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    NDC 00310-3200-04 ANDEXXA 200 mg/20mL Details

    ANDEXXA 200 mg/20mL

    ANDEXXA is a INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by AstraZeneca Pharmaceuticals LP. The primary component is ANDEXANET ALFA.

    Product Information

    NDC 00310-3200
    Product ID 0310-3200_b603803b-80eb-4097-aa98-3bd692bce171
    Associated GPIs
    GCN Sequence Number 079424
    GCN Sequence Number Description factor Xa,inactivated-zhzo VIAL 200 MG INTRAVEN
    HIC3 M9Y
    HIC3 Description ANTICOAGULANT REVERSAL AGENT FOR FACTOR XA INHIB.
    GCN 45915
    HICL Sequence Number 044899
    HICL Sequence Number Description COAGULATION FACTOR XA,INACTIVATED-ZHZO (RECOMBINANT)
    Brand/Generic Brand
    Proprietary Name ANDEXXA
    Proprietary Name Suffix n/a
    Non-Proprietary Name andexanet alfa
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
    Route INTRAVENOUS
    Active Ingredient Strength 200
    Active Ingredient Units mg/20mL
    Substance Name ANDEXANET ALFA
    Labeler Name AstraZeneca Pharmaceuticals LP
    Pharmaceutical Class n/a
    DEA Schedule n/a
    Marketing Category BLA
    Application Number BLA125586
    Listing Certified Through 2024-12-31

    Package

    NDC 00310-3200-04 (00310320004)

    NDC Package Code 0310-3200-04
    Billing NDC 00310320004
    Package 4 VIAL, SINGLE-USE in 1 CARTON (0310-3200-04) / 20 mL in 1 VIAL, SINGLE-USE (0310-3200-01)
    Marketing Start Date 2022-07-12
    NDC Exclude Flag N
    Pricing Information N/A