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    NDC 54436-0012-04 Otrexup 12.5 mg/.4mL Details

    Otrexup 12.5 mg/.4mL

    Otrexup is a SUBCUTANEOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Antares Pharma, Inc.. The primary component is METHOTREXATE.

    Product Information

    NDC 54436-0012
    Product ID 54436-012_465ff14c-acdd-4ca2-81e3-7f07cc2fb2e4
    Associated GPIs 6625005000D518
    GCN Sequence Number 076329
    GCN Sequence Number Description methotrexate/PF AUTO INJCT 12.5MG/0.4 SUBCUT
    HIC3 S2N
    HIC3 Description ANTI-ARTHRITIC, FOLATE ANTAGONIST AGENTS
    GCN 41774
    HICL Sequence Number 040683
    HICL Sequence Number Description METHOTREXATE/PF
    Brand/Generic Brand
    Proprietary Name Otrexup
    Proprietary Name Suffix n/a
    Non-Proprietary Name methotrexate
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, SOLUTION
    Route SUBCUTANEOUS
    Active Ingredient Strength 12.5
    Active Ingredient Units mg/.4mL
    Substance Name METHOTREXATE
    Labeler Name Antares Pharma, Inc.
    Pharmaceutical Class Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA204824
    Listing Certified Through 2024-12-31

    Package

    NDC 54436-0012-04 (54436001204)

    NDC Package Code 54436-012-04
    Billing NDC 54436001204
    Package 4 SYRINGE in 1 CARTON (54436-012-04) / .4 mL in 1 SYRINGE (54436-012-02)
    Marketing Start Date 2016-03-24
    NDC Exclude Flag N
    Pricing Information N/A