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    NDC 68382-0800-05 Labetalol Hydrochloride 300 mg/1 Details

    Labetalol Hydrochloride 300 mg/1

    Labetalol Hydrochloride is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Zydus Pharmaceuticals USA Inc.. The primary component is LABETALOL HYDROCHLORIDE.

    Product Information

    NDC 68382-0800
    Product ID 68382-800_f4b4d2f0-55ad-4eda-a128-5f0c21dbe86b
    Associated GPIs 33300010100315
    GCN Sequence Number 005100
    GCN Sequence Number Description labetalol HCl TABLET 300 MG ORAL
    HIC3 J7A
    HIC3 Description ALPHA/BETA-ADRENERGIC BLOCKING AGENTS
    GCN 10340
    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 300
    Active Ingredient Units mg/1
    Substance Name LABETALOL HYDROCHLORIDE
    Labeler Name Zydus Pharmaceuticals USA Inc.
    Pharmaceutical Class Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA207743
    Listing Certified Through 2024-12-31

    Package

    NDC 68382-0800-05 (68382080005)

    NDC Package Code 68382-800-05
    Billing NDC 68382080005
    Package 500 TABLET, FILM COATED in 1 BOTTLE (68382-800-05)
    Marketing Start Date 2017-12-05
    NDC Exclude Flag N
    Pricing Information
    Price Per Unit 0.19692
    Pricing Unit EA
    Effective Date 2022-11-23
    NDC Description LABETALOL HCL 300 MG TABLET
    Pharmacy Type Indicator C/I
    OTC N
    Explanation Code 1
    Classification for Rate Setting G
    As of Date 2022-11-23
    This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

    Standard Product Labeling (SPL)/Prescribing Information SPL 5942a5a8-c3c1-4ecb-921e-9bc92393bdf8 Details

    Revised: 10/2022