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    NDC 50090-7001-01 Labetalol Hydrochloride 200 mg/1 Details

    Labetalol Hydrochloride 200 mg/1

    Labetalol Hydrochloride is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by A-S Medication Solutions. The primary component is LABETALOL.

    Product Information

    NDC 50090-7001
    Product ID 50090-7001_e412cffb-19ca-49a1-8562-564d7f1fe1b8
    Associated GPIs
    GCN Sequence Number 005099
    GCN Sequence Number Description labetalol HCl TABLET 200 MG ORAL
    HIC3 J7A
    HIC3 Description ALPHA/BETA-ADRENERGIC BLOCKING AGENTS
    GCN 10341
    HICL Sequence Number 002095
    HICL Sequence Number Description LABETALOL HCL
    Brand/Generic Generic
    Proprietary Name Labetalol Hydrochloride
    Proprietary Name Suffix n/a
    Non-Proprietary Name Labetalol Hydrochloride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 200
    Active Ingredient Units mg/1
    Substance Name LABETALOL
    Labeler Name A-S Medication Solutions
    Pharmaceutical Class Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA075215
    Listing Certified Through 2025-12-31

    Package

    NDC 50090-7001-01 (50090700101)

    NDC Package Code 50090-7001-1
    Billing NDC 50090700101
    Package 90 TABLET, FILM COATED in 1 BOTTLE (50090-7001-1)
    Marketing Start Date 2023-12-28
    NDC Exclude Flag N
    Pricing Information N/A