TheraRadar
Data updated: May 26, 2026

PENICILLIN G PROCAINE

Infectious Disease Approved 1948-04-26

PENICILLIN G PROCAINE is indicated for the treatment of Upper Respiratory Tract Infection; Scarlet Fever; Erysipelas; Skin and Soft Tissue Infection; Pneumonia; Otitis Media.

Source: FDA Label • CONSOLIDATED PHARM
2
Indications
--
Phase 3 Trials
78
Years on Market

Details

Status
Discontinued
First Approved
1948-04-26
Routes
INJECTION
Dosage Forms
INJECTABLE

PENICILLIN G PROCAINE Approval History

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Original
New Indication
New Form
Label Update
48 FDA actions from 1948 to 2025
Aug 2025 SUPPL
Label · Labeling
Jun 2024 SUPPL
Label · Labeling
Jan 2019 SUPPL
Label · Labeling

What PENICILLIN G PROCAINE Treats

6 indications

PENICILLIN G PROCAINE is approved for 6 conditions since its original approval in 1948. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Upper Respiratory Tract Infection
  • Scarlet Fever
  • Erysipelas
  • Skin and Soft Tissue Infection
  • Pneumonia
  • Otitis Media
Source: FDA Label

PENICILLIN G PROCAINE Boxed Warning

NOT FOR INTRAVENOUS USE. DO NOT INJECT INTRAVENOUSLY OR ADMIX WITH OTHER INTRAVENOUS SOLUTIONS. THERE HAVE BEEN REPORTS OF INADVERTENT INTRAVENOUS ADMINISTRATION OF PENICILLIN G BENZATHINE WHICH HAS BEEN ASSOCIATED WITH CARDIORESPIRATORY ARREST AND DEATH. Prior to administration of this drug, carefully read the WARNINGS , ADVERSE REACTIONS , and DOSAGE AND ADMINISTRATION sections of the labeling....

PENICILLIN G PROCAINE 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 PENICILLIN G PROCAINE

3 of 20

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

BICILLIN C-R 900/300
PENICILLIN G BENZATHINE
6 shared
KING PHARMS LLC
Shared indications:
Upper Respiratory Tract InfectionScarlet FeverErysipelas +3 more
ACHROMYCIN V
TETRACYCLINE HYDROCHLORIDE
2 shared
LEDERLE
Shared indications:
Upper Respiratory Tract InfectionSkin and Soft Tissue Infection
PENICILLIN-VK
PENICILLIN V POTASSIUM
2 shared
Teva
Shared indications:
Scarlet FeverErysipelas
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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.

PENICILLIN G PROCAINE FDA Label Details

Indications & Usage

PENICILLIN G PROCAINE is indicated for the treatment of Upper Respiratory Tract Infection; Scarlet Fever; Erysipelas; Skin and Soft Tissue Infection; Pneumonia; Otitis Media.

⚠️ BOXED WARNING

WARNING: NOT FOR INTRAVENOUS USE. DO NOT INJECT INTRAVENOUSLY OR ADMIX WITH OTHER INTRAVENOUS SOLUTIONS. THERE HAVE BEEN REPORTS OF INADVERTENT INTRAVENOUS ADMINISTRATION OF PENICILLIN G BENZATHINE WHICH HAS BEEN ASSOCIATED WITH CARDIORESPIRATORY ARREST AND DEATH. Prior to administration of this dru...

Looking for the branded version?

DURACILLIN A.S.

Full clinical data, patents, trials, and competitive landscape for penicillin g procaine.

See DURACILLIN A.S.

Data Sources

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