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  5. NDC Package Code: 49471-001-05 Pre-pen

NDC Package 49471-001-05 Pre-pen

Benzylpenicilloyl Polylysine Injection Intradermal; Subcutaneous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
49471-001-05
Package Description:
5 AMPULE in 1 CARTON / .25 mL in 1 AMPULE
Product Code:
49471-001
Proprietary Name:
Pre-pen
Non-Proprietary Name:
Benzylpenicilloyl Polylysine
Substance Name:
Benzylpenicilloyl Polylysine
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.
11-Digit NDC Billing Format:
49471000105
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Product Type:
Human Prescription Drug
Labeler Name:
Allerquest Llc
Dosage Form:
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route(s):
  • Intradermal - Administration within the dermis.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
    • Active Ingredient(s):
  • BENZYLPENICILLOYL POLYLYSINE 60 umol/.25mL
    • Sample Package:
    No
    FDA Application Number:
    BLA050114
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    07-25-1974
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 49471-001-05?

    The NDC Packaged Code 49471-001-05 is assigned to a package of 5 ampule in 1 carton / .25 ml in 1 ampule of Pre-pen, a human prescription drug labeled by Allerquest Llc. The product's dosage form is injection and is administered via intradermal; subcutaneous form.

    Is NDC 49471-001 included in the NDC Directory?

    Yes, Pre-pen with product code 49471-001 is active and included in the NDC Directory. The product was first marketed by Allerquest Llc on July 25, 1974 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 49471-001-05?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 49471-001-05?

    The 11-digit format is 49471000105. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-249471-001-055-4-249471-0001-05