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    NDC 50228-0117-05 Rosuvastatin 10 mg/1 Details

    Rosuvastatin 10 mg/1

    Rosuvastatin is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by ScieGen Pharmaceuticals, Inc.. The primary component is ROSUVASTATIN.

    Product Information

    NDC 50228-0117
    Product ID 50228-117_09845f21-f02e-34b2-e063-6394a90a7677
    Associated GPIs
    GCN Sequence Number 051784
    GCN Sequence Number Description rosuvastatin calcium TABLET 10 MG ORAL
    HIC3 M4D
    HIC3 Description ANTIHYPERLIPIDEMIC-HMGCOA REDUCTASE INHIB(STATINS)
    GCN 19153
    HICL Sequence Number 025009
    HICL Sequence Number Description ROSUVASTATIN CALCIUM
    Brand/Generic Generic
    Proprietary Name Rosuvastatin
    Proprietary Name Suffix n/a
    Non-Proprietary Name Rosuvastatin
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 10
    Active Ingredient Units mg/1
    Substance Name ROSUVASTATIN
    Labeler Name ScieGen Pharmaceuticals, Inc.
    Pharmaceutical Class HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA206381
    Listing Certified Through 2024-12-31

    Package

    NDC 50228-0117-05 (50228011705)

    NDC Package Code 50228-117-05
    Billing NDC 50228011705
    Package 500 TABLET, FILM COATED in 1 BOTTLE (50228-117-05)
    Marketing Start Date 2023-09-07
    NDC Exclude Flag N
    Pricing Information N/A