PRE-PEN
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- PRE-PEN
- Generic name
- BENZYLPENICILLOYL POLYLYSINE
- Manufacturer
- ALK-ABELLO, INC.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 2fbcc40c-f102-4abe-bce5-a93de95874fe
- SPL ID
- 630c84ab-994f-4686-99bc-deaf6db7cff2
- Version
- 5
- Effective date
- 2024-01-12
- Source export date
- 2026-11-06
- Source partition
- 8
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-11-06/9d5577a314a25811fefbde4767c9b37f3913d9a65fdc458c6336b5aed532339e/drug-label-0008-of-0014.json.zip
- Source manifest SHA-256
- 8dff71fbef1291eb7711013e9a3a06194930757924a8946ae3034107a98d9463
- Import run
- 20261106T075659Z
- Imported at
- 2026-11-06 08:51:40
| Harmonized routes |
|---|
| INTRADERMAL, SUBCUTANEOUS |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application applno | BLA | 050114 | derived:openfda.application_number |
| application number | BLA050114 | openfda.application_number | |
| brand name | PRE-PEN | openfda.brand_name | |
| generic name | BENZYLPENICILLOYL POLYLYSINE | openfda.generic_name | |
| manufacturer name | ALK-ABELLO, INC. | openfda.manufacturer_name | |
| ndc | package | 49471-001-05 | openfda.package_ndc |
| ndc | product | 49471-001 | openfda.product_ndc |
| ndc11 | package | 49471000105 | derived:openfda.package_ndc |
| spl id | 630c84ab-994f-4686-99bc-deaf6db7cff2 | id | |
| spl set id | 2fbcc40c-f102-4abe-bce5-a93de95874fe | set_id | |
| unii | 76479814OY | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS: The risk of sensitization to repeated skin testing with PRE-PEN is not established. Rarely, a systemic allergic reaction including anaphylaxis (see below) may follow a skin test with PRE-PEN. To decrease the risk of a systemic allergic reaction, puncture skin testing should be performed first. Intradermal skin testing should be performed only if the puncture test is entirely negative.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS: Occasionally, patients may develop an intense local inflammatory response at the skin test site. Rarely, patients will develop a systemic allergic reaction, manifested by generalized erythema, pruritus, angioedema, urticaria, dyspnea, hypotension, and anaphylaxis. The usual methods of treating a skin test antigen-induced reaction — the applications of a venous occlusion tourniquet proximal to the skin test site and administration of epinephrine are recommended. The patient should be kept under observation for several hours.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.