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    NDC 33342-0384-10 Silodosin 4 mg/1 Details

    Silodosin 4 mg/1

    Silodosin is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Macleods Pharmaceuticals Limited. The primary component is SILODOSIN.

    Product Information

    NDC 33342-0384
    Product ID 33342-384_4a96f732-bbce-426f-9780-89115cac638b
    Associated GPIs 56852060000120
    GCN Sequence Number 064846
    GCN Sequence Number Description silodosin CAPSULE 4 MG ORAL
    HIC3 Q9B
    HIC3 Description BENIGN PROSTATIC HYPERTROPHY/MICTURITION AGENTS
    GCN 16857
    HICL Sequence Number 036119
    HICL Sequence Number Description SILODOSIN
    Brand/Generic Generic
    Proprietary Name Silodosin
    Proprietary Name Suffix n/a
    Non-Proprietary Name Silodosin
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form CAPSULE
    Route ORAL
    Active Ingredient Strength 4
    Active Ingredient Units mg/1
    Substance Name SILODOSIN
    Labeler Name Macleods Pharmaceuticals Limited
    Pharmaceutical Class Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA211166
    Listing Certified Through 2024-12-31

    Package

    NDC 33342-0384-10 (33342038410)

    NDC Package Code 33342-384-10
    Billing NDC 33342038410
    Package 90 CAPSULE in 1 BOTTLE (33342-384-10)
    Marketing Start Date 2018-12-03
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 58af9a98-b1a1-4f30-b535-6647f1effed4 Details

    Revised: 6/2022