Search by Drug Name or NDC

    NDC 00781-3516-75 METHYLPREDNISOLONE ACETATE 80 mg/mL Details

    METHYLPREDNISOLONE ACETATE 80 mg/mL

    METHYLPREDNISOLONE ACETATE is a INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE INJECTION, SUSPENSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Sandoz Inc.. The primary component is METHYLPREDNISOLONE ACETATE.

    Product Information

    NDC 00781-3516
    Product ID 0781-3516_83d9f077-7a63-44d3-b86d-610ea0d83635
    Associated GPIs
    GCN Sequence Number 006725
    GCN Sequence Number Description methylprednisolone acetate VIAL 80 MG/ML INJECTION
    HIC3 P5A
    HIC3 Description GLUCOCORTICOIDS
    GCN 27006
    HICL Sequence Number 002875
    HICL Sequence Number Description METHYLPREDNISOLONE ACETATE
    Brand/Generic Generic
    Proprietary Name METHYLPREDNISOLONE ACETATE
    Proprietary Name Suffix n/a
    Non-Proprietary Name METHYLPREDNISOLONE ACETATE
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, SUSPENSION
    Route INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE
    Active Ingredient Strength 80
    Active Ingredient Units mg/mL
    Substance Name METHYLPREDNISOLONE ACETATE
    Labeler Name Sandoz Inc.
    Pharmaceutical Class Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA214870
    Listing Certified Through 2024-12-31

    Package

    NDC 00781-3516-75 (00781351675)

    NDC Package Code 0781-3516-75
    Billing NDC 00781351675
    Package 1 VIAL, MULTI-DOSE in 1 CARTON (0781-3516-75) / 5 mL in 1 VIAL, MULTI-DOSE
    Marketing Start Date 2023-02-08
    NDC Exclude Flag N
    Pricing Information N/A