Prescription medicine
Benzylpenicilloyl polylysine Brand names: Pre-Pen
Benzylpenicilloyl polylysine (Pre-Pen) is a prescription medicine with an FDA approval on record since 1974. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the benzylpenicilloyl polylysine FDA label on DailyMed (effective January 12, 2024, ALK-ABELLO, INC.); the BLA 50114 record on Drugs@FDA; every benzylpenicilloyl polylysine label on DailyMed.
Highlights of the record
FDA label of January 12, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usagePRE-PEN is indicated for the assessment of sensitization to penicillin (benzylpenicillin or penicillin G) in patients suspected to have clinical penicillin hypersensitivity.
Forms and strengths
- 0.25ml
Injection.
On the market
- Earliest approval on file
- July 25, 1974 Pre-Pen, Allerquest; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 34 through July 30, 2026
What is benzylpenicilloyl polylysine used for?
From the label: indications and usagePRE-PEN is indicated for the assessment of sensitization to penicillin (benzylpenicillin or penicillin G) in patients suspected to have clinical penicillin hypersensitivity. A negative skin test to PRE-PEN is associated with an incidence of immediate allergic reactions of less than 5% after the administration of therapeutic penicillin, whereas the incidence may be more than 50% in a history-positive patient with a positive skin test to PRE-PEN. These allergic reactions are predominantly dermatologic. Whether a negative skin test to PRE-PEN predicts a lower risk of anaphylaxis is not established. […]
Source: FDA drug label (PRE-PEN), BLA050114 (Allerquest), as published by ALK-ABELLO, INC., effective January 12, 2024 (SPL set 2fbcc40c-f102-4abe-bce5-a93de95874fe), via openFDA; the full label on DailyMed
Is there a generic for benzylpenicilloyl polylysine (Pre-Pen)?
No generic benzylpenicilloyl polylysine is approved (Drugs@FDA, October 8, 2026).
- 1974 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for benzylpenicilloyl polylysine?
The FDA Adverse Event Reporting System holds 34 reports that list benzylpenicilloyl polylysine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 1 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Benzylpenicilloyl polylysine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other