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    NDC 00310-6615-02 SymlinPen 1000 ug/mL Details

    SymlinPen 1000 ug/mL

    SymlinPen is a SUBCUTANEOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by AstraZeneca Pharmaceuticals LP. The primary component is PRAMLINTIDE ACETATE.

    Product Information

    NDC 00310-6615
    Product ID 0310-6615_d75a39a9-b344-4e60-9d6f-c72df2c8e91d
    Associated GPIs 2715005010D220
    GCN Sequence Number 063804
    GCN Sequence Number Description pramlintide acetate PEN INJCTR 1500/1.5ML SUBCUT
    HIC3 C4H
    HIC3 Description ANTIHYPERGLYCEMIC, AMYLIN ANALOG-TYPE
    GCN 99514
    HICL Sequence Number 032805
    HICL Sequence Number Description PRAMLINTIDE ACETATE
    Brand/Generic Brand
    Proprietary Name SymlinPen
    Proprietary Name Suffix n/a
    Non-Proprietary Name pramlintide acetate
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION
    Route SUBCUTANEOUS
    Active Ingredient Strength 1000
    Active Ingredient Units ug/mL
    Substance Name PRAMLINTIDE ACETATE
    Labeler Name AstraZeneca Pharmaceuticals LP
    Pharmaceutical Class Amylin Agonists [MoA], Amylin Analog [EPC]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA021332
    Listing Certified Through 2023-12-31

    Package

    NDC 00310-6615-02 (00310661502)

    NDC Package Code 0310-6615-02
    Billing NDC 00310661502
    Package 2 CARTRIDGE in 1 CARTON (0310-6615-02) / 1.5 mL in 1 CARTRIDGE
    Marketing Start Date 2015-02-02
    NDC Exclude Flag N
    Pricing Information N/A