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    NDC 59767-0004-01 PERTZYE 15125; 4000; 14375 [USP'U]/1; [USP'U]/1; [USP'U]/1 Details

    PERTZYE 15125; 4000; 14375 [USP'U]/1; [USP'U]/1; [USP'U]/1

    PERTZYE is a ORAL CAPSULE, DELAYED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Digestive Care, Inc.. The primary component is PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE.

    Product Information

    NDC 59767-0004
    Product ID 59767-004_6b6ec566-325a-4038-8f90-8c02e617ad06
    Associated GPIs 51200024006709
    GCN Sequence Number 076831
    GCN Sequence Number Description lipase/protease/amylase CAPSULE DR 4000-14375 ORAL
    HIC3 D8A
    HIC3 Description PANCREATIC ENZYMES
    GCN 42634
    HICL Sequence Number 008060
    HICL Sequence Number Description LIPASE/PROTEASE/AMYLASE
    Brand/Generic Brand
    Proprietary Name PERTZYE
    Proprietary Name Suffix n/a
    Non-Proprietary Name pancrelipase
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form CAPSULE, DELAYED RELEASE
    Route ORAL
    Active Ingredient Strength 15125; 4000; 14375
    Active Ingredient Units [USP'U]/1; [USP'U]/1; [USP'U]/1
    Substance Name PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE
    Labeler Name Digestive Care, Inc.
    Pharmaceutical Class n/a
    DEA Schedule n/a
    Marketing Category BLA
    Application Number BLA022175
    Listing Certified Through 2024-12-31

    Package

    NDC 59767-0004-01 (59767000401)

    NDC Package Code 59767-004-01
    Billing NDC 59767000401
    Package 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59767-004-01)
    Marketing Start Date 2016-10-06
    NDC Exclude Flag N
    Pricing Information N/A