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    NDC 59767-0008-99 PERTZYE 30250; 8000; 28750 [USP'U]/1; [USP'U]/1; [USP'U]/1 Details

    PERTZYE 30250; 8000; 28750 [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 59767-0008
    Product ID 59767-008_6b6ec566-325a-4038-8f90-8c02e617ad06
    Associated GPIs 51200024006725
    GCN Sequence Number 069299
    GCN Sequence Number Description lipase/protease/amylase CAPSULE DR 8K-28.75K ORAL
    HIC3 D8A
    HIC3 Description PANCREATIC ENZYMES
    GCN 32298
    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 30250; 8000; 28750
    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 59767-0008-99 (59767000899)

    NDC Package Code 59767-008-99
    Billing NDC 59767000899
    Package 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59767-008-99)
    Marketing Start Date 2012-05-17
    NDC Exclude Flag N
    Pricing Information N/A