Home NDC 49471-001-05 PRE-PEN
Product NDC 49471-001
Requested package NDC 49471-001-05
11-digit product format 494710001
Labeler code 49471
Product ID 49471-001_630c84ab-994f-4686-99bc-deaf6db7cff2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name benzylpenicilloyl polylysine
Dosage form INJECTION
Route INTRADERMAL; SUBCUTANEOUS
Labeler ALK-ABELLO, INC.
Application BLA050114
Marketing category BLA
Marketing start 1974-07-25
Substance BENZYLPENICILLOYL POLYLYSINE
Active strength 60 umol/.25mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 49471-001 49471-001-05 I Inactivated by FDA excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 49471-001 49471-001-05 I Inactivated by FDA excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base PRE-PEN
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZYLPENICILLOYL POLYLYSINE 60 umol/.25mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 76479814OY Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49471-001-05 PRE-PEN 0.25 mL in 1 AMPULE INJECTION 0.25 5 49471-001-05 PRE-PEN 5 in 1 CARTON INJECTION 5 5
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49471-001 PRE-PEN (BENZYLPENICILLOYL POLYLYSINE) INJECTION [ALLERQUEST LLC] 4 Current NDC, Legacy NDC, 2 package rows 20240415_2fbcc40c-f102-4abe-bce5-a93de95874fe.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 050114 Pre-Pen benzylpenicilloyl polylysine 351(a) Rx 2026-09-01
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 49471-001-05 49471000105 5 AMPULE in 1 CARTON (49471-001-05) / .25 mL in 1 AMPULE 5 ampule 1974-07-25 0000-00-00 No No Current