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    NDC 66302-0363-84 Orenitram Details

    Orenitram

    Orenitram is a KIT in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by United Therapeutics Corporation. The primary component is .

    Product Information

    NDC 66302-0363
    Product ID 66302-363_e9babc9a-fe4f-4da1-9110-4425b17f2381
    Associated GPIs
    GCN Sequence Number 084442
    GCN Sequence Number Description treprostinil diolamine TB ER DSPK 0.125-1 MG ORAL
    HIC3 B1C
    HIC3 Description PULMONARY ANTIHYPERTENSIVES, PROSTACYCLIN-TYPE
    GCN 53747
    HICL Sequence Number 040827
    HICL Sequence Number Description TREPROSTINIL DIOLAMINE
    Brand/Generic Brand
    Proprietary Name Orenitram
    Proprietary Name Suffix n/a
    Non-Proprietary Name treprostinil
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form KIT
    Route n/a
    Active Ingredient Strength n/a
    Active Ingredient Units n/a
    Substance Name n/a
    Labeler Name United Therapeutics Corporation
    Pharmaceutical Class n/a
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA203496
    Listing Certified Through 2024-12-31

    Package

    NDC 66302-0363-84 (66302036384)

    NDC Package Code 66302-363-84
    Billing NDC 66302036384
    Package 1 KIT in 1 PACKAGE (66302-363-84) * 42 TABLET, EXTENDED RELEASE in 1 BLISTER PACK * 84 TABLET, EXTENDED RELEASE in 1 BLISTER PACK * 126 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
    Marketing Start Date 2023-02-14
    NDC Exclude Flag N
    Pricing Information N/A