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    NDC 49471-0001-05 PRE-PEN 60 umol/.25mL Details

    PRE-PEN 60 umol/.25mL

    PRE-PEN is a INTRADERMAL; SUBCUTANEOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by AllerQuest LLC. The primary component is BENZYLPENICILLOYL POLYLYSINE.

    Product Information

    NDC 49471-0001
    Product ID 49471-001_2a9d7bbb-2cf1-4043-ae71-b90ebb923e2c
    Associated GPIs 94200020002005
    GCN Sequence Number 009707
    GCN Sequence Number Description benzylpenicilloyl polylysine AMPUL 0.25 ML INTRADERM
    HIC3 W7T
    HIC3 Description ANTIGENIC SKIN TESTS
    GCN 40550
    HICL Sequence Number 004233
    HICL Sequence Number Description BENZYLPENICILLOYL POLYLYSINE
    Brand/Generic Brand
    Proprietary Name PRE-PEN
    Proprietary Name Suffix n/a
    Non-Proprietary Name benzylpenicilloyl polylysine
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION
    Route INTRADERMAL; SUBCUTANEOUS
    Active Ingredient Strength 60
    Active Ingredient Units umol/.25mL
    Substance Name BENZYLPENICILLOYL POLYLYSINE
    Labeler Name AllerQuest LLC
    Pharmaceutical Class n/a
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA050114
    Listing Certified Through 2022-12-31

    Package

    NDC 49471-0001-05 (49471000105)

    NDC Package Code 49471-001-05
    Billing NDC 49471000105
    Package 5 AMPULE in 1 CARTON (49471-001-05) / .25 mL in 1 AMPULE
    Marketing Start Date 1974-07-25
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 2fbcc40c-f102-4abe-bce5-a93de95874fe Details

    Revised: 10/2018