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    NDC 71205-0127-45 Terbinafine Hydrochloride 250 mg/1 Details

    Terbinafine Hydrochloride 250 mg/1

    Terbinafine Hydrochloride is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Proficient Rx LP. The primary component is TERBINAFINE HYDROCHLORIDE.

    Product Information

    NDC 71205-0127
    Product ID 71205-127_ebcef20e-0991-4cd7-b79c-0d1a29b90fed
    Associated GPIs 11000080100310
    GCN Sequence Number 018638
    GCN Sequence Number Description terbinafine HCl TABLET 250 MG ORAL
    HIC3 W3B
    HIC3 Description ANTIFUNGAL AGENTS
    GCN 60823
    HICL Sequence Number 007590
    HICL Sequence Number Description TERBINAFINE HCL
    Brand/Generic Generic
    Proprietary Name Terbinafine Hydrochloride
    Proprietary Name Suffix n/a
    Non-Proprietary Name Terbinafine Hydrochloride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 250
    Active Ingredient Units mg/1
    Substance Name TERBINAFINE HYDROCHLORIDE
    Labeler Name Proficient Rx LP
    Pharmaceutical Class Allylamine Antifungal [EPC], Allylamine [CS]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA077714
    Listing Certified Through 2024-12-31

    Package

    NDC 71205-0127-45 (71205012745)

    NDC Package Code 71205-127-45
    Billing NDC 71205012745
    Package 45 TABLET in 1 BOTTLE (71205-127-45)
    Marketing Start Date 2018-10-01
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 4e515f99-7fc7-4692-9105-8e87c27d4e79 Details

    Revised: 8/2022