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    NDC 55513-0283-10 EPOGEN 10000 [iU]/mL Details

    EPOGEN 10000 [iU]/mL

    EPOGEN is a INTRAVENOUS; SUBCUTANEOUS SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amgen Inc. The primary component is EPOETIN.

    Product Information

    NDC 55513-0283
    Product ID 55513-283_24d7c973-9b2d-4b32-baf5-0bcde9ce4c9b
    Associated GPIs 82401020002040
    GCN Sequence Number 058592
    GCN Sequence Number Description epoetin alfa VIAL 20000/2ML INJECTION
    HIC3 N1B
    HIC3 Description ERYTHROPOIESIS-STIMULATING AGENTS
    GCN 24059
    HICL Sequence Number 004553
    HICL Sequence Number Description EPOETIN ALFA
    Brand/Generic Brand
    Proprietary Name EPOGEN
    Proprietary Name Suffix n/a
    Non-Proprietary Name epoetin alfa
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form SOLUTION
    Route INTRAVENOUS; SUBCUTANEOUS
    Active Ingredient Strength 10000
    Active Ingredient Units [iU]/mL
    Substance Name EPOETIN
    Labeler Name Amgen Inc
    Pharmaceutical Class Erythropoiesis-stimulating Agent [EPC], Erythropoietin [CS], Increased Erythroid Cell Production [PE]
    DEA Schedule n/a
    Marketing Category BLA
    Application Number BLA103234
    Listing Certified Through 2024-12-31

    Package

    NDC 55513-0283-10 (55513028310)

    NDC Package Code 55513-283-10
    Billing NDC 55513028310
    Package 10 VIAL in 1 PACKAGE (55513-283-10) / 2 mL in 1 VIAL (55513-283-01)
    Marketing Start Date 1994-12-05
    NDC Exclude Flag N
    Pricing Information N/A