPECIALTYPrescription15 Aug 2014
PIPERACILLIN AND TAZOBACTAMEQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL; EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALinjectable · injectionSANDOZPrescription29 Oct 2014
PIPERACILLIN AND TAZOBACTAMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL; EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL; EQ 4GM BASE/VIAL;EQ 500MG BASE/VIALinjectable · injectionMILLA PHARMSPrescription13 Jan 2017
PIPERACILLIN AND TAZOBACTAMEQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL; EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALinjectable · injectionMILLA PHARMSPrescription13 Jan 2017
PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALinjectable · injectionAPOTEXPrescription17 Mar 2017
PIPERACILLIN AND TAZOBACTAMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL; EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL; EQ 4GM BASE/VIAL;EQ 500MG BASE/VIALinjectable · injectionAPOTEXPrescription22 Mar 2017
PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALinjectable · injectionFRESENIUS KABIPrescription11 May 2018
PIPERACILLIN AND TAZOBACTAMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL; EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL; EQ 4GM BASE/VIAL;EQ 500MG BASE/VIALinjectable · injectionFRESENIUS KABIPrescription18 May 2018
PIPERACILLIN AND TAZOBACTAMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL; EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL; EQ 4GM BASE/VIAL;EQ 500MG BASE/VIALinjectable · injectionSHANDONGPrescription10 Aug 2018
PIPERACILLIN AND TAZOBACTAMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL; EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL; EQ 4GM BASE/VIAL;EQ 500MG BASE/VIALinjectable · injectionSAGENT PHARMS INCPrescription16 Feb 2021
PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALinjectable · injectionSAGENT PHARMS INCPrescription16 Feb 2021
PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALinjectable · injectionSHANDONGPrescription14 Apr 2023
PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINEREQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL; EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL; EQ 4GM BASE/VIAL;EQ 500MG BASE/VIALpowder · intravenousB BRAUN MEDICALPrescription3 Apr 2025
ZOSYNEQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**injectable · injectionWYETH PHARMSDiscontinued22 Oct 1993
PIPERACILLIN AND TAZOBACTAMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL; EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL; EQ 4GM BASE/VIAL;EQ 500MG BASE/VIALinjectable · injectionHOSPIRA INCDiscontinued15 Sep 2009
PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALinjectable · injectionHOSPIRA INCDiscontinued15 Sep 2009
PIPERACILLIN AND TAZOBACTAMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL; EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL; EQ 4GM BASE/VIAL;EQ 500MG BASE/VIALinjectable · injectionSANDOZDiscontinued21 Oct 2010
PIPERACILLIN AND TAZOBACTAMEQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIALinjectable · injectionFRESENIUS KABI USADiscontinued11 May 2018
PIPERACILLIN AND TAZOBACTAMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL; EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL; EQ 4GM BASE/VIAL;EQ 500MG BASE/VIALinjectable · injectionASTRALDiscontinued29 Jul 2019
PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL; EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIALinjectable · injectionEUGIA PHARMADiscontinued12 Oct 2023

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
PIPERACILLIN AND TAZOBACTAM FOR INJECTION022996232 G / VIAL; 0.25 G / VIALPOWDER FOR SOLUTION · INTRAVENOUSSANDOZ CANADA INCORPORATED
PIPERACILLIN AND TAZOBACTAM FOR INJECTION022996313 G / VIAL; 0.375 G / VIALPOWDER FOR SOLUTION · INTRAVENOUSSANDOZ CANADA INCORPORATED
PIPERACILLIN AND TAZOBACTAM FOR INJECTION022996584 G / VIAL; 0.5 G / VIALPOWDER FOR SOLUTION · INTRAVENOUSSANDOZ CANADA INCORPORATED
PIPERACILLIN AND TAZOBACTAM FOR INJECTION023305471.5 G / VIAL; 12 G / VIALPOWDER FOR SOLUTION · INTRAVENOUSSANDOZ CANADA INCORPORATED
PIPERACILLIN AND TAZOBACTAM FOR INJECTION023626192.00 G / VIAL; 0.25 G / VIALPOWDER FOR SOLUTION · INTRAVENOUSSTERIMAX INC
PIPERACILLIN AND TAZOBACTAM FOR INJECTION023626273.000 G / VIAL; 0.375 G / VIALPOWDER FOR SOLUTION · INTRAVENOUSSTERIMAX INC
PIPERACILLIN AND TAZOBACTAM FOR INJECTION023626350.5 G / VIAL; 4.0 G / VIALPOWDER FOR SOLUTION · INTRAVENOUSSTERIMAX INC
PIPERACILLIN AND TAZOBACTAM FOR INJECTION023777481.5 G / VIAL; 12 G / VIALPOWDER FOR SOLUTION · INTRAVENOUSSTERIMAX INC
PIPERACILLIN AND TAZOBACTAM FOR INJECTION024020682 G / VIAL; 0.25 G / VIALPOWDER FOR SOLUTION · INTRAVENOUSAURO PHARMA INC
PIPERACILLIN AND TAZOBACTAM FOR INJECTION024020760.375 G / VIAL; 3 G / VIALPOWDER FOR SOLUTION · INTRAVENOUSAURO PHARMA INC
PIPERACILLIN AND TAZOBACTAM FOR INJECTION024020844 G / VIAL; 0.5 G / VIALPOWDER FOR SOLUTION · INTRAVENOUSAURO PHARMA INC
PIPERACILLIN AND TAZOBACTAM FOR INJECTION0243913136 G / VIAL; 4.5 G / VIALPOWDER FOR SOLUTION · INTRAVENOUSSTERIMAX INC
PIPERACILLIN AND TAZOBACTAM FOR INJECTION025215394.5 G / VIAL; 36 G / VIALPOWDER FOR SOLUTION · INTRAVENOUSSANDOZ CANADA INCORPORATED
PIPERACILLIN AND TAZOBACTAM FOR INJECTION025286732 G / VIAL; 0.25 G / VIALPOWDER FOR SOLUTION · INTRAVENOUSEUGIA PHARMA INC.
PIPERACILLIN AND TAZOBACTAM FOR INJECTION025287030.375 G / VIAL; 3 G / VIALPOWDER FOR SOLUTION · INTRAVENOUSEUGIA PHARMA INC.
PIPERACILLIN AND TAZOBACTAM FOR INJECTION025287110.5 G / VIAL; 4 G / VIALPOWDER FOR SOLUTION · INTRAVENOUSEUGIA PHARMA INC.

WHO WHO Model List of Essential Medicines (2025)

  • 6.2.2. Watch group antibiotics · core
    First choice: Other specified pneumonia (Hospital-acquired pneumonia); First choice: Neutropaenia (high-risk); First choice: Peritoneal abscess (severe); First choice: Peritonitis (severe); First choice: Necrotising fasciitis (co-prescribed with clindamycin)
    Parenteral > General injections > IV: 2 g (as sodium salt) + 250 mg (as sodium salt) powder for injection; 4 g (as sodium salt) + 500 mg (as sodium salt) powder for injection

Components

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.