Pre-pen Injection
NDC Package 49471-001-05

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Pre-pen (benzylpenicilloyl polylysine) injection is pREPEN is indicated for the assessment of sensitization to penicillin (benzylpenicillin or penicillin G) in patients suspected to have clinical penicillin hypersensitivity. This formulation utilizes a injection delivery system. Marketed by Alk-abello, Inc., this product is identified by NDC 49471-001 and is authorized under FDA application BLA050114.

Identification & Billing

NDC Package Code
49471-001-05
Package Description
5 AMPULE in 1 CARTON / .25 mL in 1 AMPULE
Product Code
49471-001
11-Digit Billing Format
49471000105
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Pre-pen
Non-Proprietary Name
Benzylpenicilloyl Polylysine
Substance Name
Benzylpenicilloyl Polylysine
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
  • Intradermal - Administration within the dermis.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
BENZYLPENICILLOYL POLYLYSINE 60 umol/.25mL
Usage Information
PREPEN 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 PREPEN 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 PREPEN. These allergic reactions are predominantly dermatologic. Whether a negative skin test to PREPEN predicts a lower risk of anaphylaxis is not established. Similarly, when deciding the risk of proposed penicillin treatment, there are not enough data at present to permit relative weighing in individual cases of a history of clinical penicillin hypersensitivity as compared to positive skin tests to PREPEN and/or minor penicillin determinants.

Regulatory & Marketing

Labeler Name
Alk-abello, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA050114
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
07-25-1974
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 49471-001-05 identifies a specific commercial package of 5 ampule in 1 carton / .25 ml in 1 ampule of Pre-pen, a human prescription drug labeled by Alk-abello, Inc.. This injection is formulated for intradermal; subcutaneous use and contains benzylpenicilloyl polylysine as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Alk-abello, Inc. on July 25, 1974. The current certification is valid through December 31, 2027.

How is this Alk-abello, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49471000105. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
49471-001-05
11-Digit CMS (5-4-2)
49471-0001-05

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.