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    NDC 00310-6540-85 BYDUREON BCise 2 mg/.85mL Details

    BYDUREON BCise 2 mg/.85mL

    BYDUREON BCise is a SUBCUTANEOUS INJECTION, SUSPENSION, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by AstraZeneca Pharmaceuticals LP. The primary component is EXENATIDE.

    Product Information

    NDC 00310-6540
    Product ID 0310-6540_745b5938-8834-45c4-a5f0-ba7c9e6628c6
    Associated GPIs 2717002000D420
    GCN Sequence Number 077890
    GCN Sequence Number Description exenatide microspheres AUTO INJCT 2MG/0.85ML SUBCUT
    HIC3 C4I
    HIC3 Description ANTIHYPERGLY,INCRETIN MIMETIC(GLP-1 RECEP.AGONIST)
    GCN 44039
    HICL Sequence Number 038451
    HICL Sequence Number Description EXENATIDE MICROSPHERES
    Brand/Generic Brand
    Proprietary Name BYDUREON BCise
    Proprietary Name Suffix n/a
    Non-Proprietary Name exenatide
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, SUSPENSION, EXTENDED RELEASE
    Route SUBCUTANEOUS
    Active Ingredient Strength 2
    Active Ingredient Units mg/.85mL
    Substance Name EXENATIDE
    Labeler Name AstraZeneca Pharmaceuticals LP
    Pharmaceutical Class GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA209210
    Listing Certified Through 2024-12-31

    Package

    NDC 00310-6540-85 (00310654085)

    NDC Package Code 0310-6540-85
    Billing NDC 00310654085
    Package 1 CARTRIDGE in 1 CARTON (0310-6540-85) / .85 mL in 1 CARTRIDGE
    Marketing Start Date 2017-12-01
    NDC Exclude Flag N
    Pricing Information N/A