Regulatory PathRegulatory requirements compared

Active substance

Benzylpenicillin

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
PENICILLIN G INJ 1 MILLION IU1,000,000 IUPowder for solution for injection/infusion · Intramuscular use1 VialSAR 2.10NCE · PrescriptionSANDOZWithdrawn by MAH · Not Marketed
PENICILLIN-G SOD 500000 IU VIAL500000 IUPowder for solution for injection/infusion · Intramuscular use1 VialSAR 1.75NCE · PrescriptionSANDOZWithdrawn by MAH · Not Marketed

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

ProductStrengthForm · routeApplicantStatusFirst approved
PFIZERPEN5,000,000 UNITS/VIAL; 20,000,000 UNITS/VIALinjectable · injectionPFIZERPrescription30 Aug 1968
PENICILLIN G POTASSIUM IN PLASTIC CONTAINER20,000 UNITS/ML; 40,000 UNITS/ML; 60,000 UNITS/MLinjectable · injectionBAXTER HLTHCAREPrescription25 Jun 1990
PENICILLIN G SODIUM5,000,000 UNITS/VIALinjectable · intramuscular, intravenousSANDOZPrescription26 Feb 2001
PENICILLIN G POTASSIUM5,000,000 UNITS/VIAL; 20,000,000 UNITS/VIALinjectable · injectionSANDOZPrescription30 Aug 2002
PENICILLIN G POTASSIUM1,000,000 UNITS/VIAL; 5,000,000 UNITS/VIAL; 20,000,000 UNITS/VIALinjectable · injectionHQ SPECLT PHARMAPrescription23 Jul 2009
PENICILLIN G POTASSIUM5,000,000 UNITS/VIAL; 20,000,000 UNITS/VIALinjectable · injectionACS DOBFAR SPAPrescription18 Aug 2009
PENICILLIN G POTASSIUM5,000,000 UNITS/VIAL; 20,000,000 UNITS/VIALinjectable · injectionACS DOBFAR SPAPrescription26 Oct 2018
PENICILLIN G POTASSIUM20,000,000 UNITS/VIALinjectable · injectionPFIZERDiscontinued6 Feb 1947
PFIZERPEN G50,000 UNITS; 100,000 UNITS; 200,000 UNITS; 250,000 UNITS; 400,000 UNITS; 800,000 UNITStablet · oralPFIZERDiscontinued2 Mar 1948
PFIZERPEN G400,000 UNITS/5MLfor solution · oralPFIZERDiscontinued13 Sep 1951
PENICILLIN200,000 UNITS/5ML; 400,000 UNITS/5MLfor solution · oralTEVADiscontinued27 May 1964
PENICILLIN-2250,000 UNITS/5MLfor solution · oralTEVADiscontinued27 May 1964
PFIZERPEN1,000,000 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**injectable · injectionPFIZERDiscontinued30 Aug 1968
PENICILLIN G POTASSIUM200,000 UNITS; 250,000 UNITS; 400,000 UNITS; 500,000 UNITStablet · oralTEVADiscontinued26 Jun 1979
PENICILLIN G POTASSIUM200,000 UNITS; 250,000 UNITS; 400,000 UNITS; 800,000 UNITS; 500,000 UNITStablet · oralMYLANDiscontinued10 Mar 1980
PENICILLIN G POTASSIUM1,000,000 UNITS/VIAL; 5,000,000 UNITS/VIAL; 10,000,000 UNITS/VIAL; 20,000,000 UNITS/VIALinjectable · injectionWATSON LABS INCDiscontinued13 Sep 1988
PENICILLIN G SODIUM5,000,000 UNITS/VIALinjectable · intramuscular, intravenousWATSON LABS INCDiscontinued13 Sep 1988
PENICILLIN G POTASSIUM1,000,000 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**injectable · injectionSANDOZDiscontinued30 Aug 2002
PENICILLIN G POTASSIUM400,000 UNITStablet · oralIVAX SUB TEVA PHARMSDiscontinued
PENICILLIN G POTASSIUM1,000,000 UNITS/VIAL; 20,000,000 UNITS/VIAL; 5,000,000 UNITS/VIAL; 10,000,000 UNITS/VIALinjectable · injectionAPOTHECONDiscontinued
PENICILLIN G POTASSIUM5,000,000 UNITS/VIAL; 1,000,000 UNITS/VIAL; 500,000 UNITS/VIAL; 200,000 UNITS/VIAL; 20,000,000 UNITS/VIALinjectable · injectionLILLYDiscontinued
PENICILLIN G POTASSIUM250,000 UNITStablet · oralAPOTHECONDiscontinued
PENTIDS '400'400,000 UNITStablet · oralAPOTHECONDiscontinued
PENTIDS '800'800,000 UNITStablet · oralAPOTHECONDiscontinued
PENICILLIN G POTASSIUM250,000 UNITStablet · oralLILLYDiscontinued

16 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
PENICILLIN G SODIUM FOR INJECTION, USP022202611000000 UNIT / VIALPOWDER FOR SOLUTION · INTRAVENOUS; INTRAMUSCULARFRESENIUS KABI CANADA LTD
PENICILLIN G SODIUM FOR INJECTION, USP022202885000000 UNIT / VIALPOWDER FOR SOLUTION · INTRAMUSCULAR; INTRAVENOUSFRESENIUS KABI CANADA LTD
PENICILLIN G SODIUM FOR INJECTION, USP0222029610000000 UNIT / VIALPOWDER FOR SOLUTION · INTRAVENOUS; INTRAMUSCULARFRESENIUS KABI CANADA LTD

WHO WHO Model List of Essential Medicines (2025)

  • 6.2.1. Access group antibiotics · core
    First choice: Bacterial pneumonia (Community-acquired pneumonia - severe) [children]; First choice: Acute malnutrition in infants, children or adolescents (complicated) [children]; First choice: Congenital syphilis [children]; First choice: Syphilis; First choice: Sepsis without septic shock (co-prescribed with gentamicin); Second choice: Bacterial meningitis
    Parenteral > General injections > unspecified: 600 mg in vial powder for injection (=1 million IU as sodium or potassium salt) (EMLc); 3 g in vial powder for injection (=5 million IU as sodium or potassium salt) (EMLc) | Parenteral > General injections > unspecified: 600 mg in vial powder for injection (=1 million IU as sodium or potassium salt); 3 g in vial powder for injection (=5 million IU as sodium or potassium salt)
  • 5.1.6.1. Medicines for bacterial central nervous system infections · core
    Second choice: Bacterial meningitis
    Parenteral > General injections > unspecified: 600 mg in vial powder for injection (=1 million IU as sodium or potassium salt); 3 g in vial powder for injection (=5 million IU as sodium or potassium salt)

Combinations containing Benzylpenicillin

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.