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    NDC 70436-0096-01 lurasidone hydrochloride 80 mg/1 Details

    lurasidone hydrochloride 80 mg/1

    lurasidone hydrochloride is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Slate Run Pharmaceuticals, LLC. The primary component is LURASIDONE HYDROCHLORIDE.

    Product Information

    NDC 70436-0096
    Product ID 70436-096_7e79d402-c6b9-4d74-b4f8-7d98cc2fd577
    Associated GPIs
    GCN Sequence Number 066933
    GCN Sequence Number Description lurasidone HCl TABLET 80 MG ORAL
    HIC3 H7T
    HIC3 Description ANTIPSYCHOTIC,ATYPICAL,DOPAMINE,SEROTONIN ANTAGNST
    GCN 29367
    HICL Sequence Number 037321
    HICL Sequence Number Description LURASIDONE HCL
    Brand/Generic Generic
    Proprietary Name lurasidone hydrochloride
    Proprietary Name Suffix n/a
    Non-Proprietary Name lurasidone hydrochloride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 80
    Active Ingredient Units mg/1
    Substance Name LURASIDONE HYDROCHLORIDE
    Labeler Name Slate Run Pharmaceuticals, LLC
    Pharmaceutical Class Atypical Antipsychotic [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA212091
    Listing Certified Through 2024-12-31

    Package

    NDC 70436-0096-01 (70436009601)

    NDC Package Code 70436-096-01
    Billing NDC 70436009601
    Package 100 TABLET, FILM COATED in 1 BOTTLE (70436-096-01)
    Marketing Start Date 2023-02-20
    NDC Exclude Flag N
    Pricing Information N/A