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    NDC 73562-0113-10 Zenpep 14000; 3000; 10000 [USP'U]/1; [USP'U]/1; [USP'U]/1 Details

    Zenpep 14000; 3000; 10000 [USP'U]/1; [USP'U]/1; [USP'U]/1

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

    Product Information

    NDC 73562-0113
    Product ID 73562-113_ced6785c-6d88-45c2-ade0-0c21b60f39fa
    Associated GPIs 51200024006707
    GCN Sequence Number 078418
    GCN Sequence Number Description lipase/protease/amylase CAPSULE DR 3-10-14K ORAL
    HIC3 D8A
    HIC3 Description PANCREATIC ENZYMES
    GCN 44742
    HICL Sequence Number 008060
    HICL Sequence Number Description LIPASE/PROTEASE/AMYLASE
    Brand/Generic Brand
    Proprietary Name Zenpep
    Proprietary Name Suffix n/a
    Non-Proprietary Name pancrelipase lipase, pancrelipase protease, pancrelipase amylase
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form CAPSULE, DELAYED RELEASE
    Route ORAL
    Active Ingredient Strength 14000; 3000; 10000
    Active Ingredient Units [USP'U]/1; [USP'U]/1; [USP'U]/1
    Substance Name PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE
    Labeler Name Aimmune Therapeutics, Inc.
    Pharmaceutical Class n/a
    DEA Schedule n/a
    Marketing Category BLA
    Application Number BLA022210
    Listing Certified Through 2024-12-31

    Package

    NDC 73562-0113-10 (73562011310)

    NDC Package Code 73562-113-10
    Billing NDC 73562011310
    Package 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (73562-113-10)
    Marketing Start Date 2021-01-01
    NDC Exclude Flag N
    Pricing Information N/A