Medicine
Pre-pen 60 umol/0.25 mL injection
Pre-pen 60 umol/0.25 mL injection is a prescription medicine containing Benzylpenicilloyl polylysine for intradermal, subcutaneous use, marketed by ALK-Abello, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
Store PRE-PEN refrigerated at 2°C to 8°C (36°F to 46°F). If removed from…
Key facts
- Active ingredient (INN)
- Benzylpenicilloyl polylysine
- Brand
- Pre-pen
- Strength
- 60 umol/0.25 mL
- Dosage form
- Injection
- Route
- Intradermal, subcutaneous
- Packs
- 5 ampules
- Marketing authorisation holder
- ALK-Abello
- Manufacturer
- ALK-Abello
- Origin register
- US FDA, United States
- Storage
- Store PRE-PEN refrigerated at 2°C to 8°C (36°F to 46°F). If removed from refrigerator, PRE-PEN should be kept at room temperature up to 25°C (77°F) and must be used within 24 hours.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 25 July 1974
- Identifiers
- DailyMed set ID 2fbcc40c-f102-4abe-bce5-a93de95874feNDC 49471-001Application BLA050114
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 5 ampule in 1 carton / .25 mL in 1 ampule | 49471-001-05 | Alk-Abello | 25 July 1974 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 25 July 1974 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Clinical summary
Benzylpenicilloyl polylysine is a prescription medicine indicated for the assessment of sensitization to penicillin (benzylpenicillin or penicillin G) in patients suspected to have clinical penicillin hypersensitivity. It is available as injection for intradermal and subcutaneous use. MedsAcross supplies Benzylpenicilloyl polylysine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about Benzylpenicilloyl polylysineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- PRE-PEN prescribing information (Alk-Abello) · U.S. National Library of Medicine, DailyMed
Need Pre-pen 60 umol/0.25 mL injection for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.